NIOSH 2016 supplemental information / FDA Pregnancy Categorymalignant tumors observed in male and female mice and rats; genotoxic in in vivo micronucleus test FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
abiraterone (Yonsa, Zytiga) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryWomen who are pregnant or may be pregnant should not handle without protection (e.g., gloves) FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning on adverse reproductive effects FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryConjugated monoclonal antibody FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategorySpecial warnings on contraception for females while taking and 2 weeks post-treatment FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryIncreased frequency of malignancies observed in treated patients FDA Pregancy Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
ambrisentan (Letairis) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning on adverse reproductive effects; reduced sperm counts in patients FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy Categorygenotoxic in several in vitro assays FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryTeratogenic, embryotoxic and fetotoxic in mice at exposures lower than human exposures FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
azaCITIDine (Vidaza) IV/SQ
Highest
N/A
1A↑
Yes
IARC‑2A↑NTP‑2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
azaTHIOprine (Imuran) PO
Highest
N/A
1A↑
Yes
IARC‑1↑NTP‑1↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryMay cause teratogenicity and/or embryo-fetal lethality because it is a genotoxic drug and targets actively dividing cells FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
bendamustine (Bendeka, Treanda) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
blinatumomab (Blincyto) IV
Medium
N/A
2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
bosentan (Tracleer) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning on adverse reproductive effects FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryConjugated monoclonal antibody FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
busulfan (Busulfex, Myleran) PO/IV
Highest
N/A
1A↑
Yes
IARC‑1↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
cabergoline (Cabaser, Dostinex) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryInhibition of conception and embryo fetal effects at doses below recommended human dose FDA Pregancy Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryEmbryolethal in rats at exposures below the recommended human dose FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryMetabolized to 5-fluorouracil FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for aplastic anemia; congenital malformations in offspring of mothers who took drug; rapid transplacental passage FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
carfilzomib (Kyprolis) IV
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategorySpecial warnings on contraception while taking and 2 weeks post- treatment FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
carmustine (BiCNU) IV
Highest
N/A
1A↑
Yes
IARC‑2A↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
chloramphenicol (Chloromycetin) IV
Highest
N/A
1A↑
No
IARC‑2A↑NTP‑2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
CISplatin (Platinol) IV
Highest
N/A
1A↑
Yes
IARC‑2A↑NTP‑2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
cladribine (Mavenclad) PO
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
cladribine (Mylinax) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
clofarabine (Clolar) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryIncreased risk of congenital abnormalities when taken in first trimester FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
cobimetinib (Cotellic) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy Categorypublished animal reproduction and development studies indicate it causes embryofetal toxicity, teratogenicity, and altered postnatal development at exposures within or above the clinical therapeutic range FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
cyclophosphamide (Cytoxan) IV
Highest
N/A
1A↑
Yes
IARC‑1↑NTP‑1↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
cycloSPORINE (SandIMMUNE, Gengraf, Neoral) IV
Highest
N/A
1A↑
No
IARC‑1↑NTP‑1↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
cytarabine (Cytosar, DepoCyt) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategorySpecial warnings on contraception for females while taking and 2 weeks post-treatment FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
dacarbazine (DTIC-Dome) IV
Highest
N/A
1A↑
Yes
IARC‑2B↑NTP‑2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
dasatinib (Sprycel) PO
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
DAUNOrubicin (Cerubidine, DaunoXome) IV
Highest
N/A
1A↑
Yes
IARC‑2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryAKA daunomycin FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
deferiprone (Ferriprox) PO
Medium
N/A
2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryGenotoxic in vitro and in vivo FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
degarelix (Firmagon) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy Categorysecondary malignancies observed in patients treated long term with Razoxane (a racemic mixture containing dexrazoxane); genotoxic in vitro and in vivo; in laboratory studies, testicular atrophy observed at or below the human dose FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryHazardous only for women in late pregnancy FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for teratogenicity; tumors seen in laboratory studies at doses below MRHD FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryTeratogenic in laboratory studies at ½ MRHD FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryWomen warned not to handle FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
enzalutamide (Xtandi) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryEmbryo-fetal toxicity in mice at exposures that were lower than in patients receiving the recommended dose FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
epiRUBicin (Ellence) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
eriBULin (Halaven) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryFetal malformations, fetal growth retardation, embryolethality, and reduced body weights observed in animal studies; excreted in human breast milk FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for malignant neoplasms; increased risk of endometrial cancer, breast cancer, and ovarian cancer; in laboratory studies, increased frequency of carcinomas of the breast, uterus, cervi,X vagina, testis, and liver; present in breast milk FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
estradiol (Depot-Estradiol) IM
Medium
N/A
2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for malignant neoplasms; increased risk of endometrial cancer, breast cancer, and ovarian cancer; in laboratory studies, increased frequency of carcinomas of the breast, uterus, cervi,X vagina, testis, and liver; present in breast milk FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for malignant neoplasms; increased risk of endometrial cancer, breast cancer, and ovarian cancer; in laboratory studies, increased frequency of carcinomas of the breast, uterus, cervi,X vagina, testis, and liver; present in breast milk FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for malignant neoplasms; increased risk of endometrial cancer, breast cancer, and ovarian cancer; in laboratory studies, increased frequency of carcinomas of the breast, uterus, cervi,X vagina, testis, and liver; present in breast milk FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
estrogens, conjugated (Cenestin, Enjuvia, Premarin) PO
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for endometrial cancer and cardiovascular risks; long-term use in women and laboratory studies increases frequency of several cancers FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for endometrial cancer and cardiovascular risks; long-term use in women and laboratory studies increases frequency of several cancers FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for endometrial cancer and cardiovascular risks FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
estrogens, esterified / methylTESTOSTERone (Estratest HS) PO
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for endometrial cancer and cardiovascular risks FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
estropipate (Harmogen, Improvera, Ogen, Ortho-Est, Sulestrex) PO
Medium
N/A
2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for endometrial carcinoma in postmenopausal women and use during pregnancy FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
etoposide (Toposar, Vepesid) PO
Highest
N/A
1A↑
Yes
IARC‑1↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
etoposide (Toposar, Vepesid) IV
Highest
N/A
1A↑
Yes
IARC‑1↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
exenatide (Byetta) SQ
Medium
N/A
2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
F
generic (Brand) Route
Relative Risk Level
AOR link
NIOSH 2024 Table
MSHI?↑
Warnings
fam-trastuzumab deruxtecan (Enhertu) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryWomen should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant, due to potential risk to a male fetus FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
fingolimod (Gilenya) PO
Medium
N/A
2↑
NIOSH 2016 supplemental information / FDA Pregnancy Categoryin laboratory studies, increased malformations and embryo fetal deaths at less than the recommended human dose; malignant lymphomas observed in male and female mice FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy Categorycase reports describe congenital anomalies in infants exposed in utero to maternal fluconazole (400-800 mg/ day) during most or all of the first trimester, similar to those seen in animal studies FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy Categorycase reports describe congenital anomalies in infants exposed in utero to maternal fluconazole (400-800 mg/ day) during most or all of the first trimester, similar to those seen in animal studies FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
fluorouracil (Adrucil) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
fluoxymesterone (Androxy) PO
Medium
N/A
2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryTumors in mice and rats and possibly humans FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
flutamide (Eulexin) PO
Medium
N/A
2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryIndicated only for men FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryMetabolized to phenytoin FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
ganirelix (Orgalutran) SQ
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
gemcitabine (Gemzar, Infugem) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
gemtuzumab ozogamicin (Mylotarg) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryDefects of forelimbs and central nervous system and alterations in sex ratio have been reported in laboratory studies FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
goserelin (Zoladex) SQ
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryCan cause fetal harm when administered to a pregnant patient, with the possibility of spontaneous abortion FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategorySpecial warning on handling bottles and capsules FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
I
generic (Brand) Route
Relative Risk Level
AOR link
NIOSH 2024 Table
MSHI?↑
Warnings
icatibant (Firazyr) SQ
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy Categoryin laboratory studies, premature birth and abortion rates increased at a dose that was less than 1/40th the MRHD, and delayed parturition and fetal death occurred at 0.5 and 2-fold, respectively, the MRHD FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
imatinib (Gleevec) PO
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
irinotecan (Camptosar, Onivyde) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
ISOtretinoin (Accutane) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
ixabepilone (Ixempra) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
ixazomib (Ninlaro) PO
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryMale and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryTeratogenic in laboratory studies at 1/10 human dose (HD); marked postnatal survival at 1/100 HD;severe liver injury reported in patients; carcinogenicity observed at doses below HD FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
lenalidomide (Revlimid) PO
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryAnalog of thalidomide;FDA Black Box warnings for limb abnormalities; in laboratory studies, caused thalidomide-type limb defects in monkey offspring FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
lenvatinib (Lenvima) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
lomitapide (Juxtapid) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
lomustine (Gleostine, CeeNU) PO
Highest
N/A
1A↑
Yes
IARC‑2A↑NTP‑2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
loncastuximab tesirine (Zynlonta) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for embryofetal toxicity; special warnings on contraception for females while taking and 1 month post-treatment FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryNursing should be discontinued if megestrol is required; women at risk of pregnancy should avoid exposure FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
melphalan flufenamide (Pepaxto) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryAppears in human breast milk FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
methylTESTOSTERone (Android, Methitest, Testred) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryWhen given to pregnant women, results in termination of pregnancy FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
miltefosine (Impavido) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning on hepatotoxicity FDA Pregancy Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women;
mirvetuximab soravtansine (Elahere) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
mitoMYcin (Mutamycin) IV
Highest
N/A
1A↑
Yes
IARC‑2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
mitoXANTRONE (Novantrone) IV
Highest
N/A
1A↑
Yes
IARC‑2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for embryo fetal toxicity, malignancies, and serious ifections; increased risk of first-trimester pregnancy loss and increased risk of congenital malformations; Special warning: Tablets should not be crushed and capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in capsules and oral suspension (before or after constitution). If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for embryo fetal toxicity, malignancies, and serious ifections; increased risk of first-trimester pregnancy loss and increased risk of congenital malformations; Special warning: Tablets should not be crushed and capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in capsules and oral suspension (before or after constitution). If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for embryo fetal toxicity, malignancies, and serious ifections; increased risk of first-trimester pregnancy loss and increased risk of congenital malformations; Special warning: Tablets should not be crushed and capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in capsules and oral suspension (before or after constitution). If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for first trimester pregnancy loss and an increased risk of congenital malformations; Black Box warning for lymphomas and other malignancies; genotoxic in vitro and in vivo FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryNote: Given only as nasal spray; no potential for occupational exposure FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy Categoryin laboratory studies, hepatocellular adenomas and carcinomas at doses lower than human dose FDA Pregancy Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
omacetaxine (Synribo) SQ
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning on increased risk of endometrial cancer in certain populations; risk of adverse outcomes during pregnancy and labor FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryTumors observed in laboratory studies at 1/10 MRHD FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryHazardous only for women in 3rd trimester FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
P
generic (Brand) Route
Relative Risk Level
AOR link
NIOSH 2024 Table
MSHI?↑
Warnings
PACLitaxel (Taxol, Abraxane, Onxol) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy Categorypotential for stimulation of tumor growth FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryEmbryo-fetal toxicities at doses below the recommended human dose FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
panobinostat (Farydak) PO
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategorySpecial warnings on contraception for females while taking and 1 month post-treatment FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryIncreased risk of congenital abnormalities when taken in first trimester; complications in pregnancy when taken in third trimester FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
pasireotide (Signifor) SQ/IM
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryIncreased implantation loss and decreased viable fetuses, corpora lutea, and implantation sites at doses less than the human recommended dose FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
peginesatide (Omontys) IV/SQ
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryAdverse embryo-fetal effects, including reduced fetal weight, increased resorption, embryofetal lethality, and cleft palate, observed in doses below the recommended human dose FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
PEMEtrexed (Alimta) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
pentetate calcium trisodium (Ca-DTPA) IV
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategorySevere teratogenic effects in laboratory studies in dogs; supplied in ampule, which can lead to occupational exposure FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
pentostatin (Nipent) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
pipobroman (Vercite, Vercyte) PO
Medium
N/A
2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryTeratogenic in laboratory studies FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
polatuzumab vedotin (Polivy) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryFemales of reproductive potential must use two forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping treatment FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
PRALAtrexate (Folotyn) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryAbortion and developmental abnormalities seen at low doses in laboratory studies; evidence of tumors at low doses in laboratory studies FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning on severe and sometimes fatal hepatotoxicity; total loss of pregnancy at doses lower than recommended human dose FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryTeratogenic and embryotoxic effects in several laboratory studies; contraindicated in women who are pregnant and in the male partners of women who are pregnant FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
riociguat (Adempas) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryExclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
romiDEPsin (Istodax) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryAKA rapamycin; increased risk of lymphomas and other malignancies; embryotoxic and fetotoxic at 0.2 human dose FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
SORAfenib (NexAVAR) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for tumorogenicity in laboratory studies FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryIncreased risk of lymphomas and other malignancies; reproductive effects seen in laboratory studies below the MRHD; excreted in breast milk FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryIncreased risk of congenital malformations associated with treatment during the first trimester of pregnancy FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
temsirolimus (Torisel) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
teniposide (Vumon) IV
Highest
N/A
1A↑
Yes
IARC‑2A↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning on severe hepatotoxicity and teratogenicity, including major birth defects FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
testosterone (Androderm, AndroGel, Aveed, Fortesta, Testim, Vogelxo) TOP
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryChildren should avoid contact with unwashed or unclothed application sites on skin FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryChildren should avoid contact with unwashed or unclothed application sites on skin FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
thiotepa (Tepadina) IV
Highest
N/A
1A↑
Yes
IARC‑1↑NTP‑1↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
tisotumab-vedotin (Tivdak) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for lymphoma and other malignancies FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
toremifene (Fareston) PO
Low
N/A
2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryEmbryotoxic and abortifacient at doses less than recommended human dose FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for severe birth defects; Special FDA distribution system FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
trifluridine/tipiracil (combination only) (Lonsurf) PO
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryEmbryo-fetal lethality and embryo-fetal toxicity at doses lower than or similar to exposures at the recommended human dose FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits;
uracil mustard (Uramustine) NA
Highest
N/A
1A↑
Yes
IARC‑2B↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for teratogenicity; congenital malformations, including neural tube defects; teratogenic in multiple species FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning for teratogenicity; congenital malformations, including neural tube defects; teratogenic in multiple species FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
valrubicin (Valstar) PO
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryMalformations seen in laboratory studies below the MRHD FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
vinBLAStine (Velban, Alkaban) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
vinCRIStine (Oncovin) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
vinORELBine (Navelbine) IV
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryBlack Box warning on embryo-fetal death or severe birth defects; recommend effective contraception for females during therapy and for 7 months after treatment; present in semen; no sperm donation during and 3 months post treatment FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
vorinostat (Zolinza) PO
High
N/A
1↑
Yes
NIOSH 2016 supplemental information / FDA Pregnancy CategoryAdverse embryo-fetal effects at less than the recommended human dose FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
zidovudine (Retrovir, Combivir (AZT)) PO
Medium
N/A
2↑
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryDevelopmental toxicity, including possible teratogenic effects at doses similar to human therapeutic doses; an increase in the number of pups born dead and a decrease in postnatal survival at less than MRHD FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryDevelopmental toxicity, including possible teratogenic effects at doses similar to human therapeutic doses; an increase in the number of pups born dead and a decrease in postnatal survival at less than MRHD FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryEmbryotoxic and teratogenic in rabbits at exposure levels lower than human exposures at the recommended dose, with increased incidences of external, visceral, and skeletal fetal malformations FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryNumber of stillbirths increased and survival of neonates decreased in laboratory studies at low doses FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH 2016 supplemental information / FDA Pregnancy CategoryN/A FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
NIOSH [2024]. NIOSH list of hazardous drugs in healthcare settings, 2024. By Ovesen JL, Sammons D, Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP, Whittaker C. Cincinnati, OH: U.S. Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2025-103 (Supersedes 2016-161), https://doi.org/10.26616/NIOSHPUB2025103.
NIOSH [2023]. Managing hazardous drug exposures: information for healthcare settings. By Hodson L, Ovesen J, Couch J, Hirst D, Lawson C, Lentz TJ, MacKenzie B, Mead K. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2023-130, https://doi.org/10.26616/NIOSHPUB2023130.
NIOSH [2016]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP. Cincinnati, OH: U.S. Department ofHealth and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014-138), , https://doi.org/10.26616/NIOSHPUB2016161.
World Health Organization. (n.d.). List of classifications. World Health Organization. https://monographs.iarc.who.int/list-of-classifications
U.S. Department of Health and Human Services. Completed roc evaluations. National Institute of Environmental Health Sciences. https://ntp.niehs.nih.gov/research/assessments/cancer/completed/roc
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