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estropipate

estropipate
  • Restricted Medications Non-Formulary / Not-stocked
Drug Name Form Strength Non-Formulary Restricted TX Sub Notes
Harmogen      
Improvera      
Ogen      
Ortho-Est      
Sulestrex      
Display Estrogens Class : 681604
Medication comments:
Per policy, these hazardous drugs have special waste requirements. 
Generic (Brand) Waste Requirements
estropipate (Harmogen, Improvera, Ogen, Ortho-Est, Sulestrex) Hazardous Waste ⇒  BLACK BUCKET 
USP <800> Hazardous Drugs 
Per Policy, these drugs have special handling requirements (any drug with an "AOR" is exempt from these requirements under normal circumstances).
generic (Brand) Route Relative Risk Level AOR? NIOSH 2024 Table MSHI?↑ Warnings
 estropipate (Harmogen, Improvera, Ogen, Ortho-Est, Sulestrex) PO Medium N/A 2↑    
NIOSH Supplemental information (2016): Black 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;
2023 American Geriatrics Society Beers Criteria® for potentially inappropriate medication use in older adults.
Medication: estropipate (Ogen, Ortho-Est)
Criteria 1: Potentially inappropriate medication use in older adults. (Table 2)
Drug(s) estrogens with or without progestins (includes natural and synthetic estrogen preparations)
Rationale Evidence of carcinogenic potential (breast and endometrium); lack of cardioprotective effect and cognitive protection in older women.
For women who start HRT at age 60 and older, the risks of HRT are greater than the benefits, as HRT is linked to a higher risk of heart disease, stroke, blood clots, and dementia.
Evidence indicates that vaginal estrogens for the treatment of vaginal dryness are safe and effective; women with a history of breast cancer who do not respond to nonhormonal therapies are advised to discuss the risks and benefits of low-dose vaginal estrogen (e.g., dosages of estradiol <25 mcg twice weekly) with their healthcare provider.
Recommendation Do not initiate systemic estrogen (e.g., oral tablets or transdermal patches). Consider deprescribing among older women already using this medication.
Vaginal cream or vaginal tablets: acceptable to use low-dose intravaginal estrogen for the management of dyspareunia, recurrent lower urinary tract infections, and other vaginal symptoms.
 Quality of evidence: Oral and patch: high
Vaginal cream or vaginal tablets: moderate, Strength of Recommendation: Oral and patch: strong
Topical vaginal cream or tablets: weak
 
Criteria 2: Potentially inappropriate medication use in older adults due to drug–disease or drug–syndrome interactions that may exacerbate the disease or syndrome. (Table 3)
Drug(s) ⇆ disease or syndrome estrogen, oral and transdermal (excludes intravaginal estrogen) ⇄ Urinary incontinence (all types) in women
Rationale Lack of efficacy.
Recommendation Avoid in women. See also recommendation on estrogen (Table 2)
 Quality of evidence: High, Strength of Recommendation: Strong
Last updated: Nov. 3, 2025
  • Hazard.Drug Handling(USP 800) USP<800> Hazardous Drug
  • Hazardous Waste BLACK BUCKET
UpToDate Lexidrug

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