REMS FDA Documents (opioids)

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acetaminophen-traMADol

acetaminophen-traMADol
Brand names: Ultracet
No brands, forms, or strengths have been added for this generic.
Display Opioid Agonists, Analgesics and Antipyretics, Miscellaneous Class: 280808, 280892
Medication comments:

Per policy, orders for these non-formulary agents will be changed to formulary equivalents.
Non-Formulary Agent Formulary Equivalent
traMADol-acetaminophen (Ultracet) 37.5-325 mg traMADol 50 mg (Ultram)
plus acetaminophen (Tylenol) 325 mg
2023 American Geriatrics Society Beers Criteria® for potentially inappropriate medication use in older adults.
Medication: acetaminophen-traMADol (Ultracet)
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 opioids ⇄ Delirium
Rationale Avoid in older adults with or at high risk of delirium because of the potential of inducing or worsening delirium.
Opioids: emerging data highlights an association between opioid administration and delirium. For older adults with pain, use a balanced approach, including the use of validated pain assessment tools and multimodal strategies that include nondrug approaches to minimize opioid use.
Recommendation Avoid, except in situations listed under the rationale statement.
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
Drug(s) ⇆ disease or syndrome opioids ⇄ History of falls or fractures
Rationale May cause ataxia, impaired psychomotor function, syncope, or additional falls
If one of the drugs must be used, consider reducing the use of other CNS-active medications that increase the risk of falls and fractures. (i.e., anticholinergics, selected antidepressants, antiepileptics, antipsychotics, sedative/hypnotics including benzodiazepines and, Nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids) and implement other strategies to reduce fall risk.
Recommendation Avoid except for pain management in the setting if severe acute pain.
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
Criteria 4: Potentially clinically important drug-drug interactions that should be avoided in older adults. (Table 5)
Interacting drug(s) or class(es) opioids ⇄ benzodiazepines
Risk Rationale Increased risk of overdose and adverse events.
Recommendation Avoid
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
Interacting drug(s) or class(es) opioids ⇄ CNS-active agents
Risk Rationale Increased risk of falls and of fracture with the concurrent use of ≥3 CNS-active agents (antiepileptics including gabapentinoids, antidepressants, antipsychotics, benzodiazepines, Nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids, and skeletal muscle relaxants).
Recommendation Avoid concurrent use of ≥3 CNS-active drugs Click for list; minimize the number of CNS-active drugs.
 Quality of evidence: High, Strength of Recommendation: Strong
 
Interacting drug(s) or class(es) opioids ⇄ gabapentin, pregabalin
Risk Rationale Increased risk of severe sedation-related adverse events, including respiratory depression and death.
Recommendation Avoid; exceptions are when transitioning from opioid therapy to gabapentin or pregabalin, or when using gabapentinoids to reduce opioid dose, although caution should be used in all circumstances.
 Quality of evidence: Moderate, Strength of Recommendation: Strong
Pediatric Pharmacy Association 2025 KIDs List of Key Potentially Inappropriate Drugs in Pediatrics 
Medication: acetaminophen-traMADol (Ultracet)
Key Potentially Inappropriate Drugs in Pediatrics (KIDs) List: Second Edition (Table 1)
Drug opioids
Risk/Rationale Respiratory failure, death
Recommendation Avoid in younger than 12 yr
Avoid in 12-18 yr of age after surgery to remove tonsils and/or adenoids
Caution in 12-18 yr of age
Recommend pharmacogenetic testing
 Quality of evidence: Low, Strength of Recommendation: Weak
Last updated: Sep. 24, 2025
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