Tramadol Use During Breastfeeding
Tramadol can be used with caution during breastfeeding, but should be restricted to inpatient settings with close infant monitoring and limited to the lowest effective dose for the shortest duration possible. 1
Regulatory Context and Safety Concerns
The FDA issued a warning in April 2017 against tramadol use while breastfeeding due to case reports of respiratory depression and death in infants. 1 However, the UK Drugs in Lactation Advisory Service (UKDILAS) reviewed this warning and concluded that tramadol can continue to be used with appropriate precautions. 1
The FDA drug label explicitly states that tramadol "is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied." 2 Following a single 100 mg IV dose, only 0.1% of the maternal dose appears in breast milk within 16 hours. 2
Mechanism of Risk
Tramadol and its active metabolite O-desmethyltramadol are both excreted into breast milk. 1 The drug produces analgesic effects through both opioid and non-opioid mechanisms, creating potential for infant sedation and respiratory depression. 3, 4 Research has documented breast milk concentrations ranging from 63 ng/mL to 1,254 ng/mL for tramadol, with corresponding infant exposure calculated between 10-294 μg/kg/day depending on timing and maternal dosing. 5
Clinical Recommendations for Safe Use
If tramadol must be used:
- Restrict use to inpatient settings only where both mother and infant can be monitored. 1
- Limit the total dose to the minimum effective amount. 1
- Monitor the infant closely for increased sleepiness, signs of respiratory depression, sedation, decreased alertness, and feeding difficulties. 1
- Observe the mother for excessive opioid effects, as maternal toxicity may predict infant risk. 1
Safer Alternative Options
Preferred analgesics for breastfeeding women include:
- NSAIDs (ketorolac, ibuprofen, diclofenac): These transfer minimally into breast milk and carry no risk of infant respiratory depression. 1, 6
- Paracetamol (acetaminophen): Infant exposure via breast milk is significantly less than pediatric therapeutic doses. 1, 7
- Morphine: Recommended as the opioid of choice if strong analgesia is required, with better-established safety data than tramadol. 1
- Dihydrocodeine: May be preferred over tramadol for moderate pain due to cleaner metabolism. 1
Critical Pitfalls to Avoid
- Do not prescribe tramadol for outpatient use in breastfeeding women without close monitoring capabilities. 1
- Do not assume safety based on low milk transfer percentages alone - case reports of severe adverse events exist despite relatively low drug concentrations. 1
- Do not overlook maternal side effects as a warning sign - excessive maternal sedation or respiratory depression may indicate the infant is also at risk. 1
- Avoid prolonged use - opioid therapy in breastfeeding should be limited to 2-3 days in unsupervised settings. 8
Special Considerations
Individual pharmacokinetic variability exists for tramadol metabolism (similar to codeine's CYP2D6 polymorphism), potentially causing drug accumulation in some infants even with small estimated doses through milk. 8 This unpredictability strengthens the case for preferring non-opioid alternatives whenever clinically feasible. 8