Can I take tramadol while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4) ] . Available data with tramadol hydrochloride tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1.4, 0.6, and 3.6 times the maximum recommended human daily dosage (MRHD). Tramadol decreased pup body weight and increased pup mortality at 1.2 and 1.9 times the MRHD [see Data] . Based on animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Tramadol Hydrochloride (oral), Coupler LLC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

The excretion of tramadol into milk is low and even lower amounts of the active metabolite, O-desmethyltramadol, are excreted. With usual maternal dosage, the amount excreted into breastmilk is much less than the dose that has been given to newborn infants for analgesia and is unlikely to adversely affect nursing infants.[1] Maternal use of oral opioids during breastfeeding can cause infant drowsiness, which may progress to rare but severe central nervous system depression. Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics. The US Food and Drug Administration and the manufacturer recommend against the use of tramadol during breastfeeding.[2] If the mother of a newborn requires tramadol, it is not a reason to discontinue breastfeeding; however, once the mother's milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of oral tramadol to 2 to 3 days at a low dosage with close infant monitoring. If tramadol is used, monitor infants for increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties or limpness, and contact a physician immediately if any of these occur. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped.

“Summary of Use during Lactation”, LactMed record “Tramadol” (LM391), quoted verbatim. Everything LactMed reports about Tramadol while breastfeeding.

8.2 Lactation Risk Summary Tramadol hydrochloride tablets are 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. Tramadol and its metabolite, O -desmethyltramadol (M1), are present in human milk. There is no information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. The M1 metabolite is more potent than tramadol in mu opioid receptor binding [see Clinical Pharmacology (12) ] . Published studies have reported tramadol and M1 in colostrum with administration of tramadol to nursing mothers in the early post-partum period. Women who are ultra-rapid metabolizers of tramadol may have higher than expected serum levels of M1, potentially leading to higher levels of M1 in breast milk that can be dangerous in their breastfed infants. In women with normal tramadol metabolism, the amount of tramadol secreted into human milk is low and dose-dependent.

Prescribing label, section “8.2 Lactation” (opening excerpt): Tramadol Hydrochloride (oral), Coupler LLC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.