Sign Out
Category C.
Use in pregnancy: Although there are no adequate and controlled studies to date in humans, tramadol hydrochloride has been shown to be embryotoxic and fetotoxic in mice, rats, and rabbits at maternally toxic doses. Safe use of tramadol hydrochloride in pregnancy has not been established. Tramadol hydrochloride should be used during pregnancy only if the potential benefits justify the possible risks to the fetus. Tramadol hydrochloride also should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks.
Use in nursing mother: Tramadol hydrochloride is distributed into milk. Because the safety of tramadol hydrochloride in infants and neonates has not been evaluated, the drug is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing women.
