Tapentadol Pregnancy and Breastfeeding Warnings

Brand names: Nucynta, Nucynta ER

Medically reviewed by Drugs.com. Last updated on Jan 16, 2024.

Tapentadol Pregnancy Warnings

Animal studies have revealed evidence of embryofetal toxicity, including mortality, reduced fetal viability, skeletal delays, and multiple malformations, when this drug was administered during organogenesis at doses equivalent to or less than the maximum recommended human dose. Embryofetal toxicity may have been secondary to significant maternal toxicity observed in some animals. There are no controlled data in human pregnancy.

Opioid analgesics cross the placenta in humans. Prolonged use of opioids during pregnancy for medical or non-medical purposes can result in physical dependence in the neonate and NOWS shortly after birth. The onset, duration, and severity of NOWS may vary based on the product, duration, timing, and amount used by the mother, and the rate of elimination by the newborn. The use of this drug during labor may cause prolonged labor in the mother, and respiratory depression in the newborn infant. Prolonged use of opioids may reduce fertility in males and females of reproductive potential; it is unknown if these effects are reversible.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

According to some authorities: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk Summary: Limited data are available on use of this drug in pregnant women to inform a drug-related risk; based on animal data, this drug may cause fetal harm.

Comments:
-Use of opioid analgesics for an extended period of time during pregnancy co-exposes the fetus and may cause neonatal opioid withdrawal syndrome (NOWS).
-Closely monitor neonates exposed to opioids during pregnancy/labor for signs of excess sedation and respiratory depression; ensure that appropriate treatment is readily available.
-Women should be apprised of the maternal and fetal risks associated with the use of opioids (including this drug) during pregnancy.
-This drug should not be used during and immediately prior to labor when the use of other analgesics or analgesic techniques are more appropriate.

See references

Tapentadol Breastfeeding Warnings

This drug is not recommended unless there are no safer alternatives.

Excreted into human milk: Unknown; however, limited data point to excretion in breast milk.
Excreted in animal milk: Yes

Comments:
-According to some experts, once a breastfeeding mother's milk comes in, it is best to manage pain with a non-narcotic analgesic and limit maternal intake of this drug to a low dose for 2 to 3 days; however, if this drug is required by the mother of a nursing infant, it is not a reason to discontinue breastfeeding.
-Breastfed infants exposed to this drug should be monitored for excess sedation or respiratory depression; newborns are particularly sensitive to the effects of even small doses of narcotic analgesics.
-Withdrawal symptoms can occur in nursing infants if either breastfeeding or maternal administration of this drug is stopped.
-A health care provider should be immediately contacted if an infant shows signs of unusual drowsiness, difficulty breathing/breastfeeding, or limpness.

Animal studies revealed evidence of treatment-related developmental delays in offspring after administration of this drug to lactating rats at doses associated with maternal toxicity, or up to 1.7 times the plasma exposure at the maximum recommended human dose.

Cases of infant exposure to tapentadol in breastmilk have been reported to a manufacturer of this drug. No adverse reactions were noted, but the data in these cases was limited.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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