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Tapentadol Pregnancy and Breastfeeding Warnings

Tapentadol is also known as: Nucynta, Nucynta ER

Medically reviewed on December 12, 2017

Tapentadol Pregnancy Warnings

Animal studies revealed embryo fetal toxicity including reduced fetal viability, skeletal delays, and multiple malformations, which may have occurred secondary to maternal toxicity. Opioids cross the placenta and may produce respiratory depression and psychophysiologic effects in neonates. There are no controlled data in human pregnancy.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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: C

-This drug is not for use in women during and immediately prior to labor.
-Neonates whose mothers have been taking this drug should be monitored for respiratory depression.

See references

Tapentadol Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: Withdrawal symptoms can occur in breast-feeding infants when maternal administration of this drug is stopped.

Animal studies during lactation, at doses lower than those associated with maternal toxicity, resulted in increased postnatal pup mortality.

See references

References for pregnancy information

  1. "Product Information. Nucynta (tapentadol)." PriCara Pharmaceuticals, Raritan, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Nucynta (tapentadol)." PriCara Pharmaceuticals, Raritan, NJ.

Further information

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