Pain Home > Nucynta and Pregnancy

In clinical studies on pregnant animals, Nucynta (tapentadol) increased the risk of problems such as birth defects and delayed formation of the skeleton. However, no studies have been performed on pregnant women, so it is unclear if the same problems would occur. This medication still may be prescribed during pregnancy if the benefits clearly outweigh the risks.

Is Nucynta Safe During Pregnancy?

Nucynta™ (tapentadol) is a narcotic opioid medication that is approved for the treatment of short-term pain. Based on the results of animal studies, there may be some risks associated with the use of Nucynta during pregnancy.

What Is Pregnancy Category C?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but that do appear to cause harm to the fetus in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
During animal studies, some birth defects (such as cleft palate and gastroschisis -- an opening in the abdominal wall that allows an infant's intestines to stick outside of the body) occurred, along with other problems, such as delayed skeletal formation and higher fetal and newborn mortality. It is unknown if these findings will also be seen in humans, since animal studies do not always reflect what will occur in humans.
In addition, Nucynta is a narcotic, and chronic use of the drug during the end of a pregnancy may cause narcotic withdrawal in the infant after delivery. Such withdrawal symptoms can include:
  • Hyperactive reflexes
  • Fast breathing
  • Irritability and excessive crying
  • Shakiness (tremors)
  • Increased stools
  • Sneezing
  • Yawning
  • Vomiting
  • Fever.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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