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Oxycodone/APAP and Pregnancy

In studies involving the individual components of oxycodone/APAP and pregnancy, the oxycodone component (a narcotic) increased the risk of withdrawal symptoms in the infant after delivery. Some of these withdrawal symptoms may include vomiting, tremors, and fast breathing. The APAP component is considered fairly safe for pregnant women. If you are taking oxycodone/APAP and pregnancy occurs, talk to your healthcare provider.

Oxycodone/APAP During Pregnancy: An Overview

Oxycodone/APAP (Endocet®, Magnacet™, Percocet®, Roxicet™, Tylox®) is a prescription pain medication. Based on animal studies and limited data from human studies, the drug may not be safe for use during pregnancy. Pregnant women should take oxycodone/APAP only if the potential benefits for pain control outweigh the possible risks to the fetus.

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 do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Although oxycodone/APAP has not been studied in pregnant humans or animals, the individual components (oxycodone and acetaminophen) have been. When given to pregnant animals, oxycodone did not seem to increase the risk of birth defects or other problems. Limited human studies also suggest that oxycodone does not seem to cause birth defects in humans. However, oxycodone is a narcotic, and using this drug during the end of a pregnancy may cause narcotic withdrawal in the infant after delivery. Such withdrawal symptoms may include:
  • Hyperactive reflexes
  • Fast breathing
  • Increased stools
  • Irritability and excessive crying
  • Shakiness (tremors)
  • Sneezing
  • Yawning
  • Vomiting
  • Fever.
The acetaminophen component of oxycodone/APAP is considered fairly safe for use during pregnancy (see Tylenol and Pregnancy).
Despite the apparent risks, pregnancy Category C medicines, including oxycodone/APAP, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
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Oxycodone APAP Drug Information

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