Hydrocodone/APAP and Pregnancy

In animal studies on hydrocodone/APAP and pregnancy, the hydrocodone component (a narcotic) increased the risk of cranial-related birth defects in hamsters. Limited research in humans indicates that the same types of problems could occur. The APAP component, which is another name for Tylenol, does not present any problems. If you are taking hydrocodone/APAP and pregnancy occurs, talk to your healthcare provider.

 

Can I Take Hydrocodone/APAP During Pregnancy?

Hydrocodone/APAP (hydrocodone and acetaminophen) is a prescription pain medication. It contains two different medications: hydrocodone bitartrate (a narcotic) and acetaminophen (Tylenol®, also known as APAP). Based on animal and limited human studies, the drug may not be safe for use during pregnancy.
 

Hydrocodone/APAP and 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. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
The acetaminophen component of hydrocodone/APAP is usually considered safe for pregnant women (see Tylenol and Pregnancy). However, the hydrocodone component may not be safe. When given to pregnant hamsters, a single dose of hydrocodone increased the risk of birth defects, including cranial defects. Limited human studies also indicate that hydrocodone may increase the risk of similar birth defects in humans. Hydrocodone 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
  • Sneezing
  • Irritability and excessive crying
  • Shakiness (tremors)
  • Yawning
  • Vomiting
  • Fever.
     
However, pregnancy Category C medicines, including hydrocodone/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.
 
(Hydrocodone/APAP and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;