Zydone and Pregnancy

Women are typically not advised to take Zydone when pregnant, although the drug may be prescribed if the benefits outweigh the risks. In animal studies, Zydone increased the risk of birth defects and may present a similar risk in humans. As a result, the FDA has given Zydone a pregnancy Category C rating.

 

Can I Take Zydone During Pregnancy?

Zydone® (hydrocodone/APAP) is a prescription pain medication. The drug is usually not recommended for pregnant women, although in some cases, the benefits of Zydone for a pregnant woman may outweigh the possible risks to the fetus.
 

Zydone 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 default pregnancy Category C rating.
 
The acetaminophen (Tylenol®) component of Zydone is considered safe for use during pregnancy (see Tylenol and Pregnancy). However, the other component may not be safe. A single dose of hydrocodone (the other component of Zydone) increased the risk of birth defects, including cranial (skull) defects when given to pregnant hamsters. Limited studies also suggest that Zydone may increase the risk of similar birth defects in humans. In addition, 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:
 
  • Shakiness (tremors)
  • Increased stools
  • Sneezing
  • Hyperactive reflexes
  • Irritability and excessive crying
  • Fast breathing
  • Yawning
  • Vomiting
  • Fever.
     
However, pregnancy Category C medicines, including Zydone, 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.
 
(Zydone 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;