Ultracet and Pregnancy

In animal studies on Ultracet (tramadol/acetaminophen) and pregnancy, the tramadol component of the medication caused decreased birth weight and decreased survival of the newborns when it was given to pregnant rats. However, Ultracet is a pregnancy Category C drug, which means that it may be prescribed to a woman during pregnancy under certain circumstances. If you are taking Ultracet and pregnancy occurs, let your healthcare provider know immediately.

 

Using Ultracet During Pregnancy: An Overview

Ultracet® (tramadol/acetaminophen) is a prescription pain medication approved for the short-term treatment of pain. At this time, it is not clear whether Ultracet is safe for use during pregnancy.
 

Ultracet 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 Tylenol® (acetaminophen) component of this medication is usually considered safe for use during pregnancy. However, the tramadol component may not be safe. In animal studies, tramadol did not increase the risk of birth defects or miscarriages. However, when given to pregnant rats, tramadol caused decreased birth weight and decreased survival of the newborn rats.
 
There have been reports of infant seizures, withdrawal symptoms, and stillbirth possibly related to tramadol. In other countries, tramadol has been studied as a medication to relieve pain during labor and delivery. However, it is not recommended for this use (or for treating pain after delivery) in the United States.
 
However, pregnancy Category C medicines, including Ultracet, may be given to a pregnant woman if her healthcare provider believes that the benefits outweigh any possible risks to the unborn child.
 
(Ultracet 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;