Bactrim and Pregnancy

In studies on Bactrim and pregnancy, the drug increased the risk of cleft palate when it was given to pregnant animals. If Bactrim is taken late in pregnancy, it may also increase the risk of jaundice and kernicterus in a newborn. If you are taking Bactrim and pregnancy occurs, your healthcare provider will weigh the benefits and potential risks before making a recommendation.

Is Bactrim Safe During Pregnancy?

Bactrim® (sulfamethoxazole/trimethoprim) is a prescription antibiotic. At this time, it is not clear if Bactrim is safe for use during pregnancy. The manufacturer states that pregnant women should not take Bactrim, except in rare situations when the potential benefits outweigh the risks to the fetus.
 

What Is Pregnancy Category D?

The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
 
In animal studies, Bactrim increased the risk of cleft palate. Also, trimethoprim (one of the components of Bactrim) increased the risk of fetal death in rats. In humans, studies suggest that Bactrim may increase the risk of certain birth defects (like neural tube defects, heart problems, urinary tract defects, cleft palate, and club foot). 
 
It is thought that the drug might contribute to birth defects by decreasing folic acid; if it is necessary for a pregnant woman to take Bactrim, a folic acid supplement at a higher-than-normal dose for a pregnant woman might be helpful.
 
Of possibly greater concern, Bactrim might increase the risk of jaundice and, theoretically, kernicterus (brain damage caused by severe jaundice) in the newborn, especially if a pregnant woman takes Bactrim late in pregnancy.
 
A pregnancy Category D medicine may be given to a pregnant woman if a healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child. If other, more suitable antibiotics are available (and are likely to be effective for treating a particular infection), Bactrim should be avoided. However, if the drug appears to be necessary to treat an infection, the benefits may outweigh the potential risks.
 
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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