Skin Home > Xolegel and Pregnancy

During animal studies, giving high doses of the active ingredient in Xolegel (ketoconazole gel) orally to pregnant rats appeared to increase the risk for birth defects. Due to these potential risks, Xolegel is classified as a pregnancy Category C medication. However, because this medicine is applied on the skin rather than swallowed, only a small amount of the drug is expected to reach the bloodstream.

Can Pregnant Women Use Xolegel?

Xolegel® (ketoconazole gel) is a prescription skin medication used to treat seborrhea. Based on information currently available, it is unclear whether the drug is safe for use during pregnancy. As with most medications, it should be used only if necessary, at the lowest effective dose, and for the shortest possible time as necessary during pregnancy.

What Is 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. Xolegel is classified as a pregnancy Category C medication.
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but do appear to cause fetal harm in animal studies. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Studies in rats have shown that when ketoconazole (the active ingredient) is taken by mouth, it might cause birth defects, especially when used at high doses (doses that were high enough to be toxic to the mother rats). However, very little ketoconazole is absorbed through the skin into the bloodstream with normal Xolegel use.
However, because Xolegel has not been studied in any pregnant women, the possibility of problems cannot be completely ruled out. Humans do not always respond to medications in the same way as laboratory animals, and unpredicted problems might occur.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
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