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Because it could potentially harm the fetus, Androderm (testosterone patch) is considered a pregnancy Category X medicine. This means that it should not be used by a pregnant woman. Androderm is not approved for use in women and could cause problems like masculinization of the female genitals of an unborn baby. The potential risks of using this medicine while expecting clearly outweigh any potential benefits.

Can Pregnant Women Use Androderm?

Androderm® (testosterone patch) is a prescription hormone medication used to treat low testosterone levels in men. It is not approved for use in women, and may harm an unborn baby if taken by a pregnant woman.

What Is Pregnancy Category X?

Androderm is classified as a pregnancy Category X medicine. 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 X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
Because it would be unethical to give Androderm to pregnant women, the use of this drug in pregnant women has never been studied in a clinical trial. However, we know about the problems Androderm might cause based on studies in animals, as well as reports of women who received testosterone during pregnancy.
Based on these animal studies and human reports, testosterone appears to cause masculinization of the female genitals (causes the female genitals to become more like male genitals). The risk for masculinization appears to be highest when testosterone is used in the first trimester. However, some female genital abnormalities can occur with testosterone use at any time during the pregnancy.
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Last reviewed by: Kristi Monson, PharmD;
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