AIDS Home > Complera and Pregnancy

In studies of pregnant animals, Complera (emtricitabine/rilpivirine/tenofovir) did not appear to cause harm to the fetus. As a result, the FDA has classified the drug as a pregnancy Category B medicine, which means that it is probably safe for use in pregnant women. However, because humans may respond differently than animals, Complera should only be prescribed if the benefits outweigh the risks.

Can Pregnant Women Take Complera?

Complera™ (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is a prescription HIV and AIDS medicine. Based on the results of animal studies, this drug is probably safe for use during pregnancy.

What Is Pregnancy Category B?

Complera is a pregnancy Category B 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 B is given to medicines that have not been studied in pregnant humans but did not appear to cause fetal harm in animal studies.
Animal studies have suggested that the active ingredients in Complera are unlikely to cause problems during pregnancy. Of course, Complera can sometimes cause serious side effects (see Complera Side Effects and Complera Warnings and Precautions), and such side effects could affect any individual, pregnant or not.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if a healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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