Provera and Pregnancy

Human and animal studies involving pregnancy and the hormone in Provera (medroxyprogesterone) have shown that the medication increased the risk for abnormal genital development of the fetus and low birth weight. Therefore, the FDA has classified it as a pregnancy Category X medication, meaning it should not be taken during pregnancy. If you are taking Provera and pregnancy occurs, contact your healthcare provider.

Is Provera Safe During Pregnancy?

Provera® (medroxyprogesterone acetate) is a prescription medication approved to treat irregular vaginal bleeding and restore menstruation in premenopausal women who have not been having regular periods. It is also used to help prevent cancer of the uterus in postmenopausal women who are using estrogen hormone therapy.
Provera is a pregnancy Category X medication. This means that it should not be given to women who are pregnant or who might be pregnant.

What Is Pregnancy Category X?

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 have caused fetal harm during animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
Provera contains medroxyprogesterone, a progestin hormone. Medroxyprogesterone was previously used to prevent early miscarriages during pregnancy. Although it is no longer used for this reason, studies examining this use provide information about possible effects of the medicine on the developing fetus.
Based on these studies, the use of medroxyprogesterone in the first trimester may increase the risk for abnormal genital development of the fetus. However, other studies have failed to show an association between medroxyprogesterone use and genital defects. Therefore, it is unclear if the risk truly exits.
Provera may also decrease a baby's birth weight if given to a woman early in pregnancy. However, studies have shown that any decrease in birth weight does not affect a child's later growth or development.
Although Provera is a pregnancy Category X medicine, unintentional exposure to the drug in early pregnancy does not appear to significantly increase the risk for birth defects. This could happen if a woman continues to take Provera before realizing she is pregnant. Once a woman knows she is pregnant, there is no reason to continue taking this medicine.

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Last reviewed by: Kristi Monson, PharmD
Pregnancy and Pain