Pregnancy Warnings

Terconazole topical Pregnancy and Breast Feeding Warnings

Terconazole topical is also known as: Terazol, Terazol 3, Terazol 7, Terazole 3, Zazole

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Terconazole Suppositories while you are pregnant. It is not known if Terconazole Suppositories is found in breast milk. Do not breast-feed while taking Terconazole Suppositories.

Terconazole topical Pregnancy Warnings

Terconazole has been assigned to pregnancy category C by the FDA. Animal studies utilizing high oral and subcutaneous doses have not revealed evidence of teratogenicity. Terconazole is only recommended for use during pregnancy when benefit outweighs risk.

In a review of 229,101 deliveries to Michigan Medicaid patients, 1167 first-trimester exposures to terconazole and 7551 exposures any time during pregnancy were recorded. A total of 34 birth defects were reported with first trimester exposure (48 expected) and included (observed/expected) 14/12 cardiovascular defects, 3/2 polydactyly, 1 limb reduction, and 1 hypospadias. These data do not support an association between terconazole use and birth defects. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)

Terconazole topical Lactation Warnings

There are no data on the excretion of terconazole into human milk.

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