Miconazole topical Pregnancy and Breastfeeding Warnings

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Medically reviewed by Drugs.com. Last updated on Jun 12, 2024.

Miconazole topical Pregnancy Warnings

Miconazole has not officially been assigned to a pregnancy category by the FDA. In clinical trials, miconazole treatment of vaginal candidiasis has not been associated with fetal harm. Miconazole is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Pregnancy predisposes patients to the development of vaginal candidiasis due to changes in the vaginal tract. Miconazole has been used in several clinical trials for the treatment of vaginal candidiasis, generally during the second and third trimester, without evidence of fetal harm.

In a review of 229,101 deliveries to Michigan Medicaid patients, 7266 first-trimester exposures to miconazole and 31,503 exposures any time during pregnancy were recorded. A total of 304 birth defects were reported with first trimester exposure (273 expected) and included (observed/expected) 77/73 cardiovascular defects, 14/13 clefts, 3 spina bifida, 4/4 oral clefts, 22/15 polydactyly, 12/9 limb reductions, and 20/17 hypospadias (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). These data do not support an association between first-trimester miconazole use and birth defects.

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