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Imiquimod topical Pregnancy and Breastfeeding Warnings

Imiquimod topical is also known as: Aldara, Zyclara

Imiquimod topical Pregnancy Warnings

Imiquimod topical has been assigned to pregnancy category C by the FDA. Animal studies have revealed fetal toxicities, in the presence of maternal toxicity, including fetal resorptions, decreased fetal body weights, delays in skeletal ossification, and bent limb bones following doses 163 to 577 times the MHRD (based on AUC comparisons). In this same dosage group two fetuses in one litter demonstrated exencephaly, protruding tongues, and low set ears. Animal studies have failed to reveal evidence of teratogenicity or embryofetal toxicity when administered in doses up to 28 to 98 times MHRD (based on AUC comparisons). There are no controlled data in human pregnancy. Imiquimod topical is only recommended for use during pregnancy when benefit outweighs risk.

Imiquimod topical Breastfeeding Warnings

There are no data on the excretion of imiquimod into human milk. The manufacturer recommends that caution be used when administering imiquimod to nursing women.

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