Podofilox topical has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryotoxicity at a dose 250 times the maximum human dose. There are no controlled data in human pregnancy. Podofilox topical is only recommended for use during pregnancy when benefit outweighs risk.

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There are no data on the excretion of podofilox topical into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue podofilox topical, taking into account the importance of the drug to the mother.

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