This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk Summary: Available data of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Studies with topical benzoyl peroxide have not demonstrated systemic absorption, and maternal use is not expected to result in fetal exposure to benzoyl peroxide.

Oral tretinoin has been shown to be fetotoxic in rats when administered at a dose of 2.5 mg/kg/day. Topical tretinoin has been shown to be fetotoxic in rabbits when administered at a dose of 0.5 mg/kg/day. Published data f on the use of topical tretinoin products during pregnancy have not identified an association with topical tretinoin and major birth defects or miscarriage. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

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A decision should be made, taking into account the developmental and health benefits of breastfeeding along with the mother's clinical need for treatment and any potential adverse effects on the breast-fed child or from the underlying maternal condition.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

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