Benzoyl peroxide topical Pregnancy and Breastfeeding Warnings

Brand names: Acetoxyl, Acne Treatment, Acne-Clear, Benzac, Benzac AC, Benzac W, Benzagel, Brevoxyl, Brevoxyl-4, Brevoxyl-8, Clearplex, Clearskin, Desquam-E, Desquam-X 10, Desquam-X 5, Epsolay, EthexDERM BPW, Fostex BPO, Oxy-10, PR Benzoyl Peroxide Wash, PanOxyl, Peroxin A 10, Persa-Gel, Triaz, Zeroxin

Medically reviewed by Drugs.com. Last updated on Jul 9, 2025.

Benzoyl peroxide topical Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: Not formally assigned to a pregnancy category.
US FDA pregnancy category: Not assigned

Risk summary: Malformative risk with the use of this drug in pregnant women is unlikely.

Comment:
-According to the available published literature, the use of this medication is not anticipated to result in fetal exposure to the drug.

Animal studies have not been reported. 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.

See references

Benzoyl peroxide topical Breastfeeding Warnings

This drug should be used only if the benefit outweighs the risk to the fetus.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: This drug should not be applied to the breast area to avoid accidental ingestion by the infant.

See references

Further information

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