Adapalene Gel Use During Pregnancy
Adapalene gel should be avoided during pregnancy and discontinued immediately if pregnancy occurs or is planned, as it is classified as Pregnancy Category C with unknown fetal risks. 1, 2, 3
Pregnancy Safety Profile
The FDA and American Academy of Dermatology classify adapalene as Pregnancy Category C, meaning animal reproduction studies have shown adverse effects but adequate human studies are lacking. 1
- The FDA drug label explicitly states: "Stop use and ask a doctor if you become pregnant, or planning to become pregnant while using this product." 3
- The American Academy of Dermatology recommends that "pregnancy requires immediate discontinuation of adapalene (Category C), so patients should be counseled to stop and contact their physician if pregnancy occurs or is planned." 2
- While one 2021 study calculated a margin of safety of 70 for teratogenicity and found no pregnancy malformations attributable to topical adapalene in their review, this does not override the official FDA Category C designation and guideline recommendations. 4
Safe Alternative Treatments for Acne During Pregnancy
First-line safe options include topical azelaic acid (Pregnancy Category B) or benzoyl peroxide, which can be used as baseline therapy. 5, 6
Topical Treatment Algorithm:
- Mild acne: Azelaic acid twice daily OR benzoyl peroxide once to twice daily 5, 6
- Inflammatory acne: Topical erythromycin or clindamycin combined with benzoyl peroxide (never as monotherapy to prevent resistance) 5, 6
Systemic Treatment for Moderate-to-Severe Cases:
- Oral erythromycin or cephalexin is considered safe when used for a few weeks for moderate to severe inflammatory acne 5, 6
- Short course of oral prednisolone may be used for fulminant nodular cystic acne after the first trimester 5, 7
Critical Counseling Points
All women of childbearing age using adapalene must be counseled about pregnancy risks before initiating therapy. 2, 3