The Basics
What is Adapalene?
Topical retinoid primarily used in the treatment of mild-moderate acne, and is also used off-label to treat keratosis pilaris as well as other skin conditions.
Brand names for Adapalene
Differin
How Adapalene is classified
Dermatologic Agents, Anti-Inflammatory Agents – Non-Steroidal
Adapalene During Pregnancy
Adapalene pregnancy category
Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Adapalene while pregnant
No teratogenic effects were seen in rats at oral doses of 0.15 to 5.0 mg/kg/day adapalene (up to 20 times the MRHD based on mg/m² comparisons). However, adapalene administered orally at doses of ≥ 25 mg/kg, (100 times the MRHD for rats or 200 times MRHD for rabbits) has been shown to be teratogenic. Cutaneous teratology studies in rats and rabbits at doses of 0.6, 2.0, and 6.0 mg/kg/day (24 times the MRHD for rats or 48 times the MRHD for rabbits) exhibited no fetotoxicity and only minimal increases in supernumerary ribs in rats. There are no adequate and well-controlled studies in pregnant women. Adapalene should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Taking Adapalene While Breastfeeding
What are recommendations for lactation if you're taking Adapalene?
Topical adapalene has not been studied during breastfeeding. Because it is poorly absorbed after topical application,[1] and blood levels are less than 0.25 mcg/L with long-term use, it is probably a low risk to the nursing infant. Do not apply to the nipple area and ensure that the infant’s skin does not come into direct contact with the areas of skin that have been treated. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[2]
Maternal / infant drug levels
Topical adapalene has not been studied during breastfeeding. Because it is poorly absorbed after topical application,[1] and blood levels are less than 0.25 mcg/L with long-term use, it is probably a low risk to the nursing infant. Do not apply to the nipple area and ensure that the infant’s skin does not come into direct contact with the areas of skin that have been treated. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[2]
Possible effects of Adapalene on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Adapalene
Benzoyl Peroxide, Tretinoin.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Akhavan A, Bershad S. Topical acne drugs: review of clinical properties, systemic exposure, and safety. Am J Clin Dermatol. 2003;4:473-92. PMID: 12814337
2. Noti A, Grob K, Biedermann M et al. Exposure of babies to C(15)-C(45) mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003;38:317-25. PMID: 14623482
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
