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Date of issue: November 2022, Version: 3

Adapalene is a retinoid receptor agonist used topically for the treatment of mild-to-moderate acne. It is also used off-label to treat keratosis pilaris.

The limited available data do not currently raise concern of increased risks of any adverse pregnancy outcome. Systemic adapalene delivered at high doses is teratogenic in animal models; however, topical application is not believed to result in significant systemic absorption, and adapalene has limited intracellular protein and receptor interactions; therefore, the risk of malformation following topical exposure is hypothesised to be low compared to first generation retinoids. There is one case report of anophthalmia following exposure to topical adapalene.

An increased risk of malformation is unlikely where topical adapalene is used at therapeutic doses as per the manufacturer’s instructions during pregnancy. However, due to the known teratogenicity of retinoids and inadequate pregnancy data for adapalene, its use during pregnancy cannot be recommended. Nevertheless, women who are inadvertently exposed during pregnancy should be reassured that systemic absorption of the drug is very low and that existing studies show no evidence of a teratogenic risk for topical retinoids as a group. Other risk factors may, however, be present in individual cases which may independently increase the risk of adverse pregnancy outcomes. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments. Discussion with UKTIS is recommended.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

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