Chemical formula: C₂₈H₂₈O₃ Molecular mass: 412.52 g/mol PubChem compound: 60164
Adapalene is contraindicated in pregnancy, or in women planning a pregnancy.
Animal studies by the oral route have shown reproductive toxicity at high systemic exposure. Clinical experience with locally applied adapalene in pregnancy is limited but the few available data do not indicate harmful effects on pregnancy or on the health of the foetus exposed in early pregnancy. Due to the limited available data and because a very weak cutaneous passage of adapalene is possible, adapalene should not be used during pregnancy. If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.
No study on animal or human milk transfer was conducted after cutaneous application of adapalene.
No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to adapalene is negligible. Adapalene can be used during breastfeeding. To avoid contact exposure of the infant, application of adapalene to the chest should be avoided when used during breast-feeding.
Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result in low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Adapalene has no influence on the ability to drive and use machines.
Adapalene may cause the following adverse drug reactions:
Common (≥1/100 to <1/10): Dry skin, skin irritation, skin burning sensation, erythema
Uncommon (≥1/1000 to <1/100): Dermatitis contact, skin discomfort, sunburn, pruritus, skin exfoliation, acne
Unknown*: Dermatitis allergic (allergic contact dermatitis), pain of skin, skin swelling,
Unknown*: eyelid irritation, eyelid erythema, eyelid pruritus, eyelid swelling
* Post marketing surveillance data
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