Epiduo Use In Pregnancy & Lactation

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.
Pregnancy: Epiduo is contraindicated (see Contraindications) in pregnancy, or in women planning a pregnancy. There are no or limited amount of data from the use of adapalene topically in pregnant women. Animal studies by the oral route have shown reproductive toxicity at high systemic exposure. (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Clinical experience with locally applied adapalene and benzoyl peroxide in pregnancy is limited. If the product is used during pregnancy, or if the patient becomes pregnant while using this drug, treatment should be discontinued.
Lactation: No study on animal or human milk transfer was conducted after cutaneous application of EPIDUO (adapalene/benzoyl peroxide) GEL.
EPIDUO should be used with caution in breast-feeding women and only on areas away from the chest. To avoid contact exposure of the infant, application of EPIDUO to the chest should be avoided when used during breastfeeding.
Fertility: No human fertility studies were conducted with Epiduo gel.