May 23 2022

Classification of the active ingredient adapalene

Risk level in pregnancy: This medicine is classified as Category C.

Although it is known that the derivative retinoids can cause adverse effects to the fetus when administered to pregnant women, there are no human studies with a design suited and properly controlled, so it has not been established the efficacy and safety of use of this medicine during pregnancy.

Adapalene shown teratogenicity in experimental animals, although at doses considerably high.

Oral doses up to 5 mg / kg / day no teratogenic effects were seen in laboratory animals. This dose is six times higher than the maximum recommended dose in humans. However, at doses in excess of 30-60 times this maximum dose, that is equal or greater than 25 mg/kg, produce malformations itself, among which are included microphthalmia, cleft velopalatal, omphalocele, skeletal abnormalities or renal, umbilical hernia and exophthalmos.

Cutaneous application of up to 6 mg/kg/day showed no significant fetal toxicity, although a occurred a delay in a case of rib osificaci?ny supernumerary. These doses produce a global exposure up to 28 times higher than that resulting application of adapalene in the face, chest and back of a patient.

Update 18.07.2009

Meaning of category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.