Adapalene

Pregnancy

The use of adapalene is best avoided during pregnancy because adverse effects were seen in animal studies. There are no known studies in humans that have tested whether adapalene is safe during pregnancy. 

Category: C

Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

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.

Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Breastfeeding

Excretion into human milk: Unknown 

Caution is recommended when using adapalene during breastfeeding. The risks of using adapalene when breastfeeding have not been not studied, but because adapalene is poorly absorbed by the skin after topical application the risks to the nursing infant are probably low. 

Do not apply adapalene to the nipple area and make sure the infant’s skin does not come into contact with the areas of skin that have been treated with adapalene. 

If you are breastfeeding, speak with your physician before you use adapalene.