Azelaic Acid

Pregnancy

The oral intake of azelaic acid has shown adverse events in animal studies, but the effects of topical application have not been studied. Moreover, the amount of azelaic acid that is absorbed into the bloodstream following topical use is minimal (< 4%). Given the lack of sufficient evidence for toxicity from topical application, there is no expected risk for the fetus when using topical azelaic acid when pregnant. 

Category: B

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

Azelaic acid seems to be of low risk to the infant when used topically while breastfeeding. Although topical azelaic acid use during breastfeeding has not been studied, research suggests only 4% of the topically applied amount of azelaic acid gets absorbed into the bloodstream. 

Do not apply azelaic acid 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 azelaic acid. 

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