Is azelaic acid safe during pregnancy?

The American Academy of Dermatology (AAD) says azelaic acid "is thought to be safe to use during pregnancy. In animal studies, researchers haven't seen birth defects." The FDA labels explain why: little azelaic acid is absorbed through the skin, and the 15% gel label says use by the mother "is not expected to result in fetal exposure to the drug." No controlled trials in pregnant women exist, so the advice is based on absorption data, animal studies and doctors' experience. This guide sets out exactly what each source says, what is still unknown, and what to ask your doctor or pharmacist before you use it. For the ingredient itself, see what azelaic acid is.

Skinli gives general education. A doctor is the right person to diagnose and treat your skin. Pregnancy changes which treatments are right for you, so check any skin product with your obstetrician, dermatologist or pharmacist.

What each source says

Source	What it says about pregnancy
AAD, acne during pregnancy	"This is thought to be safe to use during pregnancy. In animal studies, researchers haven't seen birth defects."
15% gel label (2025)	"Azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug."
15% foam label (2020)	The same wording as the gel label
20% cream label (2024)	"There are, however, no adequate and well-controlled studies in pregnant women." It "should be used during pregnancy only if clearly needed."
MedlinePlus	Tell your doctor if you are pregnant, plan to become pregnant or are breastfeeding, and call your doctor if you become pregnant while using it
2023 review, Dermatology and Therapy	"No adverse fetal effects have been reported, and it is considered safe during all trimesters"
2016 review, Journal of the American Board of Family Medicine	"Topical azelaic acid or benzoyl peroxide can be recommended as baseline therapy"

The labels differ in tone. The 15% gel and foam labels use a newer format that describes risk in words. The 20% cream label uses an older format and more cautious wording. The 2023 review and a 2024 review in Clinical, Cosmetic and Investigational Dermatology both describe azelaic acid as pregnancy category B.

Why it is considered low risk

Little of it reaches the blood. The 15% gel label reports that people using the gel twice a day for at least 8 weeks had blood levels of 42 to 63.1 ng/mL. People using the gel without azelaic acid had levels as high as 90.5 ng/mL. The label concludes that the gel "does not increase plasma azelaic acid concentration beyond the range derived from nutrition and endogenous metabolism," meaning diet and the body's own production. The 20% cream label says "less than 4% of a topically applied dose is systemically absorbed." The 2023 review puts it at 4% to 8%.

It occurs naturally. The 20% cream label says azelaic acid is "a dietary constituent (whole grain cereals and animal products)" and can be formed in the body. The 2023 review says it is found in milk, wheat, rye and barley.

Animal studies found no birth defects. The 15% gel label describes studies in which rats, rabbits and monkeys were given azelaic acid by mouth. Harm to the unborn young appeared at doses 162, 19 and 65 times the maximum recommended human dose, and only at doses that also harmed the mothers. "No malformations were observed," meaning no birth defects.

What is still unknown

The AAD page on acne in pregnancy explains why: "Researchers don't give pregnant women medications, so there are no studies to tell us what happens when pregnant women use a treatment. What we know comes from animal studies and women who have used acne treatments while pregnant."

The 20% cream label says the same about azelaic acid: "Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed." The 2023 review says "there are limited studies of azelaic acid use among pregnant and lactating patients."

The gel label adds that for any pregnancy, "the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively." That background risk exists with or without any medicine.

Breastfeeding

The 15% gel and foam labels say: "Azelaic acid is naturally present in human milk." When used as prescribed, azelaic acid "is unlikely to be absorbed through the skin in clinically relevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of the infant."

The older 20% cream label says passage into milk "may occur," that the small amount absorbed "is not expected to cause a significant change from baseline azelaic acid levels in the milk," and that "caution should be exercised" when a nursing mother uses it. The 2023 review rates azelaic acid as low risk during breastfeeding. Ask your doctor before using it while nursing.

Where it fits among pregnancy acne treatments

The AAD's page on acne during pregnancy sorts treatments into groups:

Treatment	What the AAD says in pregnancy
Isotretinoin, tazarotene, spironolactone	"Immediately stop taking these medications"; "These medications can cause serious birth defects"
Adapalene and tretinoin	"Most experts recommend stopping this treatment during pregnancy"
Azelaic acid	"Thought to be safe to use during pregnancy"
Benzoyl peroxide	"Safe to use in limited amounts"; talk with your obstetrician or dermatologist first
Salicylic acid	"Generally considered safe when used for a limited time"; talk with your doctor first
Clindamycin applied to the skin	"Thought to be safe"; check with your doctor first

NICE, which writes acne guidance for England, says "topical retinoids and oral tetracyclines are contraindicated during pregnancy and when planning a pregnancy." NICE's own azelaic acid option pairs it with a tetracycline antibiotic pill, and NICE marks that combination as not for use in pregnancy, pointing to its advice on oral tetracyclines.

The 2023 review lists azelaic acid, benzoyl peroxide and topical clindamycin as first choices for mild to moderate acne during pregnancy and breastfeeding, and says "it is also safe to combine azelaic acid and benzoyl peroxide during pregnancy." It adds that "twice daily usage and a maximum strength of 20% are acceptable during pregnancy and lactation."

For the other ingredients, see retinoids during pregnancy and breastfeeding, salicylic acid during pregnancy and niacinamide during pregnancy. If you used tretinoin before pregnancy, the guide to azelaic acid with tretinoin explains how the two compare.

Melasma and dark patches

Pregnancy can bring melasma, brown patches on the face. The AAD says it is normal to have skin changes such as acne or dark patches during pregnancy. The 2024 review describes a study of 28 pregnant women who applied azelaic acid 15% gel twice a day for four months. The patches faded or cleared in 92.9% to 96.4% of cases, and the review calls the treatment effective and safe. The study had no comparison group. The melasma guide covers sun protection, which comes first for these patches. The AAD's pregnancy skin care page advises "a broad-spectrum, water-resistant sunscreen with an SPF of at least 30" and suggests a mineral sunscreen with zinc oxide or titanium dioxide during pregnancy.

Store products

Store serums and creams have no pregnancy section on their labels, and many contain more than azelaic acid. The AAD's pregnancy skin care page lists ingredients to avoid, including "retinoids, including both prescription acne treatments like isotretinoin, tretinoin, and tazarotene, along with over-the-counter skin care containing retinol." It lists others to use sparingly and discuss with a dermatologist, including salicylic acid above 2%, benzoyl peroxide and some essential oils. Read the full ingredient list of any azelaic acid product. The strengths guide explains the difference between prescription and store products.

Questions to ask your doctor or pharmacist

• Is azelaic acid right for my acne, marks or melasma during this pregnancy?
• Which product and strength should I use, and how often?
• Is it safe with the other products I use, such as benzoyl peroxide?
• Should I keep using it while breastfeeding?
• What should I do if my skin stings, or if I see light patches?

When to see a doctor

See your doctor before starting any acne treatment while pregnant or trying to become pregnant, and ask about stopping any retinoid product, which the AAD says to avoid during pregnancy. See a doctor sooner for painful, deep acne, which may need a treatment plan made for pregnancy. The azelaic acid for acne guide explains how it works on acne. Skinli gives general education. A doctor is the right person to diagnose and treat your skin.