Azelaic Acid: uses, dosing, side effects & brands
Azelaic Acid is a medicine sold in the U.S. under 2 brand and generic names, for acne vulgaris and rosacea. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Acne Vulgaris and Rosacea
- Available as
- Topical
- Sold as
- 2 products — Azelex and Finacea
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- What the pharmacy pays
- about $0.46 per gm — not your price
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How azelaic acid is dosed
From the FDA label for Azelex (application NDA020428). Other azelaic acid products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
After the skin is thoroughly washed and patted dry, a thin film of AZELEX ® cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. The hands should be washed following application. The duration of use of AZELEX ® cream can vary from person to person and depends on the severity of the acne. Improvement of the condition occurs in the majority of patients with inflammatory lesions within four weeks.
Azelaic Acid side effects
During U.S. clinical trials with AZELEX ® cream, adverse reactions were generally mild and transient in nature. The most common adverse reactions occurring in approximately 1-5% of patients were pruritus, burning, stinging and tingling. Other adverse reactions such as erythema, dryness, rash, peeling, irritation, dermatitis, and contact dermatitis were reported in less than 1% of subjects. There is the potential for experiencing allergic reactions with use of AZELEX ® cream. In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.
Who shouldn’t take azelaic acid
AZELEX ® cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
Every azelaic acid product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Topical | Generic | $0 | View → | |
| 2 | Not yet rated | Prescription | Topical | Generic | $0 | View → |
Azelaic Acid recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Azelaic Acid Gel
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Glenmark Pharmaceuticals Inc., USA · Jul 23, 2026
Azelaic Acid Gel
CGMP Deviations: Market complaints received for gritty texture (grainy)
Glenmark Pharmaceuticals Inc., USA · Sep 17, 2025
How long azelaic acid keeps
The date on a sealed pack is not the only one: some azelaic acid labels start a second clock once the product is opened or mixed, as short as 8 weeks.
Does azelaic acid expire? The in-use limits and storage rules from its labelsAzelaic Acid and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for azelaic acid: levels in milk, effects in breastfed infants, and the drugs it would consider insteadTopical azelaic acid has not been studied during breastfeeding. Because only 4% of a dose is absorbed after topical application and it is a chemical that appears in foods, bloodstream, and breastmilk normally, azelaic acid is considered a low risk to the nursing infant. If azelaic acid is required by the mother, it is not a reason to discontinue breastfeeding. Do not apply azelaic acid to the breast or nipple and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.
National Institute of Child Health and Human Development, record revised March 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about azelaic acid
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 858 reports naming azelaic acid, and the FDA flagged 52% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- vomiting93 reports
- abdominal pain upper90 reports
- gastrooesophageal reflux disease87 reports
- paraesthesia86 reports
- hypoaesthesia84 reports
- migraine83 reports
- memory impairment82 reports
- drug intolerance81 reports
Read these as a signal, not a rate. A report does not mean azelaic acid caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is azelaic acid?
Azelex (Azelaic Acid) is a medication used to treat Acne Vulgaris, Rosacea.
Can you take azelaic acid with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run azelaic acid against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is azelaic acid sold under?
We track 2 azelaic acid-containing products in the U.S.: Azelex and Finacea. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does azelaic acid come in?
Across the brands we track, azelaic acid is currently marketed as topical, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic azelaic acid?
We do not currently list a generic-labelled azelaic acid product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has azelaic acid been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions azelaic acid. The most recent: Azelaic Acid Gel (Jul 23, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Azelaic Acid: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/azelaic-acid
- MLA
- “Azelaic Acid: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/azelaic-acid.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for azelaic acid on DailyMed (NIH) ↗.