Azelaic Acid for Rosacea and Acne: Evidence, Uses, and Safety

Azelaic acid is a dicarboxylic acid that occurs in nature and is used on the skin as a prescription drug. It is well tolerated, and its topical preparations carry anti-inflammatory, antioxidant and antimicrobial properties (Sauer 2024, DOI).

Prescription strengths are higher than what you find in cosmetics. The FDA-approved products are a 20% cream and a 15% gel and foam. Over-the-counter skincare often contains azelaic acid around 10% or less, which is sold as a cosmetic rather than a drug. The higher prescription strengths are what the clinical trials studied.

Azelaic acid acts through more than one route, which is why it treats both acne and rosacea. It is antimicrobial against Cutibacterium acnes, the bacteria that drive acne, and it normalizes the disordered shedding of skin cells that lines the follicle, so fewer comedones form (Sauer 2024, DOI). Those two actions target the clogged pores and the bacterial growth that produce acne.

Its benefit in rosacea comes mainly from a third action. Azelaic acid scavenges harmful free radicals and lowers the production of reactive oxygen species by neutrophils, a type of white blood cell. This anti-inflammatory effect calms the redness, papules and pustules that define rosacea.

A fourth action explains why people use it for dark spots. Azelaic acid inhibits tyrosinase, the enzyme cells use to make the pigment melanin. By slowing pigment production it lightens areas of excess color, an effect covered below.

The FDA has approved azelaic acid for two separate conditions at two separate strengths. Azelex, a 20% cream, was approved in September 1995 for mild to moderate inflammatory acne vulgaris. Finacea, a 15% gel, was approved in December 2002 for the inflammatory bumps and pustules of mild to moderate rosacea, and a 15% foam version followed in July 2015 for the same use.

The strength matched the condition in each approval, so the higher 20% cream is the acne product and the 15% gel and foam are the rosacea products. The difference reflects the formulation and the indication each maker tested, not a simple rule that more is better in the same disease. Generic versions of both are now available.

The evidence for azelaic acid in rosacea is strong. A Cochrane systematic review pooled 106 randomized trials covering 13,631 people and rated the evidence that topical azelaic acid is more effective than placebo as high quality, one of only a few rosacea treatments to earn that rating (van Zuuren 2015, DOI). In the pooled participant assessments, people using azelaic acid were 46% more likely to report improvement than those on placebo.

That review groups azelaic acid with topical metronidazole and topical ivermectin as the topical treatments with the best support for papulopustular rosacea, the form with bumps and pustules rather than only flushing. Three trials that compared azelaic acid against metronidazole gave mixed results on which one wins, so both are reasonable first choices (van Zuuren 2015, DOI).

Azelaic acid treats the inflammatory lesions of rosacea. It does not erase the background redness and visible vessels of the flushing type, which respond better to other treatments.

Azelaic acid lowers acne lesions and holds up against stronger-smelling options. In a 12-week randomized trial, the 20% cream cut inflammatory lesions by 65% and total lesions by 54%, though a benzoyl peroxide and clindamycin combination cut them more (Schaller 2016, DOI). The result confirms the cream works while placing it below the most aggressive combinations.

A head-to-head trial compared the 20% cream against tretinoin 0.025% cream over 12 weeks. Azelaic acid produced at least as much improvement as tretinoin and caused significantly less dryness, scaling and redness (Spellman 1998, DOI80134-3)). That tolerability edge is the practical reason a clinician picks it for people whose skin reacts badly to retinoids.

The 2024 American Academy of Dermatology acne guideline gives azelaic acid a conditional recommendation, behind the strong recommendations for benzoyl peroxide, topical retinoids, topical antibiotics and oral doxycycline (Reynolds 2024, DOI). In plain terms, it is an effective option rather than the first drug most guidelines push.

Azelaic acid fades areas of excess pigment because it blocks tyrosinase, the enzyme that makes melanin. This use covers melasma, the patchy facial darkening that often follows pregnancy or hormone changes, and post-inflammatory hyperpigmentation, the marks left behind after acne or other irritation clears.

The pigment effect appears to act mainly on overactive pigment cells rather than normal skin, which is part of why it is used in this setting (Sauer 2024, DOI). This use is off-label: it is supported by clinical experience and studies, but it is not one of the FDA-approved indications. A clinician can still prescribe it for pigment when the evidence supports it.

For more on this use, see our explainer on azelaic acid for melasma and post-inflammatory hyperpigmentation.

Most people tolerate azelaic acid well, and the side effects are local and short-lived. The common ones are stinging, burning, itching and dryness at the spot where it is applied, and they tend to ease over the first weeks of use (Sauer 2024, DOI). It should not touch the eyes, mouth or other mucous membranes. In darker skin there are rare reports of hypopigmentation, so people with deeper skin tones are watched for early signs of lightening.

Two practical features make it stand out. Azelaic acid does not make skin more sensitive to sunlight, which is an advantage over retinoids and many acid exfoliants that do. And because very little of it passes through the skin into the blood, it is often chosen during pregnancy, when retinoids and oral acne drugs are not options. Anyone who is pregnant or planning a pregnancy should still confirm the choice with a clinician.

For rosacea, the main alternatives are topical metronidazole and topical ivermectin. The Cochrane review rates all three highly for the bumpy form of rosacea, and trials comparing azelaic acid with metronidazole do not crown a clear winner (van Zuuren 2015, DOI). The choice often comes down to how a person's skin tolerates each one. Our guide to prescription rosacea treatment walks through these options.

For acne, azelaic acid sits alongside topical retinoids such as tretinoin and adapalene and alongside benzoyl peroxide. The retinoids and benzoyl peroxide carry stronger guideline recommendations, but azelaic acid matches tretinoin on results with less irritation, and it does not bleach fabric the way benzoyl peroxide can (Spellman 1998, DOI80134-3)).

Azelaic acid is a good fit when skin is sensitive, when pigment is also a concern, or when sun sensitivity or pregnancy rules out other drugs. It is a strong supporting option in both conditions rather than the single most powerful one.