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Last reviewed on RxList: 4/1/2019
Azelex Side Effects Center

Last reviewed on RxList 4/1/2019

Azelex (azelaic acid cream) Cream topical (for the skin) is a naturally occurring acid used to treat acne and rosacea. Common side effects of Azelex Cream include:

  • temporary stinging,
  • burning,
  • itching,
  • tingling,
  • drying, or flaking of the skin

Side effects of Azelex Cream usually lessen as your body adjusts to this medication.

After the skin is thoroughly washed and patted dry, a thin film dose of Azelex Cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. Wash hands after application. Do not use other topical preparations on the same area you use Azelex unless directed by your doctor. Avoid the use of abrasive, harsh, or drying soaps and cleansers such as alcoholic cleansers, tinctures, astringents, abrasives, or peeling agents while using Azelex topical. Tell your doctor all medications you use. During pregnancy, Azelex should be used only when clearly needed. This medication may pass into breast milk. Consult your doctor before breastfeeding.

Our Azelex (azelaic acid cream) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Azelex Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • severe burning, stinging, or warmth;
  • severe itching or tingling;
  • severe redness, dryness, peeling, or other irritation; or
  • changes in skin color.

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Azelex (Azelaic Acid Cream)

Azelex Professional Information


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.

Read the entire FDA prescribing information for Azelex (Azelaic Acid Cream)

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© Azelex Patient Information is supplied by Cerner Multum, Inc. and Azelex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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