Important safety information for Azelaic Acid

What is the FDA-approved use of azelaic acid?

Azelaic acid is used on the skin to treat the inflammatory papules (raised red spots) and pustules (small pus-filled bumps) of mild to moderate rosacea and acne.

Who should not use azelaic acid?

Do not use tretinoin if:

  • You have had an allergic reaction to azelaic acid in the past.

How should I use azelaic acid?
  • Unless directed otherwise by your provider, use the formula at nighttime before bed. 

  • Wash your face using a gentle cleanser and pat dry. Let the skin dry completely before applying the medication. Apply a thin layer to the entire face. Avoid direct contact with your eyes and eyelids (under the eyes is ok). Wash your hands after applying.

  • If you have a cold sore (oral herpes), avoid applying the cream to the area of the cold sore. Exacerbations of cold sores have been reported.

  • Avoid contact with the mouth, eyes, and other mucous membranes. If exposure to the eye occurs, wash with large amounts of water and contact your doctor or nurse practitioner if irritation persists.

What should I tell my Ro Derm-affiliated provider before using azelaic acid?
  • It’s important to tell your Ro Derm-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements. 

  • It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of asthma.

  • Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most serious side effects that I should monitor for when using azelaic acid?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.These serious side effects are rare, but can occur with azelaic acid.

  • Hypopigmentation

    : There have been isolated reports of hypopigmentation (skin lightening) with use of azelaic acid.

  • Eye and mucous membrane irritation:


    Avoid contact with the eyes and mucous membranes.

  • Worsening of asthma:


    If you have asthma and experience any signs of an asthma attack (i.e., shortness of breath, wheezing), stop using the medication and tell your doctor or nurse practitioner.

What are the most common side effects of azelaic acid?

There may be some discomfort or dryness during the early days of treatment while your skin is adjusting to azelaic acid. If side effects don’t subside within 2 to 4 weeks, or you are not seeing improvement, reach out to your Ro-affiliated provider for guidance.

  • Burning, stinging, tingling

  • Itching

  • Dry, flaky, or cracked skin

  • Redness and irritation

You are encouraged to report negative side effects of prescription products to the FDA. Visit or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.