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Azelex

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Azelex

Azelex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Azelex (azelaic acid cream) Cream topical (for the skin) is used to treat acne and rosacea. Azelaic acid is a naturally occurring acid. Common side effects include temporary stinging, burning, itching, or tingling of the skin. Effects 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 breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Azelex in Detail - Patient Information: Side Effects

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

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • 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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Azelex Overview - Patient Information: Side Effects

SIDE EFFECTS: Temporary stinging, burning, itching, or tingling of the skin may occur, usually at the beginning of treatment. These effects usually lessen as your body adjusts to this medication. However, if minor irritation continues, your doctor may instruct you to only use this product once daily. If any of these effects persist or worsen, stop using this medication and tell your doctor or pharmacist promptly.

Tell your doctor immediately if any of these unlikely side effects occur: worsening of cold sores or fever blisters (oral herpes), unusual or unwanted hair growth.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, some people may experience lightening of skin color (hypopigmentation) after using this medication. This side effect may be more noticeable in people with dark skin color. Consult your doctor for more details and report any skin color changes.

Tell your doctor immediately if any of these rare but serious side effects occur: worsening of asthma symptoms (such as shortness of breath, wheezing).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Azelex (Azelaic Acid Cream)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Azelex FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

During U.S. clinical trials with AZELEX (azelaic acid cream) 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 - User Reviews

Azelex User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Azelex sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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


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