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Azelaic Acid (Topical)

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Azelaic Acid (Topical)

US Brand Names

• Azelex

• Finevin


Azelaic acid (ay-ze-LAY-ik AS-id) is used to treat mild to moderate acne. It works in part by stopping the growth of skin bacteria that can help cause acne. Azelaic acid also helps to lessen acne by keeping skin pores (tiny openings on the skin's surface) clear.

It may also be used to treat other conditions as determined by your doctor.

Azelaic acid is available only with your doctor's prescription, in the following dosage form:


    • Cream (U.S.)

Special Considerations

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For azelaic acid, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to azelaic acid. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.


Azelaic acid has not been studied in pregnant women.


Small amounts of azelaic acid are absorbed through the skin into the bloodstream. It is possible that tiny amounts of the medicine may pass into the breast milk. However, this medicine has not been reported to cause problems in nursing babies.


Studies of this medicine have been done only in adult patients, and there is no specific information comparing use of azelaic acid in children with use in other age groups.

Older adults

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of azelaic acid in the elderly with use in other age groups.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your doctor and pharmacist if you are using any other topical prescription or nonprescription (over-the-counter [OTC]) medicine that is to be applied to the same area of the skin.


When applying the cream, use only a small amount of medicine and apply a thin film to clean, dry skin that is affected by acne. It is important to rub it in gently but well.

After applying azelaic acid cream, wash your hands well to remove any medicine that may remain on them.

Keep this medicine away from the eyes, other mucous membranes, such as the mouth, lips, and inside of the nose, and sensitive areas of the neck . If the medicine accidently gets on these areas, wash with water at once.

To help clear up your acne completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a short time. If you stop using this medicine too soon, your acne may return or get worse.


The dose of azelaic acid will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of azelaic acid. If your dose is different, do not change it unless your doctor tells you to do so.

    • For topical dosage form (cream):

      o For acne:

        Adults and teenagers-Apply a small amount two times a day, usually in the morning and the evening, to areas affected by acne. Rub in gently but well. When you are just beginning to use the medicine, your doctor may want you to apply the medicine only one time a day for a few days, to reduce the chance of skin irritation.

        Children-Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, use it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


To store this medicine:

    • Keep out of the reach of children.

    • Store away from heat and direct light.

    • Keep the medicine from freezing. Do not refrigerate.

    • Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.


If your acne does not improve within 4 weeks, or if it becomes worse, check with your health care professional. However, it may take longer than 4 weeks before you notice full improvement in your acne even if you use the medicine every day.

If this medicine causes too much redness, peeling, or dryness of your skin, check with your doctor. It may be necessary for you to reduce the number of times a day that you use the medicine or to stop using the medicine for a short time until your skin is less irritated.

If your doctor has ordered another medicine to be applied to the skin along with this medicine, it is best to apply them at different times. This may help keep your skin from becoming too irritated. Also, if the medicines are used at or near the same time, they may not work properly.

You may continue to use cosmetics (make-up) while you are using this medicine for acne. However, it is best to use only water-base cosmetics. Also, it is best not to use cosmetics too heavily or too often. They may make your acne worse. If you have any questions about this, check with your doctor.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur, they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:


White spots or lightening of treated areas of dark skin-in patients with dark complexions, although usually not lightened beyond normal skin color.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Burning, stinging, or tingling of skin, mild; dryness of skin; itching of skin; peeling of skin; redness of skin.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, azelaic acid is used in certain patients with the following medical condition:

    • Melasma

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

July 24, 2001

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