Azelex

DRUG DESCRIPTION

AZELEX (azelaic acid cream) 20% contains azelaic acid, a naturally occurring saturated dicarboxylic acid.

Structural Formula: HOOC-(CH2)7-COOH.
Chemical Name: 1,7-heptanedicarboxylic acid
Empirical Formula: C9H16O4
Molecular Weight: 188.22

Active Ingredient: Each gram of AZELEX contains azelaic acid..........0.2 gm (20% w/w).

Inactive Ingredients: cetearyl octanoate; glycerin; glyceryl stearate and cetearyl alcohol and cetyl palmitate and cocoglycerides; PEG-5 glyceryl stearate; propylene glycol; and purified water. Benzoic acid is present as a preservative.

What are the possible side effects of azelaic acid topical (Azelex, Finacea, Finevin)?

Serious side effects are not likely to occur. Stop using azelaic acid topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives).

You may experience some burning, warmth, stinging, tingling, itching, redness, dryness, peeling, or irritation while using azelaic acid topical. If these side effects are excessive, ask your doctor about using azelaic acid once daily.

If you have dark skin and you...

Read All Potential Side Effects and See Pictures of Azelex

What are the precautions when taking azelaic acid cream (Azelex)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, repeated episodes of cold sores or fever blisters (oral herpes).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk. Consult your doctor before...

Read All Potential Precautions of Azelex


Azelex Consumer (continued)

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.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, repeated episodes of cold sores or fever blisters (oral herpes).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk. Consult your doctor before breast-feeding.


Azelex Patient Information Including Side Effects

Brand Names: Azelex, Finacea, Finevin

Generic Name: azelaic acid topical (Pronunciation: ah zeh LAY ic AH sid)

  • What is azelaic acid topical (Azelex)?
  • What are the possible side effects of azelaic acid topical (Azelex)?
  • What is the most important information I should know about azelaic acid topical (Azelex)?
  • What should I discuss with my healthcare provider before using azelaic acid topical (Azelex)?
  • How should I use azelaic acid topical (Azelex)?
  • What happens if I miss a dose (Azelex)?
  • What happens if I overdose (Azelex)?
  • What should I avoid while using azelaic acid topical (Azelex)?
  • What other drugs will affect azelaic acid topical (Azelex)?
  • Where can I get more information?

What is azelaic acid topical (Azelex)?

Azelaic acid is a naturally occurring acid. It helps the skin to renew itself more quickly and therefore reduces pimple and blackhead formation. It also helps to kill the bacteria that cause acne and rosacea.

Azelaic acid topical is used to treat acne and rosacea.

Azelaic acid topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of azelaic acid topical (Azelex)?

Serious side effects are not likely to occur. Stop using azelaic acid topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives).

You may experience some burning, warmth, stinging, tingling, itching, redness, dryness, peeling, or irritation while using azelaic acid topical. If these side effects are excessive, ask your doctor about using azelaic acid once daily.

If you have dark skin and you notice changes in your skin color, contact your doctor.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about azelaic acid topical (Azelex)?

Do not use azelaic acid topical on sunburned, windburned, dry, chapped, or irritated skin. It could make these conditions worse. Also avoid using azelaic acid topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Avoid the use of abrasive, harsh, or drying soaps and cleansers such as alcoholic cleansers, tinctures, astringents, abrasives, or peeling agents while using azelaic acid topical.

Related Drug Centers
  • Finacea
  • Azelex


Related Drugs Index: