Uses
What is Azelex used for?
Azelex (azelaic acid) is commonly used to treat acne vulgaris on your skin.
Azelex may also be used for other conditions as determined by your healthcare provider.
See Azelaic Acid for information on other dosage forms.
How does Azelex work (mechanism of action)?
Azelex is believed to stop certain types of bacteria from making proteins they need to grow and multiply. Stopping these bacteria may reduce the formation of acne.
How is Azelex supplied (dosage forms)?
Azelex is available in a 20% topical cream that is applied to the skin.
How should I store Azelex?
Azelex should be stored at temperatures between 59 F to 86 F (15 C to 30 C). Do not freeze. Store the product on its side.
Side Effects
What are the most common side effects of Azelex?
The most common side effects of Azelex are skin reactions, such as itching, burning, stinging or tingling (see below). Tell your healthcare provider if you have any of these side effects that bother you.
There may be other side effects of Azelex that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Azelex?
While less common, the most serious side effects of Azelex are described below, along with what to do if they happen.
Severe Allergic Reactions. Azelex may cause allergic reactions, which can be serious. Stop using Azelex and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Lightening of Skin Color (Hypopigmentation). Azelex may cause your skin color to become lighter. Tell your healthcare provider if you notice any abnormal changes in your skin color.
Skin Reactions. Azelex may cause severe skin irritation, which may include itchiness, burning, or a stinging sensation. These skin reactions are usually temporary. Stop using Azelex and tell your healthcare provider if any of these symptoms are severe or do not go away.
Warnings & Precautions
Who should not use Azelex?
Allergies to Ingredients. People who are allergic to any of the following should not use Azelex.
- Azelaic acid
- Azelex
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Azelex.
What should I know about Azelex before using it?
Do not use Azelex unless it has been prescribed to you by a healthcare provider. Use it as prescribed.
Do not share Azelex with other people, even if they have the same condition as you. It may harm them.
Keep Azelex out of the reach of children.
Azelex is for use on the skin only. Keep Azelex away from areas such as your eyes, mouth, and vagina. If Azelex does come in contact with any of these areas, wash the area with large amounts of water. If you have irritation afterwards that does not go away, tell your healthcare provider.
Before applying Azelex, thoroughly wash the skin area and pat dry.
Wash your hands right away after applying Azelex. Do not use any dressings or wrappings that cover up the area where you applied the medicine.
What should I tell my healthcare provider before using Azelex?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Azelex is right for you.
In particular, make sure that you discuss any of the following.
Asthma. Azelex may worsen your asthma symptoms. Tell your healthcare provider if you have asthma.
Cold Sores (Herpes Labialis). Azelex may worsen recurring cold sores. Tell your healthcare provider if you have cold sores.
Pregnancy. It is not known if or how Azelex could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should use Azelex while you are pregnant or trying to get pregnant.
Breastfeeding. Azelex is only minimally absorbed by the body and is not expected to pass into breast milk in significant amounts. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Azelex while breastfeeding.
How can I get more information about Azelex?
For more information about Azelex, you can visit the manufacturer’s website at www.almirall.us or call them at 610-644-7000.
Interactions
Does Azelex interact with foods or drinks?
There are no known interactions between Azelex and foods or drinks.
There are no known interactions between Azelex and alcohol.
Does Azelex interact with other medicines (drug interactions)?
There are no known interactions between Azelex and other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Overdose/Missed Dose
What should I do if I accidentally use too much Azelex?
If you or someone else has used too much Azelex, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Azelex?
If you miss your scheduled dose of Azelex, apply it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and follow the original schedule. Do not apply Azelex more often than prescribed.
Are you currently using Azelex (azelaic acid)?
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