Generic Name: pimecrolimus (PIM-e-KROE-li-mus)
Brand Name: Elidel

The long-term safety of Elidel has not been determined. Because rare cases of cancer (eg, lymphoma, skin cancer) have been reported, continuous long-term use should be avoided and the application of Elidel should be limited to the affected areas. Elidel should not be used in children younger than 2 years old.


Elidel is used for:

Treating atopic dermatitis, also known as eczema, in patients who cannot take or whose symptoms do not respond to other treatments.

Elidel is a topical immunomodulator, which means it modulates or "changes" the body's immune system in some way. In eczema, it works by preventing the activation of certain immune cells and blocks the release of certain chemicals that cause inflammation, redness, and itching of the skin.

Do NOT use Elidel if:

  • you are allergic to any ingredient in Elidel
  • you have immune system problems (eg, weakened immune system)
  • you have Netherton syndrome
  • you are using it on skin areas that have cancers or precancerous skin growths

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Elidel:

Some medical conditions may interact with Elidel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have any bacterial (impetigo) or viral skin infections, such as chickenpox, shingles, herpes, cold sores, or warts
  • if you are receiving any form of light therapy (phototherapy, UVA, UVB) on your skin
  • if you are using any other type of skin product

Some MEDICINES MAY INTERACT with Elidel. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, fluconazole, itraconazole, ketoconazole), calcium channel blockers (eg, diltiazem), cimetidine, or macrolide antibiotics (eg, erythromycin) because they may increase the risk of Elidel's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Elidel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Elidel:

Use Elidel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Elidel comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Elidel refilled.
  • Wash your hands before using Elidel.
  • Use Elidel only on your skin. Dry your skin completely after a bath or shower before applying Elidel. Apply a thin layer to the affected skin twice daily as directed by your health care provider. You can apply it on affected areas on all skin surfaces, including your face, head, and neck. Avoid contact with your eyes, nose, mouth, vagina, or rectum.
  • If your doctor recommends using moisturizers, apply them after using Elidel.
  • Wash your hands with soap and water after using Elidel, unless your hands are part of the treated area.
  • Do not cover the skin being treated with bandages, dressings, or wraps. However, you can wear normal clothing.
  • Do not bathe, shower, or swim right after applying Elidel. This could wash off the cream.
  • Do not apply Elidel to open wounds or infected areas.
  • Do NOT use more medicine than prescribed unless your doctor tells you otherwise.
  • If you miss a dose of Elidel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Elidel.

Important safety information:

  • Elidel is for external use only. Do not get it in your eyes, nose, mouth, vagina, or rectum. If you get it in your eyes, rinse at once with cool tap water.
  • Contact your doctor if your condition worsens, returns, or does not get better after 6 weeks of using Elidel; if you have persistent eye irritation; or if a feeling of warmth or a burning sensation at the application site is severe or persists for more than 1 week.
  • Elidel may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Elidel. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Elidel should be used for short periods of time. If recommended by your doctor, treatment may be repeated with breaks in between. Do not use Elidel continuously for a long time unless directed by your doctor.
  • Elidel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
  • Elidel should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Elidel while you are pregnant. It is not known if Elidel is found in breast milk. Do not breast-feed while you are using Elidel.

Possible side effects of Elidel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning sensation, stinging, soreness, or feeling of warmth at the application site; cough; headache; nose or throat irritation; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); flu syndrome (eg, fever, muscle aches); severe or persistent burning sensation at the application site; skin infection (eg, redness, swelling, pus discharge); swollen lymph nodes (glands); warts, sores, or other new growths on the skin, including herpes skin infections (eg, cold sores, chickenpox, shingles); worsening of your condition.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Elidel may be harmful if swallowed.

Proper storage of Elidel:

Store Elidel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not leave Elidel in your car in cold or hot weather. Make sure the cap on the tube is tightly closed. Keep Elidel out of the reach of children and away from pets.

General information:

  • If you have any questions about Elidel, please talk with your doctor, pharmacist, or other health care provider.
  • Elidel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Elidel or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Elidel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Elidel. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Elidel.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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