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ELIDEL SAFETY AND TOLERABILITY1

What is the most important information I should know about ELIDEL Cream?

The safety of using ELIDEL Cream for a long period of time is not known. A very small number of people who have used ELIDEL Cream have gotten cancer (for example, skin cancer or lymphoma). But a link with ELIDEL Cream use has not been shown. Because of this concern:

  • A patient should not use ELIDEL Cream continuously for a long time.
  • ELIDEL Cream should be used only on areas of skin that have eczema.
  • ELIDEL Cream is not for use on a child under 2 years old.

What is ELIDEL Cream?

ELIDEL Cream is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis). ELIDEL Cream is in a class of medicines called topical calcineurin inhibitors. ELIDEL Cream is for adults and children aged 2 years and older who do not have a weakened immune system. ELIDEL Cream is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. ELIDEL Cream is for use after other prescription medicines have not worked for you or if your doctor recommends that other prescription medicines should not be used. It is not known if ELIDEL Cream is safe and effective in people who have a weakened immune system. ELIDEL Cream is not for use in children under 2 years of age.

Who should not use ELIDEL Cream?

Do not use ELIDEL Cream:

  • If you are allergic to ELIDEL Cream or anything in it. Take a look at the patient information leaflet that came with your medication for a complete list of ingredients in ELIDEL Cream.

What are the possible side effects of ELIDEL Cream?

ELIDEL Cream may cause serious side effects. A very small number of people who have used ELIDEL Cream have gotten cancer (for example, skin cancer or lymphoma). But a link that ELIDEL Cream caused these cancers has not been shown.

The most common side effect at the skin application site is burning or a feeling of warmth. These side effects are usually mild or moderate, happen during the first few days of treatment, and usually clear up in a few days. Call your doctor if the burning feeling is severe or lasts for more than 1 week.

Other side effects include headache, common cold or stuffy nose, sore throat, influenza, fever, viral infection, and cough. Some people may get viral skin infections (like cold sores, chicken pox, shingles, or warts) or swollen lymph nodes (glands). Tell your doctor if you have a skin infection or if you have any side effect (for example, swollen glands) that bothers you or that does not go away.

These are not all the possible side effects with ELIDEL Cream. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

 

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INDICATION (What is ELIDEL Cream?)

ELIDEL (pimecrolimus) cream, 1% is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis). ELIDEL Cream is for adults and children ages 2 years and older who do not have a weakened immune system. ELIDEL Cream is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. ELIDEL Cream is for use after other prescription medicines have not worked for you or if your doctor recommends that other prescription medicines should not be used.


IMPORTANT SAFETY INFORMATION INCLUDING LONG-TERM SAFETY BOXED WARNING

What's the most important information I need to know about ELIDEL?

ELIDEL Cream may cause serious side effects. It is not known if ELIDEL Cream is safe to use for a long period of time. A very small number of people who have used ELIDEL Cream have gotten cancer (for example, skin cancer or lymphoma). But a link that ELIDEL Cream use caused these cancers has not been shown. Because of this concern: