Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Elidel (Pimecrolimus). If you are concerned about side effects, discuss the risks and benefits of Elidel (Pimecrolimus) with your doctor.

The following side effects have been reported by at least 1% of people taking Elidel (Pimecrolimus). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• blemishes on the skin
• burning feeling or a sensation of warmth at the site of application (usually mild to moderate and temporary, or if severe and persists for more than 1 week)
• flushing
• itching or redness of skin (mild)

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

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

• flu-like symptoms (e.g., runny stuffy nose, chest congestion, cough, Fever)
• headache (with long term continual use)
• herpes skin infections (Cold Sores, Chickenpox, Shingles)
• nose and throat infection
• skin discoloration
• skin rashes or Hives
• skin Warts
• swollen lymph nodes (tenderness or pain or lumps or bumps in your neck, thigh or groin)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Elidel (Pimecrolimus).

Each g of cream contains Elidel (Pimecrolimus) 10 mg (1%). Nonmedicinal ingredients: benzyl alcohol, cetyl alcohol, citric acid, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulfate, sodium hydroxide, stearyl alcohol, triglycerides, and water.

Do not use Elidel (Pimecrolimus) cream if you:

• are allergic to Elidel (Pimecrolimus) or any ingredients of the medication
• have reduced immune function (e.g., people with AIDS, transplant recipients taking anti-rejection medications)
• have a skin infection in the area that needs to be treated

When applied to a large area of the body, there may be an interaction between Elidel (Pimecrolimus) and any of the following:

• alcohol
• anticancer medications (e.g., Cyclophosphamide, Cytarabine, Etoposide, Vincristine)
• "azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole)
• Diltiazem
• grapefruit juice
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• imatinib
• immunosuppressant medications (e.g., Cyclosporine, mycophenolate, Sirolimus, Tacrolimus)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• medications applied to the skin (e.g., tretinoin)
• monoclonal antibodies (e.g., Infliximab, Rituximab)
• oral corticosteroid medications (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• topical corticosteroid medications (e.g., beclomethasone, hydrocortisone, mometasone)
• Verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Elidel (Pimecrolimus). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Elidel (Pimecrolimus).

Eyes: Elidel (Pimecrolimus) should not be used in the eye. If it comes in contact with your eye(s), flush with plenty of water and call your doctor.

Immune system: Elidel (Pimecrolimus) should not be used by people who have problems with their immune system. If you have an immune condition or are taking medication to reduce the activity of your immune system, discuss with your doctor whether to continue using Elidel (Pimecrolimus) cream, how this mediation may affect your medical condition and whether any special monitoring is needed.

Medical conditions: Do not use Elidel (Pimecrolimus) if you have Netherton's syndrome (a rare, inherited skin disorder).

Skin infections: Do not apply Elidel (Pimecrolimus) to skin that is infected (e.g., chickenpox, cold sores, shingles, bacterial). If you develop skin infections while using Elidel (Pimecrolimus), contact your doctor immediately.

Sunlight: Avoid natural or artificial exposure to sunlight while using Elidel (Pimecrolimus). Use appropriate sun protection:

• avoid tanning beds and sunlamps
• stay out of direct sunlight between 10 am and 3 pm when possible
• wear protective clothing, sunglasses, and a hat
• use sunscreen cream and lip balm with sun protection factor (SPF) of at least 15

Pregnancy: Elidel (Pimecrolimus) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using Elidel (Pimecrolimus), contact your doctor immediately.

Breast-feeding: It is not known if Elidel (Pimecrolimus) passes into breast milk. If you are a breast-feeding mother and are taking Elidel (Pimecrolimus), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Elidel (Pimecrolimus) cream is not recommended for children less than 3 months of age. Children between 3 months and 2 years of age are at a higher risk of side effects. The effects of Elidel (Pimecrolimus) on the developing immune system are unknown.