Warnings

Pimecrolimus

Medically Reviewed by Dr. Harshi Dhingra, M.D.

Last Reviewed: Feb 21, 2025

Warnings

Pimecrolimus (Elidel) Risks, Warnings, and Complications

Pimecrolimus can cause or worsen health problems in some people. Talk to your doctor or pharmacist about other treatment options for eczema if you are at a higher risk of adverse effects from this drug.

RISK OF IMMUNOSUPPRESSION: Animal studies and studies in organ transplant patients have shown that long-term systemic use of calcineurin inhibitors is associated with an increased risk of infections, lymphomas, and skin cancers. These risks are dose- and treatment-duration dependent.
There may be similar risks associated with topical calcineurin inhibitors such as pimecrolimus. There are reports of skin cancer and lymphoma in patients who used pimecrolimus 1% cream, although a direct causal relationship has not been confirmed. To lower these risks, healthcare providers recommend:
Limit application of pimecrolimus to areas of skin affected by atopic dermatitis only.
The long-term safety of pimecrolimus has not been established. Avoid continuous long-term use of topical calcineurin inhibitors. This medicine is recommended for short-term treatment only (6 weeks).
Do not use Elidel in children younger than 2 years of age.
Avoid use in immunocompromised individuals (people with a weakened immune system) or those taking other medications that cause systemic immunosuppression.
Call your doctor for reevaluation if symptoms of eczema do not improve after 6 weeks of using pimecrolimus.
OTHER SKIN DISORDERS: Pimecrolimus 1% cream affects the body’s immune response. It should not be applied on premalignant or malignant skin lesions (skin cancer). It’s important to seek timely medical evaluation of any skin symptoms because malignant conditions like cutaneous T-cell lymphoma (CTCL) may look like dermatitis.
Pimecrolimus is also contraindicated in people with Netherton’s syndrome and other skin conditions that can lead to increased absorption of pimecrolimus. The safety of this medicine has not been established in people with generalized erythroderma.
Temporary skin irritation (stinging, burning, soreness, redness) is common when you first start using pimecrolimus. Tell your doctor if these symptoms last more than one week.
SKIN INFECTIONS AND WARTS: Your doctor will examine your skin and treat any bacterial or viral infections before starting pimecrolimus therapy. Clinical trials have not established the safety and efficacy of pimecrolimus in people with infected atopic dermatitis.
Notably, people with atopic dermatitis are at a higher risk of superficial skin infections such as eczema herpeticum (Kaposi’s varicelliform eruption). Additionally, treatment with pimecrolimus can increase the risk of eczema herpeticum and infections with VZV (varicella-zoster virus, which causes chickenpox or shingles) and HSV (herpes simplex virus).
There are rare reports of people treated with pimecrolimus developing warts (skin papillomas). If this occurs or the warts are worsening, pimecrolimus may need to be discontinued until the warts resolve.
LYMPHADENOPATHY: There are rare cases of lymphadenopathy (swollen glands) in people using pimecrolimus, usually related to infections. The lymphadenopathy resolved with treatment of the infection with antibiotics. Tell your doctor if you develop swollen neck glands while using pimecrolimus. The cause will need to be investigated. If you develop acute infectious mononucleosis, you will need to discontinue pimecrolimus.
SUN EXPOSURE: Doctors advise limiting sun exposure and avoiding artificial lights such as sunlamps and tanning beds during treatment with pimecrolimus, even when the cream is not on your skin.
IMMUNOCOMPROMISED INDIVIDUALS: The safety and efficacy of pimecrolimus have not been established in people with a weak immune system.

Precautions Before Starting Pimecrolimus (Elidel)

Tell your doctor if you are allergic to pimecrolimus, any of the active or inactive ingredients in pimecrolimus cream, or any other drugs. Your pharmacy can give you a list of ingredients.

Give your doctor and pharmacist a complete list of all your other medicines, including prescription medications, over-the-counter medicines, vitamins, supplements, and herbal products. This can help avoid possible drug interactions.

Give your doctor a complete medical history. Pimecrolimus may not be safe for people with certain medical conditions such as Netherton's syndrome (an inherited skin condition), a skin infection such as eczema herpeticum, an infected eczema rash with crusting and blistering, other skin conditions, chicken pox, shingles, herpes (cold sores), skin cancers, or lymphoma.

Tell your doctor if you are pregnant, might be pregnant, are planning a pregnancy soon, or are nursing an infant with breast milk.

Precautions During Use of Pimecrolimus (Elidel)

Avoid using pimecrolimus on unaffected areas of the skin. Use the smallest amount of cream on the affected areas. Stop pimecrolimus use as soon as your symptoms go away. Do not place occlusive dressings, wraps, or bandages on the treated area.

Tell your doctor if your eczema symptoms do not improve after 6 weeks of pimecrolimus treatment or come back after you stop treatment.

Do not use pimecrolimus in children under 2 years of age.

Wear protective clothing and sunscreen to protect your skin from sunlight. Avoid unnecessary sun exposure and exposure to artificial lights (tanning beds and sun lamps).

Avoid alcohol during treatment with pimecrolimus. Drinking alcohol while on this medicine can cause facial flushing and warmth.

Call your doctor without delay if you are exposed to someone who is sick with chickenpox, shingles, or other viral infections.

Talk to your dermatologist about appropriate moisturizers for dry skin related to eczema. Apply the moisturizer after you apply pimecrolimus.

Call your doctor if you become pregnant while using pimecrolimus.

Pimecrolimus (Elidel) Drug Interactions

Treatment with certain medications alongside pimecrolimus can affect how the medicines work. Clinically significant drug interactions can also increase the risk of severe adverse events.

Give your doctor or pharmacist a complete list of your medications, including prescription medications, over-the-counter medications, dietary supplements, and herbal remedies. Also, tell your healthcare professional if you smoke, drink alcohol, or use recreational drugs because some of these substances can cause serious health complications when used with prescription medications.

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