Knowledge about Elidel and Protopic

Elidel (pimecrolimus) and Protopic (tacrolimus) are topical medications used for the short-term treatment of eczema (atopic dermatitis). Classified as topical calcineurin inhibitors (TCIs), these drugs were the first nonsteroidal topical drugs developed for the treatment of eczema.

Unlike topical steroids, TCIs can be used on the face and eyelids without causing skin damage or loss of drug action with repeated use. Side effects tend to be mild and may include mild itching and burning.

Despite these benefits, Elidel and Protopic also have their limitations and risks. Chief among them is a possible link to certain skin and blood cancers, a concern that prompted the U.S. Food and Drug Administration (FDA) to issue a boxed warning in 2006.


Elidel and Protopic are the only topical calcineurin inhibitors currently FDA-approved. Elidel is recommended for the treatment of mild to moderate atopic dermatitis, And Protopic is labeled as moderate to severe atopic dermatitis.

Topical calcineurin inhibitors work by blocking calcineurin, a naturally occurring compound that helps activate the immune system and stimulate pro-inflammatory cytokines. By “turning off” this response, the inflammation that causes eczema can be significantly relieved.

Elidel and Protopic are also frequently used to treat other inflammatory skin conditions such as psoriasis, seborrheic dermatitis, cutaneous lupus erythematosus, oral lichen planus and vitiligo.

For cost reasons, healthcare providers sometimes reserve Elidel and Protopic for thinner/smaller skin areas (such as the face or hands) and use cheaper topical steroids for larger, thicker skin areas ( such as arms, legs and tree trunks).

Elidel and Protopic have certain benefits that make them different from topical steroids:

  • They can be used repeatedly without losing the effect of the drug.
  • They can be used for children under 2 years old.
  • They do not cause skin atrophy (thinning), streaks (stretch marks), telangiectasia (spider veins), or skin discoloration.
  • They can be safely used on the face, neck, groin, around the eyes or in skin folds.

When eczema affects your face

Before taking

Elidel and Protopic are recommended for second-line treatment of eczema when topical steroids and other conservative treatments fail to provide relief. They are intended for adults and children 2 years and older only.

Precautions and Precautions

Because Elidel and Protopic work by moderating the immune response, they should not be used by anyone with a compromised immune system. Doing so may lead to further suppression of the immune response and increase the risk of opportunistic infections.

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This includes people with advanced HIV infection, as well as organ transplant recipients and people undergoing cancer treatment (all on immunosuppressants).

Elidel and Protopic should also not be used in people with a known hypersensitivity to pimecrolimus, tacrolimus, or any of the ingredients in topical formulations. Because these effects are cross-reactive – meaning an allergy to one drug can turn into an allergy to two – you need to avoid these and any other calcineurin inhibitors, including cyclosporine and oral or injectable Prograf (tacrolimus).

Treating eczema in children


Elidel has topical creams that contain 1% pimecrolimus. Protopic is available as a topical ointment containing 0.03% or 0.1% tacrolimus. The choice of medication depends on the severity of the symptoms as diagnosed by a qualified dermatologist.

How to take and store

Elidel and Protopic are applied to the skin in thin layers twice daily. Even in severe cases, these medications should not be used as moisturizers. If symptoms do not improve after six weeks of use, treatment options should be reviewed. Applying Elidel or Protopic more frequently did not improve results.

Elidel and Protopic can be stored safely at room temperature (77 degrees Fahrenheit). Short-term exposure to temperatures between 59 degrees Fahrenheit and 86 degrees Fahrenheit will not affect the efficacy of the drug, but storing the drug in a hot place (such as a glove box) or in direct sunlight should be avoided. Never use the medicine after it has expired.

Elidel and Protopic are intended for short-term use or intermittent treatment of chronic eczema. They are not suitable for continuous, long-term use.

side effect

Like all medicines, Elidel and Protopic can cause side effects. Most are relatively mild and tend to subside once the body adjusts to the treatment.


The most common side effect is a burning or itching sensation, which occurs in about 25% of users. Headache, cough, nasal congestion, sore throat, upset stomach, and muscle aches were also noted.

Elidel has been linked to an increased risk of certain infections, including folliculitis, pneumonia, impetigo, sinusitis, otitis media, and the flu. 3% to 8% of users may be affected.

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Skin reactions to Protopic are more common and include hives (hives), erythema (redness), and bacterial skin infections. Oral antihistamines and topical antibiotics usually relieve symptoms.


Although the risk of anaphylaxis (a severe systemic allergy) is considered low, Protopic is known to cause reactivation of the chickenpox virus in some people, leading to outbreaks of shingles.

Others may develop a vesicular rash, which is characterized by the formation of tiny chickenpox-like blisters at the application site.

When to see a healthcare provider

Any type of rash should be seen by a healthcare provider. Call 911 if you are accompanied by shortness of breath, fast heartbeat, dizziness, or swelling of your face, tongue, or throat. These can be signs of an allergic emergency.


Animal studies have shown a slight increase in the risk of birth defects when Elidel and Protopic are administered in doses far exceeding those used in humans. Adequate studies in humans are lacking, but the potential benefits of the treatment may outweigh the risks.

Due to the lack of safety studies, be sure to discuss the potential benefits and risks of Elidel or Protopic with your healthcare provider if you are pregnant or breastfeeding (or plan to).

black box warning

In 2006, the FDA issued a boxed warning informing consumers and healthcare professionals that Elidel and Protopic were associated with an increased risk of skin cancer and lymphomas, particularly T-cell lymphomas.

While acknowledging that the incidence of cancer is “rare,” the FDA believes the recommendation is justified by the overprescribing of the drug in infants and young children and the off-label use of the drug in treating various other rashes.

It was a controversial decision that continues to be criticized by the American Academy of Dermatology (AAD) and the American Academy of Allergy, Asthma and Immunology (AAAAI).

A 2013 study submitted to the FDA found no evidence of an increased risk of lymphoma among 625,915 people who used Protopic or Elidel for an average of five and a half years.

Regarding skin cancer, the FDA’s conclusions are based on studies involving organ recipients exposed to intravenous tacrolimus or cyclosporine. Although these users did experience an increased risk of skin cancer and lymphoma, this increase was never observed among users of topical tacrolimus or pimecrolimus.

Among the 11 million users of Protopic or Elidel, the risk of lymphoma or skin cancer has never been higher than in the general population, according to research published at the time of the FDA warning.


It is not known whether Elidel or Protopic can interact with other drugs. Although few studies have investigated potential interactions, both drugs are known to be metabolized using an enzyme called cytochrome P450 3A4 (CYP3A4).

Therefore, Elidel or Protopic may interact with drugs that inhibit CYP3A4, resulting in abnormal accumulation of Elidel and Protopic in the body. These include:

  • calcium channel blockers
  • Dafucon (fluconazole)
  • erythromycin
  • Nizoral (ketoconazole)
  • Sporanox (itraconazole)
  • Tagamet (cimetidine)

While the significance of the interaction, if any, is unclear, it is important to inform your healthcare provider of any medications you may be taking—whether prescription, over-the-counter, nutritional, or recreational.

Frequently Asked Questions

  • Is pimecrolimus cream an over-the-counter drug?

    No, pimecrolimus cream is not an over-the-counter drug and requires a prescription. It can help manage eczema symptoms when other medications are unsuccessful or cannot be used for health reasons. Pimecrolimus cream is a generic version of Elidel.

  • Can you use Elidel for perioral dermatitis?

    Elidel is not usually used to treat perioral dermatitis. Sometimes the rash goes away on its own, but if the rash persists, topical antibiotics such as tetracycline or erythromycin can be used. Treatment of perioral dermatitis may benefit from a gentle face wash with a fragrance-free cleanser, but a healthcare provider can develop a treatment plan.

  • Can erythema cause itchy eyelids with bumps?

    Yes, erythema multiforme may cause itchy eyelids along with the formation of red spots or bumps. Other symptoms include cold sores, fatigue, fever, joint pain, and possible red spots or blisters on the face, palms, and soles. Erythema multiforme may go away on its own after a week or two, as long as no infection develops. Erythema multiforme can be serious and may require medical attention.

How to Treat Eczema