Elidel (Pimecrolimus) - Topical


The Food and Drug Administration warns that Elidel (pimecrolimus) can increase one’s chances of getting some cancers, such as skin and lymphoma. However, most of the data suggesting theoretical risk come from studies in which people received calcineurin inhibitors orally or in an intravenous form. These people were receiving doses much higher than those you would get from Elidel, which is applied to the skin in much lower doses.

In recent studies, it seems like this risk from Elidel is nonexistent or at least extremely low

What Is Elidel?

Elidel (pimecrolimus) is a prescription drug applied to the skin as a cream to treat eczema (atopic dermatitis) in people who haven’t responded well to other therapies.

Elidel is a type of drug known as a calcineurin inhibitor, which works by decreasing the inflammation that causes the red, irritated, and itchy skin of eczema. Specifically, these drugs help reduce inflammation caused by a specific type of immune cells called T cells, thereby decreasing eczema symptoms.

Drug Facts

Generic Name: Pimecrolimus

Brand Name(s): Elidel

Drug Availability: Prescription

Therapeutic Classification: Dermatological agent

Available Generically: Yes

Controlled Substance: N/A

Administration Route: Topical

Active Ingredient: Pimecrolimus

Dosage Form(s): Cream

What Is Elidel Used For?

Currently, Elidel is approved by the Food and Drug Administration (FDA) to treat only one condition: eczema (also called atopic dermatitis).

Specifically, the FDA has approved it to treat people with eczema who are 2 years of age or older and have mild or moderate levels of symptoms. It’s meant for temporary use to reduce symptoms.

You are eligible for treatment with Elidel if you:

  • Have tried other types of treatments for your eczema but still have significant symptoms
  • Are unable to use any other skin treatments

Verywell / Dennis Madamba

How to Use Elidel

Follow your healthcare provider's exact instructions when using Elidel.

Wash your skin before applying the cream, but make sure your skin is dry before you put on the cream. You’ll apply the cream to the affected area of the skin. Use only a thin layer. Often this will be done twice a day.

Do not get Elidel in your eyes, nose, or mouth, or in your vagina or rectum. These areas are sensitive, and this might cause a strong burning sensation. Rinse the area if you accidentally apply any in these regions.

After applying the cream, make sure to wash your hands with soap and water. But don’t shower or bathe right after applying it, as this might remove it.

If your healthcare provider has said it is OK to use a moisturizer, put this on your skin after the Elidel. Do not put a wrap or bandage around the area.

Your provider may instruct you to stop using the cream when your skin clears up. It can be used again at another time if your eczema comes back


Store Elidel at room temperature (about 70 degrees F).

Off-Label Uses

Health professionals sometimes prescribe Elidel off-label for use to treat a variety of other skin conditions not specified on the label.

Some of the conditions treated off-label include:

Elidel is also sometimes used off-label in children less than 2 years of age. 

For these conditions, the drug hasn’t been through the full set of studies required by the FDA to get official approval. However, some evidence still suggests that pimecrolimus is safe and effective for these conditions. It may be especially helpful for conditions that do not have other FDA-approved therapies available.

How Long Does It Take Elidel to Work?

You should notice an improvement within a couple of weeks after you start. Call your healthcare provider if you haven’t seen any improvement within several weeks.

What Are the Side Effects of Elidel?

This is not a complete list of side effects, and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Using Elidel may result in side effects, both common and severe.

Common Side Effects

The most common side effect of pimecrolimus is a sensation of warmth or slight burning where you apply the cream. Often this will go away within a few days of using the cream. Sometimes this symptom can be reduced by using a little bit of steroid (corticosteroid) cream as well, like hydrocortisone.

Many people don’t notice any side effects. However, some other potential ones are:

  • Headache
  • Stuffy nose
  • Cough

Severe Side Effects

If you are using Elidel, you might be at higher risk of another type of skin infection, like a severe bacterial infection. However, this is much more likely if you have a severe disease causing your skin to bleed from eczema, and Elidel usually isn’t prescribed in this situation. Getting your eczema under control may actually reduce your overall risk of getting a skin infection.

Call your healthcare provider right away if you experience any serious side effects. For example, seek medical attention if you have fever and redness and swelling of the skin.

Long-Term Side Effects

The FDA label for Elidel contains a black box warning regarding certain kinds of cancer. A black box warning appears on the label of prescription medication to alert you and your healthcare provider of any important safety concerns.

According to the black box warning, Elidel might increase one’s chances of getting some cancers, especially skin cancers and lymphoma.

However, most of the data suggesting theoretical risk come from studies in which people received calcineurin inhibitors orally or in an intravenous form. These people were receiving doses much higher than those you would get from Elidel, which is applied to the skin in much lower doses.

In recent studies, it seems like this risk from Elidel is nonexistent or at least extremely low. Still, it’s a good idea to discuss the possible risks and benefits in your situation. It is also recommended only to use Elidel temporarily.

The FDA also advises that people reduce their overall exposure to the sun while using Elidel, which might lessen one’s risk of skin cancer. People should also avoid such exposure through tanning beds or sun lamps.

Call your provider right away if you notice any unusual skin changes. If you have hardened lymph nodes, night sweats, or loss of appetite, you should also see your provider as soon as you can.

Report Side Effects

Elidel may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Elidel Should I Use?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For topical dosage form (cream):
    • For atopic dermatitis:
      • Adults, teenagers, and children 2 years of age and above—Apply a thin layer to the affected areas of the skin two times per day.
      • Children younger than 2 years of age—Use is not recommended.

Missed Dose

If you miss a dose, just apply the cream when you think of it. If you are close to your next dose, just wait and do it then. Do not use twice as much cream when you do use the drug.

Overdose: What Happens If I Use Too Much Elidel?

It would be very difficult to overdose on Elidel if using the drug just on your skin. However, it’s still a good idea to contact your healthcare provider if you or someone else has used noticeably more than you should have.

What Happens If I Overdose on Elidel?

If you think you or someone else may have overdosed on Elidel (pimecrolimus), call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking pimecrolimus, call 911 immediately.


Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress or your child's progress at regular visits. This will allow your doctor to see if this medicine is working properly and to decide if you should continue to use it.

If your symptoms do not improve after 6 weeks or if they become worse, check with your doctor.

Using this medicine for a long time may increase your risk of having infections, lymphoma, or skin cancer. If you have questions, discuss this with your doctor.

This medicine may cause soreness, itching, stinging, or a burning sensation on your skin. Stop using this medicine and check with your doctor right away if this reaction becomes severe or persists for more than one week.

Lymph node problems may occur while using this medicine. Check with your doctor right away if you have swollen, painful, or tender lymph glands in your neck, armpit, or groin.

Make sure your doctor knows if you are also having ultraviolet (UV) light treatment or phototherapy while you are using this medicine.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen and wear protective clothing when you are outdoors. Avoid sunlamps and tanning beds.

What Are Reasons I Shouldn’t Use Elidel?

Pimecrolimus isn’t a good choice for everyone.

You should not use Elidel if you:

  • Have a history of hypersensitivity to pimecrolimus or any of its ingredients
  • Are immunocompromised for any reason, such as having HIV
  • Have malignant or premalignant skin conditions
  • Are taking immunosuppressive medications, such as for an autoimmune disease 
  • Have a rare skin condition called Netherton syndrome

People who are pregnant should discuss the potential benefits and risks of the drug before starting it because it is not clear if it is safe for the baby. It’s generally not recommended that people use pimecrolimus while breastfeeding.

What Other Medications Interact With Elidel?

Potential drug interactions between Elidel and other drugs haven’t been well studied. Because a relatively low dose gets into your blood, using Elidel while taking other medications is unlikely to cause major problems.

Consuming alcohol while using Elidel may cause the face to become flushed or red. However, this typically resolves within an hour on average.

It’s important to discuss all your medications with your healthcare provider before starting Elidel. Your provider can let you know if you’ll need modifications to any of your treatments.

What Medications Are Similar?

Protopic (tacrolimus) is the only other type of calcineurin inhibitor applied to the skin that is available in the United States. Your healthcare provider might prescribe it to use instead of Elidel, not in addition to it.

Unlike Elidel, Protopic is available in two different strengths, which allows it to be used in smaller amounts and in people with more severe forms of eczema.

Tacrolimus is also available in an oral form, Prograf. Prograf is often prescribed for people who have had organ transplants. However, oral tacrolimus isn’t appropriate for those with eczema or the other conditions sometimes treated with Elidel off-label.

If you have eczema, other medications applied to the skin may be appropriate as well. Most commonly, this involves a topical steroid cream. Indeed, this is usually recommended as a treatment option before trying a drug like Elidel.

Steroid creams also affect the immune system. However, they don’t do it in exactly the same way as calcineurin inhibitors. Steroid creams also have additional side effects—like thinned and weakened skin—that Elidel and Protopic don’t have.

One of the advantages of Elidel is that it can often be used to reduce the amount of steroid cream that you need. You can also use it in addition to a steroid cream prescription. Your healthcare provider will advise you on how to use these drugs in your situation.

Frequently Asked Questions

  • What is Elidel used for?

    Elidel is approved to treat atopic dermatitis, commonly known as eczema. It’s especially helpful if you’ve tried steroid creams and other therapies, but your symptoms still aren’t under control. 

    Elidel is also sometimes used to treat a number of other skin conditions off-label, like seborrheic dermatitis.

  • Can I safely use Elidel for my infant's eczema?

    Elidel has been approved only for people 2 years of age and older. Children under the age of 2 were not initially included in studies evaluating the drug’s use. Therefore, using Elidel in a baby is technically an off-label use.

    However, eczema is very common in children under the age of 2. A lot of data suggest that Elidel is actually quite safe and effective for these young children when used correctly, and many clinicians have noted success in using it.⁷ The main alternative, corticosteroid cream, has known risks and side effects as well. Elidel might actually help you reduce the amount of steroid cream needed.

  • How does Elidel work?

    Elidel works on certain cells of your immune system called T cells. These cells play a role in the inflammatory problems of eczema that lead to itchy, red skin.

    By blocking a protein called “calcineurin,” Elidel blocks some of the overactivity of these T cells. They produce fewer immune signals (cytokines) that promote inflammation, thereby reducing inflammation and helping your skin return to normal.

  • When can I stop using Elidel?

    Elidel is used only for limited periods of time (e.g., a few weeks) until your symptoms have diminished. It isn’t usually used as a long-term medication.

    Make a plan with your healthcare professional ahead of time. This person can let you know when you can stop using Elidel in your particular situation. They’ll also let you know what to do if your eczema flares back up again.

How Can I Stay Healthy While Using Elidel?

If you are using pimecrolimus, you are likely trying to get your eczema under control. Make sure to use no more than your healthcare provider recommends, and not for longer than recommended, to reduce your risk of side effects.

Fortunately, pimecrolimus seems to be a very safe and effective drug for many people. Other things, like using a moisturizer regularly and avoiding your eczema triggers, may help you reduce your symptoms as well. Know that you aren’t alone—your healthcare provider will work with you to develop the best treatment plan possible.

Medical Disclaimer

Verywell Health's drug information is meant for education purposes only and not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare professional. Consult your doctor before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

5 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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  2. Carr WW. Topical calcineurin inhibitors for atopic dermatitis: review and treatment recommendations. Paediatr Drugs. 2013 Aug;15(4):303-10. doi:10.1007/s40272-013-0013-9

  3. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi:10.1016/j.jaad.2014.03.023

  4. Food and Drug Administration. Elidel label. March 2014.

  5. Sigurgeirsson B, Boznanski A, Todd G, et al. Safety and efficacy of pimecrolimus in atopic dermatitis: a 5-year randomized trial. Pediatrics. 2015 Apr;135(4):597-606. doi:10.1542/peds.2014-1990

By Ruth Jessen Hickman, MD
Ruth Jessen Hickman, MD, is a freelance medical and health writer and published book author.