Elidel (pimecrolimus) is a prescription drug used to treat atopic dermatitis. Elidel can cause side effects that range from mild to serious. Examples include headache and cold and flu symptoms.

Specifically, Elidel is prescribed for adults and children ages 2 years and older to treat mild to moderate atopic dermatitis (a type of eczema) for short periods.

The active ingredient in Elidel is pimecrolimus. (An active ingredient is what makes a drug work.) The drug comes as a cream that’s applied to the skin.

Keep reading to learn about the common, mild, and serious side effects that Elidel can cause. For a general overview of the drug, including details about its uses, see this article.

Some people may experience mild to serious side effects during Elidel treatment. A few examples of the drug’s commonly reported side effects include:

  • flu*
  • common cold*
  • a burning sensation at the application area of the skin
  • headache

* While Elidel itself doesn’t cause viral, bacterial, or other types of infection, this drug can reduce your body’s ability to fight infection. This means treatment with this medication can increase your risk of certain conditions.

Mild side effects have been reported with Elidel. These include:

  • a burning sensation at the application area of the skin
  • headache
  • common cold*
  • cough*
  • flu*
  • fever*
  • sore throat*
  • minor infection*†
  • mild allergic reaction†‡

In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. And do not stop using Elidel unless your doctor recommends it.

Elidel may cause mild side effects other than those listed above. See the drug’s prescribing information for details.

* While Elidel itself doesn’t cause viral, bacterial, or other types of infection, this drug can reduce your body’s ability to fight infection. This means treatment with this medication can increase your risk of certain conditions.
† To learn more about this side effect, see the “Side effects explained” section below.
‡ An allergic reaction is possible after using Elidel, but it’s not clear whether this side effect occurred in studies.

Serious side effects have been reported with Elidel. These include:

If you develop serious side effects while taking Elidel, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

* While Elidel itself doesn’t cause viral, bacterial, or other types of infection, this drug can reduce your body’s ability to fight infection. This means treatment with this medication can increase your risk of certain conditions.
† To learn more about this side effect, see the “Side effects explained” section below.
‡ An allergic reaction is possible after using Elidel, but it’s not clear whether this side effect occurred in studies.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Elidel, visit MedWatch.

Elidel cream is used to help treat atopic dermatitis in children ages 2 years and older.

In the drug’s studies, warts were a more commonly reported side effect in children than in adults. However, it’s a rare side effect, occurring in only 1% of patients in the study.

During Elidel treatment, your child’s doctor may monitor for warts that worsen or do not respond to wart medications. If your child gets warts while using Elidel, their doctor might suggest stopping the treatment, treating the wart until it’s gone, and then continuing with Elidel.

For more information about potential side effects of Elidel in children, talk with your doctor or pharmacist.

Get answers to some frequently asked questions about Elidel’s side effects.

Are withdrawal symptoms possible with Elidel?

Unlike stopping topical steroids, which can lead to skin discoloration, flaking, and irritation, stopping Elidel is unlikely to cause withdrawal symptoms. Withdrawal effects were not reported in the drug’s studies.

If you have more questions about withdrawal symptoms from atopic dermatitis treatments, talk with your doctor or pharmacist.

Can Elidel cause eye-related side effects?

Elidel’s initial studies mention only rare reports of eye infection during treatment with the cream. However, since the drug was approved for public use, there have been some reports of eye irritation. This occurred when the cream was applied to the eyelids or near the eyes.

It’s best to use caution when applying Elidel near the eyes. Use it sparingly, and do not put Elidel in your eye. If redness, burning, or eye irritation occurs, clean the cream off the eye area and rinse the area with cold water. If eye-related side effects do not resolve, call your doctor right away.

Learn more about some of the side effects Elidel may cause.

Boxed warning: Risks with long-term use

Elidel has a boxed warning for risks with long-term use. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

Researchers have not yet confirmed the long-term safety of Elidel and topical calcineurin inhibitors (the group of drugs Elidel belongs to).

Because this type of drug has the ability to suppress the immune system, cancer can occur. Although a direct link wasn’t seen in Elidel studies, patients who used topical calcineurin inhibitors, including Elidel cream, have reported rare cases of skin cancer and lymphoma (white blood cell cancer).

Lymphoma may cause symptoms such as:

  • unexplained weight loss
  • swollen lymph glands
  • fatigue (low energy)
  • fever, chills, and night sweats
  • loss of appetite

Skin cancer may cause a combination of symptoms, such as:

  • sores that don’t heal
  • flaky, crusty, and peeling areas
  • skin discoloration

Factors that can increase your risk of immune system problems from using Elidel cream include:

  • using it continuously for long periods
  • using it over large areas of the body
  • using excessive amounts
  • having severe atopic dermatitis

What might help

Use Elidel for the minimum time needed to get eczema symptoms under control, and apply the drug sparingly.

Do not use it on:

  • children under the age of 2 years
  • people with immune system problems
  • areas of precancerous or cancerous skin

If Elidel hasn’t improved your symptoms after 6 weeks, your doctor may suggest a different treatment. It’s best to avoid using Elidel for longer than 1 year.

Infection

Infections were a common side effect reported in studies of Elidel. While Elidel itself doesn’t cause viral, bacterial, or other types of infection, this drug can reduce your body’s ability to fight them. This means treatment with this medication can increase your risk of certain conditions. An infection may cause symptoms such as:

  • an area of pain, swelling, soreness, skin redness or discoloration
  • fever, chills, and night sweats
  • green, brown, or yellow pus drainage
  • sinus congestion
  • sore throat
  • swollen lymph glands
  • cough
  • shortness of breath

Common types of infection reported include:

Factors that can increase the risk of infection when using this drug include:

  • using topical steroids right before starting Elidel
  • having severe atopic dermatitis
  • applying Elidel to an infected area

What might help

To reduce your risk of infection during Elidel treatment, apply the cream to clean, dry skin. Avoid applying Elidel to infected areas until the infection has cleared.

Be sure to isolate yourself from anyone with an active case of shingles or chickenpox. These contagious conditions may cause a severe herpes virus skin infection in a person with atopic dermatitis.

If you have questions about infection during Elidel treatment, talk with your doctor or pharmacist.

Allergic reaction

Like most drugs, Elidel can cause an allergic reaction in some people. But it’s not clear whether this side effect occurred in studies. Symptoms can be mild to serious and can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)
  • swelling under your skin (usually in your eyelids, lips, hands, or feet)
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What might help

Wash the area with a mild soap and rinse with cool water. Keep the area clean and dry.

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment such as Benadryl (diphenhydramine) to help manage your symptoms.

If your doctor confirms you’ve had a mild allergic reaction to Elidel, they’ll decide whether you should continue using it.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Elidel, they may have you switch to a different treatment.

Keeping track of side effects

During your Elidel treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start taking a new drug or using a combination of treatments.

Your side effect notes can include things such as:

  • what dose of the drug you were using when you had the side effect
  • how soon you had the side effect after starting that dose
  • what your symptoms were
  • how your symptoms affected your daily activities
  • what other medications you were taking
  • any other information you feel is important

Keeping notes and sharing them with your doctor will help them learn more about how Elidel affects you. They can then use this information to adjust your treatment plan if needed.

Below is important information you should consider before starting Elidel treatment.

Boxed warning: Risks with long-term use

Elidel has a boxed warning for risks with long-term use. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects explained” section above.

Other warnings

Elidel can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Elidel is a good treatment option for you.

Talk with your doctor about your health history before starting Elidel. Be sure to tell them if any of the following factors apply to you:

  • Netherton syndrome (a genetic condition linked to skin, hair, and the immune system)
  • immune system problems
  • skin infection, including chickenpox or herpes
  • precancerous or cancerous skin conditions
  • swollen lymph nodes
  • frequent sun exposure
  • taking other prescription medications, over-the-counter drugs, herbs, vitamins, or supplements
  • using other skin creams, especially a topical steroid
  • previous allergic reaction to Elidel
  • pregnancy
  • breastfeeding

Alcohol and Elidel

If you drink alcohol, it’s recommended that you avoid consuming it during Elidel treatment. After the drug became available for public use, some people reported that consuming alcohol during treatment with Elidel caused skin flushing.

If you have questions about alcohol and Elidel, talk with your doctor or pharmacist.

Pregnancy and breastfeeding with Elidel

There’s limited information about the safety of Elidel use during pregnancy or while breastfeeding.

Pregnancy

It’s not known whether it’s safe to use Elidel during pregnancy. Researchers have not studied the effects of this medication in pregnant people. Elidel is usually prescribed for someone who is pregnant only if the benefits of treatment outweigh the potential risks to the fetus.

If you’re pregnant or planning to become pregnant, talk with your doctor before starting this medication. If you can become pregnant, they may recommend using a form of birth control during your Elidel treatment.

Breastfeeding

It’s not known whether Elidel is safe to use while breastfeeding a child, but it’s not recommended. There’s no information on whether the drug passes through human breast milk or whether it could lead to serious side effects in a child who is breastfed.

Consult your doctor for advice on feeding options for your child while using Elidel, or ask about other eczema treatments considered safe while breastfeeding.

Like most drugs, Elidel can cause a number of side effects that range from mild to serious. But most are temporary and go away after a few days to weeks. If you have questions about side effects this medication can cause, talk with your doctor. Examples to help get you started include:

  • What is my risk of side effects from Elidel?
  • How long does the burning sensation last after applying Elidel?
  • What symptoms should I call you about if they occur?
  • Are there any potentially life threatening side effects from Elidel?

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Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.