Specifically, the Food and Drug Administration (FDA) has approved pimecrolimus topical cream for the short-term treatment of mild to moderate atopic dermatitis in adults and children ages 2 years and older.
This article describes possible side effects of pimecrolimus topical cream. You can learn more about pimecrolimus by talking with your doctor.
Pimecrolimus topical cream is a generic version of the brand-name drug Elidel.
Pimecrolimus topical cream has a boxed warning. A boxed warning is the most serious warning from the FDA. For details, see the “Side effects of pimecrolimus in detail” section below.
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More common side effects of pimecrolimus
Pimecrolimus topical cream may cause mild or serious side effects. Below are some of the more common side effects of this medication.
Commonly reported side effects of pimecrolimus topical cream include:
- burning where the cream is applied
- headache
- common cold
- cough
- fever
Mild side effects of pimecrolimus
Pimecrolimus may cause certain mild side effects. Usually, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.
Mild side effects of pimecrolimus topical cream that occurred in studies include:
- burning where the cream is applied
- headache
- common cold
- cough
- flu symptoms
- fever
- minor infection*†
- sore throat
- skin infection†
- swollen lymph nodes
Pimecrolimus topical cream may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.
* To learn more about this side effect, see the “Side effects of pimecrolimus in detail” section below.
† While it’s not known whether pimecrolimus topical cream actually causes infections, it can weaken your body’s immune response to an infection.
Serious side effects of pimecrolimus
Pimecrolimus may cause certain serious side effects. If you have any serious side effects from pimecrolimus topical cream, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.
After the FDA approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with pimecrolimus.
Serious side effects of pimecrolimus topical cream that occurred in studies include:
- severe infection*†
- risk of certain cancers with long-term use‡
* To learn more about this side effect, see the “Side effects of pimecrolimus in detail” section below.
† While it’s not known whether pimecrolimus topical cream actually causes infections, it can weaken your body’s immune response to an infection.
‡ Pimecrolimus topical cream has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of pimecrolimus in detail” section below.
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Get free cardAllergic reaction
For some people, pimecrolimus topical cream can cause an allergic reaction.
In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep using the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to pimecrolimus topical cream, your doctor may recommend using a different medication instead.
Common questions about side effects of pimecrolimus
Here are answers to some common questions about side effects of pimecrolimus topical cream. If you have other questions, talk with your doctor or pharmacist.
Can you apply pimecrolimus cream on the face?
Yes, you can apply pimecrolimus cream to all affected areas of your skin. This includes your face.
Wash your hands before applying the cream and make sure your skin is dry. Apply a thin layer to your face where you have signs and symptoms of eczema two times per day, as prescribed by your doctor. Wash your hands with soap and water afterward.
If you have more questions about applying pimecrolimus cream on your face, talk with your doctor.
How do the side effects compare between pimecrolimus vs. tacrolimus?
Pimecrolimus topical cream and tacrolimus topical ointment are both used to treat atopic dermatitis (eczema) in adults and some children. Both medications also belong to a group of drugs called calcineurin inhibitors.
Pimecrolimus and tacrolimus also cause similar side effects. For example, common side effects of both drugs include:
- burning where the medication is applied
- flu
- headache
- skin infection
- fever
Both drugs also have boxed warnings for the risk of cancer with long-term use. A boxed warning is the most serious warning from the FDA.
If you have more questions about how these drugs compare, talk with your doctor.
Side effects of pimecrolimus in detail
Below you’ll find details on some of the side effects of pimecrolimus topical cream.
Boxed warning: Risk of cancer with long-term use
Pimecrolimus topical cream has a boxed warning for the risk of cancer with long-term use, including skin cancer and lymphoma. A boxed warning is the most serious warning from the FDA.
It’s not known whether long-term use of pimecrolimus actually causes certain cancers. However, there have been rare cases of skin cancer and lymphoma in people using the drug.
Symptoms of skin cancer include:
- new or unusual skin lesions
- skin discoloration
- flaky, crusted, or peeling skin patches
Symptoms of lymphoma include:
- chills
- cough
- fatigue
- itchy skin
- unexplained weight loss
Certain factors can increase the risk of cancers with pimecrolimus topical cream. These include:
- using pimecrolimus topical cream for a long time
- using it over a large area of your body
- using excessive amounts of pimecrolimus cream
Ways to manage
To lower the risk of certain cancers, doctors won’t prescribe pimecrolimus topical cream for long periods of time or for children under age 2 years. And you should only apply the cream to areas affected by atopic dermatitis.
If you experience symptoms of skin cancer or lymphoma, tell your doctor. They’ll likely order tests to determine the cause of your symptoms and whether you have cancer.
Infection
In studies, infections were common in people using pimecrolimus topical cream. This side effect can be mild or serious.
While it’s not known whether pimecrolimus topical cream causes infections, it can weaken your body’s immune response to an infection. This means you can be at higher risk of viral, bacterial, and other types of infections, such as:
Infections can cause symptoms including:
- fever
- sore throat
- cough
- skin redness, pain, swelling, or discoloration
- shortness of breath
- congestion or runny nose
Ways to manage
To lower your risk of infections, only apply pimecrolimus topical cream to clean, dry, and undamaged skin. You should not apply it to any areas of the skin that are infected.
If you experience symptoms of infections, tell your doctor. Depending on the type of infection and the severity, they may recommend treatment.
Warnings for pimecrolimus
Below are some factors you may want to discuss with your doctor before using pimecrolimus topical cream.
Boxed warning
Pimecrolimus topical cream has a boxed warning. A boxed warning is the most serious warning from the FDA.
For details, see the “Side effects of pimecrolimus in detail” section above.
Other warnings
It may not be safe for you to use pimecrolimus topical cream if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether pimecrolimus topical cream is a safe treatment option for you.
Before using pimecrolimus topical cream, tell your doctor about your health and medications you take. Things to consider include:
- current skin infections, such as chickenpox or herpes
- if you have a weakened immune system
- if you’re currently pregnant or breastfeeding
- Netherton syndrome (a rare genetic skin disease)
- past allergic reaction to pimecrolimus
Pimecrolimus and pregnancy
It’s not known whether pimecrolimus topical cream should be used during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before using this medication.
Pimecrolimus and breastfeeding
Pimecrolimus topical cream should not be used while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before using this medication. Your doctor may recommend other ways to feed your child during treatment with pimecrolimus.
Pimecrolimus and alcohol
Pimecrolimus topical cream is not known to interact with alcohol.
But combining alcohol consumption with pimecrolimus topical cream use can worsen certain side effects, such as skin flushing.*
If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with pimecrolimus topical cream.
* Skin flushing was reported in some people using pimecrolimus cream after the drug was approved for use. Since consuming alcohol can also cause skin flushing, combining them could worsen this side effect.
Disclaimer: Optum Perks 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.