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pimecrolimus

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Brand names: Elidel

Calcineurin Inhibitor (Topical) Rx

Pimecrolimus cream (Elidel) is a medicine that can help with eczema. It is used when other treatments have not worked well enough or are not a good choice for you.

Drug Pricing (NADAC)

Brand Price

$9.49/unit

Generic Price

$2.54/unit

Generic Savings

73%

Generic Available

Yes (2 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

This cream treats mild to moderate eczema, also known as atopic dermatitis.

Common side effects

Burning feeling on the skin where you put the cream, Headache, Runny nose

Key warnings

Using this medicine for a long time may have risks.

How It Works

Pimecrolimus cream is a calcineurin inhibitor. It works by reducing inflammation in the skin. This helps to relieve itching and rash caused by eczema.

How to Take It

Apply a thin layer of the cream to the affected skin twice a day. Stop using the cream when your eczema symptoms are gone. If your symptoms do not improve after 6 weeks, talk to your doctor. Do not use this cream for a long time.

Pregnancy & Breastfeeding

If you are pregnant, only use this cream if the benefit is greater than the risk to your baby. Talk to your doctor before using this medicine if you are breastfeeding.

Missed Dose

Apply the cream as soon as you remember. Then, continue with your regular schedule.

Storage

Store the cream at room temperature and do not freeze it.

Side Effects (from patient reports)

Based on 1,239 FDA adverse event reports.

The medicine did not work
229
Eczema
178
Skin rash
169
Itching
160
Using the medicine for a condition it is not approved for
118
Using the medicine for a condition it is not approved for
94
Eczema
80
Dry skin
79
Redness
68
Condition got worse
64

FDA Adverse Event Report Analysis

Detailed analysis of 1,541 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

1,541

Death-Related Reports

21

Hospitalization Reports

183

Top Indication

Dermatitis Atopic

Gender Distribution

Female 891 (64%)
Male 491 (35%)

Age Distribution

0–17 193
18–44 275
45–64 294
65–74 97
75+ 75

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DRUG INEFFECTIVE 229
2 DERMATITIS ATOPIC 178
3 RASH 169
4 PRURITUS 160
5 PRODUCT USE IN UNAPPROVED INDICATION 118
6 OFF LABEL USE 94
7 ECZEMA 80
8 DRY SKIN 79
9 ERYTHEMA 68
10 CONDITION AGGRAVATED 64
11 SKIN EXFOLIATION 64
12 INJECTION SITE PAIN 63
13 PAIN 60
14 PRODUCT DOSE OMISSION ISSUE 57
15 SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION 55

Reactions in Death Reports

DEATH 8
ASCITES 3
AZOTAEMIA 3
CANDIDA SEPSIS 3
MULTIPLE ORGAN DYSFUNCTION SYNDROME 3
PNEUMONIA ASPIRATION 3
PRURITUS 3
ACUTE PULMONARY OEDEMA 2
BACTERAEMIA 2
BLOOD BILIRUBIN INCREASED 2

Reactions in Hospitalization Reports

DRUG INEFFECTIVE 14
FATIGUE 12
CROHN^S DISEASE 11
PNEUMONIA 10
ARTHRALGIA 9
DIARRHOEA 9
HOSPITALISATION 9
OFF LABEL USE 9
PAIN 9
COVID-19 8

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Using this medicine for a long time may have risks. In rare cases, some people using similar medicines have gotten cancer, like skin cancer or lymphoma. Do not use this cream on children under 2 years old.

Known Drug Interactions

Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

Mechanism: Ketoconazole can slow down how your body breaks down pimecrolimus, which might lead to higher levels of the medicine in your blood. This happens because ketoconazole blocks the natural proteins that clear the drug from your system.

What to do: Use this combination with caution. Your doctor may want to monitor you for any side effects while using both medications.

Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

Mechanism: Fluconazole interferes with the way your body processes pimecrolimus, potentially causing the drug to stay in your system longer. This is because fluconazole stops the enzymes that normally get rid of the medicine.

What to do: Talk to your doctor before using these together. They may need to check for signs that you are getting too much pimecrolimus.

Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

Mechanism: Erythromycin can block the enzymes in your body that break down pimecrolimus. This can cause the amount of pimecrolimus in your body to increase.

What to do: Be careful when using these two drugs at the same time. Your healthcare provider might need to watch you more closely for side effects.

Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

Mechanism: Itraconazole stops the body from clearing pimecrolimus as quickly as it should. This can lead to higher-than-normal levels of pimecrolimus in your bloodstream.

What to do: Consult your doctor if you need to take both medications. They will decide if any changes to your treatment are necessary.

Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

Mechanism: Cimetidine can slow down the process your body uses to get rid of pimecrolimus. This might cause pimecrolimus to build up in your system.

What to do: Let your doctor know if you are taking cimetidine while using pimecrolimus. They may monitor you to ensure the combination is safe for you.

Common Questions

Can I use this cream on my baby?
No, do not use this cream on children under 2 years old.
How long can I use this cream?
Avoid using this cream for a long time. Stop when your symptoms are gone.
What should I do if my eczema gets worse?
Talk to your doctor if your eczema does not get better after 6 weeks or if it gets worse.
Can I use a bandage over the cream?
No, do not use bandages or dressings that cover the treated area.
Can I use this cream if I have a skin infection?
Talk to your doctor before using this cream if you have a skin infection.
Can I get a sunburn while using this cream?
The drug label does not mention increased risk of sunburn. Follow standard sun safety precautions.
What should I do if I accidentally swallow some of the cream?
Call your doctor or poison control center right away.
Can I use other creams or lotions with this medicine?
Ask your doctor or pharmacist before using other creams or lotions with this medicine.
Is it okay to use this cream if I have a weak immune system?
No, you should not use this cream if you have a weak immune system.
How often should I apply this cream?
Apply a thin layer of the cream to the affected skin twice a day.
What are the common side effects of pimecrolimus?
The most commonly reported side effects of pimecrolimus include Burning feeling on the skin where you put the cream, Headache, Runny nose, Cough, Flu. Based on 1,239 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does pimecrolimus interact with other medications?
Yes, pimecrolimus has 5 known drug interactions. Notable interactions include ketoconazole, fluconazole, erythromycin. Always inform your doctor about all medications you are taking.
What drug class is pimecrolimus?
pimecrolimus belongs to the Calcineurin Inhibitor (Topical) drug class. It requires a prescription (Rx). This cream treats mild to moderate eczema, also known as atopic dermatitis.
Is there a generic version of pimecrolimus?
Yes, generic pimecrolimus is available from 2 manufacturers. The generic costs $2.54 per unit compared to $9.49 for the brand version, saving approximately 73%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is pimecrolimus safe during pregnancy?
If you are pregnant, only use this cream if the benefit is greater than the risk to your baby. Talk to your doctor before using this medicine if you are breastfeeding. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for pimecrolimus

The FDA label for pimecrolimus (sold under brand names such as Elidel) classifies it as a prescription-only medication in the Calcineurin Inhibitor (Topical) class. This cream treats mild to moderate eczema, also known as atopic dermatitis. Official labeling lists 7 commonly reported side effects, including Burning feeling on the skin where you put the cream, Headache, Runny nose.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,239 voluntary reports. The database also lists 5 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $2.54 versus $9.49 for the brand — a 73% generic savings.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: September 30, 2020

All federal data sources used on this page