Prescription medication · Calcineurin Inhibitor (Topical)

pimecrolimus

Name: pimecrolimus - FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

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

Compiled by PlainMeds Editorial, Drug Information Editorial Team

Data updated 2026-05-15

1,541
FDA reportsRarely reported: 5
InteractionsFew interactions: 73% less
Generic vs brandBig savings: $9.49
Brand price (NADAC)

What the data shows

pimecrolimus (Elidel) is a prescription Calcineurin Inhibitor (Topical), among the least-reported drugs the FDA tracks (1,541 FDA reports), whose generic runs roughly half the brand price or less (73% less).

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

pimecrolimus (Elidel) is a prescription Calcineurin Inhibitor (Topical). This cream treats mild to moderate eczema, also known as atopic dermatitis.

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.

Verify with FDA → · CMS NADAC pricing →

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 →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

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.

The sections below are summarized in plain English from pimecrolimus's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

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.

This is a plain-language summary of pimecrolimus's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.

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.

This is a plain-language summary of pimecrolimus's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.

Missed Dose

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

This is a plain-language summary of pimecrolimus's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.

Storage

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

Side Effects (from patient reports)

Based on 1,541 FDA adverse event reports.

Eczema

178
Skin rash

169
Itching

160
Eczema

80
Dry skin

79
Redness

68
Condition got worse

64
Skin peeling

64
Pain where the shot was given

63
Pain

60

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Reports over time

Adverse-event reports filed for pimecrolimus each year to the FDA Adverse Event Reporting System (FAERS).

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where pimecrolimus sits

pimecrolimus has more FDA adverse-event reports than 10% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is pimecrolimus; the line is the median (50th percentile).

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

Reports Mentioning Death

1.4% of reports — not proof of cause

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
2	DERMATITIS ATOPIC	178
3	RASH	169
4	PRURITUS	160
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
15	SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION	55
16	FATIGUE	52
17	DISCOMFORT	50
18	ARTHRALGIA	49
19	SLEEP DISORDER	47

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

FATIGUE 12

CROHN^S DISEASE 11

PNEUMONIA 10

ARTHRALGIA 9

DIARRHOEA 9

HOSPITALISATION 9

PAIN 9

COVID-19 8

ERYTHEMA 8

HYPOTENSION 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.