pimecrolimus Side Effects
Also known as: Elidel
Analysis of 1,541 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
1,541
Death-Related
21
1.4% of reports
Hospitalizations
183
11.9% of reports
Top Indication
Dermatitis Atopic
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 21 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | 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 |
| CHOLESTASIS | 2 |
| DISEASE PROGRESSION | 2 |
| FALL | 2 |
| FLUID OVERLOAD | 2 |
| LACTIC ACIDOSIS | 2 |
| MALIGNANT NEOPLASM PROGRESSION | 2 |
| OFF LABEL USE | 2 |
| PORTAL HYPERTENSION | 2 |
| URINARY TRACT INFECTION | 2 |
| ABDOMINAL PAIN UPPER | 1 |
Reactions in Hospitalization Reports
Top reactions in 183 reports where hospitalization was an outcome.
| Reaction | 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 |
| ERYTHEMA | 8 |
| HYPOTENSION | 8 |
| URINARY TRACT INFECTION | 8 |
| BACK PAIN | 7 |
| DYSPNOEA | 7 |
| NAUSEA | 7 |
| PYREXIA | 7 |
| RASH | 7 |
| SKIN INFECTION | 7 |
| COUGH | 6 |
Nearby — Related Medications
What the FAERS Data Reveals About pimecrolimus Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 1,541 voluntary reports linked to pimecrolimus and its brand equivalents (Elidel), spanning 2004 through 2025. Of those, 21 (1.4%) listed death as an outcome and 183 (11.9%) involved hospitalization. The most common indication reported alongside adverse events was Dermatitis Atopic.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 64% were female and 35% male; age distribution skews toward 45-64, with 294 reports in that bracket. The single most reported reaction is drug ineffective with 229 submissions, followed by dermatitis atopic and rash.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.