Drug side effects
pimecrolimus Side Effects
The reactions most often reported to the FDA for pimecrolimus (also sold as Elidel), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 1,541
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of pimecrolimus come from 1,541 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 1,541 reports to the FDA Adverse Event Reporting System (FAERS) for pimecrolimus (Elidel): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
1,541
Reports Mentioning Death
21
1.4% of reports — not proof the medicine caused the death
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 |
| 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 |
|---|---|
| FATIGUE | 12 |
| CROHN^S DISEASE | 11 |
| PNEUMONIA | 10 |
| ARTHRALGIA | 9 |
| DIARRHOEA | 9 |
| HOSPITALISATION | 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 dermatitis atopic with 178 submissions, followed by rash and pruritus.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to pimecrolimus's 1,541.
Read our methodology - how this data is sourced, computed, and verified.