imiquimod Side Effects
Also known as: Aldara
Analysis of 2,179 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
2,179
Death-Related
65
3.0% of reports
Hospitalizations
302
13.9% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 65 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 27 |
| PNEUMONIA | 7 |
| PLEURAL EFFUSION | 5 |
| HERPES SIMPLEX | 4 |
| SEPSIS | 4 |
| ATRIAL FIBRILLATION | 3 |
| CARDIAC ARREST | 3 |
| DEHYDRATION | 3 |
| DISEASE PROGRESSION | 3 |
| DRUG INEFFECTIVE | 3 |
| DYSPNOEA | 3 |
| FALL | 3 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 3 |
| MALAISE | 3 |
| PULMONARY EMBOLISM | 3 |
| RESPIRATORY DISTRESS | 3 |
| RESPIRATORY FAILURE | 3 |
| SCAB | 3 |
| ANAEMIA | 2 |
| ANXIETY | 2 |
Reactions in Hospitalization Reports
Top reactions in 302 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| ASTHENIA | 30 |
| PNEUMONIA | 26 |
| DYSPNOEA | 21 |
| ERYTHEMA | 21 |
| ACUTE KIDNEY INJURY | 19 |
| PYREXIA | 19 |
| RENAL FAILURE | 19 |
| FATIGUE | 18 |
| INFLUENZA LIKE ILLNESS | 18 |
| CHILLS | 17 |
| DECREASED APPETITE | 17 |
| DIZZINESS | 17 |
| CHRONIC KIDNEY DISEASE | 16 |
| HYPONATRAEMIA | 16 |
| HYPOTENSION | 16 |
| NAUSEA | 16 |
| HEADACHE | 14 |
| MALAISE | 14 |
| OFF LABEL USE | 14 |
| BACK PAIN | 13 |
Nearby — Related Medications
What the FAERS Data Reveals About imiquimod Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 2,179 voluntary reports linked to imiquimod and its brand equivalents (Aldara), spanning 2004 through 2025. Of those, 65 (3.0%) listed death as an outcome and 302 (13.9%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 50% were female and 50% male; age distribution skews toward 45-64, with 376 reports in that bracket. The single most reported reaction is off label use with 257 submissions, followed by erythema and fatigue.
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.