LOW-VOLUME · HOSP-MID
imiquimod Side Effects
imiquimod (also sold as Aldara) is a LOW-VOLUME FAERS extract #453 of 524 by FAERS report count. Still opens on HOSP-MID: 13.9% mention hospitalization (302 reports).
Data updated 2026-05-15
- 2,179
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
imiquimod: 13.9% mention hospitalization (302 reports). Death stamp DEATH-MARKED; volume band LOW-VOLUME #453 of 524 by FAERS report count.
Thinner FAERS extract for imiquimod (Aldara) (2,179 reports #453 of 524 by FAERS report count). 13.9% mention hospitalization (302 reports). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2004–2025). Stamps SIGNAL · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ERYTHEMA leads 176 of 2,179 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (376 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 65 reports (3.0% - MARKED). Reactions below co-occur in those rows only.
| 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 |
| 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
Hospitalization mid-share (302, 13.9%). Co-reported reactions:
| 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 |
| BACK PAIN | 13 |
How to read imiquimod FAERS figures (SIGNAL · DEATH-MARKED · HOSP-MID)
FAERS holds 2,179 voluntary reports linked to imiquimod (Aldara), 2004-2025. Death is listed on 65 (3.0%). Hospitalization appears on 302 (13.9%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with imiquimod
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-MID stamps.
ABS(total_reports) peer at 2,164 FAERS cases (Δ 15 lighter vs imiquimod); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,157 FAERS cases (Δ 22 lighter vs imiquimod); DEATH-RARE · HOSP-LIGHT · SEX-BALANCED vs this page's SIGNAL · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,222 FAERS cases (Δ 43 heavier vs imiquimod); DEATH-HEAVY · HOSP-HEAVY · MALE-LED vs this page's SIGNAL · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,229 FAERS cases (Δ 50 heavier vs imiquimod); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 59.1 pp vs imiquimod's DEATH-MARKED): CASELOAD · HOSP-MID.
imiquimod stamps SIGNAL · SEX-BALANCED; class peers and methodology beat restating the same FAERS caveats on every effects URL.