MID-VOLUME · HOSP-MID
ketoconazole Side Effects
ketoconazole (also sold as Nizoral) sits MID-VOLUME #261 of 524 by FAERS report count. Lead signal: HOSP-MID - 22.6% mention hospitalization (3,676 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 16,231
- FAERS reports
FDA Adverse Event Reporting System extract for ketoconazole. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-MID. How figures are compiled.
ketoconazole: 22.6% mention hospitalization (3,676 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #261 of 524 by FAERS report count.
Mid-book FAERS page for ketoconazole (Nizoral) (16,231 reports). Signature HOSP-MID. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2004–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
FATIGUE leads 929 of 16,231 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (3,146 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (1,079 reports, 6.6%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 415 |
| RENAL FAILURE | 78 |
| PNEUMONIA | 72 |
| DYSPNOEA | 65 |
| ACUTE KIDNEY INJURY | 60 |
| ASTHENIA | 55 |
| NAUSEA | 54 |
| ANAEMIA | 52 |
| PYREXIA | 51 |
| CHRONIC KIDNEY DISEASE | 50 |
| DIARRHOEA | 47 |
| PAIN | 46 |
| FATIGUE | 44 |
| RESPIRATORY FAILURE | 42 |
| DISEASE PROGRESSION | 39 |
| SEPSIS | 39 |
| CARDIO-RESPIRATORY ARREST | 38 |
| CARDIAC ARREST | 36 |
Reactions in Hospitalization Reports
Hospitalization mid-share (3,676, 22.6%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| DYSPNOEA | 278 |
| FATIGUE | 276 |
| PNEUMONIA | 258 |
| DIARRHOEA | 248 |
| NAUSEA | 246 |
| FALL | 235 |
| PAIN | 234 |
| ASTHENIA | 232 |
| ACUTE KIDNEY INJURY | 205 |
| DIZZINESS | 203 |
| RENAL FAILURE | 188 |
| PYREXIA | 183 |
| VOMITING | 182 |
| HEADACHE | 164 |
| DRUG INTERACTION | 160 |
| URINARY TRACT INFECTION | 158 |
| WEIGHT DECREASED | 147 |
| ANAEMIA | 146 |
How to read ketoconazole FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-MID)
FAERS holds 16,231 voluntary reports linked to ketoconazole (Nizoral), 2004-2025. Death is listed on 1,079 (6.6%). Hospitalization appears on 3,676 (22.6%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-MID as signal-detection rates next to 22.6% mention hospitalization (3,676 reports).
Read with ketoconazole
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 16,238 FAERS cases (Δ 7 heavier vs ketoconazole); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 16,243 FAERS cases (Δ 12 heavier vs ketoconazole); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 16,062 FAERS cases (Δ 169 lighter vs ketoconazole); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 16,403 FAERS cases (Δ 172 heavier vs ketoconazole); DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 55.5 pp vs ketoconazole's DEATH-HEAVY): CASELOAD · HOSP-MID.
ketoconazole stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.