MID-VOLUME · HOSP-HEAVY
itraconazole Side Effects
itraconazole (also sold as Sporanox) sits MID-VOLUME #304 of 524 by FAERS report count. Lead signal: HOSP-HEAVY - 38.1% mention hospitalization (4,304 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 11,311
- FAERS reports
FDA Adverse Event Reporting System extract for itraconazole. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
itraconazole: 38.1% mention hospitalization (4,304 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #304 of 524 by FAERS report count.
Mid-book FAERS page for itraconazole (Sporanox) (11,311 reports). Signature HOSP-HEAVY. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2004–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
DRUG INTERACTION leads 1,118 of 11,311 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (2,648 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (2,227 reports, 19.7%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 265 |
| PNEUMONIA | 205 |
| SEPSIS | 184 |
| PYREXIA | 164 |
| RESPIRATORY FAILURE | 156 |
| SEPTIC SHOCK | 127 |
| FEBRILE NEUTROPENIA | 124 |
| CONDITION AGGRAVATED | 117 |
| DRUG INTERACTION | 102 |
| DYSPNOEA | 100 |
| PLATELET COUNT DECREASED | 97 |
| DISEASE PROGRESSION | 87 |
| RENAL FAILURE | 86 |
| DIARRHOEA | 83 |
| MULTI-ORGAN FAILURE | 82 |
| WHITE BLOOD CELL COUNT DECREASED | 80 |
| ACUTE MYELOID LEUKAEMIA | 76 |
| INFECTION | 75 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (4,304, 38.1% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| DRUG INTERACTION | 473 |
| PYREXIA | 343 |
| PNEUMONIA | 290 |
| DYSPNOEA | 281 |
| CONDITION AGGRAVATED | 227 |
| FEBRILE NEUTROPENIA | 214 |
| NAUSEA | 193 |
| ANAEMIA | 188 |
| DIARRHOEA | 186 |
| SEPSIS | 166 |
| FATIGUE | 149 |
| COUGH | 134 |
| VOMITING | 133 |
| ACUTE KIDNEY INJURY | 127 |
| RASH | 125 |
| PLEURAL EFFUSION | 120 |
| PLATELET COUNT DECREASED | 117 |
| HYPOKALAEMIA | 116 |
How to read itraconazole FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 11,311 voluntary reports linked to itraconazole (Sporanox), 2004-2025. Death is listed on 2,227 (19.7%). Hospitalization appears on 4,304 (38.1%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 38.1% mention hospitalization (4,304 reports).
Read with itraconazole
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 11,257 FAERS cases (Δ 54 lighter vs itraconazole); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 11,247 FAERS cases (Δ 64 lighter vs itraconazole); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 11,380 FAERS cases (Δ 69 heavier vs itraconazole); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 11,382 FAERS cases (Δ 71 heavier vs itraconazole); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 42.4 pp vs itraconazole's DEATH-HEAVY): CASELOAD · HOSP-MID.
itraconazole stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.