HIGH-VOLUME · HOSP-HEAVY
irbesartan Side Effects
irbesartan (also sold as Avapro) is HIGH-VOLUME in this FAERS book #154 of 524 by FAERS report count. Signature opener: HOSP-HEAVY - 42.8% mention hospitalization (18,387 reports).
Data updated 2026-05-15
- 43,004
- FAERS reports
FAERS voluntary reports, 2001 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
irbesartan: 42.8% mention hospitalization (18,387 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #154 of 524 by FAERS report count.
High-report extract for irbesartan (Avapro): 43,004 FAERS rows (2001-2025). Top named reactions: FATIGUE, NAUSEA, DIARRHOEA. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2001–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
FATIGUE leads 2,460 of 43,004 reports
Who reports · age peak 75+ (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 75+ (10,744 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (3,218 reports, 7.5%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 786 |
| ACUTE KIDNEY INJURY | 209 |
| DIARRHOEA | 172 |
| PNEUMONIA | 165 |
| RENAL FAILURE | 155 |
| CARDIAC ARREST | 147 |
| MYOCARDIAL INFARCTION | 136 |
| DYSPNOEA | 135 |
| FALL | 127 |
| NAUSEA | 126 |
| CARDIO-RESPIRATORY ARREST | 122 |
| FATIGUE | 119 |
| SEPSIS | 112 |
| LACTIC ACIDOSIS | 110 |
| VOMITING | 110 |
| DRUG INTERACTION | 107 |
| HYPOTENSION | 106 |
| ASTHENIA | 105 |
| CEREBROVASCULAR ACCIDENT | 102 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (18,387, 42.8% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| ACUTE KIDNEY INJURY | 1,540 |
| FALL | 1,383 |
| NAUSEA | 1,147 |
| DIARRHOEA | 1,067 |
| DYSPNOEA | 995 |
| VOMITING | 984 |
| ASTHENIA | 970 |
| FATIGUE | 947 |
| HYPOTENSION | 944 |
| MALAISE | 819 |
| PNEUMONIA | 817 |
| PYREXIA | 814 |
| HYPONATRAEMIA | 779 |
| DIZZINESS | 754 |
| DRUG INTERACTION | 746 |
| HEADACHE | 726 |
| PAIN | 704 |
| COUGH | 651 |
| CEREBROVASCULAR ACCIDENT | 641 |
| CONFUSIONAL STATE | 631 |
How to read irbesartan FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 43,004 voluntary reports linked to irbesartan (Avapro), 2001-2025. Death is listed on 3,218 (7.5%). Hospitalization appears on 18,387 (42.8%). Top co-reported indication: Product Used For Unknown Indication.
CASELOAD books overweight common drugs and loud reporting cultures; HOSP-HEAVY is the page opener, not a per-patient risk.
Read with irbesartan
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 42,665 FAERS cases (Δ 339 lighter vs irbesartan); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 42,504 FAERS cases (Δ 500 lighter vs irbesartan); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 43,650 FAERS cases (Δ 646 heavier vs irbesartan); DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 44,206 FAERS cases (Δ 1,202 heavier vs irbesartan); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 54.6 pp vs irbesartan's DEATH-HEAVY): CASELOAD · HOSP-MID.
irbesartan stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.