MID-VOLUME · MALE-LED
eplerenone Side Effects
eplerenone (also sold as Inspra) sits MID-VOLUME #297 of 524 by FAERS report count. Lead signal: MALE-LED - 23% of sex-coded reports are female (2,625 F / 8,579 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 12,113
- FAERS reports
FDA Adverse Event Reporting System extract for eplerenone. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
eplerenone reporting skew - 23% of sex-coded reports are female (2,625 F / 8,579 M). Volume band MID-VOLUME #297 of 524 by FAERS report count; caseload WATCHLIST.
Mid-book FAERS page for eplerenone (Inspra) (12,113 reports). Signature MALE-LED. Dominant age band on file: 75+. Educational reference only.
Counts from the openFDA FAERS extract (2004–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · MALE-LED.
DYSPNOEA leads 1,083 of 12,113 reports
MALE-LED reporters · age peak 75+
Male-led reporters (77% of sex-coded rows)
Age peak 75+ (3,218 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (1,200 reports, 9.9%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 249 |
| CARDIAC FAILURE | 147 |
| ACUTE KIDNEY INJURY | 133 |
| DYSPNOEA | 125 |
| PNEUMONIA | 95 |
| SEPSIS | 85 |
| CARDIAC FAILURE CONGESTIVE | 79 |
| CARDIAC ARREST | 78 |
| HYPOTENSION | 74 |
| PLEURAL EFFUSION | 69 |
| DRUG INTERACTION | 67 |
| MALAISE | 66 |
| RENAL IMPAIRMENT | 65 |
| PYREXIA | 64 |
| TOXICITY TO VARIOUS AGENTS | 62 |
| RENAL FAILURE | 59 |
| MYOCARDIAL ISCHAEMIA | 58 |
| COUGH | 55 |
| ASCITES | 54 |
| ANAEMIA | 53 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (6,337, 52.3% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| ACUTE KIDNEY INJURY | 749 |
| DYSPNOEA | 740 |
| CARDIAC FAILURE | 706 |
| HYPOTENSION | 624 |
| OEDEMA PERIPHERAL | 372 |
| DIZZINESS | 339 |
| ATRIAL FIBRILLATION | 310 |
| DRUG INTERACTION | 310 |
| FALL | 310 |
| DIARRHOEA | 290 |
| NAUSEA | 276 |
| FATIGUE | 275 |
| ASTHENIA | 261 |
| HYPERKALAEMIA | 259 |
| CONDITION AGGRAVATED | 258 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 249 |
| ANAEMIA | 243 |
| PNEUMONIA | 228 |
| DEHYDRATION | 227 |
How to read eplerenone FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 12,113 voluntary reports linked to eplerenone (Inspra), 2004-2025. Death is listed on 1,200 (9.9%). Hospitalization appears on 6,337 (52.3%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 23% of sex-coded reports are female (2,625 F / 8,579 M).
Read with eplerenone
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 12,302 FAERS cases (Δ 189 heavier vs eplerenone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · MALE-LED.
ABS(total_reports) peer at 11,724 FAERS cases (Δ 389 lighter vs eplerenone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · MALE-LED.
ABS(total_reports) peer at 11,723 FAERS cases (Δ 390 lighter vs eplerenone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · MALE-LED.
ABS(total_reports) peer at 11,690 FAERS cases (Δ 423 lighter vs eplerenone); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · MALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 52.2 pp vs eplerenone's DEATH-HEAVY): CASELOAD · HOSP-MID.
eplerenone stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.