eplerenone Side Effects
Also known as: Inspra
Analysis of 12,113 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
12,113
Death-Related
1,200
9.9% of reports
Hospitalizations
6,337
52.3% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 1,200 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| 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
Top reactions in 6,337 reports where hospitalization was an outcome.
| 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 |
| DRUG INEFFECTIVE | 240 |
| PNEUMONIA | 228 |
| DEHYDRATION | 227 |
Nearby — Related Medications
What the FAERS Data Reveals About eplerenone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 12,113 voluntary reports linked to eplerenone and its brand equivalents (Inspra), spanning 2004 through 2025. Of those, 1,200 (9.9%) listed death as an outcome and 6,337 (52.3%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 23% were female and 76% male; age distribution skews toward 75+, with 3,218 reports in that bracket. The single most reported reaction is dyspnoea with 1,083 submissions, followed by cardiac failure and acute kidney injury.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.