Eplerenone: adverse event reports filed with FDA

3,354

reports as suspect product

0% of all reports · about 157 a year

252

reports, 12 months to June 2026

284 in the 12 months before

94.9%

marked serious by the reporter

89.5% across the class

5.2%

record death among outcomes, as reported

173 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Eplerenone reports recording the termmedian drug in aldosterone antagonist

1. Acute kidney injurysudden loss of kidney function15%504
2. Hypotensionlow blood pressure11.6%389
3. Dyspnoeashortness of breath9.9%332
4. Cardiac failureheart failure9.5%319
5. Oedema peripheralswelling of the legs, ankles or hands7.4%249
6. Hyperkalaemiahigh blood potassium7.2%243
7. Dizzinesslight-headedness or unsteadiness6.7%226
8. Drug interactionan interaction between medicines6.7%224
9. Drug ineffectivethe medicine did not work as expected6.4%216
10. Fatiguetiredness5.4%180
11. Condition aggravatedthe condition being treated got worse4.7%156
12. Bradycardiaslow heart rate4.6%153
13. Off label useused for a purpose or in a way not on the label4.6%153
14. Nauseafeeling sick4.3%143
15. Renal impairmentreduced kidney function3.7%124
16. Falla fall3.7%123
17. General physical health deteriorationgeneral decline in health3.6%122
18. Atrial fibrillationan irregular heart rhythm3.5%119
19. Cardiac failure chronic3.5%119
20. Diarrhoealoose or frequent stools3.3%111
21. Hyponatraemialow blood sodium3.3%111
22. Blood pressure decreaseda low blood pressure reading2.8%95
23. Astheniaweakness or lack of energy2.7%89
24. Rales2.6%88
25. Glomerular filtration rate decreasedreduced kidney filtering2.5%85
26. Ventricular tachycardiaa fast rhythm from the lower heart chambers2.5%83
27. Arrhythmia2.4%81
28. Dyspnoea exertional2.4%80
29. Ejection fraction decreased2.4%80
30. N-terminal prohormone brain natriuretic peptide increased2.4%80

Top 30 of 729 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the aldosterone antagonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 31,972 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 9.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,354 reports.

Drugs most often listed in the same reports

Other products listed in reports where Eplerenone is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the aldosterone antagonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Eplerenone as a suspect or interacting product; reports listing it only as a concomitant medication (6,658) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.