Eplerenone adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Eplerenone
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Aldosterone antagonist
Also reported as: Eplerenone Tablet

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From March 2005 to June 2026, FDA received 3,354 adverse event reports that name Eplerenone. In these reports the drug is a suspect or interacting product.

In the same period, 6,658 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 252 reports in the 12 months to June 2026 and 284 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 252 (under 0.1%) name Eplerenone. Reports for male patients were 68.4% of the reports that name Eplerenone and 34.6% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Eplerenone is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 70 reports that name Eplerenone.
In January to March 2026, FDA received 72.
In April to June 2025, FDA received 43.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 478 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 3,330 of the 3,354 reports (99.3%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 478 terms.

Reaction terms in the reports that name Eplerenone, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,354 reports
Acute kidney injurysudden loss of kidney function	504	15%
Hypotensionlow blood pressure	389	11.6%
Dyspnoeashortness of breath	332	9.9%
Cardiac failureheart failure	319	9.5%
Oedema peripheralswelling of the legs, ankles or hands	249	7.4%
Hyperkalaemiahigh blood potassium	243	7.2%
Dizzinesslight-headedness or unsteadiness	226	6.7%
Drug interactionan interaction between medicines	224	6.7%
Drug ineffectivethe medicine did not work as expected	216	6.4%
Fatiguetiredness	180	5.4%
Condition aggravatedthe condition being treated got worse	156	4.7%
Bradycardiaslow heart rate	153	4.6%
Off label useused for a purpose or in a way not on the label	153	4.6%
Nauseafeeling sick	143	4.3%
Renal impairmentreduced kidney function	124	3.7%
Falla fall	123	3.7%
General physical health deteriorationgeneral decline in health	122	3.6%
Atrial fibrillationan irregular heart rhythm	119	3.5%
Cardiac failure chronic	119	3.5%
Diarrhoealoose or frequent stools	111	3.3%
Hyponatraemialow blood sodium	111	3.3%
Blood pressure decreaseda low blood pressure reading	95	2.8%
Astheniaweakness or lack of energy	89	2.7%
Rales	88	2.6%
Glomerular filtration rate decreasedreduced kidney filtering	85	2.5%
Ventricular tachycardiaa fast rhythm from the lower heart chambers	83	2.5%
Arrhythmia	81	2.4%
Dyspnoea exertional	80	2.4%
Ejection fraction decreased	80	2.4%
N-terminal prohormone brain natriuretic peptide increased	80	2.4%
Pulmonary oedemafluid in the lungs	80	2.4%
Vomitingbeing sick	80	2.4%
Blood creatinine increasedraised creatinine, a kidney test	79	2.4%
Weight increasedweight gain	79	2.4%
Cardiac failure congestivecongestive heart failure	78	2.3%
Dehydration	78	2.3%
Mitral valve incompetence	72	2.1%
Renal failurekidney failure	69	2.1%
Pleural effusionfluid around the lung	68	2%
Syncopefainting	68	2%
Hypertensionhigh blood pressure	66	2%
Anaemialow red blood cells	65	1.9%
Malaisegeneral feeling of being unwell	65	1.9%
Cardiomyopathydisease of the heart muscle	64	1.9%
Cough	64	1.9%
Weight decreasedweight loss	64	1.9%
Chest pain	63	1.9%
Feeling abnormalfeeling odd or not right	62	1.8%
Myocardial infarctionheart attack	60	1.8%
Arthralgiajoint pain	57	1.7%

Download all 478 terms of Eplerenone (CSV)

The counts add to more than 3,354 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Eplerenone with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Eplerenone (this page)	Generic name	3,354
Inspra	Brand name	1,109

Sum of the separately reported names: 4,463. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Eplerenone, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2005	7	7	0	0	3	1	0	5	0
2006	8	7	1	0	2	0	0	4	1
2007	9	8	1	1	0	0	0	8	1
2008	40	40	0	3	14	2	0	28	0
2009	21	21	1	2	12	0	0	10	0
2010	29	28	2	1	22	0	0	5	1
2011	66	62	8	3	44	1	0	21	4
2012	62	56	6	4	36	2	0	27	6
2013	25	21	1	2	12	0	0	11	4
2014	58	48	3	7	26	3	0	30	10
2015	54	38	7	3	27	0	0	9	16
2016	71	62	4	11	45	3	0	30	9
2017	75	69	0	2	38	3	0	37	6
2018	149	144	8	5	90	3	5	88	5
2019	273	263	16	11	171	12	1	176	10
2020	386	374	7	43	281	3	0	232	12
2021	407	394	10	16	258	2	0	290	13
2022	478	448	43	33	313	8	0	312	30
2023	338	328	12	28	195	5	0	242	10
2024	334	313	19	21	197	1	0	210	21
2025	295	285	20	25	167	4	0	197	10
2026	169	166	4	4	129	0	0	87	3

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Eplerenone, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Eplerenone, by the year in which FDA received them
Year	Reports
2005	7
2006	8
2007	6
2008	43
2009	19
2010	31
2011	66
2012	65
2013	32
2014	61
2015	54
2016	76
2017	81
2018	169
2019	296
2020	445
2021	494
2022	398
2023	292
2024	336
2025	233
2026	142

Reports that name Eplerenone, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Eplerenone
Age	Reports	Share
Under 2	2	0.1%
2 to 11	2	0.1%
12 to 17	2	0.1%
18 to 44	212	6.3%
45 to 64	824	24.6%
65 to 74	649	19.4%
75 and over	1,096	32.7%
Age not given	567	16.9%

Sex of the patient in the reports that name Eplerenone
Sex	Reports	Share
Female	751	22.4%
Male	2,295	68.4%
Unknown or not given	308	9.2%

Type of reporter in the reports that name Eplerenone
Reporter	Reports	Share
Physician	1,589	47.4%
Pharmacist	507	15.1%
Other health professional	810	24.2%
Lawyer	0	0%
Consumer or non-health professional	411	12.3%
Not given	37	1.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 9.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Eplerenone record
Indication as recorded (MedDRA)	Reports	Share
Cardiac failure	457	13.6%
Hypertension	272	8.1%
Cardiac failure chronic	76	2.3%
Myocardial ischaemia	54	1.6%
Cardiac failure congestive	53	1.6%
Diuretic therapy	27	0.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,354 reports.

Drugs in the same reports

Other drugs that the reports of Eplerenone name, in any role, in order of name
Drug	Reports that name the two
Allopurinol	358
Apixaban	353
Aspirin	424
Atorvastatin	695
Bisoprolol	1,066
Carvedilol	352
Dapagliflozin	335
Entresto	563
Furosemide	1,216
Ramipril	733

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Inspra same ingredient
Aldactone same class
Spironolactone same class
Epkinly next in the A to Z list
Eplontersen sodium next in the A to Z list
Epivir next in the A to Z list
Epoetin alfa next in the A to Z list
Epival next in the A to Z list
Epoetin Beta next in the A to Z list
Epitomax next in the A to Z list
Epogen next in the A to Z list
Epirubicine next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for EplerenoneThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Eplerenone: adverse event reports that FDA received. https://reportedreactions.com/drug/eplerenone/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Eplerenone as a suspect or interacting product. The 6,658 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Eplerenone was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Eplerenone?

No. It is a count of what people reported to FDA: 3,354 reports from March 2005 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (47.4%), other health professional (24.2%) and pharmacist (15.1%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

To the top of the page