Drugs › Aldosterone antagonist
Brand name · Eplerenone
Inspra: adverse event reports filed with FDA
1,109 reports list it as a suspect or interacting product, 2004–2026. Class: Aldosterone antagonist. Also reported as Inspra /01362602/, Inspra /01613601/.
- 1,109
- reports as suspect product
- 0% of all reports · about 49 a year
- 17
- reports, 12 months to June 2026
- 38 in the 12 months before
- 85.8%
- marked serious by the reporter
- 89.5% across the class
- 8.3%
- record death among outcomes, as reported
- 92 reports · not verified by FDA
1,109 adverse event reports received by FDA list the brand name Inspra (eplerenone) as a suspect or interacting product, from January 2004 to June 2026. A further 1,791 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 17 reports listed it, down 55% from 38 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 49 reports a year and 0% of the 20,646,523 reports in the database, and 3.5% of the reports for the aldosterone antagonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are acute kidney injury (11.4%), dyspnoea (6.7%) and hyperkalaemia (5.8%). A report can list several reactions, so shares add to more than 100%; 310 different terms appear across these reports. Acute kidney injury is recorded in 11.4% of these reports, about the same share as in the median aldosterone antagonist drug (13.3%).
85.8% of the reports are marked serious by the reporter (89.5% across the class); 8.3% record death among the outcomes and 42% record hospitalisation, as reported. 33.3% of the reports came from physicians, and the largest patient age group is 75 and over (26.3%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Inspra reports recording the termmedian drug in aldosterone antagonist
- Acute kidney injurysudden loss of kidney function11.4%126
- Dyspnoeashortness of breath6.7%74
- Hyperkalaemiahigh blood potassium5.8%64
- Drug ineffectivethe medicine did not work as expected5.5%61
- Diarrhoealoose or frequent stools5.4%60
- Hypotensionlow blood pressure5%56
- Cardiac disorder3.7%41
- Drug interactionan interaction between medicines3.7%41
- Eosinophilia3.7%41
- Dizzinesslight-headedness or unsteadiness3.4%38
- Renal failure acute3.4%38
- Off label useused for a purpose or in a way not on the label3.3%37
- Asthmaasthma3.2%36
- Dehydrationdehydration3.2%36
- Bronchitischest infection3.1%34
- Hyponatraemialow blood sodium3.1%34
- Cardiomyopathydisease of the heart muscle3%33
- Asthma-chronic obstructive pulmonary disease overlap syndrome2.9%32
- Breath sounds abnormal2.9%32
- Bronchial hyperreactivity2.9%32
- Drug intolerancethe medicine was not tolerated2.9%32
- Ischaemic cardiomyopathy2.9%32
- Pulmonary function test abnormal2.9%32
- Malaisegeneral feeling of being unwell2.8%31
- Bradycardiaslow heart rate2.7%30
- Renal failurekidney failure2.5%28
- Astheniaweakness or lack of energy2.4%27
- Headachehead pain2.3%26
- Fatiguetiredness2.2%24
Top 30 of 310 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 23.9% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Cardiac failure | 184 | 16.6% |
| Hypertension | 94 | 8.5% |
| Cardiac failure congestive | 25 | 2.3% |
| Myocardial ischaemia | 25 | 2.3% |
| Ill-defined disorder | 16 | 1.4% |
| Cardiomyopathy | 11 | 1% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,109 reports.
In context
| Measure | Inspra | Aldosterone antagonist | All reports |
|---|---|---|---|
| Reports as suspect product | 1,109 | 31,972 | 20,646,523 |
| Share of that pool | — | 3.5% | 0% |
| Reports, latest 12 months | 17 | — | 1,332,454 |
| Marked serious | 85.8% | 89.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 83 | 81 | 91 |
| Hospitalisation recorded, per 1,000 reports | 420 | 569 | 213 |
| Consumer-filed share | 25.2% | 18.8% | 45.8% |
| Top term, share of reports | Acute kidney injury 11.4% | median 13.3% | 0.7% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Spironolactone | generic | 20,731 | 1,457 | 87.9% |
| Aldactone | brand | 6,778 | 155 | 92.3% |
| Eplerenone | generic | 3,354 | 252 | 94.9% |
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.
Questions about Inspra reports
How many adverse event reports has FDA received for Inspra?
1,109 reports list Inspra as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 17 of them arrived in the latest 12 months. Another 1,791 list it only as a concomitant medication.
What reactions are recorded in Inspra reports?
acute kidney injury (11.4%), dyspnoea (6.7%), hyperkalaemia (5.8%), drug ineffective (5.5%) and diarrhoea (5.4%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Inspra was responsible.
How serious are the reports?
85.8% are marked serious by the reporter. Among the outcomes recorded, 8.3% of reports include death and 42% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (33.3%), consumer or non-health professional (25.2%) and other health professional (25.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Inspra rising?
17 reports in the 12 months to June 2026, down 55% from 38 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Inspra was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Inspra?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Inspra as a suspect or interacting product; reports listing it only as a concomitant medication (1,791) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.