Drugs › Aldosterone antagonist
Brand name · Spironolactone
Aldactone: adverse event reports filed with FDA
6,778 reports list it as a suspect or interacting product, 2004–2026. Class: Aldosterone antagonist. Also reported as Aldactone /00006201/, Aldactone Tablets, Aldactone Injection.
- 6,778
- reports as suspect product
- 0% of all reports · about 301 a year
- 155
- reports, 12 months to June 2026
- 251 in the 12 months before
- 92.3%
- marked serious by the reporter
- 89.5% across the class
- 10.1%
- record death among outcomes, as reported
- 682 reports · not verified by FDA
6,778 adverse event reports received by FDA list the brand name Aldactone (spironolactone) as a suspect or interacting product, from January 2004 to June 2026. A further 23,258 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, 155 reports listed it, down 38% from 251 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 301 reports a year and 0% of the 20,646,523 reports in the database, and 21.2% 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 MedDRA terms listed most often are hyperkalaemia (20.4%), acute kidney injury (12.6%) and drug interaction (12.5%). A report can list several reactions, so shares add to more than 100%; 1,012 different terms appear across these reports. Hyperkalaemia is recorded in 20.4% of these reports, a larger share than in the median aldosterone antagonist drug (10%).
92.3% of the reports are marked serious by the reporter (89.5% across the class); 10.1% record death among the outcomes and 63.5% record hospitalisation, as reported. 35.9% of the reports came from physicians, and the largest patient age group is 75 and over (38%). 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 Aldactone reports recording the termmedian drug in aldosterone antagonist
- Hyperkalaemiahigh blood potassium20.4%1,383
- Acute kidney injurysudden loss of kidney function12.6%857
- Drug interactionan interaction between medicines12.5%845
- Hyponatraemialow blood sodium9.3%633
- Renal failure acute8.9%604
- Hypotensionlow blood pressure6.9%470
- Dehydrationdehydration5.6%378
- Renal failurekidney failure5.1%345
- Falla fall4.6%315
- Bradycardiaslow heart rate4.6%314
- Dyspnoeashortness of breath3.6%245
- Astheniaweakness or lack of energy3.4%232
- Malaisegeneral feeling of being unwell3.4%232
- Cardiac failureheart failure3.3%224
- Diarrhoealoose or frequent stools3.3%223
- Off label useused for a purpose or in a way not on the label2.9%198
- Dizzinesslight-headedness or unsteadiness2.8%192
- Nauseafeeling sick2.7%183
- Vomitingbeing sick2.6%174
- Confusional stateconfusion2.5%169
- Blood creatinine increasedraised creatinine, a kidney test2.3%159
- Condition aggravatedthe condition being treated got worse2.3%157
- Fatiguetiredness2.3%155
- Drug hypersensitivityan allergic-type reaction to a medicine2.2%152
- Syncopefainting2.1%142
- Hypokalaemialow blood potassium2%133
- Oedema peripheralswelling of the legs, ankles or hands1.9%131
- Hepatic encephalopathy1.9%130
- Drug ineffectivethe medicine did not work as expected1.8%124
- Metabolic acidosistoo much acid in the body fluids1.7%118
Top 30 of 1,012 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. 16.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hypertension | 1,238 | 18.3% |
| Cardiac failure | 572 | 8.4% |
| Ascites | 144 | 2.1% |
| Cardiac failure congestive | 134 | 2% |
| Ill-defined disorder | 99 | 1.5% |
| Oedema | 80 | 1.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 6,778 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Aldactone reports |
|---|---|---|
| Furosemide | 1,105 | 16.3% |
| Lasix | 1,078 | 15.9% |
| Ramipril | 423 | 6.2% |
| Lasilix | 396 | 5.8% |
| Aspirin | 381 | 5.6% |
| Kardegic | 313 | 4.6% |
| Cordarone | 287 | 4.2% |
| Omeprazole | 286 | 4.2% |
| Digoxin | 269 | 4% |
| Entresto | 267 | 3.9% |
Other products listed in reports where Aldactone 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
| Measure | Aldactone | Aldosterone antagonist | All reports |
|---|---|---|---|
| Reports as suspect product | 6,778 | 31,972 | 20,646,523 |
| Share of that pool | — | 21.2% | 0% |
| Reports, latest 12 months | 155 | — | 1,332,454 |
| Marked serious | 92.3% | 89.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 101 | 81 | 91 |
| Hospitalisation recorded, per 1,000 reports | 635 | 569 | 213 |
| Consumer-filed share | 17% | 18.8% | 45.8% |
| Top term, share of reports | Hyperkalaemia 20.4% | median 10% | 0.2% |
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% |
| Eplerenone | generic | 3,354 | 252 | 94.9% |
| Inspra | brand | 1,109 | 17 | 85.8% |
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 Aldactone reports
How many adverse event reports has FDA received for Aldactone?
6,778 reports list Aldactone as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 155 of them arrived in the latest 12 months. Another 23,258 list it only as a concomitant medication.
What reactions are recorded in Aldactone reports?
hyperkalaemia (20.4%), acute kidney injury (12.6%), drug interaction (12.5%), hyponatraemia (9.3%) and renal failure acute (8.9%). 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 Aldactone was responsible.
How serious are the reports?
92.3% are marked serious by the reporter. Among the outcomes recorded, 10.1% of reports include death and 63.5% 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 (35.9%), other health professional (29.1%) and consumer or non-health professional (17%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Aldactone rising?
155 reports in the 12 months to June 2026, down 38% from 251 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 Aldactone 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 Aldactone?
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 Aldactone as a suspect or interacting product; reports listing it only as a concomitant medication (23,258) 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.