Spironolactone: adverse event reports filed with FDA

20,731

reports as suspect product

0.1% of all reports · about 922 a year

1,457

reports, 12 months to June 2026

1,837 in the 12 months before

87.9%

marked serious by the reporter

89.5% across the class

7.9%

record death among outcomes, as reported

1,640 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 Spironolactone reports recording the termmedian drug in aldosterone antagonist

1. Acute kidney injurysudden loss of kidney function13.9%2,873
2. Hyperkalaemiahigh blood potassium12.8%2,663
3. Hypotensionlow blood pressure7.7%1,599
4. Drug ineffectivethe medicine did not work as expected7%1,446
5. Dyspnoeashortness of breath6.9%1,426
6. Drug interactionan interaction between medicines6.2%1,277
7. Hyponatraemialow blood sodium5.4%1,129
8. Dizzinesslight-headedness or unsteadiness5%1,036
9. Fatiguetiredness4.8%991
10. Dehydrationdehydration4.5%941
11. Falla fall4.5%925
12. Off label useused for a purpose or in a way not on the label4.2%863
13. Nauseafeeling sick3.8%786
14. Headachehead pain3.6%750
15. Diarrhoealoose or frequent stools3.6%746
16. Hypertensionhigh blood pressure3.5%727
17. Cardiac failureheart failure3.5%723
18. Condition aggravatedthe condition being treated got worse3.4%710
19. Renal impairmentreduced kidney function3.4%698
20. Astheniaweakness or lack of energy3.1%641
21. Vomitingbeing sick3%630
22. Coughcough2.9%606
23. Oedema peripheralswelling of the legs, ankles or hands2.8%585
24. Blood creatinine increasedraised creatinine, a kidney test2.7%556
25. General physical health deteriorationgeneral decline in health2.6%532
26. Malaisegeneral feeling of being unwell2.4%505
27. Bradycardiaslow heart rate2.4%499
28. Renal failure acute2.4%493
29. Weight increasedweight gain2.2%463
30. Confusional stateconfusion2.2%459

Top 30 of 2,180 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. 30% 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 20,731 reports.

Drugs most often listed in the same reports

Other products listed in reports where Spironolactone 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 Spironolactone as a suspect or interacting product; reports listing it only as a concomitant medication (91,170) 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.