Spironolactone
According to the FDA label: Spironolactone tablets are an aldosterone antagonist indicated for: The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1 ). Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2 ).
108,474 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Spironolactone in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Dyspnoea 8,613 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Fatigue 7,032 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Nausea 6,592 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 6,158 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Acute Kidney Injury 5,484 reports
A sudden drop in how well the kidneys are working. It is often temporary and can have many causes.
Full definition in the glossary →Dizziness 5,376 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Headache 5,177 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 4,871 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Drug Ineffective 4,674 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Hypotension 4,643 reports
Fall 4,037 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Asthenia 3,972 reports
Physical weakness or lack of strength.
Full definition in the glossary →Death 3,968 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Vomiting 3,958 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Pain 3,677 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 59,854 |
| Male | 40,666 |
| Unknown | 123 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 2,283 |
| 18-34 | 4,257 |
| 35-49 | 8,138 |
| 50-64 | 20,641 |
| 65-74 | 19,684 |
| 75+ | 22,670 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Spironolactone. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Hospitalization | 48,942 |
| Other Serious | 48,673 |
| Non-Serious | 25,444 |
| Death | 13,176 |
| Life-Threatening | 6,658 |
| Disability | 2,679 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Spironolactone. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2003 | 1 |
| 2004 | 925 |
| 2005 | 1,122 |
| 2006 | 1,074 |
| 2007 | 1,070 |
| 2008 | 1,199 |
| 2009 | 1,458 |
| 2010 | 1,968 |
| 2011 | 2,149 |
| 2012 | 2,740 |
| 2013 | 2,708 |
| 2014 | 3,550 |
| 2015 | 5,261 |
| 2016 | 6,808 |
| 2017 | 6,303 |
| 2018 | 7,716 |
| 2019 | 8,396 |
| 2020 | 7,880 |
| 2021 | 7,792 |
| 2022 | 7,953 |
| 2023 | 8,753 |
| 2024 | 9,688 |
| 2025 | 9,659 |
| 2026 (partial) | 2,301 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Spironolactone
In FDA adverse event reports that mention Spironolactone, these medications appeared most often in the same report.
- Furosemide (44,425 reports)
- Aspirin (16,880 reports)
- Omeprazole (14,562 reports)
- Carvedilol (13,453 reports)
- Ergocalciferol (12,352 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026