Pharmacologic class (EPC) · 4 drug pages

Aldosterone antagonist: adverse event reports filed with FDA

31,972 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

31,972
reports across the class: 0.2% of all reports; 1,881
reports, 12 months to June 2026: 2,410 in the 12 months before; 89.5%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

Aldosterone antagonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 31,972 adverse event reports received by FDA, 0.2% of the database, from January 2004 to June 2026.

1,881 reports arrived in the 12 months to June 2026, down 22% from 2,410 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 89.5% of the class's reports are marked serious, 8.1% record death among the outcomes and 56.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are acute kidney injury (13.6%), hyperkalaemia (13.6%) and hypotension (7.9%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Spironolactone	generic	20,731	1,457	87.9%	Acute kidney injury
AldactoneSpironolactone	brand	6,778	155	92.3%	Hyperkalaemia
Eplerenone	generic	3,354	252	94.9%	Acute kidney injury
InspraEplerenone	brand	1,109	17	85.8%	Acute kidney injury

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Acute kidney injurysudden loss of kidney function13.6%4,360
Hyperkalaemiahigh blood potassium13.6%4,353
Hypotensionlow blood pressure7.9%2,514
Drug interactionan interaction between medicines7.5%2,387
Dyspnoeashortness of breath6.5%2,077
Hyponatraemialow blood sodium6%1,907
Drug ineffectivethe medicine did not work as expected5.8%1,847
Dizzinesslight-headedness or unsteadiness4.7%1,492
Dehydrationdehydration4.5%1,433
Falla fall4.3%1,382
Fatiguetiredness4.2%1,350
Cardiac failureheart failure4%1,287
Off label useused for a purpose or in a way not on the label3.9%1,251
Renal failure acute3.6%1,164
Diarrhoealoose or frequent stools3.6%1,140
Nauseafeeling sick3.5%1,128
Condition aggravatedthe condition being treated got worse3.3%1,041
Bradycardiaslow heart rate3.1%996
Astheniaweakness or lack of energy3.1%989
Oedema peripheralswelling of the legs, ankles or hands3.1%986
Renal impairmentreduced kidney function2.9%915
Headachehead pain2.8%900
Renal failurekidney failure2.8%889
Vomitingbeing sick2.8%889
Hypertensionhigh blood pressure2.7%879

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death8.1%2,587

Life-threatening9.3%2,969

Hospitalisation (initial or prolonged)56.9%18,193

Disability1.9%615

Congenital anomaly0.5%149

Other serious48.3%15,440

Not serious10.5%3,357

Patient age

Under 20.7%234

2 to 110.5%147

12 to 170.4%139

18 to 446.7%2,144

45 to 6420.8%6,654

65 to 7419%6,079

75 and over31.2%9,987

Age not given20.6%6,588

Who reported

Physician34.2%10,938

Pharmacist15.7%5,032

Other health professional28%8,961

Lawyer0.1%30

Consumer or non-health professional18.8%6,020

Not given3.1%991

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Aldosterone antagonist reports

Which drugs are in the Aldosterone antagonist class on this site?

Spironolactone, Aldactone, Eplerenone and Inspra. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

31,972 reports through June 2026, 1,881 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

acute kidney injury (13.6%), hyperkalaemia (13.6%), hypotension (7.9%), drug interaction (7.5%) and dyspnoea (6.5%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.