Eplerenone side effects: what 12,728 FDA adverse event reports show

Eplerenone · 1,103 reaction terms · 50,440 drug–reaction co-reports · data 2026-09-14

Drug class

Aldosterone Antagonist

FDA label (Established Pharmacologic Class)

Who reports

12,728 reports · 87% serious · 1,237 with death outcome · 23% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Eplerenone is an aldosterone antagonist indicated for: Improving survival of stable patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. ( 1.1 ) 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.

FDA label, Indications and Usage

What it is

Eplerenone is a blocker of aldosterone binding at the mineralocorticoid receptor. Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, γ-lactone, methyl ester, (7α,11α,17α)-.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Likely indication confounding 5Lab value / disease marker 3Not in label — unassessed 32

What the badges mean

Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,063 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Liver palpable	20	649.8 387.0–1,091.0ROR 650.8 · χ² 8,796 / p <1e-300	321.5 EB05 219.7 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=20 · ♀ 0% (drug 23%)	not reported in cached trials
Computerised tomogram coronary artery abnormal	19	643.0 378.1–1,093.4ROR 643.9 · χ² 8,271 / p <1e-300	314.8 EB05 213.0 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=19	not reported in cached trials
Platelet distribution width increased	13	586.6 311.2–1,105.8ROR 587.2 · χ² 5,161 / p <1e-300	264.0 EB05 164.2 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious n=13	not reported in cached trials
Hepatic vein dilatation	16	464.1 266.3–808.7ROR 464.7 · χ² 5,396 / p <1e-300	252.5 EB05 164.8 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Degenerative aortic valve disease	13	391.1 213.5–716.3ROR 391.5 · χ² 3,768 / p <1e-300	215.8 EB05 134.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Ventricular enlargement	33	380.2 260.3–555.2ROR 381.2 · χ² 9,808 / p <1e-300	261.6 EB05 194.9 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=33 · ♀ 0% (drug 23%) · 100% clinician	not reported in cached trials
N-terminal prohormone brain natriuretic peptide abnormal	14	361.0 202.3–644.0ROR 361.4 · χ² 3,822 / p <1e-300	210.9 EB05 133.5 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious n=14	not reported in cached trials
Renal phospholipidosis	20	328.2 203.0–530.4ROR 328.7 · χ² 5,158 / p <1e-300	216.8 EB05 148.2 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=20 · 100% clinician	not reported in cached trials
Atrial enlargement	42	296.6 213.6–412.0ROR 297.6 · χ² 10,215 / p <1e-300	225.3 EB05 173.7 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=41	not reported in cached trials
Glomerular filtration rate	10	262.0 134.4–510.8ROR 262.2 · χ² 2,020 / p <1e-300	158.3 EB05 91.9 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Therapeutic drug monitoring analysis incorrectly performed	10	191.1 99.3–367.9ROR 191.3 · χ² 1,526 / p <1e-300	129.5 EB05 75.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Inferior vena cava dilatation	20	173.7 109.6–275.4ROR 174.0 · χ² 2,949 / p <1e-300	136.8 EB05 93.5 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=20 · ♀ 0% (drug 23%)	not reported in cached trials
N-terminal prohormone brain natriuretic peptide increased	110	140.3 115.5–170.3ROR 141.5 · χ² 13,873 / p <1e-300	126.4 EB05 107.8 · IC025 +6.0 3/3 methods agree	Lab value / disease marker	serious n=110	not reported in cached trials
Mitral valve thickening	21	134.8 86.4–210.4ROR 135.1 · χ² 2,454 / p <1e-300	112.1 EB05 77.4 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=20 · ♀ 0% (drug 23%)	not reported in cached trials
Left ventricular enlargement	19	133.6 83.7–213.2ROR 133.8 · χ² 2,190 / p <1e-300	110.1 EB05 74.5 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=19	not reported in cached trials
Asthma-chronic obstructive pulmonary disease overlap syndrome	38	129.7 93.2–180.4ROR 130.1 · χ² 4,375 / p <1e-300	113.4 EB05 86.3 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=38	not reported in cached trials
Low cardiac output syndrome	24	127.4 84.1–193.0ROR 127.6 · χ² 2,675 / p <1e-300	108.2 EB05 76.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=24 · ♀ 0% (drug 23%) · 100% clinician	NCT00232180: 1/1,364 (0.1%) on Eplerenone; 1/1,372 (0.1%) control (serious AE)
Soft tissue mass	33	126.7 89.0–180.5ROR 127.1 · χ² 3,703 / p <1e-300	110.3 EB05 82.2 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=33 · ♀ 0% (drug 23%) · 100% clinician	not reported in cached trials
Cardiac failure chronic	272	112.5 99.6–127.0ROR 114.9 · χ² 28,009 / p <1e-300	104.5 EB05 94.5 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=272 · 93% clinician	NCT00232180: 44/1,245 (3.5%) on Eplerenone; 243/1,369 (17.8%) control (serious AE)
Cellulitis gangrenous	12	105.9 59.1–189.9ROR 106.0 · χ² 1,075 / p 6e-236	86.3 EB05 52.6 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Venous pressure jugular increased	21	99.7 64.2–154.9ROR 99.9 · χ² 1,842 / p <1e-300	86.8 EB05 59.9 · IC025 +4.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=21 · ♀ 0% (drug 23%) · 100% clinician	not reported in cached trials
Nonalcoholic fatty liver disease	11	96.6 52.6–177.4ROR 96.7 · χ² 894 / p 1e-196	79.1 EB05 47.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Left ventricular dilatation	26	90.2 60.8–133.9ROR 90.4 · χ² 2,090 / p <1e-300	80.6 EB05 57.8 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=26 · 100% clinician	not reported in cached trials
Therapeutic drug monitoring analysis not performed	15	87.3 52.0–146.8ROR 87.4 · χ² 1,134 / p 6e-249	75.3 EB05 48.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=15	not reported in cached trials
Left atrial enlargement	26	84.5 57.0–125.2ROR 84.6 · χ² 1,960 / p <1e-300	76.0 EB05 54.5 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=26 · 100% clinician	not reported in cached trials
Ventricular dyskinesia	10	83.7 44.4–158.1ROR 83.8 · χ² 701 / p 1e-154	69.5 EB05 40.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Cardiac amyloidosis	51	81.1 61.2–107.3ROR 81.4 · χ² 3,765 / p <1e-300	75.2 EB05 59.4 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=51 · 100% clinician	not reported in cached trials
Arrhythmic storm	14	73.1 42.8–124.9ROR 73.2 · χ² 885 / p 8e-195	64.2 EB05 40.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Type v hyperlipidaemia	20	72.2 46.1–112.9ROR 72.3 · χ² 1,277 / p 5e-280	65.1 EB05 44.5 · IC025 +3.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=20 · ♀ 0% (drug 23%) · 100% clinician	not reported in cached trials
Oesophageal perforation	34	70.2 49.8–98.9ROR 70.4 · χ² 2,157 / p <1e-300	65.0 EB05 48.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=34 · ♀ 0% (drug 23%) · 100% clinician	not reported in cached trials
Morganella infection	12	70.1 39.4–124.9ROR 70.2 · χ² 719 / p 1e-158	61.1 EB05 37.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Jugular vein distension	23	68.8 45.3–104.4ROR 68.9 · χ² 1,410 / p <1e-300	62.8 EB05 44.1 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=23 · ♀ 0% (drug 23%)	not reported in cached trials
Dilated cardiomyopathy	37	68.3 49.2–94.9ROR 68.5 · χ² 2,290 / p <1e-300	63.5 EB05 48.1 · IC025 +4.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=37 · 95% clinician	not reported in cached trials
Heart failure with preserved ejection fraction	10	65.5 34.8–123.2ROR 65.5 · χ² 550 / p 6e-122	56.6 EB05 32.8 · IC025 +2.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=10	not reported in cached trials
Respiratory tract haemorrhage	22	62.9 41.1–96.3ROR 63.0 · χ² 1,232 / p 4e-270	57.7 EB05 40.2 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=22 · 100% clinician	not reported in cached trials
Mitral valve calcification	23	60.8 40.1–92.2ROR 61.0 · χ² 1,248 / p 1e-273	56.1 EB05 39.4 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=23 · ♀ 0% (drug 23%)	not reported in cached trials
Hyperaldosteronism	12	59.4 33.4–105.7ROR 59.5 · χ² 610 / p 6e-135	52.8 EB05 32.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Bronchial hyperreactivity	40	56.6 41.3–77.5ROR 56.8 · χ² 2,058 / p <1e-300	53.4 EB05 40.9 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=40	not reported in cached trials
Cardiac ventricular disorder	13	53.3 30.7–92.6ROR 53.4 · χ² 597 / p 5e-132	48.2 EB05 30.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=13	NCT03342690: 1/1,139 (0.1%) on Eplerenone (serious AE)
Ischaemic cardiomyopathy	94	51.5 42.0–63.2ROR 51.9 · χ² 4,466 / p <1e-300	49.5 EB05 41.7 · IC025 +5.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=94	NCT00232180: 3/1,245 (0.2%) on Eplerenone; 2/1,369 (0.1%) control (serious AE)

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Eplerenone as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (4 of 40 signal terms matched).

NCT00232180 — A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated (N=2743, PHASE3; 698 AE terms posted; arms: Eplerenone: Double-blind Phase (May 25, ; Placebo: Double-blind Phase(May 25, 2010; Eplerenone: Double-blind Phase; Placebo: Double-blind Phase)
NCT03342690 — Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure) (N=1165, phase n/a; 149 AE terms posted; arms: Selara Tablets (Eplerenone))

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Dyspnoea (shortness of breath)	1,138	3.3 3.1–3.5ROR 3.5 · χ² 1,889 / p <1e-300	3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 2.8	NCT00232180: 3/1,245 (0.2%) on Eplerenone; 28/1,369 (2.0%) control (serious AE)
Cardiac failure (heart failure)	966	20.0 18.8–21.3ROR 21.6 · χ² 17,304 / p <1e-300	19.8 EB05 18.8 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.2	NCT00232180: 44/1,245 (3.5%) on Eplerenone; 243/1,369 (17.8%) control (serious AE)
Acute kidney injury (sudden kidney damage)	946	10.3 9.7–10.9ROR 11.0 · χ² 7,932 / p <1e-300	10.2 EB05 9.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.8 · 96% clinician	NCT03342690: 1/1,139 (0.1%) on Eplerenone
Hypotension (low blood pressure)	888	7.3 6.9–7.8ROR 7.8 · χ² 4,874 / p <1e-300	7.3 EB05 6.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	NCT00232180: 3/1,245 (0.2%) on Eplerenone; 6/1,369 (0.4%) control (serious AE)
Fatigue (tiredness)	690	1.5 1.4–1.6ROR 1.5 · χ² 105 / p 8e-25	1.5 EB05 1.4 · IC025 +0.4	Not in label — unassessed	serious PRR 1.5	NCT00232180: 1/1,245 (0.1%) on Eplerenone (serious AE)
Dizziness	674	2.2 2.1–2.4ROR 2.3 · χ² 467 / p 6e-104	2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.2	NCT00232180: 1/1,245 (0.1%) on Eplerenone; 6/1,369 (0.4%) control (serious AE)
Diarrhoea (diarrhea)	578	1.5 1.4–1.6ROR 1.5 · χ² 92 / p 3e-22	1.5 EB05 1.4 · IC025 +0.4	Not in label — unassessed	serious PRR 1.4	NCT00232180: 4/1,364 (0.3%) on Eplerenone; 2/1,369 (0.1%) control (serious AE)
Drug interaction	548	5.7 5.3–6.2ROR 5.9 · χ² 2,130 / p <1e-300	5.7 EB05 5.3 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 4.1 · 91% clinician	not reported in cached trials
Oedema peripheral (swelling of legs/feet)	528	7.1 6.6–7.8ROR 7.4 · χ² 2,784 / p <1e-300	7.1 EB05 6.6 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.1	NCT00232180: 1/1,245 (0.1%) on Eplerenone; 3/1,369 (0.2%) control (serious AE)
Drug ineffective (drug did not work)	509	0.6 0.6–0.7ROR 0.6 · χ² 112 / p 2e-26	0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 1.0	not reported in cached trials
Nausea	508	1.1 1.0–1.2ROR 1.1 · χ² 2 / p 0.092	1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 1.2	NCT00232180: 1/1,364 (0.1%) on Eplerenone; 1/1,369 (0.1%) control (serious AE)
Off label use (used outside approved label)	487	0.9 0.8–1.0ROR 0.9 · χ² 3 / p 0.040	0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.9	not reported in cached trials
Asthenia (weakness)	463	2.0 1.9–2.2ROR 2.1 · χ² 245 / p 2e-55	2.0 EB05 1.9 · IC025 +0.9	Not in label — unassessed	serious PRR 1.6	NCT00232180: 1/1,245 (0.1%) on Eplerenone; 6/1,369 (0.4%) control (serious AE)
Atrial fibrillation	431	7.3 6.7–8.0ROR 7.5 · χ² 2,340 / p <1e-300	7.2 EB05 6.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.0	NCT00232180: 7/1,245 (0.6%) on Eplerenone; 30/1,369 (2.2%) control (serious AE)
Fall	414	2.1 1.9–2.3ROR 2.1 · χ² 226 / p 3e-51	2.0 EB05 1.9 · IC025 +0.9	Not in label — unassessed	serious PRR 1.6	NCT00232180: 9/1,364 (0.7%) on Eplerenone; 10/1,369 (0.7%) control (serious AE)

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Liver palpable — n=20, PRR 649.8
Ventricular enlargement — n=33, PRR 380.2
Renal phospholipidosis — n=20, PRR 328.2
Atrial enlargement — n=42, PRR 296.6
Inferior vena cava dilatation — n=20, PRR 173.7
Mitral valve thickening — n=21, PRR 134.8
Asthma-chronic obstructive pulmonary disease overlap syndrome — n=38, PRR 129.7
Low cardiac output syndrome — n=24, PRR 127.4 (also seen in trial arm)
Soft tissue mass — n=33, PRR 126.7
Cardiac failure chronic — n=272, PRR 112.5 (also seen in trial arm)

✓ A hand-written Bradford Hill causality assessment exists for this drug: Eplerenone (MR antagonists) ↔ Hyperkalaemia.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Eplerenone?

In FDA FAERS, the most frequently co-reported reaction terms for Eplerenone are dyspnoea, cardiac failure, acute kidney injury, hypotension, fatigue, dizziness. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Eplerenone have an FDA boxed warning?

No. The FDA label retrieved for Eplerenone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Eplerenone causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 2002cf90-2d4a-43b1-bcd6-c447cbc7010f, effective 20240528; matched on openfda.generic_name.exact:"EPLERENONE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,103 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query EPLERENONE, results-bearing studies sorted by enrollment)

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.