EPLERENONE

N/A

Manufactured by Viatris Specialty LLC

25,060 FDA adverse event reports analyzed

Last updated: 2026-04-14

About EPLERENONE

EPLERENONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. The most commonly reported adverse reactions for EPLERENONE include DYSPNOEA, CARDIAC FAILURE, ACUTE KIDNEY INJURY, HYPOTENSION, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EPLERENONE.

Top Adverse Reactions

DYSPNOEA1,083 reports
CARDIAC FAILURE940 reports
ACUTE KIDNEY INJURY905 reports
HYPOTENSION859 reports
FATIGUE659 reports
DIZZINESS650 reports
DIARRHOEA551 reports
DRUG INTERACTION529 reports
OEDEMA PERIPHERAL521 reports
NAUSEA487 reports
DRUG INEFFECTIVE475 reports
OFF LABEL USE447 reports
ASTHENIA437 reports
ATRIAL FIBRILLATION421 reports
FALL397 reports
HYPERKALAEMIA385 reports
CONDITION AGGRAVATED348 reports
MALAISE317 reports
HEADACHE310 reports
COUGH307 reports
PNEUMONIA299 reports
ANAEMIA294 reports
RENAL IMPAIRMENT292 reports
VOMITING285 reports
WEIGHT INCREASED282 reports
GENERAL PHYSICAL HEALTH DETERIORATION281 reports
BRADYCARDIA275 reports
CARDIAC FAILURE CHRONIC269 reports
WEIGHT DECREASED263 reports
DEHYDRATION260 reports
RENAL FAILURE260 reports
SYNCOPE254 reports
VENTRICULAR TACHYCARDIA251 reports
DEATH250 reports
CARDIAC FAILURE CONGESTIVE246 reports
BLOOD CREATININE INCREASED243 reports
EJECTION FRACTION DECREASED236 reports
PAIN235 reports
PYREXIA233 reports
HYPERTENSION225 reports
BLOOD PRESSURE DECREASED224 reports
CHEST PAIN221 reports
PRURITUS217 reports
ARTHRALGIA215 reports
DECREASED APPETITE209 reports
DYSPNOEA EXERTIONAL206 reports
MYOCARDIAL INFARCTION203 reports
HYPONATRAEMIA199 reports
PLEURAL EFFUSION194 reports
INSOMNIA189 reports
PALPITATIONS183 reports
PULMONARY OEDEMA180 reports
MITRAL VALVE INCOMPETENCE178 reports
PERIPHERAL SWELLING178 reports
MYALGIA174 reports
ARRHYTHMIA169 reports
HYPOKALAEMIA160 reports
RASH159 reports
RALES154 reports
GASTROINTESTINAL HAEMORRHAGE151 reports
ABDOMINAL PAIN148 reports
GLOMERULAR FILTRATION RATE DECREASED148 reports
CARDIOMYOPATHY146 reports
SEPSIS144 reports
FEELING ABNORMAL143 reports
BLOOD PRESSURE INCREASED140 reports
MUSCLE SPASMS140 reports
EPISTAXIS139 reports
CARDIAC DISORDER138 reports
TACHYCARDIA136 reports
ABDOMINAL PAIN UPPER135 reports
LOSS OF CONSCIOUSNESS135 reports
PAIN IN EXTREMITY135 reports
CHRONIC KIDNEY DISEASE134 reports
CARDIAC ARREST130 reports
CONSTIPATION130 reports
ABDOMINAL DISTENSION129 reports
BACK PAIN128 reports
TOXICITY TO VARIOUS AGENTS128 reports
URINARY TRACT INFECTION127 reports
CONFUSIONAL STATE126 reports
OEDEMA126 reports
CHEST DISCOMFORT123 reports
HYPOGLYCAEMIA123 reports
ANGINA PECTORIS121 reports
HAEMOGLOBIN DECREASED121 reports
PRODUCT USE IN UNAPPROVED INDICATION121 reports
FLUID RETENTION118 reports
HEART RATE INCREASED118 reports
ANXIETY116 reports
CARDIAC FAILURE ACUTE114 reports
RENAL FAILURE ACUTE113 reports
N TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED111 reports
PRODUCT DOSE OMISSION ISSUE111 reports
BLOOD GLUCOSE INCREASED110 reports
PARAESTHESIA110 reports
ABDOMINAL DISCOMFORT106 reports
CARDIOGENIC SHOCK106 reports
SOMNOLENCE106 reports
THROMBOCYTOPENIA103 reports

Report Outcomes

Out of 12,109 classified reports for EPLERENONE:

Serious 87.0%Non-Serious 13.0%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male8,581 (76.4%)
Female2,626 (23.4%)
Unknown27 (0.2%)

Reports by Age

Age 76318 reports
Age 75316 reports
Age 70304 reports
Age 74303 reports
Age 79300 reports
Age 67293 reports
Age 69292 reports
Age 77268 reports
Age 73267 reports
Age 64262 reports
Age 78257 reports
Age 81250 reports
Age 68248 reports
Age 72246 reports
Age 71238 reports
Age 66236 reports
Age 80232 reports
Age 65230 reports
Age 63228 reports
Age 61212 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with EPLERENONE?

This profile reflects 25,060 FDA FAERS reports that mention EPLERENONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for EPLERENONE?

Frequently reported terms in FAERS include DYSPNOEA, CARDIAC FAILURE, ACUTE KIDNEY INJURY, HYPOTENSION, FATIGUE, DIZZINESS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures EPLERENONE?

Labeling and FAERS entries often list Viatris Specialty LLC in connection with EPLERENONE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.