What the label lists and what reports show
Eplerenone side effects
Eplerenone's FDA label: “Most common adverse reactions (>2% and more frequent than with placebo): hyperkalemia and increased creatinine.” FAERS holds 12,729 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (1,137 reports).
- Generic listed
Check it at the source: the eplerenone FDA label on DailyMed (effective June 23, 2025, Viatris Specialty LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>2% and more frequent than with placebo): hyperkalemia and increased creatinine.
Table 3. Rates of Hyperkalemia (>5.5 mEq/L) in EPHESUS by Baseline Creatinine Clearance*
| Baseline Creatinine Clearance | INSPRA (N=508) n (%) | Placebo (N=363) n (%) |
|---|---|---|
| ≤30 mL/min | 160 (32) | 82 (23) |
| 31-50 mL/min | 122 (24) | 46 (13) |
| 51-70 mL/min | 86 (17) | 48 (13) |
| >70 mL/min | 56 (11) | 32 (9) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling: • Hyperkalemia [see Warnings and Precautions (5.1) ] HFrEF Post-MI: Most common adverse reactions (>2% and more frequent than with placebo): hyperkalemia and increased creatinine. ( 6.1 ) Hypertension: In clinical studies, adverse reactions with INSPRA were uncommon. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Heart Failure Post-Myocardial Infarction In EPHESUS, safety was evaluated in 3307 patients treated with INSPRA and 3301 placebo-treated patients. The overall incidence of adverse events reported with INSPRA (78.9%) was similar to placebo (79.5%). Adverse events occurred at a similar rate regardless of age, gender, or race. Patients discontinued treatment due to an adverse event at similar rates in either treatment group (4.4% INSPRA vs. 4.3% placebo), with the most common reasons for discontinuation being hyperkalemia, MI, and abnormal renal function. …
Source: FDA drug label, NDA021437 (Upjohn), as published by Viatris Specialty LLC, effective June 23, 2025 (SPL set 1a52bedc-8e2c-4116-a296-a87770676b4a), via openFDA; the full label on DailyMed
What do FAERS reports show?
12,729 reports list eplerenone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,237 are coded as a death and 6,664 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 1 is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Eplerenone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions