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Eplerenone

Eplerenon +pharma, Eplerenon Actavis, Eplerenon Bluefish, Eplerenon Genericon · ATC code C03DA04

Also known as: Eplerenon · Brand names: Eplerenon +pharma, Eplerenon Actavis, Eplerenon Bluefish, Eplerenon Genericon, Eplerenon Hcs, Eplerenon Ratiopharm, Eplezot, Inspra, Epleraxiro, Epleday

Key facts
Active substance
Eplerenone
Drug class
Antimineralocorticoid
ATC code
C03DA04
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Eplerenone is an aldosterone (mineralocorticoid receptor) antagonist. Per the US prescribing information, it is used for heart failure with reduced ejection fraction after a myocardial infarction and for hypertension.

What it is used for

  • To improve survival of stable patients with symptomatic heart failure with reduced ejection fraction (≤40%) after an acute myocardial infarction
  • Hypertension, to lower blood pressure and reduce the risk of cardiovascular events

Dosing

  • Heart failure post-MI: start 25 mg once daily, titrate to 50 mg once daily, preferably within 4 weeks; then adjust according to serum potassium (withhold at 6.0 mEq/L or above) – see the full text
  • Hypertension: 50 mg once daily; if response is inadequate, 50 mg twice daily; higher doses are not recommended
  • Measure serum potassium before starting, within the first week and at one month, then periodically
  • Moderate CYP3A inhibitors (e.g. erythromycin, saquinavir, verapamil, fluconazole): post-MI do not exceed 25 mg once daily; hypertension start at 25 mg once daily, maximum 25 mg twice daily

Contraindications

  • All patients: serum potassium above 5.5 mEq/L at initiation, creatinine clearance 30 mL/min or less, strong CYP3A inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, ritonavir)
  • Hypertension: type 2 diabetes with microalbuminuria; serum creatinine above 2.0 mg/dL (men) or 1.8 mg/dL (women); creatinine clearance below 50 mL/min; potassium supplements or potassium-sparing diuretics

Important warnings

  • Hyperkalemia: higher risk with impaired renal function, proteinuria, diabetes and with ACE inhibitors, ARBs, NSAIDs and moderate CYP3A inhibitors; monitor until the effect is established and adjust the dose

Side effects

  • Heart failure post-MI, more frequent than with placebo: hyperkalemia (3.4% vs. 2.0%) and increased creatinine (2.4% vs. 1.5%)
  • Hypertension: the most common reasons for discontinuation were headache, dizziness, angina pectoris/MI and increased GGT; gynecomastia and abnormal vaginal bleeding were reported with eplerenone but not with placebo

Interactions

  • Strong CYP3A inhibitors: contraindicated; moderate CYP3A inhibitors: dose reduction
  • ACE inhibitors and/or ARBs: increased risk of hyperkalemia; monitor potassium and renal function
  • Lithium: monitor serum lithium levels frequently
  • NSAIDs: see the full text

Pregnancy and breastfeeding

  • Data in pregnant women are insufficient to establish a risk; no adverse developmental effects were seen in animal studies

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • Eplerenon +pharma+pharma Arzneimittel Gmbh · 1 register entry
  • Eplerenon ActavisActavis Group Ptc Ehf. · 1 register entry
  • Eplerenon BluefishBluefish Pharmaceuticals Ab · 1 register entry
  • Eplerenon GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry
  • Eplerenon HcsHcs Bvba · 1 register entry
  • Eplerenon RatiopharmTeva B.V · 1 register entry
  • EplezotG.L. Pharma Gmbh · 1 register entry
  • InspraViatris Healthcare Limited · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • EpleraxiroMedical Valley Invest Ab · 1 register entry
  • Eplerenon1 A Pharma Gmbh, Aaa-Pharma Gmbh, Micro Labs Gmbh, Ratiopharm Gmbh, Bluefish Pharmaceuticals Ab, Tillomed Pharma Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Vivanta Generics S.R.O., Zentiva Pharma Gmbh, Accord Healthcare B.V., Amarox Pharma Gmbh, Puren Pharma Gmbh & Co. Kg, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 16 register entries
  • InspraViatris Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • EpledayNEUTEC İLAÇ SAN. TİC. A.Ş · 6 register entries
  • InspraVİATRİS İLAÇLARI LİMİTED ŞİRKETİ · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • InspraViatris Specialty LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 26 more European countries
Belgium
Eplerenone Ab, Inspra
Bulgaria
Eспиро, Аплериа, Епленокард, Еплериум, Кардитръст
Croatia
Apleria, Diuron, Eplerenon Msn, Inspra, Noaldis, Renep, Xapla
Cyprus
Apleria, Eplerenone Accord, Fliven, Inspra
Czechia
Apleria, Eplerenon Medreg, Eplerenon Sandoz, Eplerenon Vivanta, Inspra
Denmark
Eplerathen, Eplerenon Accord, Eplerenon Bluefish, Eplerenon Krka, Eplerenon Medical Valley, Eplerenon Pharmathen, Eplerenon Stada, Eplerenon Vivanta, Eplerenone Stada, Eplerenone Teva, Inspra
Estonia
Apleria
Finland
Inspra
France
Eplerathen, Eplerenone Accord, Eplerenone Arrow, Eplerenone Biogaran, Eplerenone Cristers, Eplerenone Eg, Eplerenone Krka, Eplerenone Micro Labs, Eplerenone Sandoz, Eplerenone Teva, Eplerenone Viatris, Eplerenone Zentiva, Eplerenone Zydus, Inspra
Greece
Apleria, Eleveon, Eplerium, Evadil, Inosamin, Inspra, Licepler, Vaner
Hungary
Diupot, Eplerenon Krka, Eplezot, Inspra, Licepler
Iceland
Eplerenon Bluefish, Eplerenon Krka, Eplerenone Alvogen, Inspra
Ireland
Eplerenone Accord Healthcare, Eplerenone Krka, Eplerenone Msn, Eplerenone Rowex, Eplerenone Viatris, Inspra
Italy
Eplerenone Accord, Eplerenone Doc Generici, Eplerenone Krka, Eplerenone Mylan, Eplerenone Tecnigen, Inspra
Latvia
Enplerasa, Plecard
Lithuania
Apleria
Luxembourg
Inspra
Netherlands
Eplerenon Accord, Eplerenon Amarox, Eplerenon Aurobindo, Eplerenon Krka, Eplerenon Sandoz, Eplerenon Synthon, Eplerenon Teva, Eplerenon Viatris, Eplerenon Vivanta, Inspra
Norway
Eplerenon Accord, Eplerenon Krka, Eplerenon Medical Valley, Eplerenon Vivanta, Inspra
Poland
Eleveon, Enplerasa, Eplenocard, Eplerenon Medical Valley, Eplerenon Medreg, Espiro, Inspra, Malidum, Nonpres
Portugal
Eplerenona Biofarmoz, Eplerenona Blovasc, Eplerenona Bluepharma, Eplerenona Moodil, Eplerenona Pentafarma, Inspra
Romania
Apleria, Eplerenonă Arena, Eplohart, Inspra
Slovakia
Aldepla, Apleria, Eleveon, Eplerenon Medreg, Eplerenon Sandoz, Eplerenon Stada, Eplerenon Viatris, Eplerenone Medreg, Eplerenone Teva, Inspra
Slovenia
Elreptic, Enplerasa, Eplerenon Msn, Eplerenon Stada, Inspra
Spain
Elecor, Eplerenona Alter, Eplerenona Aurovitas Spain, Eplerenona Bluefish, Eplerenona Cinfa, Eplerenona Cinfamed, Eplerenona Combix, Eplerenona Kern Pharma, Eplerenona Krka, Eplerenona Mabo, Eplerenona Normon, Eplerenona Pensa, Eplerenona Sandoz, Eplerenona Stada, Eplerenona Tarbis, Eplerenona Tecnigen, Eplerenona Teva, Eplerenona Viatris, Eplerenona Vir, Inspra
Sweden
Eplerenon Accord, Eplerenon Bluefish, Eplerenon Krka, Eplerenon Medical Valley, Eplerenon Stada, Eplerenon Vivanta, Eplerenone Sandoz, Eplerenone Teva, Inspra

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Eplerenone (AvKARE) – Prescribing Information, 2026-01-14. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d953457e-0aff-6c38-e053-2995a90a7d32
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC C03DA.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.