Spironolactone
Aldactone, Spirobene, Spirohexal, Spirono · ATC code C03DA01
Also known as: Spironolacton, Spironolakton, Aldactone · Brand names: Spirobene, Spirohexal, Spirono, Spironolacton Agepha, Spironolacton Orion, Spironolactone Orion, Spirobeta, Dalylacton, Ridakton, Spylacton
- Key facts
- Active substance
- Spironolactone
- Drug class
- Antimineralocorticoid
- ATC code
- C03DA01
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Key facts
Spironolactone is an aldosterone antagonist and potassium-sparing diuretic. Per the US label it is used for heart failure, hypertension, oedema in cirrhosis or nephrotic syndrome, and primary hyperaldosteronism.
What it is used for
- NYHA Class III–IV heart failure with reduced ejection fraction, to increase survival and reduce hospitalisation
- Add-on therapy for hypertension not adequately controlled on other agents
- Oedema in hepatic cirrhosis or nephrotic syndrome when other measures are inadequate
- Primary hyperaldosteronism (preoperative or long-term maintenance)
Dosing
- Heart failure (potassium ≤5.0 mEq/L, eGFR >50): start 25 mg once daily, may increase to 50 mg; with hyperkalaemia reduce to 25 mg every other day
- Heart failure with eGFR 30 to 50: consider starting at 25 mg every other day
- Hypertension: initial dose 25 to 100 mg daily, titrated at two-week intervals
- Oedema: usually 100 mg daily (range 25 to 200 mg); in cirrhosis start in hospital
- Take consistently with respect to food
Contraindications
- Hyperkalaemia
- Addison's disease
- Concomitant use of eplerenone
Important warnings
- Hyperkalaemia, especially with impaired renal function or potassium supplements, ACE inhibitors or ARBs; monitor potassium within 1 week of starting and regularly
- Hypotension and worsening renal function from excessive diuresis
- Electrolyte and metabolic abnormalities
- Gynaecomastia, dose-dependent and usually reversible
- In cirrhosis with ascites, risk of impaired neurological function or coma
Side effects
- Hyperkalaemia, gynaecomastia, hypotension
- Digestive: gastric bleeding, ulceration, gastritis, diarrhoea, nausea, vomiting
- Decreased libido, erectile dysfunction, menstrual irregularities
Interactions
- Potassium supplements, ACE inhibitors, ARBs, NSAIDs, heparin, trimethoprim: risk of severe hyperkalaemia
- Lithium: reduced clearance, monitor lithium levels
- NSAIDs may reduce the effect
Pregnancy and breastfeeding
- Because of potential effects on sex differentiation of a male fetus, avoid in pregnancy or advise of the risk
- The active metabolite canrenone appears in breast milk in low amounts
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
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
- AldactoneCheplapharm Arzneimittel Gmbh · 1 register entry
- SpirobeneTeva B.V · 1 register entry
- SpirohexalHexal Pharma Gmbh · 1 register entry
- SpironoGenericon Pharma Gesellschaft M.B.H. · 1 register entry
- Spironolacton AgephaAgepha Pharma S.R.O · 1 register entry
- Spironolacton OrionOrion Corporation · 1 register entry
- Spironolactone OrionOrion Corporation · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- AldactoneEsteve Pharmaceuticals Gmbh · 1 register entry
- SpirobetaBetapharm Arzneimittel Gmbh · 1 register entry
- Spironolacton1 A Pharma Gmbh, Ratiopharm Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Accord Healthcare B.V., Aristo Pharma Gmbh (Art 57), Hexal Ag, Stadapharm Gmbh, Aliud Pharma Gmbh · 8 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- AldactoneALİ RAİF İLAÇ SAN. A.Ş. · 3 register entries
- DalylactonPHARMAPLACE İLAÇ TİC. A.Ş. · 3 register entries
- RidaktonGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 3 register entries
- SpylactonWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- AldactonePfizer Laboratories Div Pfizer Inc · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28
Brand names in 27 more European countries
- Belgium
- Aldactone, Spironolactone Eg
- Bulgaria
- Спилактон, Спиронолактон Акорд, Спиронолактон Актавис, Спиронолактон Медокеми, Спиронолактон Чайкафарма
- Croatia
- Aldactone
- Cyprus
- Spiro, Spirolon, Spironolactone Accord, Spironolactone Medochemie, Spironolactone Remedica, Uractonum
- Czechia
- Spironolactone Medreg, Spironolactone Orion, Verospiron
- Denmark
- Spirix, Spiron, Spironolactone Accord, Spironolactone Viatris
- Estonia
- Spirix, Spironolactone Accord, Spironolactone Medochemie
- Finland
- Spirix, Spironolactone Orion
- France
- Aldactone, Spironolactone Arrow, Spironolactone Cristers, Spironolactone Eg, Spironolactone Pfizer, Spironolactone Sandoz, Spironolactone Teva, Spironolactone Viatris, Spironolactone Zentiva, Spironolactone Zydus
- Greece
- Aldactone
- Hungary
- Spiron, Spironolactone Orion, Verospiron
- Iceland
- Spirix, Spiron
- Ireland
- Aldactone, Spironolactone Accord Healthcare Ireland
- Italy
- Aldactone, Spirolang, Uractone
- Latvia
- Spirix, Spironolactone Accord, Verospiron
- Lithuania
- Spirix, Spironolactone Accord, Spironolactone Medochemie, Spironolactone Orion
- Luxembourg
- Aldactone, Spironolacton Ratiopharm, Spironolactone Eg
- Malta
- Aldactone, Spirolon, Spironolactone Medochemie
- Netherlands
- Spironolacton Accord, Spironolacton Genrx, Spironolacton Mylan, Spironolacton Prolepha, Spironolactone Aurobindo
- Norway
- Spirix, Spironolactone Orion
- Poland
- Finospir, Spironol, Spironolactone Medreg, Verospiron
- Portugal
- Aldactone, Espironolactona Alter, Espironolactona Generis, Espironolactona Mylan
- Romania
- Alspiron, Spironolactonă Arena, Spironolactonă Bioeel, Spironolactonă Gemax Pharma, Spironolactonă Lph Labormed, Spironolactonă Terapia, Verospiron
- Slovakia
- Medospir, Spironolactone Accord, Spironolactone Medreg, Verospiron
- Slovenia
- Aldactone, Spironolakton Orion
- Spain
- Aldactone, Espironolactona Accord, Espironolactona Alter, Espironolactona Orion
- Sweden
- Spironolactone Accord, Spironolactone Orion, Spironolakton Orifarm, Spironolakton Pfizer
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- U.S. Food and Drug Administration. Aldactone (Pfizer Laboratories Div Pfizer Inc) – Prescribing Information, 2025-11-28. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
- Wikidata (CC0): ATC C03DA.
Editorial: Medelix editorial team · last updated 2026-10-27 · 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.