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Amiodarone

Amiodaron Hameln, Amiodaron Hcl Hikma, Amiodaron Viatris, Sedacoron · ATC code C01BD01

Also known as: Amiodaron · Brand names: Amiodaron Hameln, Amiodaron Hcl Hikma, Amiodaron Viatris, Sedacoron, Amiodarone Hcl Ct, Amiodarone Holsten, Amiodarone Ratiopharm, Amiodaronhydrochlorid Al, Amiodaronhydrochlorid Heumann, Amiodaronhydrochlorid I.V Carino, Amiodaronhydrochlorid Pro Al, Amiodaronhydrochlorid Ratiopharm, Amiodura, Amiogamma, Cordarex …

Key facts
Active substance
Amiodarone
ATC code
C01BD01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

Amiodarone hydrochloride tablets is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity [see Indications and Usage (1)].

Amiodarone hydrochloride tablets can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the time. Obtain a baseline chest X-ray and pulmonary-function tests, including diffusion capacity, when amiodarone hydrochloride tablets therapy is initiated. Repeat history, physical exam, and chest X-ray every 3 to 6 months [see Warnings and Precautions 5.2)].

Amiodarone hydrochloride tablets can cause hepatoxicity, which can be fatal. Obtain baseline and periodic liver transaminases and discontinue or reduce dose if the increase exceeds three times normal, or doubles in a patient with an elevated baseline. Discontinue amiodarone hydrochloride tablets if the patient experiences signs or symptoms of clinical liver injury [see Warnings and Precautions (5.3)].

Amiodarone hydrochloride tablets can exacerbate arrhythmias. Initiate amiodarone hydrochloride tablets in a clinical setting where continuous electrocardiograms and cardiac resuscitation are available [see Warnings and Precautions (5.4)].

Key facts

Amiodarone is an antiarrhythmic. Per the US label, the tablets are for life-threatening recurrent ventricular fibrillation or hemodynamically unstable tachycardia in adults who have not responded to or cannot tolerate other antiarrhythmics.

What it is used for

  • Documented, life-threatening recurrent ventricular fibrillation in adults
  • Life-threatening recurrent hemodynamically unstable tachycardia in adults
  • Only when other antiarrhythmics at adequate doses have failed or are not tolerated

Dosing

  • Individualise to arrhythmia severity and response; use the lowest effective dose
  • Loading: 800 to 1,600 mg/day until initial therapeutic response (usually 1 to 3 weeks)
  • Then 600 to 800 mg/day for one month, followed by maintenance, usually 400 mg/day
  • Take consistently with regard to meals; divided doses with meals for total daily doses of 1,000 mg or higher or with GI intolerance
  • Before starting: chest X-ray, pulmonary function, thyroid tests and liver aminotransferases; correct hypokalemia, hypomagnesemia and hypocalcemia

Contraindications

  • Cardiogenic shock
  • Sick sinus syndrome, second- or third-degree AV block, or bradycardia leading to syncope without a functioning pacemaker
  • Known hypersensitivity to the drug or its components, including iodine

Important warnings

  • Boxed warning: only for life-threatening arrhythmias because of substantial toxicity
  • Pulmonary toxicity (pneumonitis) at rates as high as 17% in some series, fatal about 10% of the time; baseline chest X-ray and lung function, repeat every 3 to 6 months
  • Hepatotoxicity, which can be fatal; monitor transaminases
  • Can exacerbate arrhythmias; initiate where continuous ECG and resuscitation are available
  • Visual impairment, thyroid abnormalities, bradycardia, peripheral neuropathy and photosensitivity can occur
  • Because of the long half-life, adverse reactions and interactions can persist for weeks after discontinuation

Side effects

  • At the usual maintenance dose, adverse reactions occur in about three-fourths of patients, leading to discontinuation in 7 to 18%
  • Serious: pulmonary toxicity, hepatic injury, worsened arrhythmia, loss of vision, thyroid abnormalities, bradycardia
  • Others: peripheral neuropathy, photosensitivity and skin discoloration

Interactions

  • QT-prolonging drugs (e.g. class I and III antiarrhythmics, lithium, certain fluoroquinolones, macrolides, azole antifungals): increased risk of torsade de pointes; avoid
  • Negative chronotropes (digoxin, beta blockers, verapamil, diltiazem, clonidine, ivabradine): bradycardia, sinus arrest, AV block; monitor heart rate
  • Interactions may persist for weeks to months after discontinuation

Pregnancy and breastfeeding

  • Use in pregnancy may increase the risk of fetal adverse effects, including neonatal hypo- and hyperthyroidism, bradycardia, neurodevelopmental abnormalities, preterm birth and growth restriction; amiodarone crosses the placenta

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.

Full official text →

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For patients

Patient information (US)

Patient information (US) →

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

  • Amiodaron HamelnHameln Pharma Gmbh · 1 register entry
  • Amiodaron Hcl HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry
  • Amiodaron ViatrisViatris Limited · 1 register entry
  • SedacoronEbewe Pharma · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • AmiodaronRatiopharm Gmbh, 1 A Pharma Gmbh, Puren Pharma Gmbh & Co. Kg, Hikma Farmacêutica (Portugal), S.A., Winthrop Arzneimittel Gmbh, Hameln Pharma Gmbh, Stadapharm Gmbh · 9 register entries
  • Amiodarone Hcl CtAbz-Pharma Gmbh · 1 register entry
  • Amiodarone HolstenHolsten Pharma Gmbh · 1 register entry
  • Amiodarone RatiopharmRatiopharm Gmbh · 1 register entry
  • Amiodaronhydrochlorid AlAliud Pharma Gmbh · 1 register entry
  • Amiodaronhydrochlorid HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
  • Amiodaronhydrochlorid I.V CarinoCarinopharm Gmbh · 1 register entry
  • Amiodaronhydrochlorid Pro AlAliud Pharma Gmbh · 1 register entry
  • Amiodaronhydrochlorid RatiopharmRatiopharm Gmbh · 1 register entry
  • AmioduraViatris Germany Gmbh · 1 register entry
  • AmiogammaWörwag Pharma Gmbh & Co. Kg · 1 register entry
  • CordarexSanofi-Aventis Deutschland Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • AmidovinTÜM-EKİP İLAÇ A.Ş. · 1 register entry
  • CordalinOSEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • CordaroneSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ. · 2 register entries
  • MiyocordNEUTEC İLAÇ SAN. TİC. A.Ş · 1 register entry
  • SanoroneSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

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

USA

  • NexteroneBaxter Healthcare Corporation · 1 register entry
  • Nexterone (amiodarone Hci)1 register entry
  • PaceroneUpsher-Smith Laboratories, LLC · 3 register entries

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 27 more European countries
Belgium
Amiodarone Ab, Amiodarone Eg, Cordarone
Bulgaria
Амиодарон Xамелн, Амиодарон Софарма, Кордарон
Croatia
Amiodaron Hameln, Amiodaronklorid Belupo, Amiodaronklorid Hameln, Amiokordin, Cordarone
Cyprus
Amiodarone Aurobindo, Amiodarone Medochemie, Cardilor
Czechia
Amiodaron Hameln, Amiokordin, Cordarone, Rivodaron, Sedacoron
Denmark
Amiodaron Hameln, Cordan
Estonia
Amiokordin
Finland
Amiodaron Hameln, Cordarone
France
Amiodarone Almus, Amiodarone Arrow Lab, Amiodarone Biogaran, Amiodarone Cristers, Amiodarone Eg, Amiodarone Evolugen, Amiodarone Sandoz, Amiodarone Teva, Amiodarone Viatris, Amiodarone Zentiva, Amiodarone Zydus, Cordarone
Greece
Angoron
Hungary
Amiodaron Hameln, Cordarone
Iceland
Cordarone
Ireland
Cordarone X
Italy
Amiodar, Amiodarone Aurobindo, Amiodarone Cloridrato Bioindustria Lim, Amiodarone Doc, Amiodarone Eg, Amiodarone Hameln, Amiodarone Hikma, Amiodarone Mylan, Amiodarone Ratiopharm Italia, Amiodarone Sandoz, Amiodarone Zentiva, Cordarone
Latvia
Amiokordin
Lithuania
Amiokordin, Cordarone
Luxembourg
Amiodarone Eg, Cordarone
Malta
Amiodarone Accord Healthcare, Amiodarone Ibigen, Cardilor
Netherlands
Amiodaron Hameln, Amiodaron Hcl Aurobindo, Amiodaron Hcl Hikma, Amiodaron Hcl Mylan, Amiodaron Hcl Sandoz
Norway
Amiodaron Hameln, Cordarone
Poland
Amiodaron Hameln, Amiokordin, Cordarone, Opacorden
Portugal
Amiodarona Aurovitas, Amiodarona Bluepharma, Amiodarona Generis, Amiodarona Gp, Amiodarona Hikma, Amiodarona Mylan, Cordarone
Romania
Amiodaron Hameln, Amiodarona Arena, Amiodaronă Lph Labormed, Cordarone
Slovakia
Amiodaron Hameln, Amiokordin, Cordarone, Rivodaron
Slovenia
Amiokordin, Amjodaron Hameln, Cordarone
Spain
Amiodarona Aurovitas, Trangorex
Sweden
Amiodaron Evolan, Amiodaron Hameln, Cordarone

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.

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Sources

  1. U.S. Food and Drug Administration. Amiodarone Hydrochloride (Dr. Reddy's Labratories Inc.) – Prescribing Information, 2026-04-23. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=95cef33b-c0e6-b17c-7cbb-f5c066872705
  2. 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
  3. 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
  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), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/

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.