Active substance
Amiodarone
- SFDA 5
- US FDA 36
- Health Canada 12
- US price lines 6
- NHS prices 2
- WHO EML 1
- Safety 9
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| CORDARONE 150MG-3ML AMP. | 50 mg/ml | Solution for injection · Intravenous use | 6 Ampoule | SAR 82.20 | NCE · Prescription | sanofi-aventis | Valid |
| CORDARONE 200MG TAB | 200 mg | Tablet · Oral use | 30 Blister | SAR 25.30 | NCE · Prescription | sanofi-aventis | Valid |
| SEDACORON 200MG TAB | 200 mg | Tablet · Oral use | 30 Blister | SAR 25.35 | Generic · Prescription | EBEWE PHARMA | Valid |
| SEDACORON solution for injection | 50 mg/ml | Concentrate for solution for infusion · Intravenous use | 5 Ampoule | SAR 17.25 | Generic · Prescription | EBEWE PHARMA | Valid |
| AMIRONE 200MG TABLET | 200 mg | Tablet · Oral use | 30 Blister | SAR 23.15 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ANESTHESIA-SUPPORTIVE AGENTS/ CARDIAC ARREST, CARDIOVASCULAR EMERGENCIES AND/OR DYSRHYTHMIAS; ARRHYTHMIA; ATRIAL FIBRILLATION; CARDIOMYOPATHY; SUPRAVENTRICULAR TACHYCARDIA; VENTRICULAR TACHYCARDIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PACERONE | 200MG; 100MG; 400MG | tablet · oral | UPSHER SMITH LABS | Prescription | 30 Apr 1998 |
| AMIODARONE HYDROCHLORIDE | 200MG | tablet · oral | TEVA PHARMS | Prescription | 30 Nov 1998 |
| AMIODARONE HYDROCHLORIDE | 200MG; 100MG; 400MG | tablet · oral | DR REDDYS LABS SA | Prescription | 25 Jan 2001 |
| AMIODARONE HYDROCHLORIDE | 200MG; 100MG | tablet · oral | TARO | Prescription | 30 Mar 2001 |
| AMIODARONE HYDROCHLORIDE | 50MG/ML | injectable · injection | FRESENIUS KABI USA | Prescription | 15 Oct 2002 |
| AMIODARONE HYDROCHLORIDE | 50MG/ML | injectable · injection | MYLAN INSTITUTIONAL | Prescription | 15 Oct 2002 |
| AMIODARONE HYDROCHLORIDE | 200MG; 400MG; 100MG | tablet · oral | CHARTWELL RX | Prescription | 8 Apr 2005 |
| AMIODARONE HYDROCHLORIDE | 50MG/ML | injectable · injection | GLAND PHARMA LTD | Prescription | 20 Apr 2005 |
| AMIODARONE HYDROCHLORIDE | 50MG/ML | injectable · injection | HIKMA FARMACEUTICA | Prescription | 25 Feb 2008 |
| AMIODARONE HYDROCHLORIDE | 200MG; 100MG; 400MG | tablet · oral | ZYDUS PHARMS USA INC | Prescription | 16 Sep 2008 |
| AMIODARONE HYDROCHLORIDE | 50MG/ML | injectable · injection | ACELLA | Prescription | 30 Oct 2008 |
| AMIODARONE HYDROCHLORIDE | 50MG/ML | injectable · injection | ACELLA | Prescription | 30 Oct 2008 |
| AMIODARONE HYDROCHLORIDE | 200MG; 100MG; 400MG | tablet · oral | RUBICON RESEARCH | Prescription | 6 Nov 2008 |
| NEXTERONE | 150MG/100ML (1.5MG/ML); 360MG/200ML (1.8MG/ML) | injectable · injection | BAXTER HLTHCARE | Prescription | 24 Dec 2008 |
| AMIODARONE HYDROCHLORIDE | 200MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 3 Jun 2016 |
| AMIODARONE HYDROCHLORIDE | 200MG | tablet · oral | UNICHEM | Prescription | 21 Jul 2020 |
| AMIODARONE HYDROCHLORIDE | 50MG/ML | injectable · injection | ZHEJIANG POLY PHARM | Prescription | 11 Sep 2024 |
| CORDARONE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | WYETH PHARMS | Discontinued | 24 Dec 1985 |
| CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | WYETH PHARMS INC | Discontinued | 3 Aug 1995 |
| AMIODARONE HYDROCHLORIDE | 200MG; 400MG | tablet · oral | UPSHER SMITH LABS | Discontinued | 23 Dec 1998 |
| AMIODARONE HYDROCHLORIDE | 200MG | tablet · oral | PHARMOBEDIENT | Discontinued | 24 Feb 1999 |
| AMIODARONE HYDROCHLORIDE | 200MG | tablet · oral | TEVA | Discontinued | 16 Apr 1999 |
| AMIODARONE HYDROCHLORIDE | 50MG/ML | injectable · injection | BEDFORD | Discontinued | 15 Oct 2002 |
| AMIODARONE HYDROCHLORIDE | 50MG/ML | injectable · injection | BEN VENUE | Discontinued | 15 Oct 2002 |
| AMIODARONE HYDROCHLORIDE | 50MG/ML | injectable · injection | HOSPIRA | Discontinued | 15 Oct 2002 |
11 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AMIODARONE | 02364336 | 200 MG | TABLET · ORAL | SANIS HEALTH INC |
| AMIODARONE | 02385465 | 200 MG | TABLET · ORAL | SIVEM PHARMACEUTICALS ULC |
| AMIODARONE HYDROCHLORIDE FOR INJECTION | 02242325 | 50 MG / ML | SOLUTION · INTRAVENOUS | SANDOZ CANADA INCORPORATED |
| AMIODARONE HYDROCHLORIDE FOR INJECTION, USP | 02245248 | 50 MG / ML | SOLUTION · INTRAVENOUS | FRESENIUS KABI CANADA LTD |
| APO-AMIODARONE TABLETS | 02246194 | 200 MG | TABLET · ORAL | APOTEX INC |
| JAMP AMIODARONE | 02531844 | 200 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| PMS-AMIODARONE | 02242472 | 200 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-AMIODARONE | 02292173 | 100 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PRO-AMIODARONE - 200 | 02309661 | 200 MG | TABLET · ORAL | PRO DOC LIMITEE |
| RIVA-AMIODARONE | 02247217 | 200 MG | TABLET · ORAL | LABORATOIRE RIVA INC. |
| SANDOZ AMIODARONE | 02243836 | 200 MG | TABLET · ORAL | SANDOZ CANADA INCORPORATED |
| TEVA-AMIODARONE | 02239835 | 200 MG | TABLET · ORAL | TEVA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | AMIODARONE 150 MG/3 ML VIAL | $0.52115 | per ML | 22 Jul 2026 |
| US NADAC | AMIODARONE HCL 100 MG TABLET | $0.37584 | per EA | 23 Sep 2026 |
| US NADAC | AMIODARONE HCL 200 MG TABLET | $0.12179 | per EA | 23 Sep 2026 |
| US NADAC | AMIODARONE HCL 400 MG TABLET | $0.49957 | per EA | 23 Sep 2026 |
| US NADAC | PACERONE 100 MG TABLET | $0.7762 | per EA | 17 Jun 2026 |
| US NADAC | PACERONE 200 MG TABLET | $0.12488 | per EA | 19 Nov 2025 |
| NHS Drug Tariff | Amiodarone 100mg tablets | £6.27 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Amiodarone 200mg tablets | £5.13 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 12.2. Antiarrhythmic medicines · complementary
Cardiac arrhythmia
Parenteral > General injections > IV: 50 mg per mL in 3 ampoule (hydrochloride) | Oral > Solid: 100 mg (hydrochloride); 200 mg (hydrochloride); 400 mg (hydrochloride)
Safety signals and safety-related labeling changes
- MHRA 20 May 2026 Amiodarone: reminder of risks of treatment and need for patient monitoring and supervision
Amiodarone has been associated with serious and potentially life-threatening side effects, particularly of the lung, liver, and thyroid gland. We remind healthcare professionals that patients should be supervised and reviewed regularly during treatment. Lung problems may have slow onset but then progress rapidly. Computerised tomography scans may help to confirm a suspected diagnosis of pulmonary toxicity. - US FDA 7 Sep 2021 NEXTERONE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations - US FDA 17 Oct 2018 CORDARONE — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 9 Jul 2015 PRAC signal: Pancreatitis
Action for MAH: update of the product information: No - EMA PRAC 12 Mar 2015 PRAC signal: Pancreatitis
Action for MAH: update of the product information: No - EMA PRAC 12 Feb 2015 PRAC signal: Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH)
Action for MAH: update of the product information: Yes - EMA PRAC 9 Oct 2014 PRAC signal: Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH)
Action for MAH: update of the product information: No - EMA PRAC 6 Feb 2014 PRAC signal: Carcinogenicity
Action for MAH: update of the product information: Yes - EMA PRAC 10 Oct 2013 PRAC signal: Carcinogenicity
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.