Amiodarone
Amiodarone, Nexterone, Pacerone (amiodarone) is a small molecule pharmaceutical. Amiodarone was first approved as Cordarone on 1985-12-24. It is used to treat cardiac arrhythmias, supraventricular tachycardia, and ventricular fibrillation in the USA. It is known to target muscarinic acetylcholine receptor M5, potassium voltage-gated channel subfamily A member 7, and sodium channel protein type 5 subunit alpha.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Amiodarone, Nexterone, Pacerone (discontinued: Amiodarone, Cordarone, Nexterone)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amiodarone hci | ANDA | 2022-12-10 |
| amiodarone hcl | unapproved drug other | 2014-08-20 |
| amiodarone hydrochloride | ANDA | 2025-09-24 |
| nexterone | New Drug Application | 2025-02-21 |
| nexterone (amiodarone hci) | New Drug Application | 2024-02-19 |
| pacerone | ANDA | 2025-07-14 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Amiodarone Hydrochloride, Nexterone, Baxter Hlthcare | |||
| 7635773 | 2029-03-13 | DP | |
HCPCS
Code | Description |
|---|---|
| J0282 | Injection, amiodarone hydrochloride, 30 mg |
Clinical
Clinical Trials
221 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | 3 | 10 | 36 | 49 | 50 | 145 |
| Ventricular tachycardia | D017180 | — | I47.2 | — | 2 | 4 | 9 | 10 | 25 |
| Tachycardia | D013610 | — | R00.0 | — | 1 | 4 | 8 | 12 | 25 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | 1 | 5 | 7 | 10 | 23 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | 3 | 3 | 7 | 14 |
| Atrial flutter | D001282 | EFO_0003911 | — | — | 2 | 6 | 3 | 2 | 12 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | 3 | 3 | 5 | 11 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | 1 | — | 5 | 1 | 4 | 11 |
| Ventricular fibrillation | D014693 | EFO_0004287 | I49.01 | — | 1 | 5 | 1 | 3 | 10 |
| Supraventricular tachycardia | D013617 | — | I47.1 | — | 1 | — | 1 | 3 | 5 |
Show 22 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart arrest | D006323 | EFO_0009492 | I46 | — | 2 | 5 | — | 3 | 10 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 4 | — | 3 | 7 |
| Out-of-hospital cardiac arrest | D058687 | — | — | — | 1 | 1 | — | 2 | 4 |
| Chagas cardiomyopathy | D002598 | EFO_0005529 | — | — | — | 1 | — | 2 | 3 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 2 | — | 1 | 3 |
| Sudden death cardiac | D016757 | EFO_0004278 | — | — | — | 2 | — | 1 | 3 |
| Sudden death | D003645 | — | — | — | — | 3 | — | — | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | 1 | — | 1 | 2 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | — | 1 | — | — | 2 |
| Ischemia | D007511 | EFO_0000556 | — | — | — | 1 | — | 1 | 2 |
Show 15 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | 1 | — | — | — | 1 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | — | 1 | — | — | — | 1 |
| Blood pressure | D001794 | EFO_0004325 | — | — | 1 | — | — | — | 1 |
| Esophageal neoplasms | D004938 | — | C15 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Pain | D010146 | EFO_0003843 | R52 | 1 | — | — | — | 1 | 2 |
| Postoperative complications | D011183 | — | — | 1 | — | — | — | — | 1 |
| Autosomal dominant polycystic kidney | D016891 | EFO_1001496 | Q61.2 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Phlebitis | D010689 | EFO_1001395 | I80 | — | — | — | — | 3 | 3 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 2 | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | — | 2 | 2 |
| Hyperuricemia | D033461 | — | — | — | — | — | — | 2 | 2 |
| Thyrotoxicosis | D013971 | — | E05 | — | — | — | — | 2 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
Show 35 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Amiodarone |
| INN | amiodarone |
| Description | Amiodarone is a member of the class of 1-benzofurans that is 1-benzofuran substituted by a butyl group at position 2 and a 4-[2-(diethylamino)ethoxy]-3,5-diiodobenzoyl group at position 3. It is a cardiovascular drug used for the treatment of cardiac dysrhythmias. It has a role as a cardiovascular drug. It is a member of 1-benzofurans, an organoiodine compound, an aromatic ketone and a tertiary amino compound. |
| Classification | Small molecule |
| Drug class | antiarrhythmics: indicates high iodine content |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1 |
Identifiers
| PDB | — |
| CAS-ID | 1951-25-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL633 |
| ChEBI ID | 2663 |
| PubChem CID | 2157 |
| DrugBank | DB01118 |
| UNII ID | N3RQ532IUT (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
SCN5A
SCN5A
SIRT3
SIRT3
Organism
Homo sapiens
Gene name
SCN5A
Gene synonyms
NCBI Gene ID
Protein name
sodium channel protein type 5 subunit alpha
Protein synonyms
cardiac tetrodotoxin-insensitive voltage-dependent sodium channel alpha subunit, hH1, Sodium channel protein cardiac muscle subunit alpha, Sodium channel protein type V subunit alpha, sodium channel, voltage-gated, type V, alpha subunit, Voltage-gated sodium channel subunit alpha Nav1.5
Uniprot ID
Mouse ortholog
Scn5a (20271)
sodium channel protein type 5 subunit alpha (Q9JJV9)
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Amiodarone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 32,324 documents
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Safety
Black-box Warning
Black-box warning for: Amiodarone hydrochloride, Pacerone
Adverse Events
Top Adverse Reactions
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37,917 adverse events reported
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