FDA label
What is amiodarone used for?
The FDA-approved uses of amiodarone, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.”
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Amiodarone Hydrochloride, tablet
Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc. (ANDA075424). Cross-references to other label sections are left out.
Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.
Source: DailyMed label, set id 7ccd3733-c3af-4a11-8500-0f99194c1472, version 19, effective March 11, 2026. NDC 51672-4025, one of 43 listings for this product.
Amiodarone Hydrochloride, injection, solution
Indications and Usage, quoted from the label by Fresenius Kabi USA, LLC (ANDA075761). Cross-references to other label sections are left out.
Amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy.
Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.
Source: DailyMed label, set id d8d04647-8e25-4127-8ecf-360ce1991c2f, version 6, effective March 31, 2025. NDC 63323-616, one of 25 listings for this product.
Questions
What is amiodarone used for?
The FDA label says: “Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.”
What drug class is amiodarone?
FDA lists amiodarone in the Antiarrhythmic established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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