Two medicines, side by side
Amiodarone vs dofetilide
Amiodarone has no indication this site maps; dofetilide for atrial fibrillation. Their labels share no use, so they are not alternatives to each other. Drugs@FDA records approvals of amiodarone since 1985 and of dofetilide since 1999. Pharmacies paid $0.122 per amiodarone HCl 200 mg tablet and $0.203 per dofetilide 125 mcg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Amiodarone, “Amiodarone is considered a class III antiarrhythmic drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes.”; Dofetilide, “The mechanism of action is blockade of the cardiac ion channel carrying the rapid component of the delayed rectifier potassium current, I Kr.”
Check it at the source: the amiodarone FDA label on DailyMed (effective December 9, 2025); the dofetilide FDA label on DailyMed (effective April 21, 2026).
Highlights of the amiodarone record
Amiodarone (Pacerone) · label of December 9, 2025
PULMONARY, HEPATIC AND CARDIAC TOXICITY Amiodarone hydrochloride 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 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.
Used for
From the label: indicationsAmiodarone hydrochloride is 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. Amiodarone hydrochloride is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. […]
On the market
- Earliest approval on file
- December 24, 1985
- Generic labelers
- 32 labelers
- Pharmacy cost
- $0.122 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 7
Highlights of the dofetilide record
Dofetilide (Tikosyn) · label of April 21, 2026
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. For detailed instructions regarding dose selection, see DOSAGE AND ADMINISTRATION .
Used for
From the label: indicationsMaintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) TIKOSYN is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. […]
On the market
- Earliest approval on file
- October 1, 1999
- Generic labelers
- 12 labelers
- Pharmacy cost
- $0.203 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 6
Source: FDA drug labels via openFDA (Amiodarone label of December 9, 2025, Dofetilide label of April 21, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do amiodarone and dofetilide differ on the record?
How each works, in its label's words: Amiodarone, “Amiodarone is considered a class III antiarrhythmic drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes.”; Dofetilide, “The mechanism of action is blockade of the cardiac ion channel carrying the rapid component of the delayed rectifier potassium current, I Kr.”
Both are in FDA's class antiarrhythmics.
Half-life, in each label's words: Amiodarone, “Elimination Following single dose administration in 12 healthy subjects, amiodarone exhibited multi- compartmental …”; Dofetilide, “The terminal half-life of dofetilide is approximately 10 hours; steady state plasma concentrations are attained within …”
Both labels carry a boxed warning; the records quote them.
Generics: amiodarone since 1998; dofetilide since 2016 (Drugs@FDA).
| Amiodarone | Dofetilide | |
|---|---|---|
| Labeled for | n/a | Atrial fibrillation |
| Pharmacologic class | Antiarrhythmic | Antiarrhythmic |
| How it works (label) | Amiodarone is considered a class III antiarrhythmic drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes. | Mechanism of Action Dofetilide shows Vaughan Williams Class III antiarrhythmic activity. The mechanism of action is blockade of the cardiac ion channel carrying the rapid component of the delayed rectifier potassium current, I Kr. |
| Half-life (label) | Elimination Following single dose administration in 12 healthy subjects, amiodarone exhibited multi- compartmental pharmacokinetics with a mean apparent plasma terminal elimination half-life of 58 days (range 15 to 142 … | The terminal half-life of dofetilide is approximately 10 hours; steady state plasma concentrations are attained within 2–3 days, with an accumulation index of 1.5 to 2.0. |
| Earliest approval on file (Drugs@FDA) | December 24, 1985 | October 1, 1999 |
| First generic approved | April 30, 1998 | June 6, 2016 |
| Generic labelers (NDC) | 32 labelers | 12 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.122 per tablet (Amiodarone HCl 200 mg tablet) | $0.203 per capsule (Dofetilide 125 mcg capsule) |
| 12-month price change | +4% | -6% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 7 | 6 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 11,139 | 10,448 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Dofetilide label, warningsIn clinical trials, TIKOSYN was administered to patients previously treated with oral amiodarone only if serum amiodarone levels were below 0.3 mg/L or amiodarone had been withdrawn for at least three months.
Source: FDA drug labels via openFDA
What next?
- Alternatives to amiodarone
- every medicine labeled for the same conditions