Two medicines, side by side
Propafenone vs sotalol
Propafenone and sotalol are both labeled for atrial fibrillation. Drugs@FDA records approvals of propafenone since 1989 and of sotalol since 1992. Pharmacies paid $0.115 per propafenone HCl 150 mg tablet and $0.0707 per sotalol 80 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Sotalol's other strengths are brand-only: $2.32 per mL (Sotylize 5 mg/mL oral solution). How each works, in its label's words: Propafenone, “Propafenone is a Class 1C antiarrhythmic drug with local anesthetic effects, and a direct stabilizing action on myocardial membranes.”; Sotalol, “Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties.”
Check it at the source: the propafenone FDA label on DailyMed (effective September 1, 2025); the sotalol FDA label on DailyMed (effective December 16, 2024).
Highlights of the propafenone record
Propafenone (Rythmol) · label of September 1, 2025
MORTALITY In the National Heart, Lung, and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind trial in subjects with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than 6 days but less than 2 years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in subjects treated with encainide or flecainide (Class IC antiarrhythmics) compared with that seen in subjects assigned to placebo (3.0%; 22/725).
Used for
From the label: indicationsPropafenone hydrochloride tablets are indicated to: prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease. prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease. treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. […]
On the market
- Earliest approval on file
- November 27, 1989
- Generic labelers
- 14 labelers
- Pharmacy cost
- $0.115 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 5
Highlights of the sotalol record
Sotalol (Betapace) · label of December 16, 2024
LIFE-THREATENING PROARRHYTHMIA To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life-threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug.
Used for
From the label: indicationsBetapace/Betapace AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias ( 1.1 ) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) ( 1.2 ) Limitations of Use Betapace has not been shown to enhance survival in patients with life threatening ventricular arrhythmias ( 1.1 ) Avoid use in patients with minimally symptomatic or […]
On the market
- Earliest approval on file
- October 30, 1992
- Generic labelers
- 18 labelers
- Pharmacy cost
- $0.0707 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 1
Source: FDA drug labels via openFDA (Propafenone label of September 1, 2025, Sotalol label of December 16, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do propafenone and sotalol differ on the record?
How each works, in its label's words: Propafenone, “Propafenone is a Class 1C antiarrhythmic drug with local anesthetic effects, and a direct stabilizing action on myocardial membranes.”; Sotalol, “Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties.”
Both are in FDA's class antiarrhythmics.
Half-life, in each label's words: Propafenone, “The average distribution half-life corresponding to the first phase was about 5 minutes.”; Sotalol, “The mean elimination half-life of sotalol is 12 hours.”
Both labels carry a boxed warning; the records quote them.
Generics: propafenone since 2000; sotalol since 2000 (Drugs@FDA).
| Propafenone | Sotalol | |
|---|---|---|
| Labeled for | Atrial fibrillation | Atrial fibrillation |
| Pharmacologic class | Antiarrhythmic | Antiarrhythmic |
| How it works (label) | Propafenone is a Class 1C antiarrhythmic drug with local anesthetic effects, and a direct stabilizing action on myocardial membranes. | Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. |
| Half-life (label) | The average distribution half-life corresponding to the first phase was about 5 minutes. | The mean elimination half-life of sotalol is 12 hours. |
| Earliest approval on file (Drugs@FDA) | November 27, 1989 | October 30, 1992 |
| First generic approved | October 24, 2000 | May 1, 2000 |
| Generic labelers (NDC) | 14 labelers | 18 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.115 per tablet (Propafenone HCl 150 mg tablet) | $0.0707 per tablet (Sotalol 80 mg tablet) |
| 12-month price change | +2% | +0.9% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 5 | 1 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 4,209 | 16,549 |
| 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)
What next?
- Alternatives to propafenone
- every medicine labeled for the same conditions