Prescription medicine
Propafenone First approved as Rythmol
Propafenone (Rythmol) is a prescription medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $0.115 per propafenone HCl 150 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the propafenone FDA label on DailyMed (effective September 1, 2025, Strides Pharma Science Limited); the NDA 19151 record on Drugs@FDA; every propafenone label on DailyMed.
Highlights of the record
FDA label of September 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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). The average duration of treatment with encainide or flecainide in this trial was 10 months. The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) or other antiarrhythmic drugs is uncertain, but at present, it is prudent to consider any IC antiarrhythmic to have a significant proarrhythmic risk in patients with structural heart disease. Given the lack of any evidence that these drugs improve survival, antiarrhythmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs. WARNING: MORTALITY See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usagePropafenone 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.
Forms and strengths
- 150 mg
- 225 mg
- 300 mg
- 325 mg
- 425 mg
Extended-release capsule; coated tablet; film-coated tablet.
On the market
- Earliest approval on file
- November 27, 1989 Rythmol, Glaxosmithkline Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first October 24, 2000; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 14 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.115 per tablet Propafenone HCl 150 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest March 13, 2025; 1 more by firms not listed as its makers
- FAERS reports
- 4,209 through July 30, 2026
What is propafenone used for?
From the label: indications and usagePropafenone 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. Initiate treatment in the hospital. […]
Conditions named in the indications of propafenone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Antiarrhythmic.
Source: FDA drug label (PROPAFENONE HYDROCHLORIDE), Strides Pharma Science Limited, effective September 1, 2025 (SPL set c65253ab-937f-4982-b841-69c2b9f9ccdb), via openFDA; the full label on DailyMed
Is there a generic for propafenone (Rythmol)?
The FDA approved the first generic propafenone on October 24, 2000. 16 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists propafenone from 14 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1989 earliest approval on file
- 2000 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for propafenone (Rythmol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.115 per Propafenone HCl 150 mg tablet, up 2% from $0.113 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Propafenone HCl 150 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Propafenone HCl 150 mg tablet | Generic | $0.115 per tablet | $3.45 | +2% |
| Propafenone HCl 225 mg tablet | Generic | $0.207 per tablet | $6.20 | -1% |
| Propafenone HCl 300 mg tablet | Generic | $0.388 per tablet | $11.64 | -10% |
| Propafenone HCl ER 225 mg capsule | Generic | $0.299 per capsule | $8.98 | -37% |
| Propafenone HCl ER 325 mg capsule | Generic | $0.571 per capsule | $17.13 | -13% |
| Propafenone HCl ER 425 mg capsule | Generic | $0.578 per capsule | $17.33 | -39% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has propafenone been recalled?
The FDA's Enforcement Report lists 6 recalls naming propafenone since 2013: 0 Class I (the most serious), 5 Class II, 1 Class III; 4 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of propafenone and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| August 28, 2017 | Class III | Mckesson Packaging Services | Failed moisture limits: Out of specification for moisture content. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: PROPAFENONE HCL, Tablet, 150 mg may have potentially been mislabeled as the following drug: FOSINOPRIL SODIUM, Tablet, 10 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the propafenone label say about other medicines?
The propafenone label names 18 other medicines in its interaction, contraindication or warning sections. The labels of 42 other medicines name propafenone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Concomitant administration of propafenone and amiodarone can affect conduction and repolarization and is not recommended. |
| Cimetidine | drug interactions | Concomitant administration of propafenone immediate-release tablets and cimetidine in 12 healthy subjects resulted in a 20% increase in steady-state plasma concentrations of propafenone. |
| Desipramine | drug interactions | Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, or sertraline) and CYP3A4 (such as ketoconazole, ritonavir, saquinavir, erythromycin, grapefruit juice) can be expected to cause increased plasma levels of propafenone. |
| Digoxin | drug interactions | DRUG INTERACTIONS Inhibitors of CYP2D6, 1A2, and 3A4 increase propafenone exposure. (7.1) Propafenone may increase digoxin or warfarin levels. (7.2, 7.3) Orlistat may reduce propafenone exposure. |
| Erythromycin | drug interactions | Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, or sertraline) and CYP3A4 (such as ketoconazole, ritonavir, saquinavir, erythromycin, grapefruit juice) can be expected to cause increased plasma levels of propafenone. |
| Flecainide | boxed warning | An increased rate of death or reversed cardiac arrest rate was seen in subjects treated with encainide or flecainide (Class IC antiarrhythmics) compared with that seen in subjects assigned to placebo. |
| Fluoxetine | drug interactions | Concomitant administration of propafenone and fluoxetine in extensive metabolizers increased the S-propafenone C max and AUC by 39% and 50%, respectively, and the R propafenone C max and AUC by 71% and 50%, respectively. |
| Ketoconazole | drug interactions | Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, or sertraline) and CYP3A4 (such as ketoconazole, ritonavir, saquinavir, erythromycin, grapefruit juice) can be expected to cause increased plasma levels of propafenone. |
| Lidocaine | drug interactions | Taper orlistat withdrawal. (7.4) Lidocaine may increase central nervous system side effects. |
| Metoprolol | drug interactions | In 4 patients, administration of metoprolol with propafenone increased the metoprolol plasma concentrations at steady state by 100% to 400%. |
| Orlistat | drug interactions | DRUG INTERACTIONS Inhibitors of CYP2D6, 1A2, and 3A4 increase propafenone exposure. (7.1) Propafenone may increase digoxin or warfarin levels. (7.2, 7.3) Orlistat may reduce propafenone exposure. |
| Paroxetine | drug interactions | Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, or sertraline) and CYP3A4 (such as ketoconazole, ritonavir, saquinavir, erythromycin, grapefruit juice) can be expected to cause increased plasma levels of propafenone. |
| Propranolol | drug interactions | Concomitant use of propafenone and propranolol in healthy subjects increased propranolol plasma concentrations at steady state by 113%. |
| Quinidine | drug interactions | Small doses of quinidine completely inhibit the CYP2D6 hydroxylation metabolic pathway, making all patients, in effect, slow metabolizers [see Clinical Pharmacology (12.3)]. |
Every other medicine the propafenone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Rifampin | drug interactions | Concomitant administration of rifampin and propafenone in extensive metabolizers decreased the plasma concentrations of propafenone by 67% with a corresponding decrease of 5-OH-propafenone by 65%. |
| Ritonavir | drug interactions | Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, or sertraline) and CYP3A4 (such as ketoconazole, ritonavir, saquinavir, erythromycin, grapefruit juice) can be expected to cause … |
| Sertraline | drug interactions | Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, or sertraline) and CYP3A4 (such as ketoconazole, ritonavir, saquinavir, erythromycin, grapefruit juice) can be expected to cause … |
| Warfarin | drug interactions | The concomitant administration of propafenone and warfarin increased warfarin plasma concentrations at steady state by 39% in healthy volunteers and prolonged the prothrombin time (PT) in patients … |
Other labels that name propafenone
Source: FDA drug label (PROPAFENONE HYDROCHLORIDE), Strides Pharma Science Limited, effective September 1, 2025 (SPL set c65253ab-937f-4982-b841-69c2b9f9ccdb), via openFDA; the full label on DailyMed
What do FAERS reports show for propafenone?
The FDA Adverse Event Reporting System holds 4,209 reports that list propafenone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 504 are coded as a death and 1,803 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as propafenone?
3 other medicines are given the same way (oral) and in the same FDA class as propafenone or labeled mainly for the same use (atrial fibrillation), the same class first. Atrial fibrillation lists all 17 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Sotalol | Atrial fibrillation | 18 labelers | $0.0707 per tablet 80 mg tablet | No current entry |
| Dofetilide | Atrial fibrillation | 12 labelers | $0.203 per capsule 125 mcg capsule | No current entry |
| Quinidine | Atrial fibrillation | 4 labelers | $4.92 per tablet 324 mg tablet | No current entry |
Every medicine labeled for the same conditions as propafenone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does propafenone compare with medicines for the same use?
2 side-by-side pages set propafenone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to propafenone
- 3 medicines for the same use
- Other antiarrhythmics
- the pharmacologic class, with prices and generics
- Propafenone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other