Propafenone
Propafenone is a Class 1C antiarrhythmic (heart rhythm) medicine used to help prevent recurrences of atrial fibrillation and certain other fast heart rhythms, and to treat life-threatening ventricular arrhythmias, depending on the product.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 29 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Propafenone is a heart rhythm medicine that partly blocks sodium channels to slow heart signals, with a mild beta-blocker-like effect, and it is often a first choice for keeping atrial fibrillation and some other fast rhythms from coming back in people whose heart muscle is otherwise healthy, around since about 1989 and available as a generic. Most people tolerate it well, though dizziness, an odd taste and nausea are common. Its boxed warning comes from a study where similar drugs raised deaths after a heart attack, and it can trigger dangerous rhythm problems, so expect ECGs (heart tracings) and report fainting or a racing or very slow pulse.
Clinical pearls
- Report fever, sore throat or chills promptly, since a serious drop in infection-fighting white blood cells has been reported.
- Skip grapefruit juice and have every new prescription checked, since paroxetine, sertraline, ritonavir and erythromycin can push propafenone levels up.
- If you take warfarin or digoxin, expect extra INR or digoxin level checks, because propafenone can raise both.
- New ankle swelling or worsening breathlessness can mean heart failure, which propafenone can worsen, so report it promptly.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Drugs in the same class as propafenone (Class IC antiarrhythmics) increased the risk of death in a large study of people who had a heart attack. In that study, encainide or flecainide was used in people with symptomless, non-life-threatening ventricular arrhythmias after a recent heart attack.
Deaths or cardiac arrests were more common with the drugs (7.7%) than with placebo (3.0%). It is prudent to treat any Class IC drug as carrying a significant risk of causing dangerous rhythm problems in people with structural heart disease. These drugs have not been shown to improve survival, so they should generally be avoided for non-life-threatening ventricular arrhythmias, even if the symptoms are unpleasant.
Patient information guide A plain-language walkthrough of Propafenone, written from its FDA label.
What Propafenone is used for
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Propafenone treats certain fast or irregular heart rhythms. Uses depend on the product.
- Propafenone hydrochloride tablets: prolong the time to recurrence of atrial fibrillation (or paroxysmal atrial fibrillation/flutter) in people without structural heart disease.
- Propafenone hydrochloride tablets: prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) with disabling symptoms in people without structural heart disease.
- Propafenone hydrochloride tablets: treat documented life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia.
- Propafenone hydrochloride extended-release capsules: prolong the time to recurrence of symptomatic atrial fibrillation in people with episodic AF without structural heart disease.
How Propafenone works
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Propafenone is a Class 1C antiarrhythmic. It reduces the flow of sodium into heart cells, which slows electrical signals and makes the heart less likely to fire abnormal beats. It also lengthens the recovery period of heart cells and reduces spontaneous electrical activity.
It has a weak beta-blocking effect, roughly 1/40 to 1/50 the strength of propranolol, and can lower resting heart rate slightly.
Propafenone dosage
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Propafenone is taken by mouth. Tablets are taken about every 8 hours. Extended-release capsules are taken about every 12 hours.
- Your prescriber increases the dose slowly based on response and tolerance.
- Extended-release capsules can be taken with or without food and should not be crushed or divided.
- The dose may be lowered for liver problems or certain heart conduction changes.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Propafenone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Propafenone hydrochloride tablets (immediate-release): usual titration
- Initiate therapy with 150 mg given every 8 hours (450 mg per day)
- Dosage may be increased at a minimum of 3- to 4-day intervals to 225 mg every 8 hours (675 mg per day)
- If additional therapeutic effect is needed, may be increased to 300 mg every 8 hours (900 mg per day)
- Maximum: The usefulness and safety of dosages exceeding 900 mg per day have not been established.
- Dose must be individually titrated on the basis of response and tolerance.
- Propafenone hydrochloride extended-release capsules: usual titration
- Initiate therapy with 225 mg given every 12 hours
- Dosage may be increased at a minimum of 5-day intervals to 325 mg given every 12 hours
- If additional therapeutic effect is needed, may be increased to 425 mg given every 12 hours
- Maximum: 425 mg every 12 hours
- Can be taken with or without food. Do not crush or further divide the contents of the capsule.
- Patients with hepatic impairment, significant widening of the QRS complex, or second- or third-degree AV block
- Consider reducing the dose
- Applies to both tablets and extended-release capsules.
- Elderly or ventricular arrhythmia patients with marked previous myocardial damage (tablets)
- The dose should be increased more gradually during the initial phase of treatment
- Stated for the immediate-release tablets.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION The dose of Propafenone Hydrochloride Tablets must be individually titrated on the basis of response and tolerance. Initiate therapy with Propafenone Hydrochloride Tablets 150 mg given every 8 hours (450 mg per day). Dosage may be increased at a minimum of 3- to 4- day intervals to 225 mg every 8 hours (675 mg per day). If additional therapeutic effect is needed, the dose of Propafenone Hydrochloride Tablets may be increased to 300 mg every 8 hours (900 mg per day). The usefulness and safety of dosages exceeding 900 mg per day have not been established. In patients with hepatic impairment or those with significant widening of the QRS complex or second- or third-degree AV block, consider reducing the dose. As with other antiarrhythmic agents, in the elderly or in ventricular arrhythmia patients with marked previous myocardial damage, the dose of Propafenone Hydrochloride Tablets should be increased more gradually during the initial phase of treatment. The combination of cytochrome P450 3A4 (CYP3A4) inhibition and either cytochrome P450 2D6 (CYP2D6) deficiency or CYP2D6 inhibition with the simultaneous administration of propafenone may significantly increase the concentration of propafenone and thereby increase the risk of proarrhythmia and other adverse events. Therefore, avoid simultaneous use of Propafenone Hydrochloride Tablets with both a CYP2D6 inhibitor and a CYP3A4 inhibitor [see Warnings and Precautions ( 5.4 ), Drug Interactions ( 7.1 )] . • Initiate therapy with 150 mg given every 8 hours. ( 2 ) • As needed, uptitrate in 3 to 4 days to 225 to 300 mg every 8 hours. ( 2 ) • Consider reducing the dose in patients with hepatic impairment, significant widening of the QRS complex, or second- or third-degree AV block. ( 2 )
Read the full Dosage and Administration section on DailyMed →
Propafenone side effects
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The most common side effects in studies were:
Common side effects
- Dizziness
- Palpitations (awareness of your heartbeat)
- Chest pain
- Shortness of breath
- Taste changes
- Nausea
- Fatigue
- Anxiety
- Constipation
- Upper respiratory infection, swelling and flu
When to get medical help
- Call your doctor right away if you have new or worse irregular heartbeats, fainting, or a very fast or very slow pulse.
- Report signs of infection such as fever, sore throat or chills, because a serious drop in white blood cells (agranulocytosis) has been reported.
- Get help for new or worsening swelling, shortness of breath or other signs of heart failure.
- Tell your doctor if you have worsening muscle weakness if you have myasthenia gravis.
- Seek help for allergic-type reactions, including asthma symptoms, especially if you are sensitive to aspirin or tartrazine (FD&C Yellow No. 5, in some capsule strengths).
Seek medical help for new or worse irregular heartbeat, fainting, signs of heart failure, or fever, sore throat or chills. Most stopping of treatment for side effects happened in the first 14 days.
Propafenone warnings and precautions
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- Proarrhythmia: propafenone can cause new or worse arrhythmias, including sudden death. You need an ECG before and during treatment.
- Brugada syndrome: it may unmask this condition, so an ECG is done after starting.
- Heart failure: it can weaken the heart's pumping and provoke heart failure.
- Conduction problems: it can cause AV block and may affect pacemaker and defibrillator settings.
- Agranulocytosis: a drop in white blood cells, usually within the first 2 months. Report infection signs.
- Liver and kidney disease: use cautiously, with monitoring.
- Other: it can worsen myasthenia gravis and raise ANA levels. Some capsule strengths contain tartrazine.
Propafenone interactions
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Propafenone is broken down by several liver enzymes, so many drugs affect it.
- CYP2D6 inhibitors (paroxetine, sertraline, desipramine, ritonavir) raise propafenone levels.
- CYP3A4 inhibitors (ketoconazole, erythromycin, saquinavir, grapefruit juice) raise levels. Avoid using both types together.
- Quinidine and amiodarone: avoid, as they raise levels or affect heart conduction.
- Digoxin and warfarin: levels increase, so monitoring is needed.
- Orlistat: lowers propafenone, and stopping it suddenly caused serious problems.
- Propranolol and metoprolol: their levels rise.
- Rifampin: lowers propafenone levels. Cimetidine and fluoxetine raise them.
- Lidocaine: may increase nervous system side effects.
Interactions listed in the FDA-approved label
From the Propafenone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- CYP2D6 inhibitors and CYP3A4 inhibitors (CYP2D6: desipramine, paroxetine, ritonavir, sertraline; CYP3A4: ketoconazole, ritonavir, saquinavir, erythromycin, grapefruit juice): Can be expected to cause increased plasma levels of propafenone; combining CYP3A4 inhibition with CYP2D6 deficiency or inhibition may increase the risk of adverse reactions, including proarrhythmia. Simultaneous use with both a CYP2D6 inhibitor and a CYP3A4 inhibitor should be avoided.
- Amiodarone: Concomitant administration can affect conduction and repolarization. Not recommended.
- Cimetidine: 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.
- Fluoxetine: In extensive metabolizers, increased the S-propafenone Cmax and AUC by 39% and 50% respectively and the R-propafenone Cmax and AUC by 71% and 50%, respectively.
- Quinidine: Small doses of quinidine completely inhibit the CYP2D6 pathway; steady-state propafenone concentrations increased by more than 2-fold with quinidine 50 mg 3 times daily, and 3-fold with a 100 mg dose. Avoid concomitant use of propafenone and quinidine.
- Rifampin: In extensive metabolizers, decreased the plasma concentrations of propafenone by 67% and 5-OH-propafenone by 65%; norpropafenone increased by 30%.
- Digoxin: Increased steady-state serum digoxin exposure (AUC) by 60% to 270% and decreased digoxin clearance by 31% to 67%. Monitor plasma digoxin levels and adjust digoxin dosage as needed.
- Warfarin: Increased warfarin plasma concentrations at steady state by 39% in healthy volunteers and prolonged the prothrombin time (PT) in patients. Adjust the warfarin dose as needed by monitoring INR.
- Orlistat: May limit the fraction of propafenone available for absorption; abrupt cessation in stabilized patients has resulted in convulsions, atrioventricular block and acute circulatory failure.
- Beta-antagonists (propranolol, metoprolol): Increased propranolol plasma concentrations at steady state by 113% and metoprolol by 100% to 400%; propafenone pharmacokinetics were not affected.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Inhibitors of CYP2D6, 1A2, and 3A4 may increase propafenone levels which may lead to cardiac arrhythmias. Simultaneous use with both a CYP3A4 and CYP2D6 inhibitor (or in patients with CYP2D6 deficiency) should be avoided. ( 7.1 ) • Propafenone may increase digoxin or warfarin levels. ( 7.2 , 7.3 ) • Orlistat may reduce propafenone concentrations. Abrupt cessation of orlistat in patients stable on propafenone hydrochloride extended-release capsules has resulted in convulsions, atrioventricular block, and circulatory failure. ( 7.4 ) • Concomitant use of lidocaine may increase central nervous system side effects. ( 7.6 ) 7.1 CYP2D6 and CYP3A4 Inhibitors Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, sertraline) and CYP3A4 (such as ketoconazole, ritonavir, saquinavir, erythromycin, and grapefruit juice) can be expected to cause increased plasma levels of propafenone. The combination of CYP3A4 inhibition and either CYP2D6 deficiency or CYP2D6 inhibition with administration of propafenone may increase the risk of adverse reactions, including proarrhythmia. Therefore, simultaneous use of propafenone hydrochloride extended-release capsules with both a CYP2D6 inhibitor and a CYP3A4 inhibitor should be avoided [see Warnings and Precautions ( 5.4 ) and Dosage and Administration ( 2 )]. Amiodarone Concomitant administration of propafenone and amiodarone can affect conduction and repolarization and is not recommended. Cimetidine 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. Fluoxetine 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.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Propafenone
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- Not for people with heart failure, cardiogenic shock, bradycardia, marked low blood pressure, Brugada syndrome or marked electrolyte imbalance.
- Not for people with conduction disorders without a pacemaker, or with bronchospastic disorders or severe obstructive lung disease.
- Tell your doctor about liver or kidney disease and myasthenia gravis.
- Pregnancy: propafenone crosses the placenta. Untreated arrhythmias also carry risk, and monitoring is recommended during labor and delivery.
- Breastfeeding: it is present in milk, probably at low levels.
- Children: safety and effectiveness have not been established.
- Older adults: dose is raised more gradually.
- Males: it may temporarily reduce sperm production.
Propafenone overdose
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Too much propafenone can cause low blood pressure, drowsiness, slow heart rate, conduction problems and, rarely, seizures and dangerous ventricular arrhythmias. Treatment is supportive and in a hospital. Dialysis is expected to help little.
What Propafenone does in the body
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Propafenone slows conduction through the AV node and heart tissue and lengthens the refractory period. It lengthens the PR and QRS intervals on an ECG. It can also weaken the heart's pumping force (negative inotropic effect).
How your body processes Propafenone
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Extended-release capsules reach peak blood levels in about 3 to 8 hours. Much of the drug is broken down by the liver on first pass. In over 90% of people it is cleared quickly (half-life 2 to 10 hours). In under 10% it is cleared slowly (10 to 32 hours) and levels run higher.
How to store Propafenone
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Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Propafenone
138 supplements and herbal products have documented interactions with Propafenone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 99
- Minor · 38
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Propafenone: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Propafenone — the kind of thing our pharmacy team would talk through with you at the counter.
What is propafenone for?
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How should I take it?
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What side effects are common?
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Why do I need ECGs while taking it?
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Do I need to watch other medicines or foods?
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Can I take it if I'm pregnant?
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Is Propafenone available over the counter?
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When was Propafenone first available?
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Who makes Propafenone?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Propafenone on HelloPharmacist
Propafenone forms and strengths (how it comes)
Propafenone is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Extended-release capsule
How this form is used
- Propafenone hydrochloride extended-release capsules are used to prolong the time to recurrence of symptomatic atrial fibrillation in people with episodic AF who do not have structural heart disease.
- Propafenone hydrochloride extended-release capsules can be taken with or without food.
- Do not crush or divide the contents of propafenone hydrochloride extended-release capsules.
- Propafenone hydrochloride extended-release capsules are taken about every 12 hours, with the dose raised gradually by your prescriber.
Tablet
How this form is used
- Propafenone hydrochloride tablets are used to prolong the time to recurrence of atrial fibrillation or paroxysmal atrial fibrillation/flutter, and of PSVT with disabling symptoms, in people without structural heart disease.
- Propafenone hydrochloride tablets are also used to treat documented life-threatening ventricular arrhythmias.
- Propafenone hydrochloride tablets are taken about every 8 hours, with the dose adjusted gradually by your prescriber.
- Treatment with propafenone hydrochloride tablets for life-threatening ventricular arrhythmias is started in the hospital.
Propafenone on the U.S. market: products, makers and brands
How Propafenone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
15 companies list 56 Propafenone product records with the FDA, mostly as extended-release capsule, tablet; the earliest marketing or approval year on record is 1989. Brand names on the directory include Rythmol, Rythmol SR; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (13) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Propafenone is used (Medicaid data)
A general measure of how commonly Propafenone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Propafenone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Propafenone prescribed? Of the 1,601 medications we measure, Propafenone ranks #959 by Medicaid prescriptions — more than 40% of them.
Utilization by Propafenone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
propafenone hydrochloride 150 MG Oral Tablet Most dispensed
Summed across the 5 of 31 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861424
propafenone hydrochloride 225 MG Oral Tablet
Summed across the 4 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861427
12 HR propafenone hydrochloride 225 MG Extended Release Oral Capsule
Summed across the 4 of 40 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861156
12 HR propafenone hydrochloride 325 MG Extended Release Oral Capsule
Summed across the 2 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861164
propafenone hydrochloride 300 MG Oral Tablet
Summed across the 1 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861430
12 HR propafenone hydrochloride 425 MG Extended Release Oral Capsule
Summed across the 1 of 38 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861171
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Propafenone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 17 of 186 listed Propafenone NDCs with Medicaid activity.
Compare Propafenone products
A representative set of FDA-listed product records for Propafenone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Extended-release capsule | ||||
| 225 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 325 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 425 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 225 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 325 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 425 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 225 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 325 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 425 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 225 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 325 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 425 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 225 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 325 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 425 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 225 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 325 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 425 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 225 mg | Oral | Vitruvias Therapeutics | ANDA | View NDC → |
| 325 mg | Oral | Vitruvias Therapeutics | ANDA | View NDC → |
| 425 mg | Oral | Vitruvias Therapeutics | ANDA | View NDC → |
| 225 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 325 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 425 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 225 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 325 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 425 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| 225 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 150 mg | Oral | American Health Packaging × 2 listings | ANDA | View NDC → |
| 150 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 225 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 300 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 150 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 225 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 300 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 150 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 225 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 300 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 150 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 225 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 300 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 150 mg | Oral | Strides Pharma Science Limited × 2 listings | ANDA | View NDC → |
| 225 mg | Oral | Strides Pharma Science Limited × 2 listings | ANDA | View NDC → |
| 300 mg | Oral | Strides Pharma Science Limited × 2 listings | ANDA | View NDC → |
Showing 56 of 56 products — FDA National Drug Code Directory. See every product, package size and price: browse all 56 Propafenone NDCs →
Propafenone side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Propafenone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Propafenone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Propafenone FDA approval history
How Propafenone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Propafenone recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Propafenone recall since July 2021, covering 4 product listings. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pra… Lots: Lot # 17230767, exp. date Mar-25 FDA record D-0352-2025 →
- Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01. Lots: Lot # 17230819, exp. date Mar-25 FDA record D-0351-2025 →
- Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenm… Lots: Lot # 17230767, exp. date Mar-25 FDA record D-0316-2025 →
- Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glen… Lots: Lot # 17230819, exp. date Mar-25 FDA record D-0315-2025 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 8754 2 dose forms · 6 strengths
-
Dose form (SCDF) Extended Release Oral Capsule RxCUI 406230In current FDA listingsClinical drug / strength (SCD) 12 HR propafenone hydrochloride 225 MGRxCUI 86115612 HR propafenone hydrochloride 325 MGRxCUI 86116412 HR propafenone hydrochloride 425 MGRxCUI 861171 -
Dose form (SCDF) Oral Tablet RxCUI 373637In current FDA listingsClinical drug / strength (SCD) hydrochloride 150 MGRxCUI 861424hydrochloride 225 MGRxCUI 861427hydrochloride 300 MGRxCUI 861430
Look up RxCUI 8754 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Propafenone supply and shortage status
Whether Propafenone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Propafenone costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule, Extended Release · Oral | 325 mg | $0.571 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 425 mg | $0.578 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 225 mg | $0.299 per capsule | NDC details & price history |
| Tablet, Film Coated · Oral | 150 mg | $0.115 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 225 mg | $0.207 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 300 mg | $0.388 per tablet | NDC details & price history |
| Capsule, Extended Release | 425 mg | $0.578 per capsule | NDC details & price history |
| Capsule, Extended Release | 325 mg | $0.571 per capsule | NDC details & price history |
| Capsule, Extended Release | 225 mg | $0.299 per capsule | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Propafenone brand names
Propafenone is sold under 2 brand names in the FDA directory — Rythmol, Rythmol SR. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Propafenone: manufacturers and labelers
15 companies list Propafenone products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Aurobindo Pharma Limited, Strides Pharma Science Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Propafenone drug class (RxNorm)
Propafenone belongs to the Antiarrhythmic class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Propafenone page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Vitruvias Therapeutics is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →