Propafenone is an antiarrhythmic sold in the U.S. under 3 brand and generic names, for atrial fibrillation and supraventricular tachycardia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Propafenone Hydrochloride (application ANDA205956). Other propafenone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Propafenone hydrochloride extended-release capsules can be taken with or without food. Do not crush or further divide the contents of the capsule. The dose of propafenone hydrochloride extended-release capsules must be individually titrated on the basis of response and tolerance. Initiate therapy with propafenone hydrochloride extended-release capsules 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, the dose of propafenone hydrochloride extended-release capsules may be increased to 425 mg given every 12 hours. 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. 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 extended-release capsules with both a CYP2D6 inhibitor and a CYP3A4 inhibitor [see Warnings and Precautions (5.4) , Drug Interactions (7.1) ] . Initiate therapy with 225 mg given every 12 hours. ( 2 ) Dosage may be increased at a…
The most commonly reported adverse events with propafenone (greater than 5% and greater than placebo) excluding those not reasonably associated with the use of the drug included the following: dizziness, palpitations, chest pain, dyspnea, taste disturbance, nausea, fatigue, anxiety, constipation, upper respiratory tract infection, edema, and influenza. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to propafenone hydrochloride extended-release capsules 225 mg twice daily in 126 patients, to propafenone hydrochloride extended-release capsules 325 mg twice daily in 135 patients, to propafenone hydrochloride extended-release capsules 425 mg twice daily in 136 patients, and to placebo in 126 patients for up to 39 weeks (mean: 20 weeks) in a placebo- controlled trial (RAFT) conducted in the U.S. The most commonly reported adverse events with propafenone (greater than 5% and greater than placebo) excluding those not reasonably associated with the…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Capsule | Generic | $11 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 408;G | 225 mg | white, white | capsule | — |
| 409;G | 325 mg | white, white | capsule | — |
| 410;G | 425 mg | white, white | capsule | — |
| par;210 | 325 mg | orange | capsule | — |
| par;211 | 425 mg | red | capsule | — |
| par;209 | 225 mg |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Propafenone Hydrochloride Extended-Release Capsules USP
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Propafenone Hydrochloride Extended-Release Capsules
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Propafenone Hydrochloride Extended-Release Capsules 325mg
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Propafenone Hydrochloride Extended-Release Capsules 225mg
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Propafenone hydrochloride extended-release capsules are contraindicated in the following circumstances: Heart failure Cardiogenic shock Sinoatrial, atrioventricular, and intraventricular disorders of impulse generation or conduction (e.g., sick sinus node syndrome, AV block) in the absence of an artificial pacemaker Known Brugada Syndrome Bradycardia Marked hypotension Bronchospastic disorders or severe obstructive pulmonary disease Marked electrolyte imbalance Heart failure ( 4 ) Cardiogenic shock ( 4 ) Sinoatrial, atrioventricular, and intraventricular disorders of impulse generation and/or conduction in the absence of pacemaker ( 4 ) Known Brugada Syndrome ( 4 ) Bradycardia ( 4 ) Marked hypotension ( 4 ) Bronchospastic disorders and severe obstructive pulmonary disease ( 4 ) Marked electrolyte imbalance ( 4 )
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, 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) , Dosage and Administration (2) ]. Amiodarone Concomitant administration of propafenone and amiodarone can affect conduction and…
| 70/100 |
| Prescription |
| Tablet |
| Generic |
| $11 |
| View → |
| 3 | 70/100 | Prescription | Capsule | Generic | $11 | View → |
| white |
| capsule |
| — |
| 1;L | 150 mg | white | round | — |
|---|
| 2;L | 225 mg | white | round | — |
|---|
| 4;L | 300 mg | white | round | — |
|---|
| PR;OT;225 | 225 mg | white | round | — |
|---|
| PR;OT;300 | 300 mg | white | round | — |
|---|