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Flecainide

Flecainide is a heart rhythm medicine (antiarrhythmic) used to prevent certain fast heart rhythms, including paroxysmal supraventricular tachycardia, paroxysmal atrial fibrillation/flutter, and life-threatening ventricular arrhythmias.

Brand name Tambocor
Drug class Antiarrhythmic
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 36 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 →

✓No current FDA shortage listed · checked Oct 5, 2026
Flecainide at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Flecainide (Tambocor) is a powerful Class 1C heart rhythm medicine that slows the heart's electrical signals, used to prevent PSVT (sudden runs of fast heartbeat), on-and-off atrial fibrillation or flutter, and certain life-threatening ventricular arrhythmias in carefully selected people, a closely monitored, cardiologist-guided choice on the market since the mid-1980s and available generically. Most people tolerate it fairly well, and dizziness and vision changes are what they notice most. Its boxed warning reflects more deaths and cardiac arrests in recent heart attack survivors, and it can itself trigger dangerous rhythms or heart failure, so fainting, a racing or irregular heartbeat, or chest pain needs emergency help.

Clinical pearls

  • Adding amiodarone can double flecainide levels or more, so the dose is usually halved and blood levels checked.
  • For heartburn, skip cimetidine (Tagamet), which raises flecainide levels, and choose a different acid reducer instead.
  • If you have a pacemaker, tell the device clinic you started flecainide, since pacing thresholds may need rechecking.
  • Keep every follow-up visit, because ECGs (heart tracings) and potassium checks guide each slow dose increase.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

In a large study of people who had a recent heart attack, those taking flecainide had more deaths and cardiac arrests than those on placebo (5.1% vs 2.3%). The people studied had no symptoms and only mild rhythm problems.

Because of this, flecainide is generally not acceptable for people without life-threatening ventricular arrhythmias, even if their symptoms are unpleasant. It can also cause dangerous ventricular rhythm problems in people with atrial fibrillation or flutter, and it is not recommended for chronic atrial fibrillation. In atrial flutter, the heart's lower chambers can sometimes beat too fast. Taking digoxin or a beta blocker may lower that risk. Seek help right away for fainting, a racing or irregular heartbeat, or chest pain.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record1985
Companies listing it with the FDA15
FDA label last updatedMay 29, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Flecainide, written from its FDA label.

What Flecainide is used for

▾

Flecainide helps prevent several types of fast heart rhythm.

  • Flecainide acetate tablets: prevention of paroxysmal supraventricular tachycardias (PSVT) with disabling symptoms, in people without structural heart disease.
  • Flecainide acetate tablets: prevention of paroxysmal atrial fibrillation/flutter (PAF) with disabling symptoms, in people without structural heart disease.
  • Flecainide acetate tablets: prevention of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia.

How Flecainide works

▾

Flecainide is a Class 1C antiarrhythmic with local anesthetic-like activity. It slows how fast electrical signals travel through the heart, especially in the ventricles. This helps stop abnormal rhythms from starting or repeating.

Flecainide dosage

▾

Flecainide acetate tablets are swallowed by mouth, usually twice a day. Food and antacids do not change absorption. Doses are raised slowly, no more often than every four days, because the drug takes 3 to 5 days to build up.

  • Treatment for sustained ventricular tachycardia begins in the hospital with rhythm monitoring.
  • People with kidney or liver problems may need lower doses and blood level checks.
  • Follow your prescriber and label directions, and ask your pharmacist what to do about a missed dose.

Dosing details from the FDA-approved label

From the Flecainide 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.

  • Paroxysmal supraventricular tachycardia (PSVT) and paroxysmal atrial fibrillation/flutter (PAF)
    • Starting dose 50 mg every 12 hours
    • May be increased in increments of 50 mg bid every four days until efficacy is achieved
    • For PAF, increasing from 50 mg to 100 mg bid may substantially increase efficacy without a substantial increase in discontinuations for adverse experiences
    • Maximum: 300 mg/day
    • Increases no more frequently than once every four days
  • Sustained VT
    • Starting dose 100 mg every 12 hours
    • May be increased in increments of 50 mg bid every four days until efficacy is achieved
    • An occasional patient not adequately controlled by (or intolerant to) a dose given at 12-hour intervals may be dosed at eight-hour intervals
    • Maximum: 400 mg/day
    • Initiate in-hospital with rhythm monitoring; loading dose not recommended; most patients do not require more than 150 mg every 12 hours (300 mg/day)
  • Children under six months of age
    • Initial starting dose approximately 50 mg/M2 body surface area daily, divided into two or three equally spaced doses
    • Maximum: 200 mg/M2 per day
    • Use directly supervised by a cardiologist skilled in treating arrhythmias in children; plasma trough levels and ECGs at presumed steady state
  • Children over six months of age
    • Initial starting dose may be increased to 100 mg/M2 per day
    • Maximum: 200 mg/M2 per day
    • Use directly supervised by a cardiologist; usual therapeutic level 200 to 500 ng/mL, in some cases up to 800 ng/mL
  • Severe renal impairment (creatinine clearance of 35 mL/min/1.73 square meters or less)
    • Initial dosage 100 mg once daily (or 50 mg bid)
    • Frequent plasma level monitoring required to guide dosage adjustments; increase very cautiously
  • Less severe renal disease
    • Initial dosage 100 mg every 12 hours
    • Plasma level monitoring may be useful during dosage adjustment
  • Concurrent amiodarone therapy
    • Reduce the usual flecainide dose by 50%
    • Monitor closely for adverse effects; plasma level monitoring strongly recommended
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION For patients with sustained VT, no matter what their cardiac status, Flecainide Acetate Tablets, USP like other antiarrhythmics, should be initiated in-hospital with rhythm monitoring. Flecainide has a long half-life (12 to 27 hours in patients). Steady-state plasma levels, in patients with normal renal and hepatic function, may not be achieved until the patient has received 3 to 5 days of therapy at a given dose. Therefore, increases in dosage should be made no more frequently than once every four days , since during the first 2 to 3 days of therapy the optimal effect of a given dose may not be achieved. For patients with PSVT and patients with PAF the recommended starting dose is 50 mg every 12 hours. Flecainide Acetate Tablets, USP doses may be increased in increments of 50 mg bid every four days until efficacy is achieved. For PAF patients, a substantial increase in efficacy without a substantial increase in discontinuations for adverse experiences may be achieved by increasing the Flecainide Acetate Tablets, USP dose from 50 mg to 100 mg bid. The maximum recommended dose for patients with paroxysmal supraventricular arrhythmias is 300 mg/day. For sustained VT the recommended starting dose is 100 mg every 12 hours. This dose may be increased in increments of 50 mg bid every four days until efficacy is achieved. Most patients with sustained VT do not require more than 150 mg every 12 hours (300 mg/day), and the maximum dose recommended is 400 mg/day. In patients with sustained VT, use of higher initial doses and more rapid dosage adjustments have resulted in an increased incidence of proarrhythmic events and CHF, particularly during the first few days of dosing (see WARNINGS ) . Therefore, a loading dose is not recommended. Intravenous lidocaine has been used occasionally with Flecainide Acetate Tablets, USP while awaiting the therapeutic effect of Flecainide Acetate Tablets, USP. No adverse drug interactions were apparent. However, no formal studies have been performed to demonstrate the usefulness of this regimen. An occasional patient not adequately controlled by (or intolerant to) a dose given at 12-hour intervals may be dosed at eight-hour intervals.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Flecainide side effects

▾

The most common side effects are mostly non-cardiac.

Common side effects

  • Dizziness or lightheadedness
  • Blurred vision or other vision changes
  • Shortness of breath
  • Headache
  • Nausea
  • Tiredness or weakness
  • Heart palpitations
  • Chest pain

When to get medical help

  • Call 911 or get emergency help for fainting, a very fast, pounding, or irregular heartbeat, or cardiac arrest symptoms.
  • Call your doctor if you have new or worse shortness of breath, swelling, or sudden weight gain, which can signal heart failure.
  • Call your doctor about a very slow heartbeat, severe dizziness, or near-fainting.
  • Tell your doctor right away about unexplained yellowing of the skin or eyes (jaundice), which can signal liver problems.
  • Report signs of blood problems or a serious allergic reaction, such as swollen lips, tongue, or mouth, or a severe rash.
  • Report new cough or breathing problems, since lung inflammation has been reported with long-term use.

Flecainide warnings and precautions

▾
  • Higher risk of death after a heart attack: flecainide should not be used in people with a recent heart attack.
  • New or worse arrhythmias: these are most likely in people with serious heart disease, and often occur in the first two weeks.
  • Heart failure: it can cause or worsen heart failure, especially with weak heart function.
  • Conduction problems: it can slow the heart's electrical signals and cause heart block or a slow heartbeat.
  • Pacemakers: it can raise pacing thresholds, so they need to be checked.
  • Electrolytes: low or high potassium should be corrected first.
  • Chronic atrial fibrillation: not recommended.

Flecainide interactions

▾

Several medicines can change flecainide levels or add to its effects on the heart.

  • Amiodarone: can double flecainide levels, so the dose is usually cut by half.
  • Propranolol and other beta blockers: may add to weakened heart pumping.
  • Digoxin: levels may rise slightly.
  • Disopyramide and verapamil: generally avoided together, since both weaken heart pumping.
  • Nifedipine and diltiazem: not enough experience to recommend combining.
  • Quinidine and other CYP2D6 inhibitors: may raise flecainide levels.
  • Cimetidine: raises flecainide levels by about 30%.

Interactions listed in the FDA-approved label

From the Flecainide prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Digoxin: A 13% to 19% increase in plasma digoxin levels occurred at six hours postdose in healthy subjects on maintenance digoxin.
  • Propranolol: Plasma flecainide levels increased about 20% and propranolol levels about 30%; negative inotropic effects were additive. The possibility of additive negative inotropic effects of beta blockers and flecainide should be recognized.
  • Anticoagulants and other highly protein-bound drugs: Flecainide is not extensively bound to plasma proteins, so interactions are not expected.
  • Diuretics: Used in a large number of patients without apparent interaction.
  • Enzyme inducers (phenytoin, phenobarbital, carbamazepine): Limited data indicate only a 30% increase in the rate of flecainide elimination.
  • Cimetidine: In healthy subjects, plasma flecainide levels increased by about 30% and half-life by about 10%.
  • Amiodarone: Plasma flecainide levels may increase two-fold or more in some patients if the flecainide dosage is not reduced. See Dosage and Administration: reduce the flecainide dose by 50% and monitor plasma levels.
  • Quinidine and other cytochrome P450IID6 inhibitors: Might increase plasma concentrations of flecainide in patients on chronic therapy, especially extensive metabolizers.
  • Disopyramide or verapamil: Both have negative inotropic properties and the effects of coadministration with flecainide are unknown. Should not be administered concurrently unless, in the physician's judgment, the benefits outweigh the risks.
  • Nifedipine or diltiazem: There has been too little experience with coadministration. Concomitant use is not recommended.
Read the label’s full interactions text

Drug Interactions Flecainide acetate has been administered to patients receiving digitalis preparations or beta-adrenergic blocking agents without adverse effects. During administration of multiple oral doses of flecainide acetate to healthy subjects stabilized on a maintenance dose of digoxin , a 13% to 19% increase in plasma digoxin levels occurred at six hours postdose. In a study involving healthy subjects receiving flecainide acetate and propranolol concurrently, plasma flecainide levels were increased about 20% and propranolol levels were increased about 30% compared to control values. In this formal interaction study, flecainide acetate and propranolol were each found to have negative inotropic effects; when the drugs were administered together, the effects were additive. The effects of concomitant administration of flecainide acetate and propranolol on the PR interval were less than additive. In flecainide acetate clinical trials, patients who were receiving beta blockers concurrently did not experience an increased incidence of side effects. Nevertheless, the possibility of additive negative inotropic effects of beta blockers and flecainide should be recognized. Flecainide is not extensively bound to plasma proteins. In vitro studies with several drugs which may be administered concomitantly showed that the extent of flecainide binding to human plasma proteins is either unchanged or only slightly less. Consequently, interactions with other drugs which are highly protein bound (e.g., anticoagulants ) would not be expected. Flecainide acetate has been used in a large number of patients receiving diuretics without apparent interaction. Limited data in patients receiving known enzyme inducers ( phenytoin, phenobarbital, carbamazepine ) indicate only a 30% increase in the rate of flecainide elimination. In healthy subjects receiving cimetidine (1 gm daily) for one week, plasma flecainide levels increased by about 30% and half-life increased by about 10%.

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 Flecainide

▾
  • Not for people with second- or third-degree AV block or bifascicular block without a pacemaker.
  • Not for people in cardiogenic shock or allergic to flecainide.
  • Not for use after a recent heart attack.
  • Use cautiously with heart failure, weak heart function, or sick sinus syndrome.
  • Kidney or liver disease may require blood level monitoring and lower doses.
  • Children must be supervised by a cardiologist skilled in childhood arrhythmias, and treatment starts in the hospital. In infants, milk may reduce absorption, so the dose may need adjusting if milk is removed from the diet.
  • Very alkaline urine (for example, from a strict vegetarian diet) slows flecainide elimination.

Flecainide overdose

▾

An overdose can cause nausea, vomiting, seizures, low blood pressure, a slow heartbeat, fainting, dangerous rhythm changes, heart failure, and cardiac arrest. There is no specific antidote, and dialysis does not remove it well. Treatment is supportive care and may be needed for an extended time because the drug stays in the body for a long time. Seek emergency help right away.

What Flecainide does in the body

▾

Flecainide slows electrical conduction throughout the heart in a dose-related way, with the greatest effect on the His-Purkinje system and the ventricles. It lengthens the PR, QRS, and QT intervals on an ECG. It reduces extra ventricular beats (PVCs) and can prevent ventricular tachycardia from returning. It has a negative inotropic effect, meaning it can weaken the heart's pumping, and levels above about 0.7 to 1 mcg/mL raise the rate of cardiac side effects.

How your body processes Flecainide

▾

Flecainide is almost completely absorbed after a tablet is swallowed, and levels peak at about three hours. Food and antacids do not affect absorption. Its half-life averages about 20 hours, so steady levels take 3 to 5 days to build up. The liver breaks it down (partly using the CYP2D6 enzyme) and the kidneys clear it, so kidney or liver problems can slow elimination. About 30% leaves in the urine unchanged.

How to store Flecainide

▾

Store at 20° to 25°C (68° to 77°F) . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

86

Supplements & herbs that interact with Flecainide

86 supplements and herbal products have documented interactions with Flecainide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 7
  • Moderate · 61
  • Minor · 18
Every supplement checked against Flecainide — ranked by severity The full interaction hub: 7 major · 61 moderate · 18 minor · every one linked to its full report. Check Flecainide against your exact supplements

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.

Flecainide: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Flecainide — the kind of thing our pharmacy team would talk through with you at the counter.

What is flecainide for?

▾
It helps prevent certain fast heart rhythms, including PSVT and paroxysmal atrial fibrillation/flutter, in people without structural heart disease. It is also used to prevent life-threatening ventricular arrhythmias such as sustained ventricular tachycardia. It does not treat a rhythm in the moment. It is meant to keep problem rhythms from coming back.

How should I take it?

▾
Take it by mouth exactly as prescribed, usually twice a day. Food and antacids don't change how well it's absorbed. Your doctor will raise the dose slowly, so don't change it on your own.

What side effects should I expect?

▾
Dizziness and vision changes like blurred vision are the most common. Some people also get shortness of breath, headache, nausea, tiredness, or palpitations. Call your doctor if these bother you or don't settle.

When should I get urgent help?

▾
Get emergency help for fainting, a very fast, pounding, or irregular heartbeat, or chest pain. Call your doctor for new swelling, worse shortness of breath, a very slow pulse, yellowing of the skin or eyes, or an allergic reaction like swollen lips or tongue.

Can I take it with my other medicines?

▾
Check with me first. Amiodarone can double flecainide levels, so the dose is usually cut in half. Beta blockers, digoxin, verapamil, disopyramide, diltiazem, nifedipine, quinidine, and cimetidine can also matter.

Is flecainide safe if I've had a heart attack?

▾
Flecainide should not be used in people with a recent heart attack. In a large study, people who had a heart attack and took it had more deaths and cardiac arrests than those on placebo. Make sure your doctor knows your full heart history.

Is Flecainide available over the counter?

▾
No. Flecainide is a prescription medicine: every Flecainide product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Flecainide first available?

▾
The earliest FDA record we hold for Flecainide is from 1985: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Flecainide was first used.

Who makes Flecainide?

▾
15 companies currently list Flecainide products in the FDA's NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, ANI Pharmaceuticals, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Flecainide on HelloPharmacist

Detailed data & references for Flecainide Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Flecainide forms and strengths (how it comes)

Flecainide is available in 1 form. 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.

Tablet

By mouth
How this form is used
What it may be used for
  • Flecainide Acetate tablets are used to prevent PSVT and paroxysmal atrial fibrillation/flutter with disabling symptoms in people without structural heart disease.
  • Flecainide Acetate tablets are also used to prevent life-threatening documented ventricular arrhythmias such as sustained ventricular tachycardia.
Important instructions
  • Flecainide Acetate tablets are taken by mouth, usually every 12 hours, though some people are dosed every 8 hours or once daily.
  • Flecainide Acetate dose increases are made no more often than every four days.
  • Flecainide Acetate for sustained ventricular tachycardia is started in the hospital with rhythm monitoring.
  • Food or antacids do not affect absorption of Flecainide Acetate.
Available strengths 3 strengths
134 FDA-listed product records ⓘ

Flecainide on the U.S. market: products, makers and brands

How Flecainide 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 Flecainide product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1985. Brand names on the directory include Tambocor; the rest are generics.

1
Dose forms ⓘ
15
Labelers (makers, repackagers, distributors)
1
Brand names
56
FDA-listed product records ⓘ
1985
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack29%
A-S Medication Solutions7%
ANI Pharmaceuticals, Inc.5%
Amneal Pharmaceuticals LLC5%
Amneal Pharmaceuticals of New York LLC5%
Aurobindo Pharma Limited5%
Other makers43%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Flecainide is used (Medicaid data)

A general measure of how commonly Flecainide 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 Flecainide 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.

82,857
Medicaid prescriptions filled (Q1–Q4 2025)
$1.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Flecainide prescribed? Of the 1,601 medications we measure, Flecainide ranks #539 by Medicaid prescriptions — more than 66% of them.

Where Flecainide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Flecainide 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.

The 50 mg oral tablet is the most-dispensed Flecainide product — about 50% of these Medicaid prescriptions.

flecainide acetate 50 MG Oral Tablet Most dispensed

41,167 Medicaid prescriptions (Q1–Q4 2025) 50% of Flecainide prescriptions shown $754,816 gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 8 of 45 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 886662

flecainide acetate 100 MG Oral Tablet

37,326 Medicaid prescriptions (Q1–Q4 2025) 45% of Flecainide prescriptions shown $873,664 gross reimbursement (before rebates) ≈ $23 per prescription (gross)

Summed across the 8 of 44 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 886666

flecainide acetate 150 MG Oral Tablet

4,364 Medicaid prescriptions (Q1–Q4 2025) 5% of Flecainide prescriptions shown $138,725 gross reimbursement (before rebates) ≈ $32 per prescription (gross)

Summed across the 7 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 886671

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 Flecainide, 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 23 of 125 listed Flecainide NDCs with Medicaid activity.

Compare Flecainide products

A representative set of FDA-listed product records for Flecainide — 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.)

Showing 56 of 56 products — FDA National Drug Code Directory. See every product, package size and price: browse all 56 Flecainide NDCs →

Flecainide 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 Flecainide — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Flecainide are atrial fibrillation, fatigue, dyspnoea; about 74% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

5,245
Reports mentioning it
74%
Reported as serious
12
Distinct effects shown
Most reported effects
Atrial Fibrillation
350
Fatigue
287
Dyspnoea
283
Dizziness
270
Nausea
250
Headache
224
Diarrhoea
216
Asthenia
203
Fall
190
Hypotension
178
Age groups
Elderly · 498Adult · 243Neonate · 15Infant · 12Child · 5Adolescent · 4

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 Flecainide 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.

Flecainide FDA approval history

How Flecainide went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Flecainide was first approved by the FDA in 1985 (Brand: TAMBOCOR · Alvogen); the first generic version was approved in 2001. It remains available in U.S. pharmacies today.

1985
Brand approved
Brand: TAMBOCOR · Alvogen
2001
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Flecainide 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 no Flecainide recalls since July 2021.

✅No Flecainide recalls on record since July 2021

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.

Ingredient (IN) Flecainide RxCUI 4441 2 dose forms · 4 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 498899 No current FDA listing
    Clinical drug / strength (SCD) acetate 10 MG/ML RxCUI 886676

Look up RxCUI 4441 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.

💵 What Flecainide 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.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 50 mg $0.108 per tablet NDC details & price history
Tablet · Oral 100 mg $0.171 per tablet NDC details & price history
Tablet · Oral 150 mg $0.269 per tablet NDC details & price history
Tablet 50 mg $0.108 per tablet NDC details & price history
Tablet 100 mg $0.171 per tablet NDC details & price history
Tablet 150 mg $0.269 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full 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.

Flecainide brand names

Flecainide is sold under one brand name in the FDA directory — Tambocor. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Tambocor

Who makes Flecainide: manufacturers and labelers

15 companies list Flecainide products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, ANI Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 16 A-S Medication Solutions 4 ANI Pharmaceuticals, Inc. 3 Amneal Pharmaceuticals LLC 3 Amneal Pharmaceuticals of New York LLC 3 Aurobindo Pharma Limited 3 Chartwell RX, LLC 3 Epic Pharma, LLC 3 Golden State Medical Supply, Inc. 3 Hikma Pharmaceuticals USA Inc. 3 PD-Rx Pharmaceuticals, Inc. 3 Rising Pharma Holdings, Inc. 3 Unichem Pharmaceuticals (usa), Inc. 3 AvPAK 2 Proficient Rx LP 1

Flecainide drug class (RxNorm)

Flecainide belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic
Drug family (ATC) Antiarrhythmics, class Ic

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 Flecainide 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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 29, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Flecainide.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Flecainide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
36
Finished products in the current FDA directory
56
Companies listing them (makers, repackagers, distributors)
15
FDA labeler codes behind them ⓘ
17
Linked representative label ⓘ
Epic Pharma, LLC
Linked label effective
May 29, 2026
Composite sections available
14
Linked SPL Set ID
74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc
Linked SPL Document ID
52eef22b-3545-b398-e063-6394a90aec29
Open the linked representative label on DailyMed ↗

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. Epic Pharma, LLC 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 →