Prescription medicine
Dofetilide Brand names: Tikosyn
Dofetilide (Tikosyn) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 12 generic labelers, and pharmacies paid $0.203 per dofetilide 125 mcg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the dofetilide FDA label on DailyMed (effective April 21, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 20931 record on Drugs@FDA; every dofetilide label on DailyMed.
Highlights of the record
FDA label of April 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. For detailed instructions regarding dose selection, see DOSAGE AND ADMINISTRATION .
Used for
From the label: indications and usageMaintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) TIKOSYN is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm.
Forms and strengths
- 0.125 mg
- 0.25 mg
- 0.5 mg
Capsule.
On the market
- Earliest approval on file
- October 1, 1999 Tikosyn, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first June 6, 2016; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 12 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.203 per capsule Dofetilide 125 mcg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2014 0 Class I among all firms' recalls; latest July 18, 2023
- FAERS reports
- 10,448 through July 30, 2026
What is dofetilide used for?
From the label: indications and usageMaintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) TIKOSYN is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because TIKOSYN can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES ). […]
Conditions named in the indications of dofetilide's FDA labels, with every medicine labeled for each:
From other dofetilide labelsAtrial fibrillation: … indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted …
FDA pharmacologic class: Antiarrhythmic.
Source: FDA drug label (Tikosyn), Pfizer Laboratories Div Pfizer Inc, effective April 21, 2026 (SPL set 02438044-d6a3-49e9-a1ac-3aad21ef2c8c), via openFDA; the full label on DailyMed
What does the patient leaflet for dofetilide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TIKOSYN?TIKOSYN can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, which can lead to death. To establish the right dose of TIKOSYN, treatment with TIKOSYN must be started in a hospital where your heart rate and kidney function will be checked for the first 3 days of treatment. It is important that when you go home, you take the exact dose of TIKOSYN that your doctor prescribed for you. While you take TIKOSYN, always watch for signs of abnormal heartbeat. Call your doctor and go to the hospital right away if you: • feel faint • become dizzy, or • have a fast heartbeat
From the patient leaflet: How should I store TIKOSYN?Store TIKOSYN between 59° to 86°F (15° to 30°C). • Keep TIKOSYN away from moisture and humidity. • Keep TIKOSYN in a tightly closed container. • Keep TIKOSYN and all medicines out of the reach of children.
Source: FDA drug label (Tikosyn), Pfizer Laboratories Div Pfizer Inc, effective April 21, 2026 (SPL set 02438044-d6a3-49e9-a1ac-3aad21ef2c8c), via openFDA; the full label on DailyMed
Is there a generic for dofetilide (Tikosyn)?
The FDA approved the first generic dofetilide on June 6, 2016. 14 generic applications are approved; 9 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 dofetilide from 12 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2016 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 dofetilide (Tikosyn)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.203 per Dofetilide 125 mcg capsule, down 6% from $0.216 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.
- Dofetilide 500 mcg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dofetilide 125 mcg capsule | Generic | $0.203 per capsule | $6.08 | -6% |
| Dofetilide 250 mcg capsule | Generic | $0.194 per capsule | $5.81 | -9% |
| Dofetilide 500 mcg capsule | Generic | $0.193 per capsule | $5.79 | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dofetilide been recalled?
The FDA's Enforcement Report lists 6 recalls naming dofetilide since 2014: 0 Class I (the most serious), 4 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 18, 2023 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Out of Specification result observed in content uniformity testing |
| March 9, 2023 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Content Uniformity Specifications |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| December 3, 2014 | Class II | Pfizer Inc. | Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dofetilide label say about other medicines?
The dofetilide label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 25 other medicines name dofetilide. 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 | warnings | In clinical trials, TIKOSYN was administered to patients previously treated with oral amiodarone only if serum amiodarone levels were below 0.3 mg/L or amiodarone had been withdrawn for at least three months. |
| Cimetidine | contraindications | The concomitant use of verapamil or the cation transport system inhibitors cimetidine, trimethoprim (alone or in combination with sulfamethoxazole), or ketoconazole with TIKOSYN is contraindicated (see WARNINGS and PRECAUTIONS, Drug-Drug Interactions ), as each of these drugs cause a substantial increase in dofetilide … |
| Dolutegravir | contraindications | In addition, other known inhibitors of the renal cation transport system such as prochlorperazine, dolutegravir and megestrol should not be used in patients on TIKOSYN. |
| Hydrochlorothiazide | contraindications | The concomitant use of hydrochlorothiazide (alone or in combinations such as with triamterene) with TIKOSYN is contraindicated (see PRECAUTIONS, Drug-Drug Interactions ) because this has been shown to significantly increase dofetilide plasma concentrations and QT interval prolongation. |
| Ketoconazole | contraindications | The concomitant use of verapamil or the cation transport system inhibitors cimetidine, trimethoprim (alone or in combination with sulfamethoxazole), or ketoconazole with TIKOSYN is contraindicated (see WARNINGS and PRECAUTIONS, Drug-Drug Interactions ), as each of these drugs cause a substantial increase in dofetilide … |
| Megestrol | contraindications | In addition, other known inhibitors of the renal cation transport system such as prochlorperazine, dolutegravir and megestrol should not be used in patients on TIKOSYN. |
| Prochlorperazine | contraindications | In addition, other known inhibitors of the renal cation transport system such as prochlorperazine, dolutegravir and megestrol should not be used in patients on TIKOSYN. |
| Triamterene | contraindications | The concomitant use of hydrochlorothiazide (alone or in combinations such as with triamterene) with TIKOSYN is contraindicated (see PRECAUTIONS, Drug-Drug Interactions ) because this has been shown to significantly increase dofetilide plasma concentrations and QT interval prolongation. |
| Trimethoprim | contraindications | The concomitant use of verapamil or the cation transport system inhibitors cimetidine, trimethoprim (alone or in combination with sulfamethoxazole), or ketoconazole with TIKOSYN is contraindicated (see WARNINGS and PRECAUTIONS, Drug-Drug Interactions ), as each of these drugs cause a substantial increase in dofetilide … |
| Verapamil | contraindications | The concomitant use of verapamil or the cation transport system inhibitors cimetidine, trimethoprim (alone or in combination with sulfamethoxazole), or ketoconazole with TIKOSYN is contraindicated (see WARNINGS and PRECAUTIONS, Drug-Drug Interactions ), as each of these drugs cause a substantial increase in dofetilide … |
Other labels that name dofetilide
Source: FDA drug label (Tikosyn), Pfizer Laboratories Div Pfizer Inc, effective April 21, 2026 (SPL set 02438044-d6a3-49e9-a1ac-3aad21ef2c8c), via openFDA; the full label on DailyMed
What do FAERS reports show for dofetilide?
The FDA Adverse Event Reporting System holds 10,448 reports that list dofetilide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 811 are coded as a death and 2,996 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 dofetilide?
3 other medicines are given the same way (oral) and in the same FDA class as dofetilide 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 |
| Propafenone | Atrial fibrillation | 14 labelers | $0.115 per tablet 150 mg tablet | 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 dofetilide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does dofetilide compare with medicines for the same use?
1 side-by-side page set dofetilide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to dofetilide
- 3 medicines for the same use
- Other antiarrhythmics
- the pharmacologic class, with prices and generics
- Dofetilide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other