Prescription medicine
Sotalol Brand names: Betapace, Sotylize
Sotalol (Betapace) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 18 generic labelers, and pharmacies paid $0.0707 per sotalol 80 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $2.32 per mL (Sotylize 5 mg/mL oral solution).
- Generic listed
- Boxed warning
Check it at the source: the sotalol FDA label on DailyMed (effective December 16, 2024, Legacy Pharma USA, Inc.); the NDA 19865 record on Drugs@FDA; every sotalol label on DailyMed.
Highlights of the record
FDA label of December 16, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
LIFE-THREATENING PROARRHYTHMIA.
To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life-threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug. Calculate creatinine clearance to determine appropriate dosing [see Dosage and Administration ( 2.5 ) ]. WARNING: LIFE-THREATENING PROARRHYTHMIA See full prescribing information for complete boxed warning. Betapace/Betapace AF can cause life-threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug. Initiate or reinitiate in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Adjust the dosing interval based on creatinine clearance.
Used for
From the label: indications and usageBetapace/Betapace AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias ( 1.1 ) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) ( 1.2 ) Limitations of Use Betapace has not been shown to enhance survival in patients with life threatening ventricular arrhythmias ( 1.1 ) Avoid use in patients with minimally symptomatic or easily
Forms and strengths
- 80 mg
- 120 mg
- 160 mg
- 240 mg
- 5 mg/ml
- 15 mg/ml
Tablet; injection; solution.
On the market
- Earliest approval on file
- October 30, 1992 Betapace, Legacy; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 17 first May 1, 2000; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 21 of which 18 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- August 21, 2039 Sotalol Hydrochloride injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0707 per tablet Sotalol 80 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest March 9, 2020; 3 more by firms not listed as its makers
- FAERS reports
- 16,549 through July 30, 2026
What is sotalol used for?
From the label: indications and usageBetapace/Betapace AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias ( 1.1 ) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) ( 1.2 ) Limitations of Use Betapace has not been shown to enhance survival in patients with life threatening ventricular arrhythmias ( 1.1 ) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL ( 1.2 ) 1.1 Life-Threatening Ventricular Arrhythmias Betapace/Betapace AF is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT). […]
Conditions named in the indications of sotalol's FDA labels, with every medicine labeled for each:
From other sotalol labelsAtrial fibrillation: Sotalol is also indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm and is marketed …
FDA pharmacologic class: Antiarrhythmic.
Source: FDA drug label (BETAPACE), Legacy Pharma USA, Inc., effective December 16, 2024 (SPL set a6a7702f-36c9-45db-b640-453dc324baee), via openFDA; the full label on DailyMed
What does the patient leaflet for sotalol 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 sotalol hydrochloride tablets, USP (AF)?Because you have irregular heartbeats (atrial fibrillation) that are troublesome to you, sotalol hydrochloride tablets (AF) have been prescribed to help your heart to beat in a more normal way. However, in some patients sotalol hydrochloride (AF) can cause a different type of abnormal heartbeat that can be dangerous, and in rare instances can even cause death. You may feel this different type of abnormal heartbeat as a fast beating of the heart with lightheadedness and fainting. The possibility of this different type of abnormal heartbeat is the reason you and your doctor have discussed whether your symptoms are troublesome enough for you to start taking sotalol hydrochloride tablets (AF). Clinical studies using sotalol hydrochloride tablets (AF) have shown that the most important way to decrease your chance of getting this different type of dangerous abnormal heartbeat is for you to take the dose of sotalol hydrochloride tablets (AF) that is right for you. If this abnormal heartbeat occurs, it usually happens during the first few days of treatment. This is why you should be started on sotalol hydrochloride tablets (AF) in a hospital or another place where your heartbeat can be watched closely by health care professionals for the first few days. They can help you if problems occur. When sotalol hydrochloride (AF) is started this way, this different type of abnormal heartbeat is rare and the hospital staff is there to treat it. It is important that when you go home, you take the exact dose the doctor prescribed for you. At any time while you are taking sotalol hydrochloride tablets (AF), watch for signs that you may be getting this different type of abnormal heartbeat and call your doctor if they occur. […]
From the patient leaflet: What should I avoid while taking sotalol hydrochloride tablets, USP (AF)?Certain other medicines taken with sotalol hydrochloride tablets (AF) may increase the chance that you will get the dangerous abnormal heartbeat (see "Who should not take sotalol hydrochloride tablets, USP (AF)?" ). Do not take sotalol hydrochloride tablets (AF) with these medicines. Before you start taking sotalol hydrochloride tablets (AF) tell your doctor about all prescription and non-prescription medicines you are taking (see also "Who should not take sotalol hydrochloride tablets, USP (AF)?" ). Once you begin taking sotalol hydrochloride tablets (AF), do not start taking any new medicines until you check with your doctor. Carry a list of all the medicines and supplements you take. If you have to go to the hospital or are treated by new or different health care providers, tell them you are taking sotalol hydrochloride tablets (AF) and show them the list of other medicines you take. […]
Source: FDA drug label (Sotalol Hydrochloride), Aphena Pharma Solutions - Tennessee, LLC, effective June 26, 2018 (SPL set 5ede17b7-3898-4f9f-abec-e15620cef76a), via openFDA; the full label on DailyMed
Is there a generic for sotalol (Betapace)?
The FDA approved the first generic sotalol on May 1, 2000. 17 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 sotalol from 18 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Betapace tablets; a patent listed only for Sotalol Hydrochloride injection runs to August 21, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1992 earliest approval on file
- 2000 first generic approved
- 2039 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sotalol (Betapace)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0707 per Sotalol 80 mg tablet, about the same as a year earlier. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Sotalol 80 mg tablet (generic)
- Sotylize 5 mg/mL oral solution (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sotalol 120 mg tablet | Generic | $0.110 per tablet | $3.30 | +14% |
| Sotalol 160 mg tablet | Generic | $0.130 per tablet | $3.90 | -15% |
| Sotalol 240 mg tablet | Generic | $0.201 per tablet | $6.02 | +72% |
| Sotalol 80 mg tablet | Generic | $0.0707 per tablet | $2.12 | +0.9% |
| Sotalol af 120 mg tablet | Generic | $0.110 per tablet | $3.30 | +14% |
| Sotalol af 160 mg tablet | Generic | $0.130 per tablet | $3.90 | -15% |
| Sotalol af 80 mg tablet | Generic | $0.0707 per tablet | $2.12 | +0.9% |
| Sotylize 5 mg/mL oral solution | Brand | $2.32 per mL | n/a | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has sotalol been recalled?
The FDA's Enforcement Report lists 4 recalls naming sotalol since 2013: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of sotalol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 9, 2020 | Class II | Mylan Pharmaceuticals Inc. | Presence of particulate matter. presence of metal particles. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: SOTALOL HCL, Tablet, 120 mg may have potentially been mislabeled as the following drug: NEOMYCIN SULFATE, Tablet, 500 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: SOTALOL HCL, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: DILTIAZEM HCL, Tablet, 120 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: SOTALOL HCL, Tablet, 160 mg may have potentially been mislabeled as the following drug: DISULFIRAM, Tablet, 250 mg, NDC 64980017101 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sotalol label say about other medicines?
The sotalol label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 37 other medicines name sotalol. 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 |
|---|---|---|
| Albuterol | drug interactions | Beta-2-Receptor Stimulants Beta-agonists such as albuterol, terbutaline and isoproterenol may have to be administered in increased dosages when used concomitantly with sotalol. |
| Amiodarone | drug interactions | Class Ia antiarrhythmic drugs, such as disopyramide, quinidine, and procainamide, and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy with Betapace/Betapace AF, because of their potential to prolong refractoriness [see Warnings and Precautions ( 5.2 )]. |
| Clonidine | drug interactions | Because beta-blockers may potentiate the rebound hypertension sometimes observed after clonidine discontinuation, withdraw sotalol several days before the gradual withdrawal of clonidine to reduce the risk of rebound hypertension. |
| Digoxin | drug interactions | Avoid concomitant use ( 7.1 ) Digoxin, calcium channel blocker: increased risk of bradycardia, hypotension, heart failure ( 7.2 ) Dosage of insulin or antidiabetic drugs may need adjustment ( 7.4 ) Aluminum- or magnesium-based antacids reduce sotalol exposure |
| Diltiazem | drug interactions | Digitalis glycosides, diltiazem, verapamil, and beta-blockers slow atrioventricular conduction and decrease heart rate. |
| Disopyramide | drug interactions | Class Ia antiarrhythmic drugs, such as disopyramide, quinidine, and procainamide, and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy with Betapace/Betapace AF, because of their potential to prolong refractoriness [see Warnings and Precautions ( 5.2 )]. |
| Epinephrine | warnings and precautions | Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction. |
| Isoproterenol | drug interactions | Beta-2-Receptor Stimulants Beta-agonists such as albuterol, terbutaline and isoproterenol may have to be administered in increased dosages when used concomitantly with sotalol. |
| Magnesium hydroxide | drug interactions | Avoid administration of oral sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide. |
| Procainamide | drug interactions | Class Ia antiarrhythmic drugs, such as disopyramide, quinidine, and procainamide, and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy with Betapace/Betapace AF, because of their potential to prolong refractoriness [see Warnings and Precautions ( 5.2 )]. |
| Quinidine | drug interactions | Class Ia antiarrhythmic drugs, such as disopyramide, quinidine, and procainamide, and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy with Betapace/Betapace AF, because of their potential to prolong refractoriness [see Warnings and Precautions ( 5.2 )]. |
| Terbutaline | drug interactions | Beta-2-Receptor Stimulants Beta-agonists such as albuterol, terbutaline and isoproterenol may have to be administered in increased dosages when used concomitantly with sotalol. |
| Verapamil | drug interactions | Digitalis glycosides, diltiazem, verapamil, and beta-blockers slow atrioventricular conduction and decrease heart rate. |
Other labels that name sotalol
- Artemether and lumefantrine
- Asenapine
- Azithromycin
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clozapine
- Eliglustat
- Erythromycin
- Etrasimod arginine
- Fluoxetine
- Foscarnet
- Haloperidol
- Iloperidone
- Levofloxacin
- Lidocaine and prilocaine
- Macimorelin
- Milsaperidone
- Moxifloxacin
- Ozanimod
- Paliperidone
- Pimavanserin
- Pimozide
- Ponesimod
- Quinine
- Sertraline
- Siponimod
- Tetrabenazine
- Tolterodine
- Toremifene
- Trazodone
- Vandetanib
- Vardenafil
- Ziprasidone
Source: FDA drug label (BETAPACE), Legacy Pharma USA, Inc., effective December 16, 2024 (SPL set a6a7702f-36c9-45db-b640-453dc324baee), via openFDA; the full label on DailyMed
What do FAERS reports show for sotalol?
The FDA Adverse Event Reporting System holds 16,549 reports that list sotalol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,705 are coded as a death and 7,009 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 sotalol?
3 other medicines are given the same way (oral) and in the same FDA class as sotalol 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 |
|---|---|---|---|---|
| Propafenone | Atrial fibrillation | 14 labelers | $0.115 per tablet 150 mg tablet | No current entry |
| Dofetilide | Atrial fibrillation | 12 labelers | $0.203 per capsule 125 mcg capsule | No current entry |
| Quinidine | Atrial fibrillation | 4 labelers | $4.92 per tablet 324 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does sotalol compare with medicines for the same use?
3 side-by-side pages set sotalol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to sotalol
- 3 medicines for the same use
- Other antiarrhythmics
- the pharmacologic class, with prices and generics
- Sotalol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other