Sotalol: uses, dosing, side effects & brands
Sotalol is an antiarrhythmic sold in the U.S. under 3 brand and generic names, for atrial fibrillation, atrial flutter and supraventricular tachycardia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Antiarrhythmic
- Treats
- Atrial Fibrillation, Atrial Flutter and Supraventricular Tachycardia
- Available as
- Tablet
- Sold as
- 3 products — Betapace, Betapace Af and Sorine
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 12 hours (the label gives a mean elimination half-life of 12 hours)
- What the pharmacy pays
- about $3 for a 30-count supply — not your price
- Boxed warning
- Boxed warning
How sotalol is dosed
From the FDA label for Betapace (application NDA019865). Other sotalol products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Betapace/Betapace AF: Initial dosage in adults is 80 mg twice daily. Increase the dose as needed in increments of 80 mg/day, every 3 days to a maximum 320 mg total daily dose ( 2.2 ) Pediatrics: Dosage depends on age ( 2.4 ) 2.1 General Safety Measures for Initiation of Oral Sotalol Therapy Withdraw other antiarrhythmic therapy before starting Betapace/Betapace AF and monitor for a minimum of 2 to 3 plasma half-lives prior to initiating Betapace/Betapace AF therapy if the patient's clinical condition permits [see Drug Interactions ( 7 ) ] . Hospitalize patients being initiated or re-initiated on sotalol for at least 3 days or until steady-state drug levels are achieved in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Initiate oral sotalol therapy in the presence of personnel trained in the management of serious arrhythmias. Perform a baseline ECG to determine the QT interval and measure and normalize serum potassium and magnesium levels before initiating therapy. Measure serum creatinine and calculate an estimated creatinine clearance in order to establish the appropriate dosing interval. Monitor QTc 2 to 4 hours after each uptitration in dose. Discharge patients on sotalol therapy from an in-patient setting with an adequate supply of sotalol to allow uninterrupted therapy until the patient can fill a sotalol prescription.…
Sotalol side effects
The most common adverse reactions (≥2%) for Betapace are: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Legacy Pharma Inc. at 1-800-727-7151 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions that are clearly related to sotalol are those which are typical of its Class II (beta-blocking) and Class III (cardiac action potential duration prolongation) effects and are dose related. Ventricular Arrhythmias Serious Adverse Reactions Betapace/Betapace AF can cause serious and potentially fatal ventricular arrhythmias such as sustained VT/VF, primarily Torsade de Pointes (TdP) [see Warnings and Precautions ( 5.1 ) ] . The effect on QT and the risk of Torsade de Pointes are both dose related. Pediatric Patients In an unblinded multicenter trial of 25 pediatric patients aged ≤ 1 month to 12 years with SVT and/or VT receiving daily doses of 30, 90, and 210 mg/m 2 with dosing every 8 hours for a total of 9 doses, no Torsade de Pointes or other serious new arrhythmias…
Who shouldn’t take sotalol
Betapace/Betapace AF is contraindicated in patients with: Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present Congenital or acquired long QT syndromes Cardiogenic shock or decompensated heart failure Serum potassium <4 mEq/L Bronchial asthma or related bronchospastic conditions Hypersensitivity to sotalol For the treatment of AFIB/AFL, Betapace/Betapace AF is also contraindicated in patients with: Baseline QT interval >450 msec For the treatment of AFIB/AFL or ventricular arrhythmias Sinus bradycardia, 2 nd or 3 rd degree AV block, sick sinus syndrome ( 4 ) Congenital or acquired long QT syndrome ( 4 ) Serum potassium <4 mEq/L ( 4 ) Cardiogenic shock, decompensated heart failure ( 4 ) Bronchial asthma or related bronchospastic conditions ( 4 ) Hypersensitivity to sotalol ( 4 ) For the treatment of AFIB/AFL also contraindicated for: QT interval >450 msec ( 4 )
Sotalol drug interactions
Class I or III Antiarrhythmics or other drugs that prolong the QT interval: 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 ( 7.7 ) 7.1 Antiarrhythmics and Other QT Prolonging Drugs Discontinue Class I or Class III antiarrhythmic agents for at least three half-lives prior to dosing with sotalol. 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 )] . 7.2 Negative Chronotropes Digitalis glycosides, diltiazem, verapamil, and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use with negative chronotropes can increase the risk of bradycardia or hypotension. 7.3 Catecholamine-Depleting Agents Concomitant use of catecholamine-depleting drugs, such as reserpine and guanethidine, with a beta-blocker may produce an excessive reduction of resting sympathetic nervous tone. Monitor such patients for evidence of hypotension and/or marked bradycardia which may produce syncope. 7.4 Insulin and Oral Antidiabetics Hyperglycemia may occur, and the dosage of insulin or antidiabetic drugs may require adjustment [see Warnings and Precautions ( 5.7 ) ] . 7.5 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. 7.6 Clonidine Concomitant use with sotalol increases the risk of bradycardia and AV block. 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. 7.7 Antacids Avoid administration of oral sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide. 7.8 Drug/Laboratory Test Interactions The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine when measured by fluorimetric or photometric methods.
Every sotalol product we track (3)
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? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Tablet | Generic | $3 | View → | |
| 2 | Not yet rated | Prescription | Tablet | Generic | $3 | View → | |
| 3 | Not yet rated | Prescription | Tablet | Generic | $3 | View → |
What sotalol pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
How long sotalol keeps
No sotalol label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does sotalol expire? The in-use limits and storage rules from its labelsSotalol and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for sotalol: levels in milk, effects in breastfed infants, and the drugs it would consider insteadBecause of its extensive excretion into breastmilk and its renal excretion, other beta-adrenergic blocking drugs are preferred to sotalol, especially while nursing a newborn or preterm infant. Some authors recommend using sotalol during breastfeeding only while monitoring the infant closely for signs of beta-blockade. Infant exposure is predicted to less after the infant is 4 weeks of age or older.
National Institute of Child Health and Human Development, record revised November 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about sotalol
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,686 reports naming sotalol, and the FDA flagged 84% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- atrial fibrillation182 reports
- electrocardiogram qt prolonged149 reports
- hypotension134 reports
- dyspnoea126 reports
- bradycardia119 reports
- dizziness118 reports
- nausea100 reports
- fatigue99 reports
Read these as a signal, not a rate. A report does not mean sotalol caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 26, 2026.
How long sotalol stays in your system
The elimination half-life of sotalol is about 12 hours (the label gives a mean elimination half-life of 12 hours). No active metabolite to worry about: the label states sotalol is not metabolized and is excreted by the kidney in unchanged form, so the parent drug's half-life is the whole story. It is not a prodrug. Kidney function is what moves this number: because clearance is almost entirely renal, the label says half-life is prolonged up to 69 hours in anuric patients, and there is a direct relationship between creatinine clearance and the elimination rate. Older adults: age by itself does not significantly change the pharmacokinetics, but the label notes that reduced kidney function common in older patients can lengthen the terminal elimination half-life and lead to drug accumulation. Liver: patients with hepatic impairment show no change in sotalol clearance. (The 30-hour "slow elimination phase" mentioned elsewhere on the label appears only in the overdose section, where hypotension temporarily reduces kidney function — it is not the normal-adult half-life.)
DailyMed — SOTALOL HYDROCHLORIDE tablet (FDA label, §12.3 Pharmacokinetics) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is sotalol?
Betapace/Betapace AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Betapace is supplied as a light-blue, capsule-shaped tablet for oral administration. Betapace AF is supplied as a white, capsule-shaped tablet for oral administration.
What kind of drug is sotalol?
The FDA classifies sotalol as an antiarrhythmic. Antiarrhythmics steady an irregular heartbeat by controlling the flow of sodium, potassium, or calcium ions through heart-cell channels (or blunting adrenaline's effect), which slows or normalizes the heart's electrical signals so it beats in a more regular rhythm. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does sotalol stay in your system?
The elimination half-life of sotalol is about 12 hours (the label gives a mean elimination half-life of 12 hours) — that is how long the body takes to clear half of a dose. No active metabolite to worry about: the label states sotalol is not metabolized and is excreted by the kidney in unchanged form, so the parent drug's half-life is the whole story. It is not a prodrug. Kidney function is what moves this number: because clearance is almost entirely renal, the label says half-life is prolonged up to 69 hours in anuric patients, and there is a direct relationship between creatinine clearance and the elimination rate. Older adults: age by itself does not significantly change the pharmacokinetics, but the label notes that reduced kidney function common in older patients can lengthen the terminal elimination half-life and lead to drug accumulation. Liver: patients with hepatic impairment show no change in sotalol clearance. (The 30-hour "slow elimination phase" mentioned elsewhere on the label appears only in the overdose section, where hypotension temporarily reduces kidney function — it is not the normal-adult half-life.) Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take sotalol with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run sotalol against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is sotalol sold under?
We track 3 sotalol-containing products in the U.S.: Betapace, Betapace Af and Sorine. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does sotalol come in?
Across the brands we track, sotalol is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic sotalol?
Yes. Our catalog lists 1 generic sotalol product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Sotalol: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/sotalol
- MLA
- “Sotalol: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/sotalol.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
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.
Read the full FDA label for sotalol on DailyMed (NIH) ↗ — including its boxed warning in full.