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Sotalol

Sotalol is an antiarrhythmic (heart rhythm) medicine used to treat life-threatening ventricular arrhythmias and to help keep a normal rhythm in people with highly symptomatic atrial fibrillation or flutter.

Brand names BetapaceBetapace AfSorineSotylizeSotalol Hydrochloride AF
Drug classes Adrenergic Beta-antagonists
Rx Forms 3
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 47 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 7, 2026
Sotalol 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

Sotalol, a specialist heart rhythm medicine around since the early 1990s and available generically, treats life-threatening ventricular arrhythmias (fast rhythms from the heart's lower chambers) and, in some products, highly symptomatic atrial fibrillation or flutter by slowing the heart like a beta-blocker and lengthening each beat's electrical reset. Most people tolerate it like other beta-blockers, noticing tiredness, a slower pulse or dizziness. It can itself cause dangerous rhythms, notably Torsade de Pointes, so its boxed warning requires starting or restarting it in a facility with continuous ECG monitoring for at least three days, with kidney-based dosing. Never stop it suddenly, which can trigger chest pain or a heart attack.

Clinical pearls

  • Other drugs that lengthen the QT interval (the heart's reset time) add to sotalol's rhythm risk, so screen every new prescription.
  • Take it the same way relative to meals every day, and not within two hours before an aluminum-magnesium antacid.
  • Severe or prolonged vomiting or diarrhea can drain potassium and magnesium and raise rhythm risk, so call your prescriber promptly.
  • Betapace and sotalol AF tablets are not interchangeable, so check that every refill is the same product you started on.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Starting or restarting sotalol can cause dangerous heart rhythm problems, so it is started in a facility with heart monitoring for at least 3 days. There, staff can monitor your heart with continuous ECG, perform resuscitation if needed, and check your kidney function. Kidney problems require special dosing care.

Sotalol hydrochloride tablets (AF) must not be swapped for Betapace, nor the reverse, because the labeling, dosing and safety information differ. Always read the patient information you receive with each refill.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Injection, Oral solution
Earliest FDA record1992
Companies listing it with the FDA21
FDA label last updatedApr 22, 2026
FDA’s strongest warning (boxed)Yes, read the warning

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

What Sotalol is used for

▾

Sotalol is an antiarrhythmic used for these conditions, depending on the product:

  • Documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (all supported products).
  • Keeping a normal rhythm in highly symptomatic atrial fibrillation or flutter (Betapace/Betapace AF, sotalol AF tablets, Sotylize and sotalol injection).
  • Sotalol hydrochloride tablets, USP: indicated for life-threatening ventricular arrhythmias. Use for less severe arrhythmias is generally not recommended.
  • Sotalol injection: also covers adult and pediatric patients for both uses.

Sotalol has not been shown to improve survival in life-threatening ventricular arrhythmias.

How Sotalol works

▾

Sotalol has two actions. It blocks beta receptors (a beta-blocker), which slows the heart rate and the signals passing through the heart's AV node. It also lengthens the time the heart muscle takes to reset after each beat. This lengthening shows up as a longer QT interval on an ECG.

Together these actions help stabilize abnormal rhythms. Most of the beta-blocking comes from one of its two mirror-image forms, while both contribute to rhythm effects.

Sotalol dosage

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Sotalol tablets and Sotylize oral solution are taken by mouth, usually twice daily. The intravenous form is given by a healthcare professional. Your prescriber raises the dose slowly and adjusts how often you take it based on your kidney function.

  • Starting or restarting happens in a facility with continuous heart monitoring for at least 3 days.
  • Other antiarrhythmic drugs are stopped first when possible.
  • A standard meal reduces absorption by about 20% compared with fasting.
  • Do not stop suddenly. If stopping, the dose is usually lowered over 1 to 2 weeks.

Dosing details from the FDA-approved label

From the Sotalol 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.

  • Adults (sotalol hydrochloride / sotalol hydrochloride AF tablets)
    • Initial dosage is 80 mg twice daily
    • Increase as needed in increments of 80 mg/day, every 3 days
    • Maximum: 320 mg total daily dose
    • Dosing interval is established by estimated creatinine clearance; hospitalize for at least 3 days or until steady-state drug levels are achieved on initiation or re-initiation
  • Adult dose for ventricular arrhythmias
    • Recommended initial dose is 80 mg twice daily
    • May be increased in increments of 80 mg per day every 3 days
    • Monitor QTc 2 to 4 hours after each uptitration in dose
  • Pediatrics
    • Dosage depends on age
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Dosing and Administration in Adults Therapy with sotalol hydrochloride tablets (AF) must be initiated (and, if necessary, titrated) in a setting that provides continuous electrocardiographic (ECG) monitoring and in the presence of personnel trained in the management of serious ventricular arrhythmias. Patients should continue to be monitored in this way for a minimum of 3 days on the maintenance dose. In addition, patients should not be discharged within 12 hours of electrical or pharmacological conversion to normal sinus rhythm. The QT interval is used to determine patient eligibility for sotalol hydrochloride tablet (AF) treatment and for monitoring safety during treatment. The baseline QT interval must be ≤450 msec in order for a patient to be started on sotalol hydrochloride tablet (AF) therapy. During initiation and titration, the QT interval should be monitored 2 to 4 hours after each dose. If the QT interval prolongs to 500 msec or greater, the dose must be reduced or the drug discontinued. The dose of Sotalol Hydrochloride Tablets, USP (AF) must be individualized according to calculated creatinine clearance. In patients with a creatinine clearance >60 mL/min Sotalol Hydrochloride Tablets, USP (AF) is administered twice daily (BID) while in those with a creatinine clearance between 40 and 60 mL/min, the dose is administered once daily (QD). In patients with a creatinine clearance less than 40 mL/min Sotalol Hydrochloride Tablets, USP (AF) is contraindicated. The recommended initial dose of Sotalol Hydrochloride Tablets, USP (AF) is 80 mg and is initiated as shown in the dosing algorithm described below. The 80 mg dose can be titrated upward to 100mg or 120mg during initial hospitalization or after discharge on 80 mg in the event of recurrence, by rehospitalization and repeating the same steps used during the initiation of therapy (see Upward Titration of Dose ). Patients with atrial fibrillation should be anticoagulated according to usual medical practice. Hypokalemia should be corrected before initiation of sotalol hydrochloride tablet (AF) therapy (see WARNINGS , Ventricular Arrhythmia ).

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

Sotalol side effects

▾

The most common side effects are:

Common side effects

  • Fatigue
  • Slow heartbeat (bradycardia)
  • Shortness of breath
  • Weakness (asthenia)
  • Dizziness
  • Chest pain
  • Headache
  • Nausea, vomiting or diarrhea

When to get medical help

  • Fainting, a racing or pounding heartbeat, or severe dizziness could signal a dangerous rhythm (Torsade de Pointes). Get emergency help.
  • Call your doctor if you have a very slow heartbeat, or new or worsening swelling or shortness of breath (heart failure).
  • Chest pain (angina) or a heart attack can occur if sotalol is stopped suddenly. Do not stop it without your doctor's advice.
  • Seek emergency care for severe low blood sugar. Sotalol can hide early warning signs such as a fast heartbeat.
  • Wheezing or breathing trouble may signal bronchospasm (airway tightening). Tell your doctor right away.
  • Severe or prolonged diarrhea or vomiting can upset potassium and magnesium levels and raise rhythm risk. Call your doctor.
  • Severe allergic reactions may be worse in people on beta-blockers and may not respond to usual epinephrine doses.

Seek help for fainting, a racing or irregular heartbeat, very slow pulse, worsening heart failure symptoms, wheezing, or severe low blood sugar.

Sotalol warnings and precautions

▾
  • Dangerous rhythms: sotalol can cause Torsade de Pointes and other life-threatening arrhythmias, mostly within the first week or after a dose increase.
  • Slow heartbeat, heart block and low blood pressure can occur.
  • Heart failure may develop or worsen.
  • Stopping suddenly can worsen angina or cause a heart attack.
  • Breathing: people with bronchospastic disease (such as chronic bronchitis and emphysema) generally should not take beta-blockers.
  • Diabetes: low blood sugar signs may be hidden and blood sugar may rise.
  • Thyroid disease and surgery: sotalol may mask hyperthyroidism signs. Tell your surgeon you take it.
  • Allergic reactions may be more severe and less responsive to epinephrine.

Sotalol interactions

▾

Several medicines and conditions can change how safe sotalol is:

  • Other QT-prolonging drugs: raise the risk of dangerous rhythms.
  • Digoxin: further slows the heart rate.
  • Calcium channel blockers: added effects on heart conduction and blood pressure.
  • Reserpine and guanethidine: can cause very low blood pressure or slow heartbeat.
  • Insulin and diabetes drugs: doses may need adjusting.
  • Albuterol, terbutaline and similar drugs: may need higher doses.
  • Clonidine: rebound high blood pressure may be worse when stopping it.
  • Aluminum/magnesium antacids: avoid within 2 hours before sotalol.
  • Water pills and severe diarrhea: can lower potassium and magnesium.

Interactions listed in the FDA-approved label

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

  • Drugs undergoing CYP450 metabolism: Sotalol is primarily eliminated by renal excretion, so drugs metabolized by CYP450 are not expected to alter the pharmacokinetics of sotalol.
  • Digoxin: Proarrhythmic events were more common in sotalol treated patients also receiving digoxin; it is not clear whether this is an interaction or related to CHF. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate, and concomitant use can increase the risk of bradycardia.
  • Calcium blocking drugs: Possible additive effects on atrioventricular conduction or ventricular function, and additive effects on blood pressure, possibly leading to hypotension. Administer sotalol (AF) with caution.
  • Catecholamine-depleting agents (e.g., reserpine, guanethidine): May produce an excessive reduction of resting sympathetic nervous tone, with hypotension and/or marked bradycardia which may produce syncope. Closely monitor patients for hypotension and/or marked bradycardia.
  • Insulin and oral antidiabetics: Hyperglycemia may occur, and symptoms of hypoglycemia may be masked. The dosage of insulin or antidiabetic drugs may require adjustment.
  • Beta-2-receptor stimulants (salbutamol, terbutaline, isoprenaline): Beta-agonists may have to be administered in increased dosages when used with sotalol (AF).
  • Clonidine: Beta-blocking drugs may potentiate the rebound hypertension sometimes observed after discontinuation of clonidine. Use caution when discontinuing clonidine in patients receiving sotalol (AF).
  • Hydrochlorothiazide or warfarin: No pharmacokinetic interactions were observed.
  • Antacids containing aluminum oxide and magnesium hydroxide: Sotalol (AF) within 2 hours of these antacids may reduce Cmax and AUC by 26% and 20%, respectively, and reduce the bradycardic effect at rest by 25%. Avoid administering sotalol (AF) within 2 hours of these antacids; antacid given two hours after sotalol (AF) has no effect.
Read the label’s full interactions text

Drug Interactions Drugs undergoing CYP450 metabolism Sotalol is primarily eliminated by renal excretion; therefore, drugs that are metabolized by CYP450 are not expected to alter the pharmacokinetics of sotalol. Digoxin Proarrhythmic events were more common in sotalol treated patients also receiving digoxin; it is not clear whether this represents an interaction or is related to the presence of CHF, a known risk factor for proarrhythmia, in the patients receiving digoxin. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Calcium blocking drugs Sotalol (AF) should be administered with caution in conjunction with calcium blocking drugs because of possible additive effects on atrioventricular conduction or ventricular function. Additionally, concomitant use of these drugs may have additive effects on blood pressure, possibly leading to hypotension. 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. Patients treated with sotalol (AF) plus a catecholamine depletor should therefore be closely monitored for evidence of hypotension and/or marked bradycardia which may produce syncope. Insulin and oral antidiabetics Hyperglycemia may occur, and the dosage of insulin or antidiabetic drugs may require adjustment. Symptoms of hypoglycemia may be masked. Beta-2-receptor stimulants Beta-agonists such as salbutamol, terbutaline and isoprenaline may have to be administered in increased dosages when used concomitantly with sotalol (AF). Clonidine Beta-blocking drugs may potentiate the rebound hypertension sometimes observed after discontinuation of clonidine; therefore, caution is advised when discontinuing clonidine in patients receiving sotalol (AF).

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.

🌿43 supplements and herbs with documented Sotalol interactions, ranked by severity Check Sotalol against a supplement or herb →

Before taking Sotalol

▾
  • Do not use with sinus bradycardia, sick sinus syndrome or second- or third-degree AV block unless a pacemaker is present.
  • Not for long QT syndromes, cardiogenic shock or decompensated heart failure.
  • Tell your doctor about kidney disease, asthma or emphysema, diabetes, thyroid disease and heart failure.
  • Potassium and magnesium need to be normal before starting.
  • Pregnancy: sotalol crosses the placenta and may affect the baby. Use only if the benefit outweighs the risk.
  • Breastfeeding: sotalol is present in breast milk. Breastfeeding is not advised.
  • Children: oral sotalol safety and effectiveness are not established. Close inpatient monitoring is recommended.

Sotalol overdose

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Overdose has caused death. Signs include a slow heartbeat, heart failure, low blood pressure, bronchospasm, low blood sugar and dangerous rhythms. Treatment includes stopping sotalol, close monitoring, and supportive measures. Dialysis can lower sotalol levels. Seek emergency help right away.

What Sotalol does in the body

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Sotalol slows heart rate, slows conduction through the AV node, and lengthens the refractory period (the recovery time) of heart muscle. On an ECG it lengthens the QT interval in a dose-related way, with no significant change in the QRS interval. In children, the QTc increases also rose with dose.

How your body processes Sotalol

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Oral sotalol is almost fully absorbed (90 to 100%), peaking in about 2.5 to 4 hours. A standard meal reduces absorption by about 20%. It does not bind to plasma proteins and is not metabolized. It leaves the body mostly unchanged through the kidneys, with a half-life of about 12 hours. Steady levels are reached in 2 to 3 days, and lower doses are needed with kidney impairment.

How to store Sotalol

▾

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 →

43

Supplements & herbs that interact with Sotalol

43 supplements and herbal products have documented interactions with Sotalol 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 · 8
  • Moderate · 26
  • Minor · 9
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major ARSENIC Major CESIUM Major EPHEDRA Major GRAPEFRUIT Major INDIAN SNAKEROOT Major SIDA CORDIFOLIA Major +35 more
Every supplement checked against Sotalol — ranked by severity The full interaction hub: 8 major · 26 moderate · 9 minor · every one linked to its full report. Check Sotalol 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.

1

Nutrient depletion considerations

Sotalol has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

COENZYME Q10 Insufficient Evidence
See the full Sotalol nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Sotalol: pharmacist answers to common questions

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

What is sotalol for?

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Sotalol treats life-threatening ventricular arrhythmias. Some products also help keep a normal rhythm in people with highly symptomatic atrial fibrillation or flutter. It has not been shown to improve survival in the ventricular rhythm problems.

Why do I have to start it in the hospital?

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Sotalol can cause dangerous rhythm problems, especially in the first days or after a dose increase. In the hospital your heart is monitored continuously and your kidney function is checked. Staff can act right away if something goes wrong.

Can I stop taking it if I feel fine?

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No. Stopping suddenly can cause chest pain or even a heart attack, especially if you have heart disease. If you need to stop, your doctor will usually lower the dose over 1 to 2 weeks.

What side effects should I expect?

▾
Tiredness, dizziness, a slower heartbeat, shortness of breath and weakness are the most common. Call your doctor if they are bothersome. Get emergency help for fainting, a racing or pounding heartbeat, or trouble breathing.

Can I take antacids with it?

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Avoid taking sotalol within 2 hours before an antacid that contains aluminum oxide and magnesium hydroxide, because it can lower how much sotalol you absorb. Taking the antacid 2 hours after sotalol does not cause this problem.

Is it safe in pregnancy or while breastfeeding?

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Sotalol crosses the placenta, so use in pregnancy is a careful risk-versus-benefit decision with your doctor. It also passes into breast milk, and breastfeeding is not advised while taking it.

Is Sotalol available over the counter?

▾
No. Sotalol is a prescription medicine: every Sotalol 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 Sotalol first available?

▾
The earliest FDA record we hold for Sotalol is from 1992: 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 Sotalol was first used.

Who makes Sotalol?

▾
21 companies currently list Sotalol products in the FDA's NDC Directory, including Bryant Ranch Prepack, Apotex Corp., Legacy Pharma USA, 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 Sotalol on HelloPharmacist

📊Sotalol supplement interactions43 checked — ranked by severity 🌿Drug & Supplement CheckerSotalol vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Sotalol NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Sotalol 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.

Sotalol forms and strengths (how it comes)

Sotalol is available in 3 forms. 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Sotalol inactive ingredients by manufacturer.

Tablet

By mouth
Brands Betapace Betapace Af
How this form is used
What it may be used for
  • Sotalol hydrochloride tablets, USP are indicated for documented life-threatening ventricular arrhythmias.
  • Betapace/Betapace AF and sotalol (AF) tablets treat life-threatening ventricular arrhythmias and help maintain normal rhythm in highly symptomatic atrial fibrillation or flutter.
Important instructions
  • Betapace/Betapace AF is started at a low dose twice daily and increased gradually by the prescriber.
  • Betapace/Betapace AF treatment starts in a facility with cardiac resuscitation and continuous ECG monitoring for at least 3 days.
  • Sotalol hydrochloride tablets (AF) must not be substituted for Betapace, or the reverse.
Available strengths 4 strengths
80 mg 120 mg 160 mg 240 mg
172 FDA-listed product records ⓘ

Injection

Into a vein
How this form is used
What it may be used for
  • Sotalol hydrochloride injection treats documented life-threatening ventricular arrhythmias in adult and pediatric patients.
  • Sotalol hydrochloride injection helps maintain normal sinus rhythm in adults and pediatric patients with highly symptomatic atrial fibrillation or flutter.
Important instructions
  • Sotalol hydrochloride injection must be diluted before infusion and given with a volumetric infusion pump.
  • Sotalol hydrochloride injection is started or restarted in a facility with cardiac resuscitation and continuous ECG monitoring.
  • Sotalol hydrochloride injection can substitute for oral sotalol in people unable to take oral drugs, or be used to reach steady levels faster.
Available strengths 1 strength
15 mg/mL
3 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Sotylize
How this form is used
What it may be used for
  • Sotylize treats documented life-threatening ventricular arrhythmias.
  • Sotylize helps maintain normal sinus rhythm in highly symptomatic atrial fibrillation or flutter.
Important instructions
  • Sotylize treatment starts in a facility with cardiac resuscitation and continuous ECG monitoring for at least 3 days.
  • Sotylize is taken twice daily at first, and the dose is increased gradually by the prescriber.
  • Sotylize is taken once daily with moderately reduced kidney function and is not recommended with low creatinine clearance.
Available strengths 1 strength
5 mg/mL
2 FDA-listed product records ⓘ

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

How Sotalol 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.

21 companies list 80 Sotalol product records with the FDA, mostly as tablet, injection, oral solution; the earliest marketing or approval year on record is 1992. Brand names on the directory include Betapace, Betapace Af, Sorine and 2 more; the rest are generics.

3
Dose forms ⓘ
21
Labelers (makers, repackagers, distributors)
6
Brand names
80
FDA-listed product records ⓘ
1992
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack24%
Apotex Corp.9%
Legacy Pharma USA, Inc.8%
Unichem Pharmaceuticals (usa), Inc.8%
Aphena Pharma Solutions - Tennessee, LLC6%
AiPing Pharmaceutical, Inc.5%
Other makers41%

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

How widely Sotalol is used (Medicaid data)

A general measure of how commonly Sotalol 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 Sotalol 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.

45,834
Medicaid prescriptions filled (Q1–Q4 2025)
$2.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Sotalol prescribed? Of the 1,601 medications we measure, Sotalol ranks #651 by Medicaid prescriptions — more than 59% of them.

Where Sotalol ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #651 of 1,601
#646 Capsaicin Topical 46,781 Rx #647 Bimatoprost 46,752 Rx #648 Conjugated Estrogens /... 46,742 Rx #649 Trastuzumab Injection 46,422 Rx #650 Bimatoprost Ophthalmic 46,251 Rx #651 Sotalol 45,834 Rx #652 Pilocarpine 45,043 Rx #653 Glecaprevir and Pibren... 44,772 Rx #654 Plecanatide 44,504 Rx #655 Oxaliplatin Injection 44,448 Rx #656 Sirolimus 44,322 Rx

Utilization by Sotalol 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 80 mg oral tablet is the most-dispensed Sotalol product — about 67% of these Medicaid prescriptions.

sotalol hydrochloride 80 MG Oral Tablet Most dispensed

30,876 Medicaid prescriptions (Q1–Q4 2025) 67% of Sotalol prescriptions shown $439,560 gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 4 of 81 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1923426

sotalol hydrochloride 120 MG Oral Tablet

10,439 Medicaid prescriptions (Q1–Q4 2025) 23% of Sotalol prescriptions shown $177,642 gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 4 of 37 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1923422

sotalol hydrochloride 5 MG/ML Oral Solution

2,392 Medicaid prescriptions (Q1–Q4 2025) 5% of Sotalol prescriptions shown $1.9M gross reimbursement (before rebates) ≈ $810 per prescription (gross)

Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1593725

sotalol hydrochloride 160 MG Oral Tablet

1,579 Medicaid prescriptions (Q1–Q4 2025) 3% of Sotalol prescriptions shown $38,372 gross reimbursement (before rebates) ≈ $24 per prescription (gross)

Summed across the 3 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1923424

Atrial Fibrillation sotalol hydrochloride 80 MG Oral Tablet

511 Medicaid prescriptions (Q1–Q4 2025) 1% of Sotalol prescriptions shown $8,025 gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 3 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1922765

Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet

37 Medicaid prescriptions (Q1–Q4 2025) <1% of Sotalol prescriptions shown $641 gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 1 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1922720

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 Sotalol, 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 17 of 167 listed Sotalol NDCs with Medicaid activity.

Compare Sotalol products

A representative set of FDA-listed product records for Sotalol — 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 80 of 80 products — FDA National Drug Code Directory. See every product, package size and price: browse all 80 Sotalol NDCs →

Sotalol 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 Sotalol recalls since July 2021.

✅No Sotalol 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) Sotalol RxCUI 9947 4 dose forms · 12 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 376365 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 904622
  3. Dose form (SCDF) Oral Solution RxCUI 1593724 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 5 MG/ML RxCUI 1593725

Look up RxCUI 9947 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 Sotalol 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 80 mg $0.071 per tablet NDC details & price history
Tablet · Oral 120 mg $0.110 per tablet NDC details & price history
Tablet · Oral 160 mg $0.130 per tablet NDC details & price history
Tablet · Oral 240 mg $0.201 per tablet NDC details & price history
Solution · Oral 5 mg/mL $2.32–$2.32 per mL 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.

Sotalol brand names

Sotalol is sold under 5 brand names in the FDA directory — Betapace, Betapace Af, Sorine, Sotylize and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Betapace Betapace Af Sorine Sotylize Sotalol Hydrochloride AF

Who makes Sotalol: manufacturers and labelers

21 companies list Sotalol products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Apotex Corp., Legacy Pharma USA, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 19 Apotex Corp. 7 Legacy Pharma USA, Inc. 6 Unichem Pharmaceuticals (usa), Inc. 6 Aphena Pharma Solutions - Tennessee, LLC 5 AiPing Pharmaceutical, Inc. 4 Oxford Pharmaceuticals, LLC 4 PD-Rx Pharmaceuticals, Inc. 4 Proficient Rx LP 4 Teva Pharmaceuticals USA, Inc. 4 Aurobindo Pharma Limited 3 Epic Pharma, LLC 3 A-S Medication Solutions 2 AvPAK 2 ALTATHERA Pharmaceuticals, LLC 1 American Health Packaging 1 Azurity Pharmaceuticals, Inc. 1 Cardinal Health 107, LLC 1 Golden State Medical Supply, Inc. 1 Major Pharmaceuticals 1 Northwind Health Company, LLC 1

Sotalol drug class (RxNorm)

Sotalol belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic
Drug family (ATC) Beta blocking agents, non-selective
How it works Adrenergic beta-Antagonists

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 Sotalol 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 Apr 22, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Sotalol.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Sotalol after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
47
Finished products in the current FDA directory
80
Companies listing them (makers, repackagers, distributors)
21
FDA labeler codes behind them ⓘ
25
Linked representative label ⓘ
Bayshore Pharmaceuticals LLC
Linked label effective
Apr 22, 2026
Composite sections available
24
Linked SPL Set ID
56879738-8662-4f5c-8386-761ab2b5e46f
Linked SPL Document ID
96bb0a48-48ee-4756-959b-f901434fd629
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. Bayshore Pharmaceuticals 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 →