sotalol
Brand names: Betapace
Sotalol is a medicine that helps keep your heart beating regularly. It can treat dangerous fast heartbeats and help prevent irregular heartbeats from coming back.
Drug Pricing (NADAC)
Generic Price
$0.08/unit
Generic Available
Yes (9 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Sotalol is used to treat life-threatening fast heartbeats in the lower chambers of the heart.
Common side effects
Feeling tired, Slow heart rate (less than 50 bpm), Shortness of breath
Key warnings
Sotalol can cause life-threatening irregular heartbeats.
How It Works
Sotalol works by slowing down the electrical signals in your heart. It has two actions: it blocks beta receptors (like a beta-blocker) and it prolongs the action potential duration in the heart. This helps to stabilize your heart rhythm and prevent irregular heartbeats.
How to Take It
Take sotalol tablets as your doctor tells you. The usual starting dose for adults is 80 mg twice a day. Your doctor may increase your dose every 3 days as needed, up to a maximum of 320 mg per day. It is important to take sotalol exactly as prescribed and do not miss doses.
Pregnancy & Breastfeeding
Sotalol can harm your unborn baby, so talk to your doctor if you are pregnant or plan to become pregnant. Sotalol can pass into breast milk and may harm a nursing infant, so do not breastfeed while taking sotalol.
Missed Dose
If you miss a dose of sotalol, take your next dose at the usual time. Do not double the dose or take it closer together.
Storage
Store sotalol tablets at room temperature, between 68° to 77°F (20° to 25°C).
Side Effects (from patient reports)
Based on 7,908 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 16,062 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.
Total Reports
16,062
Death-Related Reports
1,665
Hospitalization Reports
6,822
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | ATRIAL FIBRILLATION | 1,179 |
| 2 | DRUG INEFFECTIVE | 945 |
| 3 | DYSPNOEA | 912 |
| 4 | FATIGUE | 868 |
| 5 | DIZZINESS | 734 |
| 6 | DIARRHOEA | 721 |
| 7 | NAUSEA | 693 |
| 8 | OFF LABEL USE | 656 |
| 9 | ASTHENIA | 625 |
| 10 | HYPOTENSION | 580 |
| 11 | FALL | 555 |
| 12 | DRUG INTERACTION | 503 |
| 13 | DEATH | 497 |
| 14 | MALAISE | 474 |
| 15 | HEADACHE | 453 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Sotalol can cause life-threatening irregular heartbeats. To lower this risk, you will start or restart sotalol in a hospital where your heart can be monitored. If your QT interval (a measure on your heart tracing) gets too long (500 msec or greater), your doctor may lower your dose or stop the medicine. Your doctor will check your kidney function to decide the right dose for you.
Known Drug Interactions
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.
Mechanism: Both of these medicines slow down your heart rate, which can cause your heart to beat too slowly. Additionally, taking them together can cause a dangerous spike in blood pressure if the clonidine is stopped suddenly.
What to do: If you need to stop these drugs, your doctor should have you stop sotalol several days before you slowly lower your clonidine dose. Monitor your heart rate and blood pressure closely.
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 sotalol hydrochloride, because of their potential to prolong refractoriness [see Warnings and Precautions ( 5.2 )].
Mechanism: Both drugs affect the electrical timing of your heartbeat in the same way. Taking them together can cause the heart's resting phase to last too long, which increases the risk of life-threatening heart rhythm problems.
What to do: This combination is not recommended. Your doctor should avoid prescribing these two heart rhythm medications at the same time to ensure your heart rhythm stays stable.
Clinically Significant Drug Interactions with Clarithromycin Tablets Drugs That Are Affected By Clarithromycin Tablets Drug(s) with Pharmacokinetics Affected by Clarithromycin Tablets Recommendation Comments Antiarrhythmics: Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: There have been postmarketing reports of torsades de pointes occurring with concurrent use of clarithromycin and quinidine or disopyramide.
Mechanism: Clarithromycin interferes with how this heart medication is handled by the body, potentially leading to serious heart rhythm issues.
What to do: This combination is not recommended; your doctor should avoid prescribing these two drugs together.
Antiarrthymics Dofetilide Concomitant administration with digoxin was associated with a higher rate of torsades de pointes Sotalol Proarrhythmic events were more common in patients receiving sotalol and digoxin than on either alone; it is not clear whether this represents an interaction or is related to the presence of CHF, a known risk factor for proarrhythmia, in patients receiving digoxin.
Mechanism: Using these two drugs together can increase the chance of developing dangerous, irregular heartbeats. This may be due to the drugs themselves or the heart condition being treated.
What to do: Your doctor should monitor your heart rhythm carefully. Let your healthcare provider know if you feel dizzy or have a racing heart.
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.
Mechanism: Sotalol blocks the effects of albuterol, which can make it harder for the inhaler to help you breathe.
What to do: You may need to use a higher dose of albuterol to get the same relief while taking sotalol.
Common Questions
Can I stop taking sotalol suddenly?
Will sotalol cure my irregular heartbeat?
Can I drink alcohol while taking sotalol?
What should I tell my doctor before starting sotalol?
How often will I need to see my doctor while taking sotalol?
Can sotalol cause low blood pressure?
Can sotalol affect my diabetes?
What if I have diarrhea while taking sotalol?
Can I take antacids with sotalol?
What if I feel dizzy while taking sotalol?
What are the common side effects of sotalol?
Does sotalol interact with other medications?
What drug class is sotalol?
Is sotalol safe during pregnancy?
Related Medications in Class III Antiarrhythmic / Beta-Blocker
Other drugs grouped near sotalol — same-class peers and common alternatives.
adenosine
Adenocard
Adenosine (Adenocard) is a medicine used to treat certain types of irregular heartbeats.
Compare with sotalol →
amiodarone
Cordarone, Pacerone
Amiodarone (Pacerone) is a medicine used to treat life-threatening, irregular heartbeats.
Compare with sotalol →
atropine
AtroPen
Atropine is a medicine that can temporarily block severe effects on your body.
Compare with sotalol →
bumetanide
Bumex
Bumetanide is a water pill (diuretic).
Compare with sotalol →
carvedilol
Coreg
Carvedilol is a medicine that lowers blood pressure and helps your heart work better.
Compare with sotalol →
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What the FDA Data Shows for sotalol
The FDA label for sotalol (sold under brand names such as Betapace) classifies it as a prescription-only medication in the Class III Antiarrhythmic / Beta-Blocker class. Sotalol is used to treat life-threatening fast heartbeats in the lower chambers of the heart. Official labeling lists 6 commonly reported side effects, including Feeling tired, Slow heart rate (less than 50 bpm), Shortness of breath.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 7,908 voluntary reports. The database also lists 13 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.08.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 3, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages