Prescription medication · Class III Antiarrhythmic / Beta-Blocker
sotalol
Also sold as Betapace. Sotalol is used to treat life-threatening fast heartbeats in the lower chambers of the heart.
Data updated 2026-05-15
- 16,062
- FDA reportsModerately reported
- 13
- InteractionsSeveral interactions
- $0.08
- Generic price (NADAC)
What the data shows
sotalol (Betapace) is a prescription Class III Antiarrhythmic / Beta-Blocker, reported at a middle-of-the-pack volume (16,062 FDA reports), with 13 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
sotalol (Betapace) is a prescription Class III Antiarrhythmic / Beta-Blocker. Sotalol is used to treat life-threatening fast heartbeats in the lower chambers of the heart.
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.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from sotalol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 16,062 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for sotalol, by number of reports
- Atrial Fibrillation
Atrial Fibrillation
1,179 reports
- Dyspnoea
Dyspnoea
912 reports
- Fatigue
Fatigue
868 reports
- Dizziness
Dizziness
734 reports
- Diarrhoea
Diarrhoea
721 reports
- Nausea
Nausea
693 reports
- Asthenia
Asthenia
625 reports
- Hypotension
Hypotension
580 reports
- Fall
Fall
555 reports
- Drug Interaction
Drug Interaction
503 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for sotalol each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where sotalol sits
sotalol has more FDA adverse-event reports than 50% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is sotalol; the line is the median (50th percentile).
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
Reports Mentioning Death
1,665
10.4% of reports — not proof of cause
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 |
| 3 | DYSPNOEA | 912 |
| 4 | FATIGUE | 868 |
| 5 | DIZZINESS | 734 |
| 6 | DIARRHOEA | 721 |
| 7 | NAUSEA | 693 |
| 9 | ASTHENIA | 625 |
| 10 | HYPOTENSION | 580 |
| 11 | FALL | 555 |
| 12 | DRUG INTERACTION | 503 |
| 13 | DEATH | 497 |
| 14 | MALAISE | 474 |
| 15 | HEADACHE | 453 |
| 16 | ELECTROCARDIOGRAM QT PROLONGED | 437 |
| 17 | PAIN | 425 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for sotalol?
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 →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for sotalol: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 16,062.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 10.37%.
- prednisone Δ 0.01 pts · 482,856 reports · Corticosteroid 10.37%death share
- chlorzoxazone Δ 0.02 pts · 1,256 reports · Muscle Relaxant 10.35%death share
- nisoldipine Δ 0.04 pts · 1,191 reports · Calcium Channel Blocker 10.33%death share
- labetalol Δ 0.04 pts · 12,726 reports · Alpha/Beta-Blocker 10.33%death share
Medication Guides
Understanding Drug Interactions
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Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 16,062 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: April 3, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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