What the label lists and what reports show
Sotalol side effects
Sotalol's FDA label: “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%.” FAERS holds 16,549 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (945 reports).
- Generic listed
- Boxed warning
Check it at the source: the sotalol FDA label on DailyMed (effective December 16, 2024, Legacy Pharma USA, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of sotalol hydrochloride tablets, USP (AF)?Sotalol hydrochloride tablets (AF) most serious side effect, a different type of dangerous abnormal heartbeat, is discussed in " What is the most important information I should know about sotalol hydrochloride tablets, USP (AF)? " . Dangerous abnormal heartbeats happen rarely. But they can be serious and, in rare instances, can even cause death. Sotalol hydrochloride tablets (AF) most common side effects are tiredness, slow rate, shortness of breath, and dizziness. Sotalol hydrochloride tablets (AF) can also cause other side effects. If you are concerned about these or any other side effects, ask your doctor. Important points about sotalol hydrochloride tablets, USP (AF) Sotalol hydrochloride tablets (AF) can help you best if you take it as your doctor has prescribed it. […]
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
What does the label list?
From the label: adverse reactionsThe 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%.
Table 2: Incidence (%) of Common Adverse Reactions (≥ 2% in the Placebo Group and Less Frequent Than in the Betapace AF Groups) in Four Placebo-controlled Studies of Patients with AFIB/AFL
| Reaction | Adverse Reaction N = 282 (%) | Placebo 160-240 mg N = 153 (%) | Betapace AF Total Daily Dose >240-320 mg N = 122 (%) |
|---|---|---|---|
| Bradycardia | 3 | 13 | 12 |
| Diarrhea | 2 | 5 | 6 |
| Nausea/Vomiting | 5 | 8 | 6 |
| Fatigue | 9 | 20 | 19 |
| Hyperhidrosis | 3 | 5 | 5 |
| Weakness | 3 | 5 | 5 |
| Dizziness | 12 | 16 | 13 |
| Headache | 5 | 3 | 12 |
| Dyspnea | 7 | 9 | 10 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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. …
Source: FDA drug label, 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?
16,549 reports list sotalol among the medicines taken, 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. Of the 20 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Sotalol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions