Sotalol: Side Effects, Uses & Monitoring
Sotalol hydrochloride tablets, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening.
- Data source
- FDA labeling via NIH DailyMed (label 6481858a…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Dyspnea | 21% |
| Fatigue | 20% |
| Dizziness | 20% |
| Bradycardia | 16% |
| Chest pain | 16% |
| Palpitation | 14% |
| Asthenia | 13% |
| Light-headed | 12% |
| Nausea/vomiting | 10% |
| Edema | 8% |
| Headache | 8% |
| Sleep problem | 8% |
| Pulmonary problem | 8% |
| Ecg abnormal | 7% |
| Diarrhea | 7% |
| Extremity pain | 7% |
| Hypotension | 6% |
| Perspiration | 6% |
| Dyspepsia | 6% |
| Proarrhythmia | 5% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Sotalol hydrochloride tablets, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of sotalol hydrochloride tablets, USP (see WARNINGS ), including a 1.5 to 2% rate of Torsade de Pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of sotalol hydrochloride treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. The response to treatment should then be evaluated by a suitable method (e.g., PES or Holter monitoring) prior to continuing the patient on chronic therapy. Various approaches have been used to determine the response to antiarrhythmic therapy, including sotalol hydrochloride tablets, USP. In the ESVEM Trial, response by Holter monitoring was tentatively defined as 100% suppr…
Conditions associated with Sotalol in labeling
Frequently Asked Questions
What is Sotalol used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Sotalol?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Sotalol. Individual risk varies.
Does Sotalol require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Sotalol.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.