Sotalol: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Sotalol. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| 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 across placebo-controlled trial tables summarized in current labeling.
Labeled uses
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…
Medical disclaimer: Always consult a qualified healthcare professional about any medication.