Sotalol Side Effects

Some side effects of sotalol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to sotalol: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking sotalol: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• feeling like you might pass out;

• slow heartbeats;

• trouble breathing;

• unusual sweating, increased thirst; or

• swelling, rapid weight gain.

Less serious side effects of sotalol may include:

• headache, mild dizziness;

• feeling weak or tired;

• mild diarrhea, nausea, vomiting;

• heartburn, stomach pain, loss of appetite;

• joint or muscle pain; or

• cold symptoms such as stuffy nose, sneezing, sore throat, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to sotalol: intravenous solution, oral tablet

Cardiovascular

Sotalol dosages should be reduced in patients with QTc intervals of 550 msec or greater, as the incidence of torsades de pointes is approximately 10% in such patients.

Limited animal data have shown that the incidence of potentially deleterious QT prolongation and associated risk of torsades de pointes can be significantly reduced with coadministration of mexiletine.

The SWORD (Survival with Oral d-Sotalol) trial was prematurely discontinued because the overall mortality of patients with a recent acute myocardial infarction and left ventricular systolic dysfunction who received sotalol was significantly greater than in those patients who received placebo.

Sotalol may significantly depress atrial inotropic activity after electrical cardioversion of atrial fibrillation.

Limited data have suggested that sotalol demonstrates "reverse use dependence", or a decreased effect of action potential prolongation at high (200 beat/min +) heart rates. Small in vivo studies in humans have not confirmed this potential lack of efficacy, but more data are needed.

Cardiovascular arrhythmias are the most serious side effects and are usually observed within one week of therapy initiation or dosage increases. Sotalol may prolong the QT interval in 5% of patients, and may induce arrhythmias, including torsades de pointes in 1% to 5% of patients. A proarrhythmic effect is more likely in female patients, in patients who present with sustained ventricular tachycardia or fibrillation, congestive heart failure, pre-existing QT prolongation, bradycardia, or hypokalemia, or patients who receive > 320 mg/day. Sustained ventricular tachycardia or fibrillation is reported in 0.8% of patients. Sinus bradycardia is reported in up to 13% of patients and predisposes patients to torsades de pointes.

Less common cardiovascular problems include worsened or new congestive heart failure in 0.4% to 3.3%, hypotension in 2%, and sinus arrest or AV block in 1% of patients.

Nervous system

Nervous system complaints are mainly limited to general fatigue, headache, or dizziness in up to 15% of patients. One case of sotalol-related depression has been reported.

Respiratory

Respiratory problems are mainly limited to dyspnea in 1% to 7% of patients. Like other beta-blockers, sotalol may inhibit beta-mediated bronchodilatory mechanisms, inducing wheezing in some patients with reactive airways disease.

Gastrointestinal

Gastrointestinal side effects include diarrhea, nausea, and vomiting in 1% to 5% of patients.

Metabolic

Metabolic changes are mainly limited to increased total serum triglycerides. Limited data show decreased HDL cholesterol associated with sotalol therapy. It is recommended that sotalol not be used in patients with preexisting hypokalemia or hypomagnesemia since these conditions may contribute to the proarrhythmic effects of sotalol.

Dermatologic

Six cases of sclerodermatous changes associated with sotalol therapy in patients with hyperthyroidism are reported.

Dermatologic side effects are uncommon. Two to 5% of patients develop a rash during sotalol therapy.

Musculoskeletal

Musculoskeletal side effects are extremely rare. Cases of retroperitoneal fibrosis, proximal muscle weakness, and facial atrophy associated with sotalol are reported.

A 55-year-old woman who was taking sotalol for hypertension developed a fever and bilateral hydronephrosis associated with retroperitoneal fibrosis which obstructed both ureters.

A 68-year-old woman with exertional angina pectoris developed proximal extremity weakness associated with elevated skeletal muscle creatine kinase 6 months after starting sotalol 80 mg every 8 hours. The problem persisted despite substitution with propranolol, and resolved when both drugs were withheld.

A 44-year-old man who was taking sotalol for hypertension developed facial atrophy after exposure to sub-zero weather. His facial muscle atrophy and edema were thought to be due to ischemia caused by the combined vasoconstrictive effects of the cold and beta-blockade.

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