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Sotalol Hydrochloride AF Side Effects

Generic Name: sotalol

Note: This page contains side effects data for the generic drug sotalol. It is possible that some of the dosage forms included below may not apply to the brand name Sotalol Hydrochloride AF.

It is possible that some side effects of Sotalol Hydrochloride AF may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to sotalol: oral solution, oral tablet

Other dosage forms:

As well as its needed effects, sotalol (the active ingredient contained in Sotalol Hydrochloride AF) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sotalol, check with your doctor immediately:

More common
  • Blurred vision
  • chest pain or discomfort
  • confusion
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, slow, irregular, pounding, or racing heartbeat or pulse
  • lightheadedness, dizziness, or fainting
  • nausea and vomiting
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach pain or swelling
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • cough or hoarseness
  • decreased alertness
  • difficulty with speaking
  • dilated neck veins
  • double vision
  • extreme fatigue
  • feeling of warmth or heat
  • fever or chills
  • flushing or redness of the skin, especially on the face and neck
  • headache
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • irregular breathing
  • joint pain or swelling
  • loss of voice
  • lower back or side pain
  • nervousness
  • noisy breathing
  • painful, burning, or difficult urination
  • pounding in the ears
  • slow speech
  • weight gain
  • Fast breathing
  • pinpoint red spots on the skin

If any of the following symptoms of overdose occur while taking sotalol, get emergency help immediately:

Symptoms of overdose
  • Anxiety
  • cold sweats
  • cool, pale skin
  • depression
  • increased hunger
  • nightmares
  • seizures
  • shakiness
  • slurred speech

Some sotalol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Acid or sour stomach
  • difficulty with sleeping
  • heartburn or indigestion
  • pain in the arms or legs
Less common
  • Changes in vision
  • decreased sexual performance or desire
  • loss of appetite
  • mood changes
  • night blindness
  • passing gas
  • skin rash
  • weight changes
  • Feeling of constant movement of self or surroundings
  • hair loss or thinning of the hair
  • itching skin
  • muscle aching or cramping
  • muscle pains or stiffness
  • quick to react or overreact emotionally
  • sensation of spinning
  • severe sunburn

For Healthcare Professionals

Applies to sotalol: intravenous solution, oral solution, oral tablet


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 (the active ingredient contained in Sotalol Hydrochloride AF) 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.[Ref]

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.[Ref]

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.[Ref]


Respiratory problems are mainly limited to dyspnea in 1% to 7% of patients. Like other beta-blockers, sotalol (the active ingredient contained in Sotalol Hydrochloride AF) may inhibit beta-mediated bronchodilatory mechanisms, inducing wheezing in some patients with reactive airways disease.[Ref]


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


Metabolic changes are mainly limited to increased total serum triglycerides. Limited data show decreased HDL cholesterol associated with sotalol (the active ingredient contained in Sotalol Hydrochloride AF) 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.[Ref]


Six cases of sclerodermatous changes associated with sotalol (the active ingredient contained in Sotalol Hydrochloride AF) therapy in patients with hyperthyroidism are reported.[Ref]

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


Musculoskeletal side effects are extremely rare. Cases of retroperitoneal fibrosis, proximal muscle weakness, and facial atrophy associated with sotalol (the active ingredient contained in Sotalol Hydrochloride AF) are reported.[Ref]

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.[Ref]


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