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Sotalol Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 12, 2019.

In Summary

Commonly reported side effects of sotalol include: bradycardia, fatigue, and headache. Other side effects include: dyspnea, ecg abnormality, insomnia, and nausea and vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to sotalol: oral solution, oral tablet

Other dosage forms:

Warning

Oral route (Solution)

To minimize the risk of induced arrhythmia, patients initiated or reinitiated on oral sotalol or converted from IV sotalol to oral administration should be placed in a facility that can provide cardiac resuscitation, continuous electrocardiographic monitoring and calculations of creatinine clearance. Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. Do not initiate sotalol therapy if the baseline QTc is longer than 450 ms. If the QT interval prolongs to 500 ms or greater, the dose must be reduced, the interval between doses prolonged, or the drug discontinued. Adjust the dosing interval based on creatinine clearance.

Oral route (Tablet)

To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug. Calculate creatinine clearance to determine appropriate dosing.

Along with its needed effects, sotalol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sotalol:

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

Rare

  • Fast breathing
  • pinpoint red spots on the skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking sotalol:

Symptoms of Overdose

Some side effects of sotalol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Less Common

  • Changes in vision
  • decreased sexual performance or desire
  • loss of appetite
  • mood changes
  • night blindness
  • passing gas
  • skin rash
  • weight changes

Rare

  • 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

Cardiovascular

Very common (10% or more): Bradycardia (up to 16%), chest pain (up to 16%), palpitation (up to 14%)

Common (1% to 10%): Edema, abnormal ECG, hypotension, proarrhythmia (including Torsade de Pointes), syncope, heart failure, presyncope, vasodilation, Automatic Implantable Cardioverter-Defibrillator (AICD) discharge, hypertension, stroke[Ref]

Nervous system

Very common (10% or more): Fatigue (up to 20%), dizziness (up to 20%), asthenia (up to 13%), light headedness (up to 12%)

Common (1% to 10%): Headache, perspiration, paresthesia[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 21%)

Common (1% to 10%): Pulmonary problem, upper respiratory tract problem, asthma[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (up to 10%)

Common (1% to 10%): Appetite disorder, diarrhea, dyspepsia, abdominal pain, colon problem, flatulence, cramps[Ref]

Metabolic

Common (1% to 10%): Weight change[Ref]

Dermatologic

Common (1% to 10%): Rash[Ref]

Musculoskeletal

Common (1% to 10%): Extremity pain, back pain[Ref]

Genitourinary

Common (1% to 10%): Genitourinary disorder, sexual dysfunction[Ref]

Hematologic

Common (1% to 10%): Bleeding[Ref]

Immunologic

Common (1% to 10%): Infection[Ref]

Local

Common (1% to 10%): Localized pain[Ref]

Ocular

Common (1% to 10%): Vision problem[Ref]

Other

Common (1% to 10%): Fever, abnormal lab value

Frequency not reported: Taste abnormalities, hearing disturbances[Ref]

Psychiatric

Common (1% to 10%): Depression, sleep problem, altered consciousness, anxiety, mood change[Ref]

References

1. "Product Information. Betapace (sotalol)." Berlex, Richmond, CA.

2. Hohnloser SH, Vandeloo A, Baedeker F "Efficacy and proarrhythmic hazards of pharmacologic cardioversion of atrial fibrillation: prospective comparison of sotalol versus quinidine." J Am Coll Cardiol 26 (1995): 852-8

3. British Medical Association. Royal Pharmaceutical Society of Great Britain. Joint Formulary Committee "British National Formulary. Available from: URL: http://bnf.org/bnf/"

4. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

5. Gossinger HD, Siostrzonek P, Schmoliner R, Grimm G, Jager U, Mosslacher H "Sotalol-induced torsades de pointes in a patient with pre-existent normal response to programmed ventricular stimulation." Eur Heart J 8 (1987): 1351-3

6. Lehtonen A, Hietanen E, Marniemi J, Peltonen P, Nikkila EA "Effect of sotalol withdrawal on serum lipids and lipoprotein lipase activity." Int J Clin Pharmacol Ther Toxicol 21 (1983): 73-6

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Related questions

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