Sotalol Side Effects
Medically reviewed by Drugs.com. Last updated on June 18, 2020.
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.
Side effects requiring immediate medical attention
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
- Anxiety
- cold sweats
- cool, pale skin
- depression
- increased hunger
- nightmares
- seizures
- shakiness
- slurred speech
Side effects not requiring immediate medical attention
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
- 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
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
Frequently asked questions
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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.