Sotalol Side Effects
Medically reviewed by Drugs.com. Last updated on Mar 14, 2024.
Applies to sotalol: oral solution, oral tablet.
Other dosage forms:
Important warnings
This medicine can cause some serious health issues
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.
Serious side effects of sotalol
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 side effects
- blurred vision
- chest pain, tightness, 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
- unusual tiredness or weakness
Less common side effects
- 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
- 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
- stomach pain or swelling
- weight gain
Rare side effects
- fast breathing
- pinpoint red spots on the skin
Incidence not known
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- blue lips and fingernails
- coughing that sometimes produces a pink frothy sputum
- crying
- delusions of persecution, mistrust, suspiciousness, or combativeness
- false or unusual sense of well-being
- feeling of unreality
- mental depression
- not able to move
- pale skin
- pinpoint red spots on the skin
- quick to react or overreact emotionally
- rapidly changing moods
- sense of detachment from self or body
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling in the legs and ankles
- swollen glands
- unusual bleeding or bruising
Get emergency help immediately if any of the following symptoms of overdose occur while taking sotalol:
Symptoms of overdose
- anxiety
- blurred vision
- chest pain or discomfort
- cold sweats
- confusion
- cool, pale skin
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- depression
- fast, pounding, or irregular heartbeat or pulse
- increased hunger
- nightmares
- seizures
- shakiness
- slow or irregular heartbeat
- slurred speech
- sweating
- unusual tiredness or weakness
Other side effects of sotalol
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 side effects
- acid or sour stomach
- difficulty with sleeping
- heartburn or indigestion
- pain in the arms or legs
Less common side effects
- changes in vision
- decreased sexual performance or desire
- loss of appetite
- mood changes
- night blindness
- passing gas
- skin rash
- weight changes
Rare side effects
For healthcare professionals
Applies to sotalol: intravenous solution, oral solution, oral tablet.
Cardiovascular adverse events
- 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. Gossinger HD, Siostrzonek P, Schmoliner R, Grimm G, Jager U, Mosslacher H (1987) "Sotalol-induced torsades de pointes in a patient with pre-existent normal response to programmed ventricular stimulation." Eur Heart J, 8, p. 1351-3
2. (2001) "Product Information. Betapace (sotalol)." Berlex Laboratories
3. Hohnloser SH, Vandeloo A, Baedeker F (1995) "Efficacy and proarrhythmic hazards of pharmacologic cardioversion of atrial fibrillation: prospective comparison of sotalol versus quinidine." J Am Coll Cardiol, 26, p. 852-8
4. British Medical Association. Royal Pharmaceutical Society of Great Britain. Joint Formulary Committee (2006) British National Formulary. http://bnf.org/bnf/
5. Pharmaceutical Society of Australia (2006) APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp
6. Lehtonen A, Hietanen E, Marniemi J, Peltonen P, Nikkila EA (1983) "Effect of sotalol withdrawal on serum lipids and lipoprotein lipase activity." Int J Clin Pharmacol Ther Toxicol, 21, p. 73-6
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Further information
Sotalol side effects can vary depending on the individual. 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.