Sotalol Side Effects

In Summary

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

For the Consumer

Applies to sotalol: oral solution, oral tablet

As well as its needed effects, sotalol may cause unwanted side effects that require medical attention.

Major Side Effects

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

• 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

• 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:

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

Minor Side Effects

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:

• Acid or sour stomach
• difficulty with sleeping
• heartburn or indigestion
• pain in the arms or legs

• 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

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]

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

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