Summary

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

Applies to sotalol: oral solution, oral tablet. Other dosage forms:

• intravenous solution

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

• 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

• 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

• 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

• 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 aches, cramps, 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]