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Sotylize Side Effects

Generic Name: sotalol

Note: This document contains side effect information about sotalol. Some of the dosage forms listed on this page may not apply to the brand name Sotylize.

For the Consumer

Applies to sotalol: oral solution, oral tablet

Other dosage forms:

Along with its needed effects, sotalol (the active ingredient contained in Sotylize) 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

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. 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

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

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

Some side effects of Sotylize may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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