Betapace AF 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 Betapace AF.
Some side effects of Betapace AF may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to sotalol: oral tablet
Other dosage forms:
Along with its needed effects, sotalol (the active ingredient contained in Betapace AF) 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
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- fast, slow, irregular, pounding, or racing heartbeat or pulse
- lightheadedness, dizziness, or fainting
- nausea and vomiting
- shortness of breath
- swelling of face, fingers, feet, or lower legs
- tightness in chest
- unusual tiredness or weakness
- Abdominal pain or swelling
- back pain
- black, tarry stools
- blood in eyes
- blood in urine
- body aches or pain
- bruising or purple areas on skin
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in consciousness
- cold hands and feet
- cough or hoarseness
- coughing up blood
- decreased alertness
- decreased urine output
- difficulty in speaking
- dilated neck veins
- double vision
- ear congestion
- extreme fatigue
- feeling of warmth or heat
- fever or chills
- flushing or redness of skin, especially on face and neck
- inability to move arms, legs, or facial muscles
- inability to speak
- irregular breathing
- joint pain or swelling
- loss of voice
- lower back or side pain
- nasal congestion
- noisy breathing
- painful, burning, or difficult urination
- pounding in the ears
- runny nose
- slow speech
- sore throat
- troubled breathing
- weight gain
- Bleeding gums
- fast breathing, sometimes with wheezing
- large amount of fat in the blood
- not able to move
- pinpoint red spots on skin
- sores, ulcers, or white spots on lips or in mouth
- 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
- cold sweats
- cool, pale skin
- increased hunger
- no heartbeat
- 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 in sleeping
- lack or loss of strength
- pain in arms or legs
- stomach discomfort or upset
- Abnormal ejaculation
- decreased sexual performance or desire
- disturbed color perception
- double vision
- excess air or gas in stomach or intestines
- full feeling
- halos around lights
- loss of appetite
- loss of vision
- mood changes
- night blindness
- overbright appearance of lights
- passing gas
- skin rash
- tunnel vision
- weight changes
- difficulty in moving
- feeling of constant movement of self or surroundings
- hair loss, thinning of hair
- increased sensitivity of skin to sunlight
- itching skin
- lack of coordination
- mental depression
- muscle aching or cramping
- muscle pains or stiffness
- quick to react or overreact emotionally
- rapidly changing moods
- redness or other discoloration of skin
- sensation of spinning
- severe sunburn
For Healthcare Professionals
Applies to sotalol: intravenous solution, oral tablet
Sotalol dosages should be reduced in patients with QTc intervals of 550 msec or greater, as the incidence of torsades de pointes is approximately 10% in such patients.
Limited animal data have shown that the incidence of potentially deleterious QT prolongation and associated risk of torsades de pointes can be significantly reduced with coadministration of mexiletine.
The SWORD (Survival with Oral d-Sotalol) trial was prematurely discontinued because the overall mortality of patients with a recent acute myocardial infarction and left ventricular systolic dysfunction who received sotalol (the active ingredient contained in Betapace AF) was significantly greater than in those patients who received placebo.
Sotalol may significantly depress atrial inotropic activity after electrical cardioversion of atrial fibrillation.
Limited data have suggested that sotalol demonstrates "reverse use dependence", or a decreased effect of action potential prolongation at high (200 beat/min +) heart rates. Small in vivo studies in humans have not confirmed this potential lack of efficacy, but more data are needed.
Cardiovascular arrhythmias are the most serious side effects and are usually observed within one week of therapy initiation or dosage increases. Sotalol may prolong the QT interval in 5% of patients, and may induce arrhythmias, including torsades de pointes in 1% to 5% of patients. A proarrhythmic effect is more likely in female patients, in patients who present with sustained ventricular tachycardia or fibrillation, congestive heart failure, pre-existing QT prolongation, bradycardia, or hypokalemia, or patients who receive > 320 mg/day. Sustained ventricular tachycardia or fibrillation is reported in 0.8% of patients. Sinus bradycardia is reported in up to 13% of patients and predisposes patients to torsades de pointes.
Less common cardiovascular problems include worsened or new congestive heart failure in 0.4% to 3.3%, hypotension in 2%, and sinus arrest or AV block in 1% of patients.
Nervous system complaints are mainly limited to general fatigue, headache, or dizziness in up to 15% of patients. One case of sotalol-related depression has been reported.
Respiratory problems are mainly limited to dyspnea in 1% to 7% of patients. Like other beta-blockers, sotalol (the active ingredient contained in Betapace AF) may inhibit beta-mediated bronchodilatory mechanisms, inducing wheezing in some patients with reactive airways disease.
Gastrointestinal side effects include diarrhea, nausea, and vomiting in 1% to 5% of patients.
Metabolic changes are mainly limited to increased total serum triglycerides. Limited data show decreased HDL cholesterol associated with sotalol (the active ingredient contained in Betapace AF) therapy. It is recommended that sotalol not be used in patients with preexisting hypokalemia or hypomagnesemia since these conditions may contribute to the proarrhythmic effects of sotalol.
Six cases of sclerodermatous changes associated with sotalol (the active ingredient contained in Betapace AF) therapy in patients with hyperthyroidism are reported.
Dermatologic side effects are uncommon. Two to 5% of patients develop a rash during sotalol therapy.
Musculoskeletal side effects are extremely rare. Cases of retroperitoneal fibrosis, proximal muscle weakness, and facial atrophy associated with sotalol (the active ingredient contained in Betapace AF) are reported.
A 55-year-old woman who was taking sotalol for hypertension developed a fever and bilateral hydronephrosis associated with retroperitoneal fibrosis which obstructed both ureters.
A 68-year-old woman with exertional angina pectoris developed proximal extremity weakness associated with elevated skeletal muscle creatine kinase 6 months after starting sotalol 80 mg every 8 hours. The problem persisted despite substitution with propranolol, and resolved when both drugs were withheld.
A 44-year-old man who was taking sotalol for hypertension developed facial atrophy after exposure to sub-zero weather. His facial muscle atrophy and edema were thought to be due to ischemia caused by the combined vasoconstrictive effects of the cold and beta-blockade.
More Betapace AF resources
- Betapace AF Concise Consumer Information (Cerner Multum)
- Betapace AF Prescribing Information (FDA)
- Betapace AF Advanced Consumer (Micromedex) - Includes Dosage Information
- Betapace AF MedFacts Consumer Leaflet (Wolters Kluwer)
- Sotalol Prescribing Information (FDA)
- Betapace Prescribing Information (FDA)
- Betapace Concise Consumer Information (Cerner Multum)
- Betapace MedFacts Consumer Leaflet (Wolters Kluwer)
- Sorine Prescribing Information (FDA)
- Sotalol Hydrochloride Monograph (AHFS DI)
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