Betapace Side Effects Center

Last updated on RxList: 6/18/2021
Betapace Side Effects Center

What Is Betapace?

Betapace (sotalol) is an antiarrhythmic agent used for treating ventricular arrhythmias. Betapace is available in generic form.

What Are Side Effects of Betapace?

Common side effects of Betapace include:

  • headache,
  • indigestion,
  • dizziness,
  • fatigue,
  • weakness,
  • tiredness,
  • slow heart rate,
  • chest pain,
  • palpitations,
  • diarrhea,
  • nausea,
  • vomiting,
  • upset stomach,
  • sleep problems (insomnia),
  • pain in your arms or legs, or
  • decreased sexual ability.

Dosage for Betapace

The recommended dose for adults is 80 to 160 mg twice daily.

What Drugs, Substances, or Supplements Interact with Betapace?

Betapace may interact with amiodarone, ketoconazole, itraconazole, calcium channel blockers, beta-blockers, beta-agonists, tricyclic antidepressants, and antacids containing aluminum or magnesium. Abrupt withdrawal may lead to to myocardial infarction due to catecholamine sensitivity.

Betapace During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant during treatment with Betapace. Betapace is not expected to harm a fetus. Betapace passes into breast milk and may harm a nursing baby. Breastfeeding while using Betapace is not recommended.

Additional Information

Our Betapace (sotalol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Betapace Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • chest pain;
  • fast or pounding heartbeats, fluttering in your chest;
  • sudden dizziness (like you might pass out);
  • slow heartbeats (especially if you feel light-headed);
  • swelling, rapid weight gain; or
  • feeling short of breath.

Common side effects may include:

  • slow heartbeats;
  • trouble breathing;
  • dizziness; or
  • feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Betapace (Sotalol)

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Betapace Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reactions that are clearly related to sotalol are those which are typical of its Class II (beta-blocking) and Class III (cardiac action potential duration prolongation) effects and are dose related.

Ventricular Arrhythmias

Serious Adverse Reactions

Betapace/Betapace AF can cause serious and potentially fatal ventricular arrhythmias such as sustained VT/VF, primarily Torsade de Pointes (TdP) [see WARNINGS AND PRECAUTIONS]. The effect on QT and the risk of Torsade de Pointes are both dose related.

Pediatric Patients

In an unblinded multicenter trial of 25 pediatric patients aged ≤ 1 month to 12 years with SVT and/or VT receiving daily doses of 30, 90, and 210 mg/m2 with dosing every 8 hours for a total of 9 doses, no Torsade de Pointes or other serious new arrhythmias were observed. The clinical trial safety profile in pediatric patients was similar to that in adult patients. Both the Class III and beta-blocking effects of sotalol were linearly related to the plasma concentration [see CLINICAL PHARMACOLOGY].

Atrial Fibrillation/Atrial Flutter

Placebo-controlled Clinical Trials

In a pooled clinical trial population consisting of 4 placebo-controlled studies with 275 patients with atrial fibrillation (AFIB)/atrial flutter (AFL) treated with 160 to 320 mg of Betapace AF, the following adverse reactions presented in Table 2 occurred in at least 2% of placebo-treated patients and at a lesser rate than Betapace-treated patients. The data are presented by incidence of reactions in the Betapace AF and placebo groups by body system and daily dose.

Table 2: Incidence (%) of Common Adverse Reactions (≥ 2% in the Placebo Group and Less Frequent Than in the Betapace AF Groups) in Four Placebo-controlled Studies of Patients with AFIB/AFL

Adverse Reaction Placebo Betapace AF Total Daily Dose
N = 282 (%) 160-240 mg
N = 153 (%)
>240-320 mg
N = 122 (%)
Bradycardia 3 13 12
Diarrhea 2 5 6
Nausea/Vomiting 5 8 6
Fatigue 9 20 19
Hyperhidrosis 3 5 5
Weakness 3 5 5
Dizziness 12 16 13
Headache 5 3 12
Dyspnea 7 9 10

Overall, discontinuation because of unacceptable adverse events was necessary in 17% of the patients and occurred in 10% of patients less than two weeks after starting treatment. The most common adverse reactions leading to discontinuation of Betapace AF were: fatigue 4.6%, bradycardia 2.4%, proarrhythmia 2.2%, dyspnea 2%, and QT interval prolongation 1.4%.

Postmarketing Experience

The following adverse drug reactions have been identified during post-approval use of sotalol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: emotional lability, slightly clouded sensorium, incoordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritis, and alopecia.

DRUG INTERACTIONS

Antiarrhythmics And Other QT Prolonging Drugs

Discontinue Class I or Class III antiarrhythmic agents for at least three half-lives prior to dosing with sotalol. Class Ia antiarrhythmic drugs, such as disopyramide, quinidine, and procainamide, and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy with Betapace/Betapace AF, because of their potential to prolong refractoriness [see WARNINGS AND PRECAUTIONS].

Negative Chronotropes

Digitalis glycosides, diltiazem, verapamil, and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use with negative chronotropes can increase the risk of bradycardia or hypotension.

Catecholamine-Depleting Agents

Concomitant use of catecholamine-depleting drugs, such as reserpine and guanethidine, with a beta-blocker may produce an excessive reduction of resting sympathetic nervous tone. Monitor such patients for evidence of hypotension and/or marked bradycardia which may produce syncope.

Insulin And Oral Antidiabetics

Hyperglycemia may occur, and the dosage of insulin or antidiabetic drugs may require adjustment [see WARNINGS AND PRECAUTIONS].

Beta-2-Receptor Stimulants

Beta-agonists such as albuterol, terbutaline and isoproterenol may have to be administered in increased dosages when used concomitantly with sotalol.

Clonidine

Concomitant use with sotalol increases the risk of bradycardia and AV block. Because betablockers may potentiate the rebound hypertension sometimes observed after clonidine discontinuation, withdraw sotalol several days before the gradual withdrawal of clonidine to reduce the risk of rebound hypertension.

Antacids

Avoid administration of oral sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide.

Drug/Laboratory Test Interactions

The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine when measured by fluorimetric or photometric methods.

Read the entire FDA prescribing information for Betapace (Sotalol)

© Betapace Patient Information is supplied by Cerner Multum, Inc. and Betapace Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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