Disopyramide Side Effects

Some side effects of disopyramide 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 disopyramide: oral capsule, oral capsule extended release

If you experience any of the following serious side effects, stop taking disopyramide and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• a new or a worsening irregular heartbeat pattern;

• chest pain, chest discomfort, shortness of breath, or swelling of your legs or feet; or

• severe dizziness.

Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

• mild dizziness or tiredness,

• headache,

• blurred vision,

• dry mouth,

• rash, itching,

• muscle aches or pains, or

• difficulty urinating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to disopyramide: compounding powder, oral capsule, oral capsule extended release

Gastrointestinal

Gastrointestinal side effects including anticholinergic side effects have been the most common cause of gastrointestinal complaints. Dry mouth (40%), constipation (11%) and nausea, pain/bloating/gas (3% to 9%) have been reported. Anorexia, diarrhea, and vomiting have occurred. Two cases of paralytic ileus have been reported. A case of oral mucosal ulceration has been associated with the (unapproved) sublingual use of disopyramide.

Cardiovascular

Cardiovascular side effects have included arrhythmias, conduction disturbances, hypotension, and heart failure. Like other class I antiarrhythmic agents, disopyramide can be proarrhythmic and decrease cardiac contractility. The risk of proarrhythmias may be increased in patients with left ventricular dysfunction. Various ventricular tachyarrhythmias accompanied by disopyramide-induced QT interval prolongation, including ventricular tachycardia or fibrillation and torsades de pointes, have been associated with usual therapeutic doses. Evidence of QRS segment or QT widening are indications to either reduce the dose or stop the drug. Conduction disturbances, including AV block, have occurred, and are more likely in patients with preexisting conduction disorders.

Contributing factors towards the development of torsades de pointes included female gender, hypokalemia, underlying arrhythmias, mitral valve abnormalities, or congestive heart failure.

Hypotension, pulmonary edema, and frank cardiogenic shock have been associated with both the oral and intravenous administration of disopyramide. Most affected patients had underlying congestive heart failure.

Nervous system

A patient developed a severe sensory-motor polyneuropathy after receiving disopyramide 500 mg daily for 4 years. Symptoms did not respond to corticosteroids, but did resolve a few months after withdrawal of disopyramide.

Nervous system side effects including anticholinergic symptoms have been reported. Other nervous system side effects have been rare, and included nervousness, insomnia, depression, and peripheral paresthesia or neuropathy.

Genitourinary

Genitourinary side effects were related to anticholinergic properties of the drug. Urinary hesitancy (10% to 40%) has occurred. Urinary retention, frequency, and urgency has been reported in up to 9% of patients. Recommended management consisted of lowering the dose, discontinuing the drug, or if necessary, using a cholinergic drug to counteract this effect. Sexual impotence has been reported.

Hepatic

Hepatic side effects including reversible, dose-independent intrahepatic cholestasis, hepatocellular damage, and nonspecific hepatic inflammatory changes have been reported in rare cases where venous congestion secondary to heart failure was reasonably excluded. Manifestations of liver dysfunction usually appeared during the first week of treatment (malaise, dark urine) and resolved promptly upon discontinuation of the drug. In one review, 20 cases were reported during a 14-year period.

Endocrine

Endocrine side effect have included hypoglycemia due to stimulation of insulin secretion and rare cases of hypokalemia and dyslipidemia. Hypoglycemia can occur in nondiabetic patients at therapeutic plasma disopyramide levels.

Elevated insulin levels have been measured during disopyramide-associated hypoglycemic episodes. Data have revealed that disopyramide blocks pancreatic ATP-sensitive potassium channels, enhancing insulin release. Other factors such as increased peripheral utilization of glucose or decreased glycogenolysis have not been fully evaluated.

Immunologic

Immunologic side effects, such as the production of antinuclear antibodies and other immunologically-mediated changes associated with other class 1 antiarrhythmic agents, do not appear to occur during disopyramide therapy.

Dermatologic

Dermatologic reactions have been reported rarely, usually presenting as a rash or pruritus.

Ocular

Ocular side effects of blurred vision (3% to 9%) have been associated with the anticholinergic effects of disopyramide.

General

General body symptoms of fatigue, muscle weakness, malaise, and aches/pains have been reported in 3% to 9% of patients administered disopyramide. Rarely, fever has occurred.

Psychiatric

Psychiatric side effects including reversible psychiatric symptoms of psychosis have been reported rarely.

Hematologic

Hematologic adverse effects of thrombocytopenia, and reversible agranulocytosis have occurred rarely.

Other

Gynecomastia has been reported.

Respiratory

Respiratory difficulty has been reported rarely.

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