Disopyramide Side Effects

Brand Names: Norpace, Norpace CR

Please note - some side effects for Disopyramide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Disopyramide - for the Consumer

Disopyramide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Disopyramide:

Aches or pain; bloating; blurred vision; constipation; difficulty urinating; dizziness; dryness of the eyes, mouth, nose, or throat; fatigue; frequent and urgent urination; gas; general body discomfort; headache; muscle weakness; nausea; tiredness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or slow heartbeat; fever; lightheadedness; heart rhythm problems; severe difficulty urinating; shortness of breath; sore throat; swelling.

Disopyramide Sustained-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Disopyramide Sustained-Release Capsules:

Aches or pain; bloating; blurred vision; constipation; difficulty urinating; dizziness; dryness of the eyes, mouth, nose, or throat; fatigue; frequent and urgent urination; gas; general body discomfort; headache; muscle weakness; nausea; tiredness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or slow heartbeat; fever; lightheadedness; heart rhythm problems; severe difficulty urinating; shortness of breath; sore throat; swelling.

Disopyramide Side Effects - for the Professional

Disopyramide

The adverse reactions which were reported in Disopyramide Phosphate clinical trials encompass observations in 1,500 patients, including 90 patients studied for at least 4 years. The most serious adverse reactions are hypotension and congestive heart failure. The most common adverse reactions, which are dose dependent, are associated with the anticholinergic properties of the drug. These may be transitory, but may be persistent or can be severe. Urinary retention is the most serious anticholinergic effect.

The following reactions were reported in 10% to 40% of patients:

Anticholinergic: dry mouth (32%), urinary hesitancy (14%), constipation (11%)

The following reactions were reported in 3% to 9% of patients:

Anticholinergic: blurred vision, dry nose/eyes/throat

Genitourinary: urinary retention, urinary frequency and urgency

Gastrointestinal: nausea, pain/bloating/gas

General: dizziness, general fatigue/muscle weakness, headache, malaise, aches/pains

The following reactions were reported in 1% to 3% of patients:

Genitourinary: impotence

Cardiovascular: hypotension with or without congestive heart failure, increased congestive heart failure, cardiac conduction disturbances, edema/weight gain, shortness of breath, syncope, chest pain

Gastrointestinal: anorexia, diarrhea, vomiting

Dermatologic: generalized rash/dermatoses, itching

Central nervous system: nervousness

Other: hypokalemia, elevated cholesterol/triglycerides

The following reactions were reported in less than 1%:

Depression, insomnia, dysuria, numbness/tingling, elevated liver enzymes, AV block, elevated BUN, elevated creatinine, decreased hemoglobin/hematocrit

Hypoglycemia has been reported in association with Disopyramide Phosphate administration.

Infrequent occurrences of reversible cholestatic jaundice, fever, and respiratory difficulty have been reported in association with Disopyramide therapy, as have rare instances of thrombocytopenia, reversible agranulocytosis, and gynecomastia. Some cases of LE (lupus erythematosus) symptoms have been reported; most cases occurred in patients who had been switched to Disopyramide from procainamide following the development of LE symptoms. Rarely, acute psychosis has been reported following Disopyramide Phosphate therapy, with prompt return to normal mental status when therapy was stopped. The physician should be aware of these possible reactions and should discontinue Disopyramide Phosphate therapy promptly if they occur.

Side Effects by Body System

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.

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 information does not endorse drugs, diagnose patients, or recommend therapy. This drug 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 drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information 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 drugs you are taking, check with your doctor, nurse, or pharmacist.