Bepridil Side Effects

Applies to bepridil: oral tablet.

If you experience any of the following serious side effects, stop taking bepridil and call your doctor immediately or seek emergency medical treatment:

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

• unusually fast or slow heartbeat;

• fainting or severe dizziness;

• chest pain;

• abnormal behavior or psychosis;

• yellowing of your skin or eyes (jaundice); or

• swelling of your legs or ankles.

Other, less serious side effects may be more likely to occur. Continue to take bepridil and talk to your doctor if you experience

• unusual fatigue or tiredness;

• nausea, upset stomach, diarrhea, or constipation;

• headache;

• nervousness or mild dizziness;

• insomnia; or

• tremor (shaking).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to bepridil: oral tablet.

General

Bepridil has generally been well-tolerated. Although adverse side effects have been reported in up to 87% of patients, most were mild to moderate in severity.^[Ref]

Cardiovascular

Cardiovascular side effects have been uncommon, but potentially serious. The use of bepridil has been associated with dose-related QT segment prolongation in up to 80% of patients, which may be associated with torsades de pointes in up to 1% of patients and ventricular tachycardia or fibrillation in up to 3% of patients. The manufacturer has recommended that the dose be reduced if the QT interval exceeds 0.52 seconds during treatment.

Palpitations and edema have been reported in 1% to 2% of patients. Exacerbation of congestive heart failure has been associated with the use of bepridil in 1% of patients.^[Ref]

Serious arrhythmias associated with the use of bepridil have been more prevalent among patients with increased QT segment lengthening (on ECG), hypokalemia, advanced age, and among female patients.^[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, dyspepsia, and general abdominal discomfort in up to 20% of patients and diarrhea in 8% of patients.^[Ref]

Rare gastrointestinal side effects have included anorexia, dry mouth, and constipation in less than 4% of patients.^[Ref]

Nervous system

Nervous system side effects have included headache in 11%, tremor in 5%, dizziness in 15%, nervousness in 7%, and asthenia in 10% to 17% of patients.^[Ref]

Rare nervous system side effects have included drowsiness, insomnia, and paresthesias in less than 4% of patients.^[Ref]

Hepatic

Hepatic side effects including elevated serum hepatic enzyme concentrations have been observed in 1% of patients.^[Ref]

Hematologic

Hematologic side effects have been rare. In a study of over 800 patients, 2 with a history of diabetes developed agranulocytosis, one of whom died.^[Ref]

Two patients who developed leukopenia were elderly and diabetic. One surviving patient recovered after bepridil was discontinued.

In another case, a 72-year-old man with severe angina pectoris developed a fever and chills associated with an absolute neutrophil count of 35 per mm3 six weeks after switching from diltiazem and nitrates to bepridil and nitrates. A bone marrow biopsy revealed profound myeloid hypoplasia. The patient recovered after discontinuation of bepridil, institution of granulocyte colony-stimulating factor, and broad-spectrum antibiotics.^[Ref]

Respiratory

Respiratory side effects including at least one case of pulmonary fibrosis associated with bepridil has been reported.^[Ref]

A 72-year-old man with coronary artery disease, status post myocardial infarction, and congestive heart failure developed a dry cough and dyspnea 1 week after beginning bepridil. Associated findings included hypoxemia, chest X-ray evidence of a left perihilar infiltrate, and interstitial pulmonary fibrosis per a transbronchial biopsy. The patient's signs and symptoms resolved after substitution of bepridil with diltiazem and institution of oxygen and prednisone therapy. The recent history of congestive heart failure may have predisposed this patient to the adverse effects of bepridil.

The authors of this case report found no other well-described cases of interstitial pulmonary disease associated with bepridil, but noted approximately four incidentally-described cases of inflammatory pulmonary infiltrates associated with bepridil either from the manufacturer or from large studies.^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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