Bepridil Side Effects
Applies to bepridil: oral tablet
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 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.
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]
Hepatic side effects including elevated serum hepatic enzyme concentrations have been observed in 1% of patients.[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]
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]
Respiratory side effects including at least one case of pulmonary fibrosis associated with bepridil has been reported.[Ref]
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Some side effects may not be reported. You may report them to the FDA.