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Bepridil Side Effects

Applies to bepridil: oral tablet.

Important warnings This medicine can cause some serious health issues

Do not stop taking this medication unless your doctor approves.

If you stop taking your medication, your condition could become much worse.

Follow any diet or exercise recommendations for your condition.

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

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

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 adverse events

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]

References

1. Narahara KA, Singh BN, Karliner JS, Corday SR, Hossack KF (1992) "Bepridil hydrochloride compared with placebo in patients with stable angina pectoris." Am J Cardiol, 69, d37-42

2. Singh BN (1991) "Comparative efficacy and safety of bepridil and diltiazem in chronic stable angina pectoris refractory to diltiazem. The Bepridil Collaborative Study Group." Am J Cardiol, 68, p. 306-12

3. Hollingshead LM, Faulds D, Fitton A (1992) "Bepridil. A review of its pharmacological properties and therapeutic use in stable angina pectoris." Drugs, 44, p. 835-57

4. Singh BN (1992) "Bepridil therapy: guidelines for patient selection and monitoring of therapy." Am J Cardiol, 69, d79-85

5. Coumel P (1992) "Safety of bepridil: from review of the European data." Am J Cardiol, 69, d75-8

6. Singh BN (1992) "Safety profile of bepridil determined from clinical trials in chronic stable angina in the United States." Am J Cardiol, 69, d68-74

7. Shapiro W (1992) "Comparative efficacy of bepridil versus placebo in angina pectoris: treatment and withdrawal studies." Am J Cardiol, 69, d43-9

8. Alpert JS, Coumel P, Greeff K, Krikler DM, Remme WJ, Schonbaum E, Verduyn CW (1985) "Bepridil: a review of its pharmacology and clinical efficacy as an anti-anginal agent with anti-arrhythmic properties." Pharmatherapeutica, 4, p. 195-222

9. (2002) "Product Information. Vascor (bepridil)." McNeil Pharmaceutical

10. Weiss RJ (1993) "Bepridil and agranulocytosis." Am Heart J, 125, p. 1819-20

11. Vasilomanolakis EC, Goldberg NM (1993) "Bepridil-induced pulmonary fibrosis." Am Heart J, 126, p. 1016-7

Further information

Bepridil side effects can vary depending on the individual. 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.