Vascor
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Vascor
Please Note: This Brand Name drug is no longer available in the US.(Generic versions may still be available.)
Vascor Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Vascor in Detail - Patient Information: Side Effects
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.
Read the entire detailed patient monograph for Vascor (Bepridil) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Vascor FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Adverse reactions were assessed in placebo and active-drug controlled trials of 4-12 weeks duration and longer-term uncontrolled studies. The most common side effects occurring more frequently than in control groups were upper gastrointestinal complaints (nausea, dyspepsia or GI distress) in about 22%, diarrhea in about 8%, dizziness in about 15%, asthenia in about 10% and nervousness in about 7%. The adverse reactions seen in at least 2% of bepridil patients in controlled trials are shown in the following table.
| Adverse Experiences by Body System and Treatment in Greater Than 2% of Bepridil Patients in Controlled Trials | |||||
| Bepridil HCl (N = 529) | Nifedipine (N = 50) | Propranolol (N = 88) | Diltiazem (N = 41) | Placebo (N = 190) | |
| Body as a Whole | |||||
| Asthenia | 9.83 | 22.00 | 22.73 | 12.20 | 7.37 |
| 11.34 | 22.00 | 13.64 | 7.32 | 14.21 | |
| 2.08 | 8.00 | 2.27 | a | 1.05 | |
| Cardiovascular/Respiratory | |||||
| 2.27 | 6.00 | 2.27 | 0.00 | 1.58 | |
| 3.59 | 4.00 | 5.68 | 4.88 | 2.11 | |
| 2.84 | 4.00 | 3.41 | 4.88 | 3.68 | |
| Gastrointestinal | |||||
| Dyspepsia | 6.81 | 4.00 | 5.68 | 4.88 | 1.58 |
| G.I. Distress | 4.35 | 10.00 | 6.82 | a | 2.11 |
| Nausea | 12.29 | 14.00 | 11.36 | 2.44 | 3.68 |
| 3.40 | 0.00 | 0.00 | 2.44 | 2.63 | |
| 3.02 | 0.00 | 2.27 | 0.00 | 1.58 | |
| Diarrhea | 7.75 | 2.00 | 9.09 | 2.44 | 2.63 |
| 3.02 | 4.00 | 1.14 | a | 3.16 | |
| 2.84 | 6.00 | 1.14 | 4.88 | 2.11 | |
| Drowsy | 3.78 | 4.00 | 4.55 | a | 3.68 |
| 2.65 | 6.00 | 3.41 | a | 1.05 | |
| Dizziness | 14.74 | 30.00 | 10.23 | 4.88 | 9.47 |
| 4.91 | 4.00 | 0.00 | a | 1.05 | |
| Tremor of Hand | 3.02 | 4.00 | 0.00 | a | 0.53 |
| 2.46 | 2.00 | 1.14 | 4.88 | 3.16 | |
| Nervous | 7.37 | 16.00 | 1.14 | 2.44 | 3.68 |
| a No data available. | |||||
In one twelve week controlled study, daily doses of 200, 300, and 400 mg were compared to placebo. The following table shows the rates of more common reactions (at least 5% in at least one bepridil group).
| Adverse Experiences by Body System and Treatment In Greater Than 5% of Bepridil Patients in Controlled Trials | ||||
| Adverse Reaction | Bepridil HCl 200 mg | Bepridil HCl 300 mg | Bepridil HCl 400 mg | Placebo |
| (N = 43) | (N = 46) | (N = 44) | (N = 44) | |
| Body as a Whole | ||||
| Asthenia | 13.95 | 6.52 | 11.36 | 2.27 |
| Headache | 6.98 | 8.70 | 13.64 | 15.91 |
| Cardiovascular/Respiratory | ||||
| Palpitations | 0.00 | 6.52 | 4.55 | 0.00 |
| Dyspnea | 2.33 | 8.70 | 0.00 | 2.27 |
| Gastrointestinal | ||||
| G.I. Distress | 6.98 | 0.00 | 4.55 | 4.55 |
| Nausea | 6.98 | 26.09 | 18.18 | 2.27 |
| Anorexia | 0.00 | 2.17 | 6.82 | 2.27 |
| Diarrhea | 0.00 | 10.87 | 6.82 | 0.00 |
| Central Nervous System | ||||
| Drowsy | 6.98 | 6.52 | 0.00 | 4.55 |
| Dizziness | 11.63 | 15.22 | 27.27 | 6.82 |
| Tremor | 6.98 | 0.00 | 4.55 | 0.00 |
| Tremor of Hand | 9.30 | 0.00 | 4.55 | 0.00 |
| Psychiatric | ||||
| Nervous | 11.63 | 8.70 | 11.36 | 0.00 |
| Special Senses | ||||
| 0.00 | 6.52 | 2.27 | 2.27 | |
Adverse experiences in long-term open studies were generally similar to those seen in controlled trials.
Although adverse experiences were frequent (at least one being reported in 71% of patients participating in controlled clinical trials), most were well-tolerated. About 15% of patients however, discontinued bepridil treatment because of adverse experiences. In controlled clinical trials, these were principally gastrointestinal (1.0%), dizziness (1.0%) ventricular arrhythmias (1.0%) and syncope (0.6%). The major reasons for discontinuation, with comparison to control agents, are shown below.
| Most Common Events Resulting in Discontinuation | |||
| Adverse Reaction | Bepridil (N = 515) n (%) | Placebo (N = 288) n (%) | Positive Control (N = 119) n (%) |
| Dizziness | 5 (0.97) | 0 (0.0) | 2 (1.68) |
| Gastrointestinal Symptoms | 5 (0.97) | 0 (0.0) | 5 (4.20) |
| 5 (0.97) | 0 (0.0) | 0 (0.0) | |
| Syncope | 3 (0.58) | 0 (0.0) | 0 (0.0) |
Across all controlled and uncontrolled trials, VASCOR (bepridil) was evaluated in over 800 patients with chronic angina. In addition to the adverse reactions noted above, the following were observed in 0.5 to 2.0% of the VASCOR (bepridil) patients or are rarer, but potentially important events seen in clinical studies or reported in post marketing experience. In most cases it is not possible to determine whether there is a causal relationship to bepridil treatment.
Body as a Whole: Fever, pain, myalgic asthenia, superinfection, flu syndrome.
Cardiovascular/Respiratory: Sinus tachycardia, sinus bradycardia, hypertension, vasodilation, edema, ventricular premature contractions, ventricular tachycardia, prolonged QT interval, rhinitis, cough, pharyngitis.
Gastrointestinal: Flatulence, gastritis, appetite increase, dry mouth, constipation.
Musculoskeletal: Arthritis.
Central Nervous System: Fainting, vertigo, akathisia, drowsiness, insomnia, tremor.
Psychiatric: Depression, anxiousness, adverse behavior effect.
Skin: Rash, sweating, skin irritation.
Special Senses: Blurred vision, tinnitus, taste change.
Urogenital: Loss of libido, impotence.
Abnormal Lab Values: Abnormal liver function test, SGPT increase.
In postmarketing experience with other calcium blockers, gynecomastia has been rarely observed.
Certain cardiovascular events, such as acute myocardial infarction (about 3% of patients) worsened heart failure (1.9%), worsened angina (4.5%), severe arrhythmia (about 2.4% VT/VF) and sudden death (1.6%) have occurred in patients receiving bepridil, but have not been included as adverse events because they appear to be, and cannot be distinguished from, manifestations of the patient's underlying cardiac disease. Such events as torsades de pointes arrhythmias, prolonged QT/QTc, bradycardia, first degree heart block, which are probably related to bepridil, are included in the tables.
Read the entire FDA prescribing information for Vascor (Bepridil) »
Additional Vascor Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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