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Vascor

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Vascor

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Vascor Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Vascor (bepridil hydrochloride) is a calcium channel blocker used to treat hypertension (high blood pressure) and to treat angina (chest pain). The brand name of this medication is discontinued, but generic versions may be available. Common side effects include unusual fatigue or tiredness, nausea, upset stomach, diarrhea, constipation, headache, nervousness, dizziness, insomnia, or tremor (shaking).

The usual starting dose of Vascor is 200 mg once daily. Vascor may interact with other heart medicines. Tell your doctor all medications and supplements you use. It is unknown if Vascor will harm a fetus. Do not take Vascor without first talking to your doctor if you are pregnant. This drug passes into breast milk and may harm a nursing infant. Consult your doctor before breastfeeding.

Our Vascor (bepridil hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 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
  Headache
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
  Dyspnea
 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
  Constipation
 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
  Tremor
 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) »

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