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Mibefradil Side Effects

Applies to mibefradil: oral tablet

General

The following ADEs were more common among patients treated with mibefradil compared with placebo in controlled trials (incidence of ADE associated with mibefradil 100 mg/day vs. placebo): headache (8% vs. 6%), leg edema (4% vs. 3%), rhinitis (3% vs. 0%), abdominal pain (2% vs. 1%), lightheadedness (3% vs. 0%), dyspepsia (2% vs. 1%).[Ref]

In general, data from safety evaluations in 3,430 patients with hypertension or chronic stable angina pectoris, show that mibefradil was well tolerated. Most adverse drug events (ADEs) were mild to moderate and transient. In placebo-controlled trials the rate of discontinuation of therapy due to ADEs was similar to that of placebo except for dizziness, which was more common among patients treated with mibefradil.[Ref]

Nervous system

Two side effects of the nervous system have more often been associated with the use of mibefradil compared with placebo: headache (8% vs 6%) and lightheadedness (3% vs. 0%). Dizziness has often been reported as one of the more common side effects, seen in approximately 7% of patients. In some controlled trials, the incidence of dizziness among treated patients exceeded that among patients who received placebo.[Ref]

The following nervous system side effects have been associated with the use of 100 mg of mibefradil, but occured at a frequency equal to or less than placebo: dizziness, and fatigue. Dizziness occurred in a dose-related manner in placebo-controlled trials over a daily dose range of 50 to 100 mg. Whether related to mibefradil therapy or not, the following have occurred in at least 0.5% of patients in controlled trials: increased sweating, generalized weakness, parestheias, and ear buzzing.[Ref]

Cardiovascular

The following cardiovascular side effects occurred in at least 1% of patients treated with daily doses of 100 mg, but occurred at a frequency equal to or less than placebo: angina pectoris, flushing, and palpitations. Flushing occurred in a dose-related manner in placebo-controlled trials over a daily dose range of 50 to 100 mg. Whether related to mibefradil or not, the following have occurred in at least 0.5% of patients in controlled trials: orthostatic complaints, postural hypotension, syncope, bradycardia, cardiac failure, nonspecific chest pain, angioedema, and hypotension. Flushing and orthostatic hypotension have been attributed to the peripheral vasodilatory properties of this drug.[Ref]

The only cardiovascular side effect that has occurred more often among treated patients compared with placebo is leg edema (4% vs. 3%). Leg edema has been dose-related. When ECG testing was performed, the main events observed among patients treated with mibefradil were first-degree AV block (8%, maximal PQ interval 240 msec), sinus bradycardia (5%), and short Wenckebach episodes during sleep (5%). All ECG events were dose-related. (Patients were treated with up to 150 mg/day.) As a selective T-channel calcium ion influx antagonist, mibefradil has not been associated with negative effects on left ventricular cardiac contractility at therapeutic doses and plasma levels.[Ref]

Respiratory

Rhinitis is the only reported respiratory system side effect that occurred significantly more often among treated patients compared with placebo (3% vs. 0%).[Ref]

Rarely, upper respiratory infection has been associated with the use of mibefradil (at least 1% of patients). A causal relationship has not been established, and the incidence of upper respiratory tract infection among patients treated with placebo was similar or greater in controlled studies. Bronchitis, coughing, dyspnea, nasal congestion, pharyngitis, and sinusitis have been associated with the use of mibefradil in approximately 0.5% of patients.[Ref]

Gastrointestinal

Gastrointestinal side effects have basically been limited to abdominal pain in 2%, dyspepsia in 2%, and nausea or vomiting in 1% of patients. In general, the frequency of these side effects was similar among placebo-treated patients in controlled trials.[Ref]

Whether related to mibefradil therapy or not, the following have occurred in at least 0.5% of patients in controlled trials: constipation, diarrhea, flatulence, gastroenteritis, and rectal hemorrhage.[Ref]

Hypersensitivity

Hypersensitivity reactions to mibefradil have occurred in approximately 1% of patients treated with daily doses of 100 mg. (Similar "allergic reactions" or rashes were observed among placebo-treated patients at a similar frequency.) Angioedema has rarely been associated with the use of this drug.[Ref]

Exfoliative dermatitis has been associated with the use of mibefradil in approximately 0.5% of patients.[Ref]

Musculoskeletal

Musculoskeletal pains and cramps and arthritic pains have been associated with the use of mibefradil in approximately 0.5% of patients.[Ref]

Psychiatric

Psychiatric complaints that have occurred in approximately 0.5% of treated patients include anxiety, depression, and insomnia.[Ref]

Genitourinary

The only reported genitourinary side effect has been impotence in approximately 0.5% of male patients.[Ref]

Dermatologic

Dermatologic side effects have been associated with hypersensitivity reactions, and include exfoliative dermatitis or rash in approximately 0.5% of patients.[Ref]

Ocular

Conjunctivitis is the only reported ocular side effect. Its frequency approximates 0.5% and compares with similar complaints among placebo-treated patients in controlled trials.[Ref]

References

1. van der Vring JA, Bernink PJ, van der Wall EE, van Velhuisen DJ, Braun S, Kobrin I "Evaluating the safety of mibefradil, a selective T-type calcium antagonist, in patients with chronic congestive heart failure." Clin Ther 18 (1996): 1191-206

2. "Product Information. Posicor (mibefradil)." Roche Laboratories, Nutley, NJ.

3. Bernink PJ, Prager G, Schelling A, Kobrin I "Antihypertensive properties of the novel calcium antagonist mibefradil (Ro 40-5967): a new generation of calcium antagonists Mibefradil International Study Group." Hypertension 27 (1996): 426-32

4. Bakx AL, van der Wall EE, Braun S, Emanuelsson H, Bruschke AV, Kobrin I "Effects of the new calcium antagonist mibefradil (Ro 40-5967) on exercise duration in patients with chronic stable angina pectoris: multicenter, placebo-controlled study. Ro 40-5967 International Stud Group." Am Heart J 130 (1995): 748-57

5. Schmitt R, Kleinbloesem CH, Belz GG, Schroeter V, Feifel U, Pozenel H, Kirch W, Halabi A, Woittiez AJ, Welker HA, et al "Hemodynamic and humoral effects of the novel calcium antagonist Ro 40- 5967 in patients with hypertension." Clin Pharmacol Ther 52 (1992): 314-23

6. Braun S, van der Wall EE, Emanuelsson H, Kobrin I "Effects of a new calcium antagonist, mibefradil (Ro 40-5967), on silent ischemia in patients with stable chronic angina pectoris: multicenter placebo-controlled study. The Mibefradil Internationa Study Group." J Am Coll Cardiol 27 (1996): 317-22

7. Clozel JP, Veniant M, Osterrieder W "The structurally novel Ca2+ channel blocker Ro 40-5967, which binds to the [3H] desmethoxyverapamil receptor, is devoid of the negativ inotropic effects of verapamil in normal and failing rat hearts." Cardiovasc Drugs Ther 4 (1990): 731-6

Not all side effects for mibefradil may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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