Verapamil Side Effects

Verapamil Information

Verapamil Side Effects

In 4826 patients treated with Isoptin tablets for arrhythmias, angina or hypertension, the overall adverse reaction rate in these patients was 37.1% and the dropout rate was 10.2%. The majority of these patients were seriously ill and treated under emergency drug regulations.

In controlled pivotal studies with 128 patients treated with Isoptin SR tablets for hypertension the overall adverse reaction rate was 21.7% and the dropout rate was 3.9%.

The most common adverse reactions were: constipation (7.3%), dizziness (3.2%) and nausea (2.7%). In hypertension studies, constipation occurred in 18.5% of patients on Isoptin and 4.7% of patients on Isoptin SR.

The most serious adverse reactions reported with verapamil are heart failure (1.8%), hypotension (2.5%), AV block (1.2%) and rapid ventricular response (see Warnings).

The following adverse reactions divided by body system have been reported in clinical trials or marketing experience. When incidences are shown, they are calculated based on the 4954 (4826+128) patient base.

Cardiovascular: Hypotension 2.5%; edema 2.1%; CHF/pulmonary edema 1.9%; bradycardia 1.4%; AV block, total (first, second and third degree) 1.2% or second and third degree 0.8%.
CNS: Dizziness 3.2%, headache 2.2%, fatigue 1.7%.
Gastrointestinal: Constipation 7.3%, nausea 2.7%.

The following reactions were reported in 1% or less of patients:

Cardiovascular

Flushing, angina pectoris, atrioventricular dissociation, chest pain, claudication, myocardial infarction, palpitations, purpura, syncope, severe tachycardia, developing or worsening of heart failure, development of rhythm disturbances, ventricular dysrhythmias, painful coldness and numbness of extremities.

CNS

Cerebrovascular accident, confusion, equilibrium disorders, insomnia, muscle cramps, paresthesia, psychotic symptoms, shakiness, somnolence, excitation, depression, rotary nystagmus, vertigo, tremor, extrapyramidal disorders, muscle fatigue, hyperkinesis.

Gastrointestinal

Diarrhea, dry mouth, gastrointestinal distress, gingival hyperplasia, vomiting.

Respiratory

Dyspnea, bronchospasm.

Urogenital

Gynecomastia, increased frequency of urination, spotty menstruation, oligomenorrhea, impotence.

Hematologic and Lymphatic

Ecchymosis or bruising.

Skin

Arthralgia and rash, exanthema, hair loss, hyperkeratosis, macules, sweating, urticaria, Stevens-Johnson Syndrome, erythema multiforme, pruritus.

Special Senses

Blurred vision, diplopia.

Hepatotoxicity with elevated enzymes ([AST (SGOT), ALT (SGPT), alkaline phosphatase]) and bilirubin levels, jaundice and associated symptoms of hepatitis with cholestasis have been reported (see Warnings).

In clinical trials related to the control of ventricular response in digitalized patients who had atrial fibrillation or flutter, ventricular rates below 50 at rest occurred in 15% of patients and asymptomatic hypotension occurred in 5% of patients.

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