Nebilet Adverse Reactions



A. Menarini


Full Prescribing Info
Adverse Reactions
Adverse events are listed separately for hypertension and chronic heart failure because of differences in the background diseases.
Hypertension: The adverse reactions reported, which are in most of the cases of mild to moderate intensity, are tabulated (see table), classified by system organ class and ordered by frequency. The following adverse reactions have also been reported with some β-adrenergic antagonists: Hallucinations, psychoses, confusion, cold/cyanotic extremities, Raynaud's phenomenon, dry eyes and oculo-mucocutaneous toxicity of the practolol type. (See table.)

Click on icon to see table/diagram/image

Chronic Heart Failure: Data on adverse reactions in chronic heart failure patients are available from 1 placebo-controlled clinical trial involving 1067 patients taking nebivolol and 1061 patients taking placebo. In this study, a total of 449 nebivolol patients (42.1%) reported at least possibly casually related adverse reactions compared to 334 placebo patients (31.5%). The most commonly reported adverse reactions in nebivolol patients were bradycardia and dizziness, both occurring in approximately 11% of patients. The corresponding frequencies among placebo patients were approximately 2% and 7%, respectively.
The following incidences were reported for adverse reactions (at least possibly drug-related) which are considered specifically relevant in the treatment of chronic heart failure: Aggravation of cardiac failure occurred in 5.8% of nebivolol patients compared to 5.2% of placebo patients; postural hypotension was reported in 2.1% of nebivolol patients compared to 1% of placebo patients; drug intolerance occurred in 1.6% of nebivolol patients compared to 0.8% of placebo patients; 1st-degree atrioventricular block occurred in 1.4% of nebivolol patients compared to 0.9% of placebo patients; edema of the lower limb were reported by 1% of nebivolol patients compared to 0.2% of placebo patients.
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