Nebilet Adverse Reactions



A. Menarini


Agencia Lei Va Hong


A. Menarini
Full Prescribing Info
Adverse Reactions
Adverse events are listed separately for hypertension and CHF 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 as follows, classified by system organ class and ordered by frequency: See table.

Click on icon to see table/diagram/image

The following adverse reactions have also been reported with some beta-adrenergic antagonists: hallucinations, psychoses, confusion, cold/cyanotic extremities, Raynaud phenomenon, dry eyes, and oculo-mucocutaneous toxicity of the practolol-type.
Chronic heart failure: Data on adverse reactions in CHF patients are available from one 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 causally 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 1.0% of placebo patients.
Drug intolerance occurred in 1.6% of nebivolol patients compared to 0.8% of placebo patients.
First degree atrio-ventricular block occurred in 1.4% of nebivolol patients compared to 0.9% of placebo patients.
Oedema of the lower limb was reported by 1.0% of nebivolol patients compared to 0.2% of placebo patients.
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