Nebilet

Nebilet Adverse Reactions

nebivolol

Manufacturer:

A. Menarini

Distributor:

Zuellig
/
Agencia Lei Va Hong

Marketer:

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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