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| __NOTOC__
| | #REDIRECT [[Nebivolol#Adverse Reactions]] |
| {{Nebivolol}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Adverse Reactions==
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| ==Clinical Studies Experience==
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| BYSTOLIC has been evaluated for safety in patients with [[hypertension]]and in patients with heart failure. The observed adverse reaction profile was consistent with the pharmacology of the drug and the health status of the patients in the clinical trials. Adverse reactions reported for each of these patient populations are provided below. Excluded are adverse reactions considered too general to be informative and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population.
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| The data described below reflect worldwide clinical trial exposure to BYSTOLIC in 6545 patients, including 5038 patients treated for [[hypertension]]and the remaining 1507 subjects treated for other cardiovascular diseases. Doses ranged from 0.5 mg to 40 mg. Patients received BYSTOLIC for up to 24 months, with over 1900 patients treated for at least 6 months, and approximately 1300 patients for more than one year.
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| HYPERTENSION: In placebo-controlled clinical trials comparing BYSTOLIC with placebo, discontinuation of therapy due to adverse reactions was reported in 2.8% of patients treated with nebivolol and 2.2% of patients given placebo. The most common adverse reactions that led to discontinuation of BYSTOLIC were headache (0.4%), nausea (0.2%) and bradycardia (0.2%).
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| Table 1 lists treatment-emergent adverse reactions that were reported in three 12-week, placebo-controlled monotherapy trials involving 1597 hypertensive patients treated with either 5 mg, 10 mg, or 20-40 mg of BYSTOLIC and 205 patients given placebo and for which the rate of occurrence was at least 1% of patients treated with nebivolol and greater than the rate for those treated with placebo in at least one dose group. ==
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| Listed below are other reported adverse reactions with an incidence of at least 1% in the more than 4300 patients treated with BYSTOLIC in controlled or open-label trials except for those already appearing in Table 1, terms too general to be informative, minor symptoms, or adverse reactions unlikely to be attributable to drug because they are common in the population. These adverse reactions were in most cases observed at a similar frequency in placebo-treated patients in the controlled studies.
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| '''Body as a Whole''': [[asthenia]].
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| '''Gastrointestinal System Disorders''': abdominal pain
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| '''Metabolic and Nutritional Disorders''': [[hypercholesterolemia]]
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| '''Nervous System Disorders''': [[paraesthesia]]
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| ===Laboratory Abnormalities===
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| In controlled monotherapy trials of [[hypertensive]] patients, BYSTOLIC was associated with an increase in BUN, [[uric acid]], [[triglyceride]]s and a decrease in [[HDL]] cholesterol and platelet count.
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| ===Postmarketing Experience===
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| The following adverse reactions have been identified from spontaneous reports of BYSTOLIC received worldwide and have not been listed elsewhere. These adverse reactions have been chosen for inclusion due to a combination of seriousness, frequency of reporting or potential causal connection to BYSTOLIC. Adverse reactions common in the population have generally been omitted. Because these adverse reactions were reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency or establish a causal relationship to BYSTOLIC exposure: abnormal hepatic function (including increased AST, ALT and bilirubin), acute pulmonary [[edema]], [[acute renal failure]], [[atrioventricular block]] (both second and third degree), bronchospasm, [[erectile dysfunction]], [[hypersensitivity]] (including [[urticaria]], [[allergic vasculitis]] and rare reports of [[angioedema]]), [[myocardial infarction]], [[pruritus]], [[psoriasis]], [[Raynaud's phenomenon]], [[peripheral ischemia]]/[[claudication]], [[somnolence]], [[syncope]], [[thrombocytopenia]], [[various rashes]] and [[skin disorders]], [[vertigo]], and [[vomiting]].
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| </div></div>
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| <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8 | publisher = | date = | accessdate = 4 February 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Beta blockers]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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