Bystolic Side Effects

Generic Name: nebivolol

Please note - some side effects for Bystolic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Bystolic - for the Consumer

Bystolic

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Bystolic:

Dizziness; fatigue; headache; nausea; stomach pain; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or tightness; fainting; mental or mood changes; numbness or tingling of the hands; persistent or severe vision changes; red, swollen, blistered, or peeling skin; severe dizziness; shortness of breath or wheezing; sudden, unusual weight gain; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusual tiredness or weakness; unusually slow or irregular heartbeat; very cold or blue fingers or toes.

Bystolic Side Effects - for the Professional

Bystolic

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. In placebo-controlled clinical trials comparing Bystolic with placebo, discontinuation of therapy due to adverse events was reported in 2.8% of patients treated with nebivolol and 2.2% of patients given placebo. The most common adverse events that led to discontinuation of Bystolic were headache (0.4%), nausea (0.2%) and bradycardia (0.2%).

Adverse Reactions in Controlled Trials

Table 2 lists treatment-emergent signs and symptoms 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.

Other Adverse Events Observed During Worldwide Clinical Trials

Listed below are other reported adverse events with an incidence of at least 1% in the more than 5300 patients treated with Bystolic in controlled or open-label trials, whether or not attributed to treatment, except for those already appearing in Table 2, terms too general to be informative, minor symptoms, or events unlikely to be attributable to drug because they are common in the population. These adverse events were in most cases observed at a similar frequency in placebo-treated patients in the controlled studies.

Body as a whole: asthenia.

Gastrointestinal System Disorders: abdominal pain

Metabolic and Nutritional Disorders: hypercholesterolemia and hyperuricemia

Nervous System Disorders: paraesthesia

Laboratory

In controlled monotherapy trials, Bystolic was associated with an increase in BUN, uric acid, triglycerides and a decrease in HDL cholesterol and platelet count.

Events Identified from Spontaneous Reports of Bystolic Received Worldwide

The following adverse events have been identified from spontaneous reports of Bystolic received worldwide and have not been listed elsewhere. These adverse events have been chosen for inclusion due to a combination of seriousness, frequency of reporting or potential causal connection to Bystolic. Events common in the population have generally been omitted. Because these events 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.

Side Effects by Body System

General

The most common adverse events leading to discontinuation of nebivolol in clinical trials were headache (0.4%), nausea (0.2%), and bradycardia (0.2%).

Cardiovascular

Cardiovascular side effects have included bradycardia, chest pain, and peripheral edema.

Nervous system

Nervous system side effects have included headache, dizziness, paraesthesias, asthenia, insomnia, and fatigue.

Gastrointestinal

Gastrointestinal side effects have included nausea, diarrhea, and abdominal pain.

Respiratory

Respiratory side effects have included dyspnea.

Dermatologic

Dermatologic side effects have included rash.

Metabolic

Metabolic side effects have included hypercholesterolemia and hyperuricemia.

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