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Bystolic Side Effects

Generic Name: nebivolol

Note: This document contains side effect information about nebivolol. Some of the dosage forms listed on this page may not apply to the brand name Bystolic.

In Summary

More frequent side effects include: fatigue. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to nebivolol: oral tablet

Along with its needed effects, nebivolol (the active ingredient contained in Bystolic) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nebivolol:

Less common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • chest pain or discomfort
  • difficult or labored breathing
  • lightheadedness, dizziness, or fainting
  • rapid weight gain
  • shortness of breath
  • slow or irregular heartbeat
  • tightness in the chest
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • wheezing

Get emergency help immediately if any of the following symptoms of overdose occur while taking nebivolol:

Symptoms of overdose
  • Absence of or decrease in body movement
  • anxiety
  • blue lips, fingernails, or skin
  • blurred vision
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • cough
  • decreased urine output
  • depression
  • dilated neck veins
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • extreme fatigue
  • fast heartbeat
  • headache
  • increased hunger
  • increased sweating
  • increased thirst
  • irregular, fast or slow, or shallow breathing
  • loss of appetite
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • nervousness
  • nightmares
  • noisy breathing
  • numbness in the hands, feet, or lips
  • seizures
  • shakiness
  • slurred speech
  • troubled breathing
  • vomiting
  • weight gain

Some side effects of nebivolol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Mild headache
Less common
  • Diarrhea
  • rash
  • sleeplessness
  • trouble sleeping
  • unable to sleep

For Healthcare Professionals

Applies to nebivolol: oral tablet

General

The more frequently reported side effects in patients treated for hypertension were headache, dizziness, and fatigue; additionally, bradycardia was frequently reported in patients treated for chronic heart failure.[Ref]

Cardiovascular

Very common (10% or more): Bradycardia (up to 11%)
Common (1% to 10%): Cardiac failure aggravation, edema, postural hypotension, first degree atrioventricular (AV) block, atrial fibrillation, hypertension, angina pectoris, chest pain
Uncommon (0.1% to 1%): Heart failure, slowed AV conduction, AV block (both second and third degree), hypotension, increased intermittent claudication, edema of the lower limbs,
Postmarketing reports: Raynaud's phenomenon, myocardial infarction, peripheral ischemia[Ref]

Bradycardia was a dose-related effect in hypertensive patients. Bradycardia occurred more frequently in chronic heart failure patients (11%) than hypertensive patients (1%) at doses of 20 to 40 mg.

Aggravation of cardiac failure occurred in 19% of patients with chronic heart failure compared to 21.3% of placebo-treated patients in the SENIORS (Study on the Effects of Nebivolol Interventions on Outcomes and Rehospitalizations in Seniors with heart failure; n = 2128; median age = 75.2 years). Heart failure occurred in 0.1% to 1% of hypertensive patients.[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 11%)
Common (1% to 10%): Headache, paresthesia, somnolence, hypoesthesia
Uncommon (0.1% to 1%): Vertigo
Very rare (less than 0.01%): Syncope[Ref]

Respiratory

Common (1% to 10%): Dyspnea, exacerbated dyspnea, common cold, coughing, bronchitis, pharyngitis
Uncommon (0.1% to 1%): Bronchospasm
Postmarketing reports: Acute pulmonary edema[Ref]

Dermatologic

Common (1% to 10%): Increased sweating
Uncommon (0.1% to 1%): Pruritus, erythematous rash
Very rare (less than 0.01%): Psoriasis aggravated
Frequency not reported: Angioneurotic edema, urticaria
Postmarketing reports: Rash, skin disorders[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, arthrosis, back pain[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea, nausea
Uncommon (0.1% to 1%): Dyspepsia, flatulence, vomiting
Frequency not reported: Abdominal pain[Ref]

Other

Common (1% to 10%): Tiredness, drug intolerance, pain, injury, fatigue
Frequency not reported: Asthenia[Ref]

Psychiatric

Common (1% to 10%): Nervousness
Uncommon (0.1% to 1%): Nightmares, depression, insomnia, anxiety[Ref]

Genitourinary

Uncommon (0.1% to 1%): Impotence[Ref]

Ocular

Uncommon (0.1% to 1%): Impaired vision[Ref]

Hematologic

Frequency not reported: Decreased platelet count
Postmarketing reports: Thrombocytopenia[Ref]

Renal

Frequency not reported: Increased BUN
Postmarketing reports: Acute renal failure[Ref]

Metabolic

Frequency not reported: Hypercholesterolemia, hyperuricemia, increased uric acid, increased triglycerides, decreased HDL cholesterol[Ref]

Hepatic

Postmarketing reports: Abnormal hepatic function (e.g., increased AST, ALT, and bilirubin)[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity (e.g., allergic vasculitis, angioedema, urticaria)[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Bystolic (nebivolol)." Forest Pharmaceuticals, St. Louis, MO.

Some side effects of Bystolic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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