What are the side effects of Bystolic (nebivolol)?

Side Effects of Bystolic (Nebivolol)

Bystolic (nebivolol) is generally well-tolerated with the most common side effects being headache, fatigue, dizziness, and nausea, occurring at rates similar to or lower than other beta-blockers. 1

Most Common Side Effects from Clinical Trials

The FDA-approved labeling identifies the following adverse reactions occurring in ≥1% of hypertensive patients treated with nebivolol in placebo-controlled trials 1:

Cardiovascular Effects

• Bradycardia (slow heart rate): Occurs in up to 1% of patients at higher doses (20-40 mg), though not observed at lower doses 1
• Peripheral edema: Reported in 1% of patients 1
• Chest pain: Occurs in 1% of patients 1

Neurological Effects

• Headache: Most common side effect, occurring in 6-9% of patients (compared to 6% with placebo) 1
• Dizziness: Affects 2-4% of patients in a dose-dependent manner 1
• Paresthesias (tingling sensations): Reported in at least 1% of patients 1
• Insomnia: Occurs in 1% of patients 1

Gastrointestinal Effects

• Nausea: Affects 1-3% of patients, dose-dependent (0.4% led to discontinuation) 1
• Diarrhea: Occurs in 2-3% of patients 1
• Abdominal pain: Reported in ≥1% of patients 1

General Effects

• Fatigue: Dose-dependent, ranging from 2% at 5 mg to 5% at 20-40 mg daily 1
• Dyspnea (shortness of breath): Occurs in 1% of patients 1
• Rash: Reported in 1% of patients 1

Serious but Less Common Side Effects

Postmarketing Reports

The FDA label identifies serious adverse reactions reported after market approval 1:

• Cardiac: Atrioventricular block (second and third degree), myocardial infarction, syncope
• Respiratory: Bronchospasm, acute pulmonary edema
• Renal: Acute renal failure
• Hepatic: Abnormal liver function (increased AST, ALT, bilirubin)
• Vascular: Hypotension, Raynaud's phenomenon, peripheral ischemia/claudication
• Hematologic: Thrombocytopenia
• Allergic: Hypersensitivity reactions including urticaria, allergic vasculitis, and rare angioedema
• Other: Erectile dysfunction, vertigo, vomiting, various rashes and skin disorders including psoriasis

Laboratory Abnormalities

In controlled trials, nebivolol was associated with 1:

• Increased: BUN, uric acid, triglycerides
• Decreased: HDL cholesterol, platelet count

Beta-Blocker Class Effects in Older Adults

European Society of Cardiology guidelines highlight important considerations for beta-blockers in elderly patients 2:

• Bradycardia and atrioventricular block: Monitor BP and ECG regularly
• Confusion and fatigue: More common in older adults
• Bronchospasm: Can occur, though nebivolol may be preferred in patients with peripheral artery disease or mild COPD due to its β1-selectivity
• Depression: May exacerbate symptoms; hydrophilic beta-blockers (atenolol, nadolol) may be preferable if depression is a concern
• Intermittent claudication: Nebivolol and carvedilol are preferred in patients with peripheral artery disease

Comparative Tolerability

Nebivolol demonstrates a favorable side effect profile compared to traditional beta-blockers 3, 4:

• In comparative trials, nebivolol showed no significant difference in adverse event frequency versus atenolol, enalapril, or placebo 3
• Lower incidence of adverse events compared to nifedipine and metoprolol 3
• No reports of impotence or decreased libido with nebivolol, unlike atenolol or enalapril in some studies 3
• No orthostatic hypotension reported in several studies 3, 5

Important Clinical Warnings

Contraindications (Do Not Use) 1

• Heart failure requiring ICU care or inotropic support
• Severe bradycardia or irregular heartbeat (heart block)
• Severe liver damage
• Allergy to nebivolol or its components

Special Monitoring Required 1

• Diabetes patients: Nebivolol can mask signs of low blood sugar (except sweating); monitor glucose carefully
• Thyroid disease: May mask symptoms of hyperthyroidism
• Peripheral vascular disease: Can worsen symptoms of poor circulation
• Scheduled surgery: Inform anesthesiologist about nebivolol use

Critical Safety Considerations

Never stop nebivolol suddenly - this can cause chest pain or heart attack; tapering is required under physician supervision 1

Dosing to minimize side effects: Starting at 1.25 mg once daily for heart failure patients and titrating slowly over weeks to months reduces adverse effects 2, 6. For hypertension, the standard starting dose is 5 mg once daily 1.

The unique vasodilatory properties of nebivolol through nitric oxide pathways may explain its better tolerability profile compared to traditional beta-blockers, particularly regarding peripheral circulation and sexual function 7, 4, 8.