Note: This document contains side effect information about bisoprolol. Some dosage forms listed on this page may not apply to the brand name Zebeta.
Summary
More frequent side effects include: fatigue. Continue reading for a comprehensive list of adverse effects.
Applies to bisoprolol: oral tablets.
Side effects include:
Fatigue, headache, diarrhea, peripheral edema, and upper respiratory tract infection.
For Healthcare Professionals
Applies to bisoprolol: oral tablet.
General
The more commonly reported side effects observed with this drug are bradycardia, dizziness, and hypotension.[Ref]
Cardiovascular
Very common (10% or more): Bradycardia (up to 15.2%)
Common (1% to 10%): Chest pain, heart failure aggravation, hypotension, cold extremities, peripheral edema, ischemia, conduction disorder, left cardiac failure, palpitation, vein disorder
Uncommon (0.1% to 1%): Atrioventricular (AV) disturbances, orthostatic hypotension
Frequency not reported: Other rhythm disturbances, claudication[Ref]
Bradycardia occurred as a dose-related event.
Cardiac failure occurred in 18.4% of patients (n=1328) compared with 22.8% of placebo-treated patients (n=1321).[Ref]
Nervous system
Very common (10% or more): Dizziness (up to 13.3%)
Common (1% to 10%): Headache, extremity numbness, cerebrovascular disorder, syncope, hypoesthesia
Frequency not reported: Vertigo, paresthesia, hypoesthesia, hyperesthesia, somnolence, decreased concentration/memory, tremor, taste abnormalities
Postmarketing reports: Unsteadiness[Ref]
Respiratory
Very common (10% or more): Dyspnea (up to 13.8%)
Common (1% to 10%): Pneumonia, bronchitis, coughing, exertional dyspnea, upper respiratory tract infection, respiratory distress, stridor, respiratory tract edema, respiratory tract hemorrhage, sinusitis
Uncommon (0.1% to 1%): Bronchospasm
Rare (0.01% to 0.1%): Allergic rhinitis[Ref]
Sinusitis occurred as a dose-related event.[Ref]
Immunologic
Very common: Antinuclear antibody (ANA) conversions (up to 15%)
Common (1% to 10%): Viral infection[Ref]
Dermatologic
Common (1% to 10%): Pruritus
Uncommon (0.1% to 1%): Sweating
Rare (0.01% to 0.1%): Itching, flushing, rash
Very rare (less than 0.01%): Alopecia, psoriasis-like rash, psoriasis exacerbation
Frequency not reported: Acne, eczema, skin irritation, cutaneous vasculitis
Postmarketing reports: Dermatitis, exfoliative dermatitis[Ref]
Gastrointestinal
Common (1% to 10%): Nausea, vomiting, diarrhea, constipation, dyspepsia, epigastric pain (not food related), abdominal pain, gastritis, dry mouth
Frequency not reported: Gastric pain, peptic ulcer[Ref]
Diarrhea occurred as a dose-related event.[Ref]
Metabolic
Uric acid, serum potassium, glucose, and phosphorus increases associated with use of this drug were not of clinical importance and rarely resulted in discontinuation.[Ref]
Common (1% to 10%): Purine metabolism disorder, carbohydrate metabolism disturbed, weight changes, cholesterol changes, potassium levels altered, blood lipid changes
Rare (0.01% to 0.1%): Increased triglycerides
Frequency not reported: Gout
Postmarketing reports: Increased uric acid and glucose[Ref]
Musculoskeletal
Common (1% to 10%): Limb pain, myalgia, arthropathy, arthralgia
Uncommon (0.1% to 1%): Muscular weakness, cramps
Frequency not reported: Back pain, neck pain, twitching[Ref]
Other
Fatigue and asthenia occurred as dose-related events.[Ref]
Common (1% to 10%): Asthenia, fatigue, body pain, fever, malaise
Rare (0.01% to 0.1%): Hearing disorders
Frequency not reported: Earache, tinnitus[Ref]
Psychiatric
Common (1% to 10%): Insomnia, anxiety
Uncommon (0.1% to 1%): Sleep disorders, depression
Rare (0.01% to 0.1%): Nightmares, hallucinations
Frequency not reported: Restlessness[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection
Rare (0.01% to 0.1%): Potency disorders
Frequency not reported: Decreased libido, Peyronie's disease, polyuria[Ref]
Hepatic
Transaminase elevations of 1 to 2 times the upper limit of normal were reported in 6.2% of patients, with a multiple occurrence rate of 1.9%. Generally, this increase was the result of underlying disorders or resolved with continued use of this drug.[Ref]
Common (1% to 10%): Hepatomegaly
Rare (0.01% to 0.1%): Increased liver enzymes (ALT, AST), hepatitis[Ref]
Hypersensitivity
Rare (0.01% to 0.1%): Hypersensitivity
Postmarketing reports: Angioedema[Ref]
Of the 15% of patients who developed positive ANA status, one-third of patients converted back to a negative titer with continued use.[Ref]
Ocular
Rare (0.01% to 0.1%): Reduced tear flow
Very rare (less than 0.01%): Conjunctivitis
Frequency not reported: Visual disturbances, ocular pain, ocular pressure[Ref]
Renal
Creatinine and BUN were associated with slightly increased levels, but these effects were generally not of clinical importance and rarely resulted in discontinuation.[Ref]
Frequency not reported: Cystitis, renal colic
Postmarketing reports: Increased creatinine and BUN[Ref]
Hematologic
Postmarketing reports: Purpura, decreases in WBC and platelets[Ref]
During treatment with this drug, decreased levels of WBCs and platelets were not of clinical importance and rarely resulted in discontinuation.[Ref]