Bisoprolol Side Effects
Medically reviewed by Drugs.com. Last updated on Feb 8, 2023.
Summary
More frequently reported 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]
Frequently asked questions
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References
1. Product Information. Zebeta (bisoprolol). Lederle Laboratories. 2001.
2. Cerner Multum, Inc. UK Summary of Product Characteristics.
3. Cerner Multum, Inc. Australian Product Information.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.