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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

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.