Zebeta Side Effects

Generic name: bisoprolol

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

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

For the Consumer

Applies to bisoprolol: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking bisoprolol (the active ingredient contained in Zebeta) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• slow, fast, or pounding heartbeats;

• chest pain, feeling like you might pass out;

• confusion, hallucinations;

• feeling short of breath, even with mild exertion;

• swelling of your ankles or feet;

• pain or burning when you urinate; or

• numbness, tingling, or cold feeling in your hands and feet.

Less serious side effects of bisoprolol may include:

• dry mouth, nausea, vomiting, stomach pain;

• diarrhea, constipation, increased urination;

• runny or stuffy nose, ringing in your ears;

• feeling tired or weak;

• sleep problems (insomnia);

• drowsiness, dizziness, spinning sensation;

• depression, anxiety, restless feeling;

• joint or muscle pain;

• mild itching or skin rash; or

• loss of interest in sex.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to bisoprolol: oral tablet

General

Bisoprolol is generally well-tolerated. In one placebo-controlled trial, the withdrawal rate associated with bisoprolol (the active ingredient contained in Zebeta) and placebo were 3.3% and 6.8%, respectively.

In a review of heart failure trials, beta-blockers (i.e., carvedilol, metoprolol, bisoprolol) were associated with increased risks of hypotension, dizziness, and bradycardia, but not fatigue compared with placebo. In addition, beta-blocker therapy was associated with fewer overall all-cause withdrawals and less heart failure deterioration than placebo.

Cardiovascular

Cardiovascular side effects include bradycardia, dizziness, and dyspnea. Like other beta-blockers, bisoprolol (the active ingredient contained in Zebeta) may decrease myocardial contractility, which may be important in some patients with poor left ventricular systolic function. Unusual side effects include palpitations, mild heart rhythm disturbances, and orthostatic hypotension. Claudication is reported, and may be more likely in patients with peripheral vascular disease.

Nervous system

More common nervous system side effects include fatigue (4% to 25%), dizziness (3% to 10%), and headache (2% to 10%). Paresthesias, somnolence, decreased concentration or memory, anxiety, and vertigo have been reported in 1% to 10% of patients. Abnormal dreams have been reported rarely.

Respiratory

Wheezing is a rare respiratory system side effect that is associated with beta-blockers. This is due to beta-blockade of bronchial dilation, and may be important in patients with reactive airways disease.

Dermatologic

Dermatologic problems associated with bisoprolol (the active ingredient contained in Zebeta) include rash, acne, eczema, skin irritation, pruritus, flushing, sweating, alopecia, angioedema, and exfoliative dermatitis.

Endocrine

Endocrinologic changes are unusual, and include hyperglycemia and hypercholesterolemia. Sporadic reports of elevated serum triglycerides are found. While rare and often clinically insignificant, these problems may be important in patients with or at risk of diabetes or coronary artery disease. Thyroid function tests are unaffected by bisoprolol (the active ingredient contained in Zebeta) This may be relevant if bisoprolol is used to treat the symptoms of hyperthyroidism.

Hepatic

The incidence of elevated liver function tests (SGOT and SGPT) of between one and two times normal is approximately 6%, of greater than two times normal is approximately 2%.

Genitourinary

Genitourinary problems include decreased libido, impotence, Peyronie's disease, cystitis, and renal colic.

Psychiatric

Psychiatric problems associated with bisoprolol (the active ingredient contained in Zebeta) include vivid dreams, hallucinations, and insomnia. Rare cases of catatonia are reported. Depression is reported, as with some other beta-blockers.

Hematologic

Hematologic side effects are rare. Purpura, agranulocytosis, and thrombocytopenia are reported.

Musculoskeletal

Musculoskeletal side effects have included rare reports of musculoskeletal pain and acute quadriplegic myopathy.

Acute quadriplegic myopathy was reported in an anephric patient receiving bisoprolol 2.5 mg daily. Muscle function and strength returned to normal following discontinuation of bisoprolol. Symptoms recurred when the patient was started on carvedilol and resolved within 3 days after discontinuation of carvedilol.

Immunologic

Approximately 15% of patients on long-term bisoprolol (the active ingredient contained in Zebeta) therapy develop a positive ANA titer. Other immunologic changes are not reported.

Other

Other side effects including dry mouth have been reported.

Metabolic

Metabolic side effects have included gout. Gout and elevated serum uric acid levels are reported in at least 1% of patients.

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