Bisoprolol Side Effects

Brand Names: Zebeta

Please note - some side effects for Bisoprolol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Bisoprolol - for the Consumer

Bisoprolol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Bisoprolol:

Diarrhea; dizziness; drowsiness; fatigue; headache; lightheadedness; nausea; sleeplessness; unusual tiredness; weakness.

Severe allergic reactions (rash; hives; itching, difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty breathing; lightheadedness or dizziness when rising from a lying or sitting position; very slow heartbeat.

Bisoprolol/Hydrochlorothiazide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Bisoprolol/Hydrochlorothiazide:

Cough; dizziness; lightheadedness; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; irregular heartbeat; muscle pain or weakness; swelling of ankles or feet; unusual thirst or fatigue; unusually slow or irregular heartbeat.

Bisoprolol Side Effects - for the Professional

Bisoprolol

Safety data are available in more than 30,000 patients or volunteers. Frequency estimates and rates of withdrawal of therapy for adverse events were derived from two U.S. placebo controlled studies.

In Study A, doses of 5 mg, 10 mg and 20 mg Bisoprolol fumarate were administered for 4 weeks. In Study B, doses of 2.5 mg, 10 mg and 40 mg of Bisoprolol fumarate were administered for 12 weeks. A total of 273 patients were treated with 5 mg to 20 mg of Bisoprolol fumarate; 132 received placebo.

Withdrawal of therapy for adverse events was 3.3% for patients receiving Bisoprolol fumarate and 6.8% for patients on placebo. Withdrawals were less than 1% for either bradycardia or fatigue/lack of energy.

The following table presents adverse experiences, whether or not considered drug related, reported in at least 1% of patients in these studies, for all patients studied in placebo controlled clinical trials (2.5 mg to 40 mg), as well as for a subgroup that was treated with doses within the recommended dosage range (5 mg to 20 mg). Of the adverse events listed in the table, bradycardia, diarrhea, asthenia, fatigue and sinusitis appear to be dose related.

The following is a comprehensive list of adverse experiences reported with Bisoprolol fumarate in worldwide studies, or in postmarketing experience (in italics):

Central Nervous System: Dizziness, unsteadiness, vertigo, syncope, headache, paresthesia, hypoaesthesia, hyperesthesia, somnolence, sleep disturbances, anxiety/restlessness, decreased concentration/memory.

Autonomic Nervous System: Dry mouth.

Cardiovascular: Bradycardia, palpitations and other rhythm disturbances, cold extremities, claudication, hypotension, orthostatic hypotension, chest pain, congestive heart failure, dyspnea on exertion.

Psychiatric: Vivid dreams, insomnia, depression.

Gastrointestinal: Gastric/epigastric/abdominal pain, gastritis, dyspepsia, nausea, vomiting, diarrhea, constipation, peptic ulcer.

Musculoskeletal: Muscle/joint pain, arthralgia, back/neck pain, muscle cramps, twitching/tremor.

Skin: Rash, acne, eczema, psoriasis, skin irritation, pruritus, flushing, sweating, alopecia, dermatitis,angioedema, exfoliative dermatitis, cutaneous vasculitis.

Special Senses: Visual disturbances, ocular pain/pressure, abnormal lacrimation, tinnitus, decreased hearing, earache, taste abnormalities.

Metabolic: Gout.

Respiratory: Asthma/bronchospasm, bronchitis, coughing, dyspnea, pharyngitis, rhinitis, sinusitis, URI.

Genitourinary: Decreased libido/impotence, Peyronie’s disease, cystitis, renal colic, polyuria.

Hematologic: Purpura.

General: Fatigue, asthenia, chest pain, malaise, edema, weight gain, angioedema.

In addition, a variety of adverse effects have been reported with other beta-adrenergic blocking agents and should be considered potential adverse effects of Bisoprolol fumarate:

Central Nervous System: Reversible mental depression progressing to catatonia, hallucination, an acute reversible syndrome characterized by disorientation to time and place, emotional lability slightly clouded sensorium.

Allergic: Fever, combined with aching and sore throat, laryngospasm, respiratory distress.

Hematologic: Agranulocytosis, thrombocytopenia, thrombocytopenic purpura.

Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis.

Miscellaneous: The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with Bisoprolol fumarate during investigational use or extensive foreign marketing experience.

Laboratory Abnormalities

In clinical trials, the most frequently reported laboratory change was an increase in serum triglycerides, but this was not a consistent finding.

Sporadic liver test abnormalities have been reported. In the U.S. controlled trials experience with Bisoprolol fumarate treatment for 4 to 12 weeks, the incidence of concomitant elevations in SGOT and SGPT from 1 to 2 times normal was 3.9%, compared to 2.5% for placebo. No patient had concomitant elevations greater than twice normal.

In the long-term, uncontrolled experience with Bisoprolol fumarate treatment for 6 to 18 months, the incidence of one or more concomitant elevations in SGOT and SGPT from 1 to 2 times normal was 6.2%. The incidence of multiple occurrences was 1.9%. For concomitant elevations in SGOT and SGPT of greater than twice normal, the incidence was 1.5%. The incidence of multiple occurrences was 0.3%. In many cases these elevations were attributed to underlying disorders, or resolved during continued treatment with Bisoprolol fumarate.

Other laboratory changes included small increases in uric acid, creatinine, BUN, serum potassium, glucose, and phosphorus and decreases in WBC and platelets. These were generally not of clinical importance and rarely resulted in discontinuation of Bisoprolol fumarate.

As with other beta-blockers, ANA conversions have also been reported on Bisoprolol fumarate. About 15% of patients in long-term studies converted to a positive titer, although about one-third of these patients subsequently reconverted to a negative titer while on continued therapy.

Side Effects by Body System

General

Bisoprolol is generally well-tolerated. In one placebo-controlled trial, the withdrawal rate associated with bisoprolol 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 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 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. 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 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 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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