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Zebeta (Bisoprolol Fumarate) - Side Effects and Adverse Reactions



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, 10, and 20 mg bisoprolol fumarate were administered for 4 weeks. In Study B, doses of 2.5, 10, and 40 mg of bisoprolol fumarate were administered for 12 weeks. A total of 273 patients were treated with 5-20 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 (2.5-40 mg), as well as for a subgroup that was treated with doses within the recommended dosage range (5-20 mg). Of the adverse events listed in the table, bradycardia, diarrhea, asthenia, fatigue, and sinusitis appear to be dose related.

Body System/Adverse Experience All Adverse Experiences (% 1)
Bisoprolol Fumarate
5-20 mg
2.5-40 mg
% % %
     increased sweating 1.5 0.7 1.0
     arthralgia 2.3 2.2 2.7
Central Nervous System
     dizziness 3.8 2.9 3.5
      headache 11.4 8.8 10.9
     hypoaesthesia 0.8 1.1 1.5
Autonomic Nervous System
     dry mouth 1.5 0.7 1.3
Heart Rate/Rhythm
     bradycardia 0 0.4 0.5
     vivid dreams 0 0 0
     insomnia 2.3 1.5 2.5
     depression 0.8 0 0.2
     diarrhea 1.5 2.6 3.5
     nausea 1.5 1.5 2.2
     vomiting 0 1.1 1.5
     bronchospasm 0 0 0
     cough 4.5 2.6 2.5
     dyspnea 0.8 1.1 1.5
     pharyngitis 2.3 2.2 2.2
     rhinitis 3.0 2.9 4.0
     sinusitis 1.5 2.2 2.2
     URI 3.8 4.8 5.0
Body as a Whole
     asthenia 0 0.4 1.5
     chest pain 0.8 1.1 1.5
     fatigue 1.5 6.6 8.2
     edema (peripheral) 3.8 3.7 3.0

1 percentage of patients with event

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, hypoesthesia, hyperesthesia, somnolence, sleep disturbances , anxiety/restlessness, decreased concentration/memory.

Autonomic Nervous System

Dry mouth.


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


Vivid dreams, insomnia, depression.


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


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


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.




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


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




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 ZEBETA:

Central Nervous System

Reversible mental depression progressing to catatonia, hallucinations, an acute reversible syndrome characterized by disorientation to time and place, emotional lability, slightly clouded sensorium.


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


Agranulocytosis, thrombocytopenia, thrombocytopenic purpura.


Mesenteric arterial thrombosis, ischemic colitis.


The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with ZEBETA (bisoprolol fumarate) during investigational use or extensive foreign marketing experience.


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 4-12 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 6-18 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.


Below is a sample of reports where side effects / adverse reactions may be related to Zebeta. The information is not vetted and should not be considered as verified clinical evidence.

Possible Zebeta side effects / adverse reactions in 71 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-03

Patient: 71 year old female

Reactions: Hypotension, Dizziness

Adverse event resulted in: hospitalization

Suspect drug(s):
    Dosage: 50 mg, unk
    Administration route: Oral
    Start date: 2012-02-09

    Dosage: 100 mg, unk
    Administration route: Oral
    Start date: 2012-02-08
    End date: 2012-02-08

    Dosage: 50 mg, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-01-27
    End date: 2012-02-07

    Dosage: 15 mg, daily
    Administration route: Oral
    Start date: 2012-01-26

    Dosage: 160 mg, daily
    Administration route: Oral
    Start date: 2012-02-07
    End date: 2012-02-08

    Dosage: 80 mg, daily
    Administration route: Oral
    Start date: 2012-01-31

    Dosage: 40 mg, single
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-30
    End date: 2012-01-30

    Dosage: 2.5 mg, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

    Dosage: 100 mg, daily
    Administration route: Oral

    Dosage: 50 mg, daily
    Administration route: Oral

    Dosage: 2.5 mg, daily
    Administration route: Oral

Other drugs received by patient: Voltaren; Moviprep; Pantoprazole; Simvastatin; Gliquidone; Acetylsalicylic Acid; Clonazepam

See index of all Zebeta side effect reports >>

Drug label data at the top of this Page last updated: 2010-11-16

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