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Zebeta

Last reviewed on RxList: 9/19/2016
Zebeta Side Effects Center

Last reviewed on RxList 9/14/2016

Zebeta (bisoprolol fumarate) is a type of antihypertensive drug called a beta-adrenergic receptor blocking agent (beta blocker) used to treat hypertension (high blood pressure). Zebeta is available in generic form. Common side effects of Zebeta include:

  • tiredness,
  • drowsiness,
  • slow heartbeat,
  • lightheadedness upon standing,
  • dizziness,
  • spinning sensation,
  • dry mouth,
  • nausea,
  • vomiting,
  • stomach pain,
  • diarrhea,
  • constipation,
  • increased urination,
  • runny or stuffy nose,
  • ringing in your ears,
  • weakness,
  • sleep problems (insomnia),
  • depression,
  • anxiety,
  • restless feeling,
  • joint or muscle pain,
  • itching or skin rash, or
  • loss of interest in sex.

Tell your doctor if you experience unlikely but serious side effects of Zebeta including:

  • very slow heartbeat,
  • severe dizziness,
  • fainting,
  • blue fingers/toes,
  • trouble breathing, or
  • mental/mood changes (such as confusion, mood swings, depression).

The dose of Zebeta is individualized to the needs of the patient, ranging from 2.5 to 20 mg once daily. Zebeta may interact with other medications including other beta blockers, heart medicines, clonidine, digitalis, disopyramide, guanethidine, rifampin, insulin or diabetes medication you take by mouth, and medicine for asthma or other breathing disorders. During pregnancy, this medication should be used only when prescribed. It may harm a fetus. It is unknown if this medication passes into breast milk or if it may harm a nursing infant. Discuss the risks and benefits with your doctor before breastfeeding.

Our Zebeta Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Zebeta Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zebeta (Bisoprolol Fumarate)

Zebeta Professional Information

SIDE EFFECTS

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 (% )
Bisoprolol Fumarate
Placebo
(n=132)
%
5-20 mg
(n=273)
%
2.5-40 mg
(n=404)
%
Skin      
  increased sweating 1.5 0.7 1.0
Musculoskeletal      
  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
Psychiatric      
  vivid dreams 0 0 0
  insomnia 2.3 1.5 2.5
  depression 0.8 0 0.2
Gastrointestinal      
  diarrhea 1.5 2.6 3.5
  nausea 1.5 1.5 2.2
  vomiting 0 1.1 1.5
Respiratory      
  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
*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.

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 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.

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 ZEBETA (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 4-12 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.

Read the entire FDA prescribing information for Zebeta (Bisoprolol Fumarate)

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