Bisoprolol Fumarate

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• The dose of bisoprolol fumarate tablets must be individualized to the needs of the patient.
• The usual starting dose is 5 mg once daily.
• In some patients, 2.5 mg may be an appropriate starting dose (see Bronchospastic Disease in WARNINGS ).
• If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily.
• Patients with Renal or Hepatic Impairment In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min), the initial daily dose should be 2.5 mg and caution should be used in dose-titration.
• Since limited data suggest that bisoprolol fumarate is not dialyzable, drug replacement is not necessary in patients undergoing dialysis.
• Geriatric Patients It is not necessary to adjust the dose in the elderly, unless there is also significant renal or hepatic dysfunction (see above and Geriatric Use in PRECAUTIONS ).
• Pediatric Patients There is no pediatric experience with bisoprolol fumarate tablets.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

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 (% a ) Bisoprolol Fumarate Placebo (n=132) % 5-20 mg (n=273) % 2.5-40 mg (n=404) % a percentage of patients with event 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 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 bisoprolol fumarate.
• 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 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.

Quoted from the official label, section “Adverse Reactions”.

Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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