Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Bisoprolol fumarate and hydrochlorothiazide tablets Bisoprolol fumarate/HCTZ 6.25 mg is well tolerated in most patients.
Most adverse effects (AEs) have been mild and transient.
In more than 65,000 patients treated worldwide with bisoprolol fumarate, occurrences of bronchospasm have been rare.
Discontinuation rates for AEs were similar for bisoprolol fumarate/HCTZ 6.25 mg and placebo-treated patients.
In the United States, 252 patients received bisoprolol fumarate (2.5, 5, 10, or 40 mg)/HCTZ 6.25 mg and 144 patients received placebo in two controlled trials.
In Study 1, bisoprolol fumarate 5/HCTZ 6.25 mg was administered for 4 weeks.
In Study 2, bisoprolol fumarate 2.5, 10, or 40/HCTZ 6.25 mg was administered for 12 weeks.
All adverse experiences, whether drug related or not, and drug related adverse experiences in patients treated with bisoprolol fumarate 2.5 10/HCTZ 6.25 mg, reported during comparable, 4 week treatment periods by at least 2% of bisoprolol fumarate/HCTZ 6.25 mg-treated patients (plus additional selected adverse experiences) are presented in the following table: a) Averages adjusted to combine across studies.
b) Combined across studies.
Other adverse experiences that have been reported with the individual components are listed below.
WARNINGS Cardiac Failure In general, beta-blocking agents should be avoided in patients with overt congestive failure.
However, in some patients with compensated cardiac failure, it may be necessary to utilize these agents.
In such situations, they must be used cautiously.
Patients Without a History of Cardiac Failure Continued depression of the myocardium with beta-blockers can, in some patients, precipitate cardiac failure.
At the first signs or symptoms of heart failure, discontinuation of bisoprolol fumarate and hydrochlorothiazide tablets should be considered.
Like all medications, Bisoprolol Fumarate And Hydrochlorothiazide can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: