Binosto Adverse Reactions

In a one-year study in post-menopausal women with osteoporosis the overall safety profiles of alendronate 70 mg once weekly (n=519) and alendronate 10 mg/day (n=370) were similar.
In two three-year studies of virtually identical design, in post-menopausal women (alendronate 10 mg: n=196, placebo: n=397) the overall safety profiles of alendronate 10 mg/day and placebo were similar.
Adverse reactions reported by the investigators as possibly, probably or definitely drug-related are presented as follows if they occurred in ≥1% in either treatment group in the one-year study, or in ≥1% of patients treated with alendronate 10 mg/day and at a greater incidence than in patients given placebo inthe three-year studies: (See Table 1.)

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The following adverse reactions have been reported during clinical studies and/or post-marketing use of oral alendronate tablets: (See Table 2.)

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Reporting of suspected adverse reactions: Inform healthcare professionals about these unexpected effect when using drug.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to local safety authority or marketing authorization holder.