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 in the 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.