Forosa Adverse Reactions

Summary of the safety profile: In a one-year study in post-menopausal women with osteoporosis, the overall safety profiles of alendronate once-weekly 70 mg (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 experiences 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 experiences have also been reported during clinical studies and/or post-marketing use: Frequencies are defined as: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000). (See Table 2.)

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