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Clinical Studies: FOSAMAX: In clinical studies Fosamax was generally well tolerated. In studies of up to five years in duration, side effects, which usually were mild, generally did not require discontinuation of therapy.
Treatment of Osteoporosis: Postmenopausal women: In two three-year, placebo-controlled, double-blind, multicenter studies (United States and Multinational) of virtually identical design, the overall safety profiles of FOSAMAX 10 mg/day and placebo were similar. The following upper gastrointestinal adverse experiences were reported by the investigators as possibly, probably, or definitely drug related in ≥1% of patients treated with FOSAMAX 10 mg/day and at a greater incidence than in patients treated with placebo: abdominal pain (FOSAMAX 6.6% vs. placebo 4.8%), dyspepsia (3.6%, 3.5%), esophageal ulcer (1.5%, 0.0%), dysphagia (1.0%, 0.0%), and abdominal distention (1.0%, 0.8%).
Rarely, rash and erythema have occurred.
Additionally, the following adverse experiences were reported by the investigators as possibly, probably, or definitely drug related in ≥1% of patients treated with FOSAMAX 10 mg/day and at a greater incidence than in patients treated with placebo: musculoskeletal (bone, muscle or joint) pain (FOSAMAX 4.1% vs. placebo 2.5%), constipation (3.1%, 1.8%), diarrhea (3.1%, 1.8%), flatulence (2.6%, 0.5%), and headache (2.6%, 1.5%).
In the two-year extension (treatment years 4 and 5) of the previously mentioned studies, the overall safety profile of FOSAMAX 10 mg/day was similar to that observed during the three-year placebo-controlled period. Additionally, the proportion of patients who discontinued FOSAMAX 10 mg/day due to any clinical adverse experience was similar to that during the first three years of the study.
In a one-year, double-blind, multicenter study, the overall safety and tolerability profiles of FOSAMAX once weekly 70 mg (n=519) and FOSAMAX 10 mg daily (n=370) were similar. The following adverse experiences were reported by the investigators as possibly, probably, or definitely drug related in ≥1% of patients in either treatment group: abdominal pain (FOSAMAX once weekly 70 mg, 3.7%; FOSAMAX 10 mg daily, 3.0%), musculoskeletal (bone, muscle or joint) pain (2.9%, 3.2%), dyspepsia (2.7%, 2.2%), acid regurgitation (1.9%, 2.4%), nausea (1.9%, 2.4%), abdominal distention (1.0%, 1.4%), constipation (0.8%, 1.6%), flatulence (0.4%, 1.6%), muscle cramp (0.2%, 1.1%), gastritis (0.2%, 1.1%), and gastric ulcer (0.0%, 1.1%).
Men: In two, placebo-controlled, double-blind, multicenter studies in men (a two-year study of FOSAMAX 10 mg/day [n=146] and a one-year study of FOSAMAX once weekly 70 mg [n=109]), the safety profile of FOSAMAX was generally similar to that seen in postmenopausal women.
Other Studies in men and women: In a ten-week endoscopy study in men and women (n=277; mean age: 55), no difference was seen in upper gastrointestinal tract lesions between FOSAMAX once weekly 70 mg and placebo.
In an additional one-year study in men and women (n=335; mean age: 50) the overall safety and tolerability profiles of FOSAMAX once weekly 70 mg were similar to that of placebo and no difference was seen between men and women.
In two one-year studies in men and women (n=477) receiving glucocorticoids, melena was reported in two patients treated with FOSAMAX 10 mg/day.
Concomitant use with estrogen/hormone replacement therapy: In two studies (of one and two years' duration) of postmenopausal osteoporotic women (total: n=853), the safety and tolerability profile of combined treatment with FOSAMAX 10 mg once daily and estrogen ± progestin (n=354) was consistent with those of the individual treatments.
FOSAMAX PLUS: In a 15-week, double-blind, multinational study in osteoporotic postmenopausal women (n=682) and men (n=35), the safety profile of once weekly FOSAMAX PLUS (alendronate 70 mg/vitamin D3 2800 IU) was similar to that of FOSAMAX once weekly 70 mg. In the 24-week double-blind extension study in women (n=619) and men (n=33), the safety profile of FOSAMAX PLUS (70 mg/2800 IU) administered with an additional 2800 IU vitamin D3 for a total of 5600 IU was similar to that of FOSAMAX PLUS (70 mg/2800 IU).
Post-Marketing Experience: The following adverse reactions have been reported in post-marketing use with alendronate: Body as a Whole: hypersensitivity reactions including urticaria and rarely angioedema. As with other bisphosphonates, transient symptoms as in an acute-phase response (myalgia, malaise, asthenia and rarely, fever) have been reported with alendronate, typically in association with initiation of treatment. Rarely, symptomatic hypocalcemia has occurred, generally in association with predisposing conditions. Rarely, peripheral edema.
Gastrointestinal: nausea, vomiting, esophagitis, esophageal erosions, esophageal ulcers, rarely, esophageal stricture or perforation and oropharyngeal ulceration; rarely, gastric or duodenal ulcers, some severe and with complications (see PRECAUTIONS and DOSAGE & ADMINISTRATION). Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis), with delayed healing has been reported rarely (see PRECAUTIONS).
Musculoskeletal: bone, joint, and/or muscle pain, rarely severe and/or incapacitating (see PRECAUTIONS); joint swelling; low-energy fractures of the femoral shaft and other bones (see PRECAUTIONS).
Nervous System: dizziness, vertigo, dysgeusia.
Skin: rash (occasionally with photosensitivity), pruritus, alopecia, rarely severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Special Senses: rarely uveitis, scleritis or episcleritis. Cholesteatoma of the external auditory canal (focal osteonecrosis) has been reported rarely.
Laboratory Test Findings: In double-blind, multicenter, controlled studies, asymptomatic, mild and transient decreases in serum calcium and phosphate were observed in approximately 18% and 10%, respectively, of patients taking FOSAMAX versus approximately 12 and 3% of those taking placebo. However, the incidences of decreases in serum calcium to <8.0 mg/dL (2.0 mM) and serum phosphate to ≤2.0 mg P/dL (0.65 mM) were similar in both treatment groups.
