Alendronate Sandoz Adverse Reactions

Summary of 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.

Click on icon to see table/diagram/image

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, < 1/10); Uncommon: (≥ 1/1,000, < 1/100); Rare: (≥ 1/10,000, < 1/1,000); Very rare: (< 1/10,000).
Immune system disorders: Rare: Hypersensitivity reactions including urticaria and angioedema.
Metabolism and nutrition disorders: Rare: Symptomatic hypocalcaemia, often in association with predisposing conditions^§.
Nervous system disorders: Common: Headache, dizziness^†.
Uncommon: Dysgeusia^†.
Eye disorders: Uncommon: Eye inflammation (uveitis, scleritis, episcleritis).
Ear and labyrinth disorders: Common: Vertigo^†.
Gastrointestinal disorders: Common: Abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer*, dysphagia*, abdominal distension, acid regurgitation.
Uncommon: Nausea, vomiting, gastritis, oesophagitis*, oesophageal erosions*, melena^†.
Rare: Oesophageal stricture*, oropharyngeal ulceration*, upper gastrointestinal PUBs (perforation, ulcers, bleeding)^§.
Skin and subcutaneous tissue disorders: Common: Alopecia^†, pruritus^†.
Uncommon: Rash, erythema.
Rare: Rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis^‡.
Musculoskeletal and connective tissue disorders: Very common: Musculoskeletal (bone, muscle or joint) pain which is sometimes severe^†§.
Common: Joint swelling^†.
Rare: Osteonecrosis of the jaw^‡§; atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)^⊥.
Very rare: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction).
General disorders and administration site conditions: Common: Asthenia^†, peripheral oedema^†.
Uncommon: Transient symptoms as in an acute phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment^†.
^§See Precautions.
^†Frequency in clinical trials was similar in the medicinal product and placebo group.
^*See Dosage & Administration and Precautions.
^‡This adverse reaction was identified through post-marketing surveillance. The frequency of rare was estimated based on relevant clinical trials.
^⊥Identified in post-marketing experience.