Upper Gastrointestinal Tract Safety Profile of Alendronate

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Abstract
SYMPTOMS OF upper gastrointestinal (GI) tract mucosal irritation, including nausea, vomiting, epigastric pain, esophagitis, and dyspepsia, have been reported1-11 with use of a variety of oral bisphosphonates, including etidronate disodium, pamidronate disodium, tiludronate disodium, risedronate sodium, clodronate, and alendronate sodium. Alendronate is a potent bisphosphonate approved in many countries for prevention and treatment of osteoporosis.12-14 In previously reported clinical trials,11,13,15 the overall safety profile of alendronate sodium, 10 mg/d, was similar to that of placebo, although some upper GI tract adverse experiences (AEs) were observed with slightly higher frequency in patients treated with alendronate. In these studies, the AE most commonly associated with alendronate use was abdominal pain, which was generally mild and was not associated with an excess discontinuation rate relative to placebo use.11