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warnings and cautions
Warnings and Precautions •Symptomatic response does not preclude presence of gastric malignancy. •Atrophic gastritis has been noted with long-term therapy. •PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea. •Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. •Hypomagnesemia has been reported rarely with prolonged treatment with PPIs
Adverse Reactions The most frequently occurring adverse reactions are as follows: •For adult use (> 2%) are headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch