Amylaseside effects

The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Fibrosing Colonopathy Irritation of the Oral Mucosa Hyperuricemia Risk of Viral Transmission Hypersensitivity Reactions The data described below reflect exposure to PANCREAZE in 57 adult and pediatric patients with exocrine pancreatic insufficiency due to cystic fibrosis in two clinical trials. Study 1 was conducted in 40 patients, aged 8 years to 57 years; Study 2 was conducted in 17 pediatric patients, aged 6 months to 30 months. The most common adverse reactions were gastrointestinal, including diarrhea and vomiting. The following adverse reactions have been identified during post-approval use of PANCREAZE or other pancreatic enzyme products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Most common adverse reactions are gastrointestinal, including nausea and vomiting. To report SUSPECTED ADVERSE REACTIONS, contact VIVUS LLC at 1-888-998-4887 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Eye Disorders blurred vision Gastrointestinal Disorders fibrosing colonopathy, distal intestinal obstruction syndrome abdominal pain, flatulence, constipation, and nausea Immune System Disorders anaphylaxis, asthma, hives, and pruritus Investigations asymptomatic elevations of liver enzymes Musculoskeletal System myalgia, muscle spasm Skin and Subcutaneous Tissue Disorders urticaria and rash