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 Most common adverse reactions (≥ 10%) are: diarrhea, dyspepsia, and cough. To report SUSPECTED ADVERSE REACTIONS, contact Digestive Care Inc. at 1-877-882-5950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to PERTZYE in 21 patients, aged 8 to 43 years, with exocrine pancreatic insufficiency due to cystic fibrosis in a placebo-controlled clinical trial. Table 1 enumerates adverse reactions that occurred in at least 2 patients (greater than or equal to 10%) treated with PERTZYE at a higher rate than with placebo. Table 1. Adverse Reactions Reported in at least 2 PERTZYE-treated patients (≥10%) and at a higher rate than placebo-treated patients in a Clinical Trial of Adult and Pediatric Patients 8 Years of Age and Older with Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis Adverse Reaction PERTZYE N=21 (%) Placebo N=24 (%) Diarrhea 10% 4% Dyspepsia 10% 4% Cough 10% 4%

6.2 Postmarketing

Experience The following adverse reactions have been identified during post-approval use of PERTZYE 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. 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