Adverse reactions to COTAZYM® (pancrelipase capsules, USP) have been reported uncommonly. The most frequent adverse reactions reported during clinical use are diarrhea and stool abnormalities, such as green stools. Other reactions reported include pharyngitis, vomiting, abdominal pain, gastric burning, syncope, mouth irritation, mouth ulcers, mild anemia, abnormal smell and taste, stomach trouble and belching. Hyperuricosuria and/or hyperuricemia have been reported in patients taking high doses of COTAZYM®, pancreatic extracts have high purine content. Renal damage has not been reported. Hypersensitivity reactions, such as anaphylaxis, allergy, nasal irritation, coughing spells and episodes of bronchospasm, can occur in people exposed to the enzyme powder from opened capsules. High doses of the powder may cause mouth or perianal excoriation. In addition, pancreatic enzyme preparations may interfere with folic acid and iron absorption.

There is a report of a child with cystic fibrosis who developed fibrosing colonopathy, and who has been treated with delayed-release pancreatic enzyme preparations as well as COTAZYM® prior to detection of the lesion.

Antacids containing calcium carbonate and magnesium hydroxide should not be taken concurrently with pancrelipase. The combination of calcium carbonate and magnesium hydroxide with pancrelipase may precipitate glycine-conjugated bile acids and may form calcium and magnesium fatty acid soaps, causing a decrease in fat absorption and thus an increase in steatorrhea.

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