Creon 10000 Adverse Reactions

In clinical trials, more than 900 patients were exposed to Pancreatin (Creon 10000).
The most commonly reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in severity.
The following adverse reactions have been observed during clinical trials with the indicated frequencies as follows. (See table.)

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Strictures of the ileo-cecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations, see Precautions.
Allergic reactions mainly but not exclusively limited to the skin have been observed and identified as adverse reactions during post-approval use. Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.
Pediatric population: No specific adverse reactions were identified in the pediatric population. Frequency, type and severity of adverse reactions were similar in children with cystic fibrosis as compared to adults.