CREON has a well-characterized safety profile

Safety data collected from clinical trials of CREON in various patient populations.

Most common adverse reactions (≥4%) in a clinical trial of adult patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy1
CREON vs Placebo CREON N=25 (%) Placebo N=29 (%)
Hyperglycemia 2 (8%) 2 (7%)
Hypoglycemia 1 (4%) 1 (3%)
Abdominal pain 1 (4%) 1 (3%)
Abnormal feces 1 (4%) 0 (0%)
Flatulence 1 (4%) 0 (0%)
Frequent bowel movements 1 (4%) 0 (0%)
Nasopharyngitis 1 (4%) 0 (0%)
Most common adverse reactions (≥4%) in two clinical trials of adult and pediatric patients 7 years of age and older with EPI due to cystic fibrosis
CREON vs Placebo CREON N=49 (%) Placebo N=47 (%)
Vomiting 3 (6%) 1 (2%)
Dizziness 2 (4%) 1 (2%)
Cough 2 (4%) 0 (0%)

An open-label, single-arm study assessed the short-term safety and tolerability of CREON in 18 infants and children with EPI due to CF1

  • The primary objective of this study was to observe the safety and tolerability profile of CREON compared with the standard PERT therapy in children under 71
  • This study included patients with a confirmed diagnosis of EPI due to CF aged 4 months to 6 years1
  • Adverse reactions that occurred in patients during treatment with CREON in this open-label study were vomiting, irritability, and decreased appetite, each occurring in 6% of patients1

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In clinical trials, CREON demonstrated efficacy across multiple indications and age groups.1

Review efficacy data

CF = cystic fibrosis; EPI = exocrine pancreatic insufficiency; PERT = pancreatic enzyme replacement therapy.