Review safety data collected from clinical trials of CREON in various patient populations.
Adults with EPI due tochronic pancreatitis (CP)
or
pancreatectomy Children and adults with
EPI
due to cystic fibrosis (CF) Short-term data in infants and
children
with EPI due to CF
Adverse reactions reported in clinical studies of patients with EPI due to chronic pancreatitis (CP) or pancreatectomy1,2
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%) |
- Adverse reactions reported in at least 1 patient (≥4%) treated with CREON at a higher rate than placebo in the Chronic Pancreatitis and Pancreatectomy Study
- The most common adverse reactions reported in this study were related to glycemic control and were reported more commonly with CREON treatment than with placebo treatment
Adverse reactions reported in combined clinical studies of patients with EPI due to cystic fibrosis1,3,4
CREON vs Placebo | CREON n=49 (%) |
Placebo n=47 (%) |
---|---|---|
Vomiting | 3 (6%) | 1 (2%) |
Dizziness | 2 (4%) | 1 (2%) |
Cough | 2 (4%) | 0 (0%) |
- Adverse reactions reported in at least 2 patients (≥4%) treated with CREON at a higher rate than placebo in adult and pediatric CF studies combined
An open-label, single-arm study
assessed the short-term safety and
tolerability of CREON in 18 infants
and children with EPI due to CF1,5
- 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 7
- This study included patients with a confirmed diagnosis of EPI due to CF aged 4 months to 6 years, the youngest population studied for PERT use
- 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 patients

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