Table 1: Adverse Reactions Occurring in at Least 2 Patients (greater than or equal to 4%) in Cystic Fibrosis (Studies 1 and 2) Adverse Reaction Creon Capsules
n = 49 (%) Placebo
n = 47 (%)
     Vomiting 3 (6) 1 (2)
     Dizziness 2 (4) 1 (2)
     Cough 2 (4) 0
An additional open-label, single-arm study assessed the short-term safety and tolerability of Creon in 18 infants and children, ages 4 months to 6 years, with EPI due to cystic fibrosis. Patients received their usual pancreatic enzyme replacement therapy (mean dose of 7,000 lipase units/kg/day for a mean duration of 18.2 days) followed by Creon (mean dose of 7,500 lipase units/kg/day for a mean duration of 12.6 days). There were no serious adverse reactions. Adverse reactions that occurred in patients during treatment with Creon were vomiting, irritability, and decreased appetite, each occurring in 6% of patients.

Chronic Pancreatitis or Pancreatectomy

A randomized, double-blind, placebo-controlled, parallel group study was conducted in 54 adult patients, ages 32 to 75 years, with EPI due to chronic pancreatitis or pancreatectomy. Patients received single-blind placebo treatment during a 5-day run-in period followed by an intervening period of up to 16 days of investigator-directed treatment with no restrictions on pancreatic enzyme replacement therapy. Patients were then randomized to receive Creon or matching placebo for 7 days. The Creon dose was 72,000 lipase units per main meal (3 main meals) and 36,000 lipase units per snack (2 snacks). The mean exposure to Creon during this study was 6.8 days in the 25 patients that received Creon.

The most common adverse reactions reported during the study were related to glycemic control and were reported more commonly during Creon treatment than during placebo treatment.

Table 2 enumerates adverse reactions that occurred in at least 1 patient (greater than or equal to 4%) treated with Creon at a higher rate than with placebo.

Table 2: Adverse Reactions in at Least 1 Patient (greater than or equal to 4%) in the Chronic Pancreatitis or Pancreatectomy Trial Adverse Reaction Creon Capsules
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
     Flatulence 1 (4) 0
     Frequent Bowel Movements 1 (4) 0
     Nasopharyngitis 1 (4) 0
Postmarketing Experience
Postmarketing data from this formulation of Creon have been available since 2009. The following adverse reactions have been identified during post approval use of this formulation of Creon. 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.

Gastrointestinal disorders (including abdominal pain, diarrhea, flatulence, constipation and nausea), skin disorders (including pruritus, urticaria and rash), blurred vision, myalgia, muscle spasm