Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Fibrosing Colonopathy [see Warnings and Precautions ( 5.1 )] Irritation of the Oral Mucosa [see Warnings and Precautions ( 5.2 )] Hyperuricemia [see Warnings and Precautions ( 5.3 )] Risk of Viral Transmission [see Warnings and Precautions ( 5.4 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] Most Common Adverse R eactions ( 6.1 ) C ystic fibrosis adult and pediatric patients : 7 years and older (≥4%): vomiting, dizziness, cough.
4 months to 6 years (6%): vomiting, irritability, decreased appetite.
C hronic pancreatitis or pancreatectomy patient s: Adults (≥ 4%): hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, nasopharyngitis.
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc.
at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to CREON in 92 patients: 67 patients aged 4 months to 43 years with exocrine pancreatic insufficiency due to cystic fibrosis (Studies 1, 2, and 3) and 25 adults with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy (Study 4) [see Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14.1 , 14.2 )] .
Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis in Adult and Pediatric Patients Adult and Pediatric Patients 7 Years of Age and Older The most common adverse reactions, reported in at least 2 CREON-treated patients (greater than or equal to 4%) and at a higher rate than in placebo-treated patients in Studies 1 and 2, are shown in Table
Table 1: Adverse Reactions* in Clinical Trials of Adult and Pediatric Patients 7 Years of Age and Older with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis (Studies 1 and 2) Adverse Reaction CREON N = 49 n (%) Placebo N = 47 n (%) Vomiting 3 (6%) 1 (2%) Dizziness 2 (4%) 1 (2%) Cough 2 (4%) 0 (0%) * Reported in at least 2 CREON-treated patients (greater than or equal to 4%) and at a higher rate than placebo-treated patients.
In Study 1, one patient experienced duodenitis and gastritis of moderate severity 16 days after completing treatment with CREON.
5 WARNINGS AND PRECAUTIONS Fibrosing C olonopathy : Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis.
Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal.
Monitor during treatment for progression of preexisting disease.
Do not exceed the recommended dosage, unless clinically indicated.
( 2.1 , 5.1 ) I rritation of the O ral M ucosa : May occur due to loss of protective enteric coating on the capsule contents.
Like all medications, Creon can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: