Creon 10 Side Effects

Generic Name: pancrelipase

Please note - some side effects for Creon 10 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Creon 10 - for the Consumer

Creon 10 Delayed-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Creon 10 Delayed-Release Capsules:

Bloating; constipation; diarrhea; nausea; stomach cramps or pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); mouth irritation; severe or persistent diarrhea; severe stomach pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

General

In general, pancreatic enzymes are well tolerated at recommended therapeutic doses. Gastrointestinal symptoms appear to be the primary, and most common adverse effect.

Gastrointestinal

Fibrosing colonopathy should be suspected in patients who present with obstruction, bloody diarrhea, chylous ascites, or a combination of abdominal pain with chronic diarrhea, inadequate weight gain, or both. Patients with fibrosing colonopathy should have their enzyme dosage reduced to the recommended range of 500 to 2500 units/kg per meal. Surgical intervention is often needed in patients who cannot maintain their nutritional status.

Gastrointestinal side effects have included cramping, nausea, abnormal feces, flatulence abdominal pain, upper abdominal pain, and diarrhea, particularly with high doses. Fibrosing colonopathy has been reported. Animal studies suggest that the fibrosing colonopathy seen in some patients receiving high doses of pancreatic enzymes may be due to a plasticizer (methacrylic acid copolymer) found in some of the enteric coatings.

Metabolic

Krasinger and colleagues suggest that it may be reasonable to add allopurinol to the pancreatic enzyme treatment regimen in CF patients that have a urine pH of less than 6 and also excrete large amounts of uric acid. The addition of allopurinol may help to protect the renal tubules from long-term damage due to uric acid crystallization.

Metabolic side effects reported with high doses of pancreatic enzymes have included hyperuricosuria and hyperuricemia. It appears that both the enzyme product and some undefined aspect of the disease may lead to increased uric acid levels. Postmarketing reports of inadequate control of diabetes melitius have been reported.

Hypersensitivity

Hypersensitivity side effects have included reversible bronchial asthma and nasal rhinitis due to exposure to pancreatic enzyme powder.

Local

Local side effects have included ulcerations and stomatitis after a prolonged retention of pancreatic enzyme formulations in the mouth.

Nervous system

Nervous system side effects have included several case reports of elevation in intracranial pressure (leading to a bulging cranial fontanelle) in cystic fibrosis children receiving pancreatic enzymes. The adverse effect has been self-limiting without interruption of cystic fibrosis therapy in most cases.

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