Pancrelipase Side Effects

Brand Names: Creon, Creon 10, Dygase, Pancreaze, Zenpep

Please note - some side effects for Pancrelipase 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 Pancrelipase - for the Consumer

Pancrelipase

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 Pancrelipase:

Dizziness; gas; headache; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Pancrelipase:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); painful, swollen joints; severe or persistent loose stools, diarrhea, or constipation; severe or unusual nausea, vomiting, or 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.

Pancrelipase 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 Pancrelipase Capsules:

Decreased appetite; dizziness; frequent or abnormal bowel movements; gas; headache; irritability; sore throat or cough; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Pancrelipase Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); painful, swollen joints; severe or persistent loose stools, diarrhea, or constipation; severe or unusual nausea, vomiting, or stomach pain; stomach bloating; symptoms of high blood sugar (eg, increased urination, thirst, or hunger; confusion; unusual drowsiness; fast breathing; flushing); symptoms of low blood sugar (eg, anxiety, dizziness, drowsiness, fast heartbeat, headache, lightheadedness, tremors, unusual sweating, weakness).

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.

Pancrelipase Capsules (Enteric-Coated)

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 Pancrelipase Capsules (Enteric-Coated):

Bloating; constipation; diarrhea; gas; headache; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Pancrelipase Capsules (Enteric-Coated):

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); painful, swollen joints; severe or persistent loose stools, diarrhea, or constipation; severe or unusual nausea, vomiting, or 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.

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Pancrelipase Side Effects - for the Professional

Pancrelipase

The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (Pancrelipase) include fibrosing colonopathy, hyperuricemia and allergic reactions [see Warnings and Precautions, (5)]

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 clinical practice.

The short-term safety of Pancrelipase was assessed in two clinical trials conducted in 53 patients, ages 1 to 23 years, with exocrine pancreatic insufficiency (EPI) due to CF.  In both studies, Pancrelipase was administered in doses of approximately 5,000 lipase units per kilogram per day, for lengths of treatment ranging from 19 to 42 days.  The population was nearly evenly distributed in gender, and approximately 96% of patients were Caucasian.

Study 1 was a randomized, double-blind, placebo-controlled, 2-treatment, crossover study of 34 patients, ages 7 to 23 years, with EPI due to CF.  In this study, patients were randomized to receive Pancrelipase  at individually titrated doses (not to exceed 2,500 lipase units per kilogram per meal) or matching placebo for 6 to 7 days of treatment, followed by crossover to the alternate treatment for an additional 6 to 7 days.  The mean exposure to Pancrelipase  during this study, including titration period and open label transition, was 30 days.

The incidence of adverse events (regardless of causality) was similar during double blind Pancrelipase  treatment (56%) and placebo treatment (50%).  The most common adverse events reported during the study were gastrointestinal complaints, which were reported more commonly during placebo treatment (41%) than during Pancrelipase treatment (32%), and headache, which was reported more commonly during Pancrelipase treatment (15%) than during placebo treatment (0).  The type and incidence of adverse events were similar in children (7-11 years), adolescents (12-16 years), and adults (greater than 18 years).

Because clinical trials are conducted under controlled conditions, the observed adverse event rates may not reflect the rates observed in clinical practice.

Table 1 enumerates treatment-emergent adverse events that occurred in at least 2 patients (greater than or equal to 6%) treated with either Pancrelipase or placebo in Study 1. Adverse events were classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology.

Table 1: Treatment-Emergent Adverse Events Occurring in at least 2 Patients (greater than or equal to 6%) During Treatment Period and Crossover  Treatment Period of the Placebo-Controlled, Crossover Clinical Study of Pancrelipase (Study 1)

MedDRA Primary System Organ Class Preferred Term	Pancrelipase	Placebo
	(N=34) %	(N=32) %
Gastrointestinal Disorders
Abdominal pain	6 (18%)	9 (28%)
Flatulence	2 (6%)	3 (9%)
Nervous System Disorders
Headache	5 (15%)	0
Injury, Poisoning and Procedural Complications
Contusion	2 (6%)	0
Investigations
Weight decreased	2 (6%)	2 (6%)
Respiratory, Thoracic and Mediastinal Disorders
Cough	2 (6%)	0
General Disorders and Administration Site Conditions
Early Satiety	2 (6%)	0

Study 2 was an open-label, uncontrolled study of 19 patients, ages 1 to 6 years, with EPI due to CF.  After a 4-14 days screening period on the current PEP, patients in Study 2 received Pancrelipase at individually titrated doses ranging between 2,300 and 10,000 lipase units per kg body weight per day, with a mean of approximately 5000 lipase units per kg body weight per day (not to exceed 2,500 lipase units per kilogram per meal) for 14 days. There was no comparator treatment, and adverse events were collected on patient diary entries and at each study visit.

The most commonly reported adverse events were gastrointestinal, including abdominal pain and steatorrhea, and were similar in type and frequency to those reported in the double-blind, placebo-controlled trial (Study 1).

Postmarketing Experience

There is no postmarketing experience with this formulation of Pancrelipase.

Delayed- and immediate-release pancreatic enzyme products with different formulations of the same active ingredient (Pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis. The long-term safety profile of these products has been described in the medical literature. The most serious adverse events include fibrosing colonopathy, distal intestinal obstruction syndrome (DIOS), recurrence of pre-existing carcinoma, and severe allergic reactions including anaphylaxis, asthma, hives, and pruritus. The most commonly reported adverse events are gastrointestinal disorders, including abdominal pain, diarrhea, flatulence, constipation and nausea, and skin disorders, including pruritus, urticaria and rash. In general, pancreatic enzyme products have a well defined and favorable risk-benefit profile in exocrine pancreatic insufficiency.

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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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