Pancrelipase: Indications, How to Use, Dosing & Side Effects

Daisy Oliveira
Created by: Daisy Oliveira Registered Nurse CNO #13564387

Pancrelipase is a pancreatic enzyme replacement medicine used when the pancreas does not make or release enough digestive enzymes. It contains the enzymes lipase, protease, and amylase, which help the body digest fats, proteins, and carbohydrates.

This medicine is mainly used to treat exocrine pancreatic insufficiency, also called EPI. EPI can occur with conditions that affect the pancreas, including cystic fibrosis and chronic pancreatitis, or after surgery that removes part or all of the pancreas.

Pancrelipase is available in different formulations and strengths, and the dose is measured mainly according to the amount of lipase it contains. Treatment should be individualized because the appropriate dose can vary with age, body weight, diet, symptoms, nutritional status, and the cause of pancreatic insufficiency.

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Indications for use

Pancrelipase is indicated for the treatment of exocrine pancreatic insufficiency (EPI), a condition in which the pancreas does not provide enough digestive enzymes for normal digestion.

FDA-approved delayed-release pancrelipase capsules, such as Creon, Zenpep, Pancreaze, and Pertzye, can be used to treat EPI in adults and children.

Pancrelipase may be prescribed for EPI associated with conditions such as cystic fibrosis and other diseases or situations that interfere with pancreatic function.

Viokace, a non-enteric-coated pancrelipase tablet, has a more specific FDA-approved indication. It is used in adults with EPI caused by chronic pancreatitis or pancreatectomy, which is surgery to remove part or all of the pancreas. Viokace must be taken together with a proton pump inhibitor, or PPI, because stomach acid can break down the enzymes before they reach the intestine.

How to take it

Pancrelipase should be taken with every meal and snack. The dose is measured in lipase units and varies according to age, body weight, diet, symptoms, and the specific product prescribed.

Pancrelipase products are not always interchangeable, so the dose may need to be adjusted when changing brands or formulations.

Dosing

Group Typical starting dose
Children 12 months to under 4 years 1,000 lipase units/kg with each meal
Children 4 years and older and adults 500 lipase units/kg with each meal
Adults, according to clinical guidelines About 40,000 to 50,000 lipase units with meals and 20,000 to 25,000 units with snacks
Snacks Usually about half the meal dose

The dose can be increased if symptoms of poor digestion or nutrient absorption continue.

Without further medical evaluation, FDA labeling generally recommends not exceeding 2,500 lipase units/kg per meal, 10,000 lipase units/kg per day, or 4,000 lipase units per gram of dietary fat per day.

Delayed-release capsules

Delayed-release capsules should usually be swallowed whole with liquid and should not be crushed or chewed.

When swallowing capsules is difficult, some products can be opened and sprinkled onto a small amount of acidic soft food, such as applesauce or fruit purée. The mixture should be swallowed immediately without chewing.

The dose may also be spread throughout the meal.

Infants

Infant dosing depends on the product. Zenpep recommends 3,000 lipase units per 120 mL of formula or per breastfeeding, while Pancreaze recommends 2,600 lipase units per 120 mL of formula or per breastfeeding.

Pancrelipase tablets

Viokace tablets are used in adults with EPI caused by chronic pancreatitis or pancreatectomy. They must be taken with a proton pump inhibitor and swallowed whole with liquid.

Viokace tablets should not be crushed or chewed.

Possible side effects

Pancrelipase can cause side effects and, less commonly, serious complications.

Possible adverse effects and important safety concerns described in pancrelipase prescribing information include:

  • irritation of the mouth, particularly if capsules or enzyme granules are crushed, chewed, or allowed to remain in the mouth;

  • increased uric acid levels, known as hyperuricemia;

  • allergic reactions, including potentially serious reactions to proteins of pig origin; and

  • fibrosing colonopathy, a rare condition involving narrowing or scarring of the intestine.

Fibrosing colonopathy has been associated mainly with prolonged use of high pancreatic enzyme doses, particularly in children with cystic fibrosis. This is one reason pancrelipase doses should remain within recommended limits unless higher doses have been carefully evaluated.

Contraindications

Prescribing information for Creon and Viokace lists no formal contraindications.

However, pancrelipase is made from pig pancreatic tissue, so special caution is necessary in people who have previously experienced allergic reactions to proteins of pig origin.

Additional caution may be appropriate for people with gout or high uric acid levels, kidney impairment, a history of fibrosing colonopathy, or narrowing of the intestine. High pancrelipase doses also require careful evaluation because of the association between prolonged high-dose treatment and fibrosing colonopathy.

  • || website || website || CREON (pancrelipase) delayed-release capsules: prescribing information || NA || DailyMed || DailyMed || NA || NA || NA || NA || NA || https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d || February 28, 2024 || August 20, 2026 || NA || NA ||

  • || website || website || ZENPEP (pancrelipase) delayed-release capsules: prescribing information || NA || DailyMed || DailyMed || NA || NA || NA || NA || NA || https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f16f2d4-8df6-4bd7-ac10-56994fa257b0 || December 24, 2024 || August 20, 2026 || NA || NA ||

  • || website || website || PANCREAZE (pancrelipase) delayed-release capsules: prescribing information || NA || DailyMed || DailyMed || NA || NA || NA || NA || NA || https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e8f5d2fe-728d-42af-99a6-83dddc6539c5 || June 6, 2025 || August 20, 2026 || NA || NA ||

  • || website || website || PERTZYE (pancrelipase) delayed-release capsules: prescribing information || NA || DailyMed || DailyMed || NA || NA || NA || NA || NA || https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=481eec00-9abf-11dd-b71c-0002a5d5c51b || March 11, 2024 || August 20, 2026 || NA || NA ||

  • || website || website || VIOKACE (pancrelipase) tablets: prescribing information || NA || DailyMed || DailyMed || NA || NA || NA || NA || NA || https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=58bdb8de-582d-44e6-9b72-8d5a42fdf501 || August 14, 2025 || August 20, 2026 || NA || NA ||

  • || article || article || European guidelines for the diagnosis and treatment of pancreatic exocrine insufficiency: UEG, EPC, EDS, ESPEN, ESPGHAN, ESDO, and ESPCG evidence-based recommendations || NA || Domínguez-Muñoz JE, Vujasinovic M, European PEI Multidisciplinary Group, de la Iglesia D, Cahen D, Capurso G, et al. || United European Gastroenterology Journal || NA || 125-172 || 1 || 13 || 2025 || NA || NA || NA || NA || NA ||

  • || article || article || Consensus for the management of pancreatic exocrine insufficiency: UK practical guidelines || NA || Phillips ME, Hopper AD, Leeds JS, Roberts KJ, McGeeney L, Duggan SN, Kumar R || BMJ Open Gastroenterology || NA || e000643 || 1 || 8 || 2021 || NA || NA || NA || NA || NA ||

  • || article || article || Exocrine pancreatic insufficiency dosing guidelines for pancreatic enzyme replacement therapy vary widely across disease types || NA || Lewis DM, Rieke JG, Almusaylim K, Kanchibhatla A, Blanchette JE, Lewis C || Digestive Diseases and Sciences || NA || 615-633 || 2 || 69 || 2024 || NA || NA || NA || NA || NA ||

  • || article || article || Pancreatic enzyme replacement therapy for people with cystic fibrosis || NA || Somaraju URR, Solis-Moya A || Cochrane Database of Systematic Reviews || NA || CD008227 || 8 || 8 || 2020 || NA || NA || NA || NA || NA ||

Update History
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References
  • D'HAESE, J. G.; et al. Pancreatic enzyme replacement therapy in patients with exocrine pancreatic insufficiency due to chronic pancreatitis: a 1-year disease management study on symptom control and quality of life. Pancreas. 2014;43(6):834-41.
  • Creon (pancreatina) cápsulas sob a forma de microgrânulos com revestimento acidorresistente 10.000 U.F.E. e 25.000 U.F.E. Anvisa. 2023. Accessed 21 Nov 2023 https://consultas.anvisa.gov.br/#/bulario/q/?nomeProduto=CREON
  • Creon (pancreatin)- Introduction to Effective Dosing. Mylan UK Healthcare Limited. 2020. Accessed 21 Nov 2023 https://www.creon.co.uk/hcp/Effective-Dosing/Introduction-to-Effective-Dosing
  • KASHIRSKAYA, N. Y.; et al. Safety and efficacy of Creon® micro in children with exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2015;14(2):275-81.