Pancreatin: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 22, 2026

Pancreatin

Active ingredient

Sold as NUTRIZYM 22

GB MHRACA Health Canada

Drug class: -
Availability: See label
Routes: Oral
Markets covered: 2
Products on record: 41

Overview

Pancreatin is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	40	May 22, 2026
CA Canada	Health Canada	1	March 22, 2025

GBUnited Kingdom· MHRA

40 products

Uses

GBOfficial regulatory label· revised May 15, 2026[1]

For the symptomatic relief of pancreatic exocrine insufficiency such as in fibrocystic disease of the pancreas and chronic pancreatitis.

How to take

CACanada· Health Canada

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [2].

Sources & citations

[1]MHRA (UK) · PL177801025 · revised May 15, 2026
[2]Health Canada (DPD) · 02231774 · revised March 22, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 15, 2026[1]

In clinical trials, more than 900 patients were exposed to pancreatin. The most commonly reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in severity. The following adverse reactions have been observed during clinical trials with the below indicated frequencies: Organ system Very common ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1000 to < 1/100 Frequency not known Gastrointestinal disorders abdominal pain* nausea, vomiting, constipation, abdominal distention, diarrhoea strictures of the ileo-caecum and large bowel (fibrosing colonopathy) including children with cystic fibrosis**, oral mucosa irritation Skin and subcutaneous tissue disorders rash pruritus, urticaria Immune system disorders hypersensitivity (anaphylactic reactions including urticaria and angioedema) Metabolism and nutrition disorders Hyperuricemia Renal and urinary disorders Hyperuricosuria* ** *Gastrointestinal disorders are mainly associated with the underlying disease.
Similar or lower incidences compared to placebo were reported for abdominal pain and diarrhoea. 4 - Special warnings and precautions for use *** Hyperuricosuria has been reported when high doses of pancreatin have been taken Allergic reactions mainly, but not exclusively, limited to the skin have been observed and identified as adverse reactions during post-approval use.
Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency. As with any pancreatin extract, high doses may cause buccal and perianal irritation, in some cases resulting in inflammation.
4). Abdominal symptoms (those not usually experienced by the patient) or changes in abdominal symptoms should be reviewed to exclude the possibility of colonic damage - especially if the patient is taking in excess of 10,000 units of lipase/kg/day.
Paediatric population No specific adverse reactions were identified in the paediatric population. Frequency, type and severity of adverse reactions were similar in children with cystic fibrosis as compared to adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised May 15, 2026[1]

In several patients with cystic fibrosis (including children), high doses of pancreatin caused fibrosing colonopathy (narrowing of the colon and ileocecal part of the intestine). If symptoms of ileus occur in patients taking pancreatin, fibrosing colonopathy should be considered as potential cause.
Hyperuricaemia and hyperuricosuria have been reported to occur in cystic fibrosis patients; pancreatin extracts contain a small amount of purine which might, in high doses, contribute to this condition. Important information about the ingredients of Nutrizym 22 Nutrizym 22 contains castor oil which may cause stomach upset and diarrhoea.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

This is not medical advice. Consult a qualified healthcare professional.