Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pancrelipase
Drug ID BADD_D01664
Description Pancrelipase, in general, is composed of a mixture of pancreatic enzymes which include amylases, lipases, and proteases. These enzymes are extracted from porcine pancreatic glands.[L2509] The pancrelipase mixture was developed by Ortho-McNeil-Janssen Pharmaceuticals, Inc and FDA approved on April 12, 2010.[L2510] For further information on the components of this mixture please visit [DB11065], [DB11066] and [DB13147].
Indications and Usage The use of pancrelipase amylase is part of the pancreatic enzyme replacement therapy. This therapy is indicated for the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis or any other medically defined pancreatic disease that might require it.[A32721, A32736] Pancreatic diseases are associated with the deterioration of pancreatic parenchyma and of the dual physiological functions of the pancreas. Once established, pancreatic insufficiency results in malnutrition, weight loss, and steatorrhea.[A32723]
Marketing Status approved; investigational
ATC Code Not Available
DrugBank ID DB00085
KEGG ID D05349
MeSH ID D020799
PubChem ID 8519
TTD Drug ID D0A5DJ
NDC Product Code 31387-137; 51421-001; 57298-807; 57298-803; 0032-1212; 59767-004; 59767-008; 0032-1203; 73562-208; 68621-0061; 31387-165; 54809-1024; 73562-104; 31387-205; 57298-804; 59767-024; 0032-1224; 31387-219; 54809-1025; 57298-806; 59767-016; 0032-1206; 0032-3016; 54809-1026; 54809-3823; 54809-9048; 57298-802; 57298-805
UNII FQ3DRG0N5K
Synonyms Pancrelipase | Cotazyme | Creon | Encron | Ilozyme | Ku-Zyme | Ku Zyme | Lipram | Pancrease | Pancrecarb | Pancron | Panokase | Pertzye | Protilase | Ultrase | Viokase | Zymase | Cotazym-S | Cotazym S
Chemical Information
Molecular Formula C8H8Na2O5
CAS Registry Number 129-67-9
SMILES C1CC2C(C(C1O2)C(=O)[O-])C(=O)[O-].[Na+].[Na+]
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Asthma10.01.03.010; 22.03.01.002---
Constipation07.02.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dyspepsia07.01.02.001--
Flatulence07.01.04.002--
Gastrointestinal disorder07.11.01.001---
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Nausea07.01.07.001--
Neoplasm malignant16.16.01.001---
Pruritus23.03.12.001--
Rash23.03.13.001---
Rash macular23.03.13.003---
Skin disorder23.03.03.007---
Urticaria10.01.06.001; 23.04.02.001--
Fibrosing colonopathy07.13.03.002---
Distal intestinal obstruction syndrome07.13.01.006---
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