pancrelipase Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
enzymes 5161 53608-75-6

Description:

MoleculeDescription

Synonyms:

  • pancrelipase
  • pancreatin
  • pancreatic extract pancrelipase
A standardized enzyme concentrate containing the pancreatic enzymes, lipase, protease and amylase used in enzyme substitution therapy. Lipase, protease and amylase break down fat, protein, and starches, respectively in the small intestine, thereby promoting digestion. Pancrelipase is used to reduce malabsorption when the pancreas is unable to secrete sufficient amounts of these enzymes.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

None

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Angina bullosa haemorrhagica 64.28 15.97 12 6663 134 46679253
Needle issue 54.27 15.97 23 6652 5781 46673606
Muscle swelling 53.19 15.97 12 6663 357 46679030
Cystic fibrosis 49.66 15.97 19 6656 3669 46675718
Facial asymmetry 46.32 15.97 12 6663 644 46678743
Vulval disorder 46.05 15.97 12 6663 659 46678728
Early satiety 44.22 15.97 12 6663 771 46678616
Pancreatic carcinoma 39.13 15.97 19 6656 6538 46672849
Frequent bowel movements 34.83 15.97 22 6653 12610 46666777
Body temperature decreased 31.21 15.97 21 6654 13388 46665999
Liver abscess 29.82 15.97 12 6663 2647 46676740
Infectious thyroiditis 29.54 15.97 5 6670 30 46679357
Breast pain 28.15 15.97 16 6659 7578 46671809
Rales 27.12 15.97 17 6658 9614 46669773
Abdominal distension 26.84 15.97 42 6633 73309 46606078
Thrombophlebitis superficial 25.43 15.97 13 6662 4990 46674397
Infective pulmonary exacerbation of cystic fibrosis 25.33 15.97 17 6658 10790 46668597
Pancreatic carcinoma recurrent 24.72 15.97 5 6670 87 46679300
Pancreatolithiasis 24.66 15.97 6 6669 249 46679138
Intestinal dilatation 24.27 15.97 9 6666 1593 46677794
Biliary sepsis 24.27 15.97 7 6668 562 46678825
General physical health deterioration 23.03 15.97 51 6624 115718 46563669
Pallor 22.99 15.97 22 6653 23144 46656243
Dehydration 22.92 15.97 62 6613 159478 46519909
Haemorrhoids 22.87 15.97 20 6655 18757 46660630
Pyrexia 22.53 15.97 104 6571 348698 46330689
Underdose 22.17 15.97 20 6655 19538 46659849
Subileus 21.92 15.97 10 6665 2993 46676394
Blood calcium decreased 21.76 15.97 18 6657 15655 46663732
Drug ineffective 20.88 15.97 41 6634 677797 46001590
Faeces discoloured 20.69 15.97 18 6657 16769 46662618
Flatulence 20.66 15.97 23 6652 28855 46650532
Blood pressure diastolic increased 20.57 15.97 12 6663 5962 46673425
Blood magnesium decreased 20.42 15.97 15 6660 10977 46668410
Crepitations 20.36 15.97 12 6663 6080 46673307
Carcinoid tumour of the small bowel 19.66 15.97 3 6672 8 46679379
Weight decreased 18.40 15.97 69 6606 210780 46468607
Mass 17.48 15.97 14 6661 11639 46667748
Localised oedema 16.98 15.97 10 6665 5059 46674328
Inappropriate schedule of product administration 16.89 15.97 32 6643 64981 46614406
Metastases to liver 16.48 15.97 17 6658 19568 46659819
Lip pain 16.47 15.97 7 6668 1771 46677616

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infective pulmonary exacerbation of cystic fibrosis 61.07 16.51 30 5281 8542 29938625
Pancreatic carcinoma 60.57 16.51 29 5282 7808 29939359
General physical health deterioration 46.94 16.51 72 5239 99872 29847295
Abdominal pain upper 35.03 16.51 49 5262 62502 29884665
Toxic optic neuropathy 34.28 16.51 10 5301 672 29946495
Pancreatic carcinoma metastatic 31.27 16.51 14 5297 3233 29943934
Cystic fibrosis 29.13 16.51 12 5299 2262 29944905
Needle issue 29.05 16.51 14 5297 3818 29943349
Abdominal pain 25.86 16.51 67 5244 135587 29811580
Blood pressure systolic increased 24.95 16.51 21 5290 15089 29932078
Cholangitis 24.57 16.51 16 5295 7786 29939381
Hypertransaminasaemia 22.99 16.51 12 5299 3873 29943294
Pancreatic neoplasm 22.99 16.51 8 5303 951 29946216
Liver abscess 21.99 16.51 11 5300 3251 29943916
Product residue present 20.96 16.51 10 5301 2668 29944499
Biliary tract infection 19.84 16.51 6 5305 457 29946710
Hepatic infection 19.60 16.51 6 5305 476 29946691
Diarrhoea 19.49 16.51 113 5198 333990 29613177
Hydrocholecystis 19.38 16.51 5 5306 212 29946955
Body temperature decreased 19.29 16.51 15 5296 9640 29937527
Immune-mediated hepatitis 18.16 16.51 7 5304 1109 29946058
Enterocolitis infectious 17.82 16.51 7 5304 1167 29946000
Pancreatic failure 16.96 16.51 6 5305 748 29946419
Pancreatic pseudocyst 16.61 16.51 6 5305 795 29946372

Pharmacologic Action:

SourceCodeDescription
MeSH PA D005765 Gastrointestinal Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Exocrine pancreatic insufficiency indication 47367009 DOID:13316

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4018109 VANDF
4018414 VANDF
C0770343 UMLSCUI
CHEMBL2108073 ChEMBL_ID
CHEMBL2108074 ChEMBL_ID
D010194 MESH_DESCRIPTOR_UI
D020799 MESH_DESCRIPTOR_UI
DB00085 DRUGBANK_ID
FQ3DRG0N5K UNII
235379 RXNORM
41216 MMSL
5227 MMSL
5615 MMSL
d01002 MMSL
d01003 MMSL
001234 NDDF
001235 NDDF
12236006 SNOMEDCT_US
387049005 SNOMEDCT_US
387265002 SNOMEDCT_US
48647005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
FESTAL PLUS HUMAN OTC DRUG LABEL 3 72689-0010 TABLET 315 mg ORAL unapproved drug other 6 sections
Stozyme HUMAN OTC DRUG LABEL 4 72850-0004 TABLET 36.46 1 ORAL unapproved drug other 7 sections