choline fenofibrate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
clofibrate derivatives, peroxisome proliferator activated receptor-alpha(PPAR-alpha) agonists 4505 42017-89-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • choline fenofibrate
  • fenofibric acid
  • procetofenic acid
metabolite of lipantyl; structure; salt of cholesterylamine & 2-(4-(p-chlorobenzoyl)phenoxy)2-methylpropionic acid
  • Molecular weight: 318.75
  • Formula: C17H15ClO4
  • CLOGP: 4.07
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 63.60
  • ALOGS: -4.80
  • ROTB: 5

Drug dosage:

DoseUnitRoute
0.14 g O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 15, 2008 FDA ABBVIE

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
Myalgia 68.29 22.65 49 1850 123039 46561124
Blood triglycerides increased 51.49 22.65 19 1880 11764 46672399
Pancreatitis acute 40.79 22.65 20 1879 24852 46659311
Hepatic enzyme increased 33.01 22.65 27 1872 81760 46602403
Rash 26.73 22.65 50 1849 356462 46327701
Rhabdomyolysis 26.20 22.65 18 1881 41891 46642272
Muscle spasms 25.34 22.65 28 1871 123085 46561078

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
Blood triglycerides increased 132.18 24.65 45 1890 13972 29936571
Myalgia 87.92 24.65 57 1878 76610 29873933
Low density lipoprotein increased 76.07 24.65 22 1913 3994 29946549
High density lipoprotein decreased 67.14 24.65 19 1916 3191 29947352
Pancreatitis 51.44 24.65 31 1904 36459 29914084
Rash 41.34 24.65 56 1879 191833 29758710
Blood creatinine increased 38.93 24.65 38 1897 91337 29859206
Blood creatine phosphokinase increased 36.86 24.65 27 1908 43821 29906722
Hepatic enzyme increased 36.04 24.65 24 1911 33470 29917073

Pharmacologic Action:

SourceCodeDescription
ATC C10AB11 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
Fibrates
FDA EPC N0000175596 Peroxisome Proliferator Receptor alpha Agonist
MeSH PA D000924 Anticholesteremic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D057847 Lipid Regulating Agents
CHEBI has role CHEBI:49103 drug metabolites
CHEBI has role CHEBI:83399 marine xenobiotic metabolites

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypercholesterolemia indication 13644009
Hyperlipidemia indication 55822004 DOID:1168
Hypoalphalipoproteinemia indication 190785000
Familial hypercholesterolemia - heterozygous indication 238079002
Mixed hyperlipidemia indication 267434003
Hypertriglyceridemia indication 302870006
Agranulocytosis contraindication 17182001 DOID:12987
Myositis contraindication 26889001 DOID:633
Primary biliary cirrhosis contraindication 31712002 DOID:12236
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Diabetes mellitus contraindication 73211009 DOID:9351
Leukopenia contraindication 84828003 DOID:615
Chronic renal failure syndrome contraindication 90688005
Disorder of muscle contraindication 129565002 DOID:423
Liver function tests abnormal contraindication 166603001
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Rhabdomyolysis contraindication 240131006
Calculus in biliary tract contraindication 266474003
Anemia contraindication 271737000 DOID:2355
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Thromboembolic disorder contraindication 371039008
Breastfeeding (mother) contraindication 413712001

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.71 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Peroxisome proliferator-activated receptor alpha Nuclear hormone receptor AGONIST Ki 4.46 CHEMBL CHEMBL
Fatty acid-binding protein, intestinal Cytosolic other Ki 6 CHEMBL
Fatty acid-binding protein, liver Unclassified Kd 7.03 CHEMBL

External reference:

IDSource
D08890 KEGG_DRUG
856676-23-8 SECONDARY_CAS_RN
4028374 VANDF
C2586675 UMLSCUI
CHEBI:83469 CHEBI
F5A PDB_CHEM_ID
CHEMBL1201745 ChEMBL_ID
CHEMBL981 ChEMBL_ID
DB13873 DRUGBANK_ID
C006012 MESH_SUPPLEMENTAL_RECORD_UI
11350701 PUBCHEM_CID
2662 IUPHAR_LIGAND_ID
C014892 MESH_SUPPLEMENTAL_RECORD_UI
8868 INN_ID
4BMH7IZT98 UNII
1433887 RXNORM
167897 MMSL
26077 MMSL
d07371 MMSL
012921 NDDF
012922 NDDF
442749005 SNOMEDCT_US
442750005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Trilipix HUMAN PRESCRIPTION DRUG LABEL 1 0074-3161 CAPSULE, DELAYED RELEASE 45 mg ORAL NDA 25 sections
Trilipix HUMAN PRESCRIPTION DRUG LABEL 1 0074-3162 CAPSULE, DELAYED RELEASE 135 mg ORAL NDA 25 sections
Trilipix HUMAN PRESCRIPTION DRUG LABEL 1 0074-9189 CAPSULE, DELAYED RELEASE 135 mg ORAL NDA 25 sections
Trilipix HUMAN PRESCRIPTION DRUG LABEL 1 0074-9642 CAPSULE, DELAYED RELEASE 45 mg ORAL NDA 25 sections
Fenofibric Acid HUMAN PRESCRIPTION DRUG LABEL 1 0115-1459 CAPSULE, DELAYED RELEASE 45 mg ORAL NDA authorized generic 25 sections
Fenofibric Acid HUMAN PRESCRIPTION DRUG LABEL 1 0115-1460 CAPSULE, DELAYED RELEASE 135 mg ORAL NDA authorized generic 25 sections
Fenofibric Acid HUMAN PRESCRIPTION DRUG LABEL 1 0115-1554 CAPSULE, DELAYED RELEASE 45 mg ORAL NDA authorized generic 25 sections
Fenofibric Acid HUMAN PRESCRIPTION DRUG LABEL 1 0115-1555 CAPSULE, DELAYED RELEASE 135 mg ORAL NDA authorized generic 25 sections
Fenofibric AcidDelayed-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-209 CAPSULE, DELAYED RELEASE 45 mg ORAL ANDA 25 sections
Fenofibric AcidDelayed-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-210 CAPSULE, DELAYED RELEASE 135 mg ORAL ANDA 25 sections
FIBRICOR HUMAN PRESCRIPTION DRUG LABEL 1 13310-101 TABLET 35 mg ORAL NDA 27 sections
FIBRICOR HUMAN PRESCRIPTION DRUG LABEL 1 13310-102 TABLET 105 mg ORAL NDA 27 sections
Fenofibric AcidDelayed-Release HUMAN PRESCRIPTION DRUG LABEL 1 24979-109 CAPSULE, DELAYED RELEASE 45 mg ORAL ANDA 25 sections
Fenofibric AcidDelayed-Release HUMAN PRESCRIPTION DRUG LABEL 1 24979-112 CAPSULE, DELAYED RELEASE 135 mg ORAL ANDA 25 sections
FENOFIBRIC ACID DELAYED-RELEASE HUMAN PRESCRIPTION DRUG LABEL 1 42385-944 CAPSULE, DELAYED RELEASE 45 mg ORAL ANDA 18 sections
FENOFIBRIC ACID DELAYED-RELEASE HUMAN PRESCRIPTION DRUG LABEL 1 42385-945 CAPSULE, DELAYED RELEASE 135 mg ORAL ANDA 18 sections
Fenofibric acid HUMAN PRESCRIPTION DRUG LABEL 1 42571-347 CAPSULE, DELAYED RELEASE 45 mg ORAL ANDA 25 sections
Fenofibric acid HUMAN PRESCRIPTION DRUG LABEL 1 42571-348 CAPSULE, DELAYED RELEASE 135 mg ORAL ANDA 25 sections
Fenofibric Acid Human Prescription Drug Label 1 46708-244 CAPSULE, DELAYED RELEASE 45 mg ORAL ANDA 26 sections
Fenofibric Acid Human Prescription Drug Label 1 46708-245 CAPSULE, DELAYED RELEASE 135 mg ORAL ANDA 26 sections
Fenofibric acid HUMAN PRESCRIPTION DRUG LABEL 1 50090-4373 CAPSULE, DELAYED RELEASE 135 mg ORAL ANDA 27 sections
Fenofibric Acid HUMAN PRESCRIPTION DRUG LABEL 1 50090-4561 CAPSULE, DELAYED RELEASE 135 mg ORAL NDA authorized generic 27 sections
FENOFIBRIC ACID Human Prescription Drug Label 1 50090-5369 CAPSULE, DELAYED RELEASE 135 mg ORAL ANDA 25 sections
Trilipix HUMAN PRESCRIPTION DRUG LABEL 1 54868-5986 CAPSULE, DELAYED RELEASE 135 mg ORAL NDA 26 sections
FENOFIBRIC ACID Human Prescription Drug Label 1 59651-216 CAPSULE, DELAYED RELEASE 45 mg ORAL ANDA 25 sections
FENOFIBRIC ACID Human Prescription Drug Label 1 59651-217 CAPSULE, DELAYED RELEASE 135 mg ORAL ANDA 25 sections
Fenofibric AcidDelayed-Release HUMAN PRESCRIPTION DRUG LABEL 1 60429-432 CAPSULE, DELAYED RELEASE 135 mg ORAL ANDA 25 sections
Fenofibric Acid Human Prescription Drug Label 1 62332-244 CAPSULE, DELAYED RELEASE 45 mg ORAL ANDA 25 sections
Fenofibric Acid Human Prescription Drug Label 1 62332-245 CAPSULE, DELAYED RELEASE 135 mg ORAL ANDA 25 sections
Fenofibric Acid HUMAN PRESCRIPTION DRUG LABEL 1 68134-601 TABLET 35 mg ORAL NDA authorized generic 26 sections