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

Stem definitionDrug idCAS RN
prednisone and prednisolone derivatives 3142 23674-86-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • difluprednate
  • durezol
  • Molecular weight: 508.56
  • Formula: C27H34F2O7
  • CLOGP: 3.44
  • LIPINSKI: 1
  • HAC: 7
  • HDO: 1
  • TPSA: 106.97
  • ALOGS: -4.72
  • ROTB: 8

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
June 23, 2008 FDA ALCON PHARMS LTD

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
Eye pain 83.62 27.50 33 1642 27907 46656480
Cataract 80.55 27.50 37 1638 45378 46639009
Vision blurred 60.94 27.50 37 1638 79671 46604716
Visual impairment 58.93 27.50 34 1641 66655 46617732
Eye irritation 58.12 27.50 22 1653 16592 46667795
Eye inflammation 51.01 27.50 14 1661 3795 46680592
Intraocular pressure increased 49.05 27.50 15 1660 5942 46678445
Corneal oedema 41.41 27.50 10 1665 1636 46682751
Anterior chamber cell 39.72 27.50 8 1667 567 46683820
Endophthalmitis 39.07 27.50 11 1664 3267 46681120
Product delivery mechanism issue 38.05 27.50 7 1668 307 46684080
Uveitis 35.93 27.50 13 1662 8628 46675759
Ocular discomfort 35.34 27.50 10 1665 3025 46681362
Ocular hyperaemia 34.68 27.50 16 1659 19694 46664693
Anterior chamber fibrin 34.33 27.50 6 1669 196 46684191
Product container issue 30.64 27.50 8 1667 1791 46682596
Visual acuity reduced 29.95 27.50 15 1660 22098 46662289

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
Intraocular pressure increased 96.80 32.61 24 909 5096 29946449
Corneal oedema 73.74 32.61 15 918 1297 29950248
Eye irritation 51.86 32.61 15 918 5681 29945864
Anterior chamber cell 50.81 32.61 9 924 369 29951176
Visual impairment 45.22 32.61 21 912 30417 29921128
Eye pain 44.89 32.61 16 917 11773 29939772
Toxic anterior segment syndrome 43.62 32.61 10 923 1511 29950034
Product quality issue 41.02 32.61 17 916 18757 29932788
Cataract 38.54 32.61 17 916 21818 29929727
Eye inflammation 37.65 32.61 9 924 1628 29949917
Vision blurred 33.39 32.61 19 914 41797 29909748

Pharmacologic Action:

SourceCodeDescription
ATC D07AC19 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, potent (group III)
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Post-Op Ocular Inflammation indication
Postoperative Ocular Pain indication
Cyclitis off-label use 17657000
Iritis off-label use 65074000 DOID:1406
Iridocyclitis off-label use 77971008
Uveitis off-label use 128473001 DOID:13141
Allergic conjunctivitis off-label use 473460002 DOID:11204
Ocular hypertension contraindication 4210003 DOID:9282
Herpes simplex dendritic keratitis contraindication 29943008
Tuberculosis of eye contraindication 49107007
Bacterial keratitis contraindication 314557000
Fungal keratitis contraindication 314558005
Vaccinia keratitis contraindication 397552005
Herpes zoster keratitis contraindication 397573005

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.49 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
Glucocorticoid receptor Nuclear hormone receptor AGONIST CHEMBL CHEMBL

External reference:

IDSource
4027694 VUID
N0000179107 NUI
D01266 KEGG_DRUG
4027694 VANDF
C0058004 UMLSCUI
CHEBI:31485 CHEBI
CHEMBL1201749 ChEMBL_ID
DB06781 DRUGBANK_ID
C015808 MESH_SUPPLEMENTAL_RECORD_UI
443936 PUBCHEM_CID
7474 IUPHAR_LIGAND_ID
2652 INN_ID
S8A06QG2QE UNII
23043 RXNORM
146969 MMSL
22956 MMSL
005778 NDDF
438200007 SNOMEDCT_US
440063000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DUREZOL HUMAN PRESCRIPTION DRUG LABEL 1 0065-9240 EMULSION 0.50 mg OPHTHALMIC NDA 23 sections
DUREZOL HUMAN PRESCRIPTION DRUG LABEL 1 54868-6296 EMULSION 0.50 mg OPHTHALMIC NDA 23 sections