difluprednate 🐶 Veterinary Use | 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
Cataract 100.19 26.53 44 1825 47256 50555999
Eye pain 92.61 26.53 36 1833 28413 50574842
Vision blurred 70.83 26.53 41 1828 78606 50524649
Eye irritation 67.70 26.53 25 1844 17115 50586140
Intraocular pressure increased 62.95 26.53 18 1851 5498 50597757
Visual impairment 62.53 26.53 36 1833 68239 50535016
Eye inflammation 58.37 26.53 16 1853 4192 50599063
Corneal oedema 53.57 26.53 12 1857 1375 50601880
Uveitis 49.73 26.53 17 1852 9293 50593962
Ocular discomfort 47.59 26.53 13 1856 3360 50599895
Anterior chamber fibrin 41.64 26.53 6 1863 52 50603203
Anterior chamber cell 40.70 26.53 8 1861 486 50602769
Endophthalmitis 40.03 26.53 11 1858 2905 50600350
Product delivery mechanism issue 37.76 26.53 7 1862 311 50602944
Product container issue 37.31 26.53 9 1860 1423 50601832
Ocular hyperaemia 36.89 26.53 17 1852 20275 50582980
Toxic anterior segment syndrome 36.51 26.53 9 1860 1556 50601699
Visual acuity reduced 33.90 26.53 16 1853 20123 50583132
Product quality issue 27.47 26.53 16 1853 30842 50572413
Hypopyon 26.99 26.53 6 1863 663 50602592

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 95.63 30.91 24 1009 4765 29568729
Corneal oedema 80.07 30.91 16 1017 1126 29572368
Toxic anterior segment syndrome 63.61 30.91 13 1020 1023 29572471
Anterior chamber cell 52.16 30.91 9 1024 281 29573213
Eye pain 50.85 30.91 18 1015 11577 29561917
Eye irritation 49.63 30.91 15 1018 5883 29567611
Visual impairment 49.54 30.91 23 1010 29685 29543809
Product quality issue 41.86 30.91 17 1016 15878 29557616
Cataract 39.39 30.91 18 1015 22360 29551134
Vision blurred 37.41 30.91 21 1012 40155 29533339
Eye inflammation 36.31 30.91 9 1024 1687 29571807

FDA Adverse Event Reporting System (Geriatric)

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 129.18 24.83 34 2176 8268 64488254
Corneal oedema 113.02 24.83 24 2186 2319 64494203
Cataract 93.45 24.83 42 2168 51220 64445302
Anterior chamber cell 91.90 24.83 17 2193 807 64495715
Toxic anterior segment syndrome 89.73 24.83 20 2190 2419 64494103
Visual impairment 64.95 24.83 37 2173 74040 64422482
Anterior chamber fibrin 64.45 24.83 10 2200 161 64496361
Endophthalmitis 60.21 24.83 17 2193 5348 64491174
Eye inflammation 57.28 24.83 16 2194 4841 64491681
Eye pain 42.42 24.83 21 2189 31604 64464918
Corneal disorder 39.79 24.83 10 2200 2017 64494505
Vision blurred 39.14 24.83 29 2181 90287 64406235
Hypopyon 35.45 24.83 8 2202 1021 64495501
Paronychia 32.16 24.83 11 2199 6481 64490041
Ulcerative keratitis 31.09 24.83 9 2201 3088 64493434
Aqueous fibrin 30.01 24.83 5 2205 128 64496394
Vitritis 27.31 24.83 7 2203 1526 64494996
Infective keratitis 26.80 24.83 4 2206 49 64496473
Vitreal cells 26.30 24.83 4 2206 56 64496466
Stomatitis 26.25 24.83 25 2185 109580 64386942
Visual acuity reduced 24.93 24.83 14 2196 27127 64469395

FDA Adverse Event Reporting System (Pediatric)

None

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 | Suggest Off label Use Form| |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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
7474 IUPHAR_LIGAND_ID
2652 INN_ID
S8A06QG2QE UNII
443936 PUBCHEM_CID
23043 RXNORM
146969 MMSL
22956 MMSL
350413 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
Difluprednate Ophthalmic HUMAN PRESCRIPTION DRUG LABEL 1 0781-6000 EMULSION 0.50 mg OPHTHALMIC NDA authorized generic 21 sections
DUREZOL HUMAN PRESCRIPTION DRUG LABEL 1 54868-6296 EMULSION 0.50 mg OPHTHALMIC NDA 23 sections
DIFLUPREDNATE HUMAN PRESCRIPTION DRUG LABEL 1 69097-341 EMULSION 0.50 mg OPHTHALMIC ANDA 20 sections
Difluprednate HUMAN PRESCRIPTION DRUG LABEL 1 69238-1380 EMULSION 0.50 mg OPHTHALMIC ANDA 23 sections
Difluprednate HUMAN PRESCRIPTION DRUG LABEL 1 69238-1380 EMULSION 0.50 mg OPHTHALMIC ANDA 23 sections
DIFLUPREDNATE HUMAN PRESCRIPTION DRUG LABEL 1 76282-708 EMULSION 0.50 mg OPHTHALMIC ANDA 20 sections