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Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
prednisone and prednisolone derivatives	3142	23674-86-4

Description:

Molecule	Description
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

Molecule

Description

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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value
kinase-safety-class	ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CG,PRKDC,STK33,SYK,TEK	24
kinase-selectivity-class	AXL,GRK2,MAP2K6	3
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company	Orphan
June 23, 2008	FDA	ALCON PHARMS LTD

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Cataract	131.27	24.41	56	2548	72036	90553807
Eye pain	128.07	24.41	48	2556	44120	90581723
Uveitis	117.54	24.41	35	2569	15868	90609975
Endophthalmitis	100.65	24.41	24	2580	4661	90621182
Eye inflammation	88.35	24.41	24	2580	7827	90618016
Vision blurred	83.29	24.41	47	2557	110246	90515597
Eye irritation	70.48	24.41	29	2575	33949	90591894
Intraocular pressure increased	62.92	24.41	18	2586	7075	90618768
Glaucoma	61.70	24.41	23	2581	20732	90605111
Corneal oedema	58.23	24.41	13	2591	1888	90623955
Visual impairment	55.82	24.41	39	2565	132326	90493517
Blindness unilateral	48.44	24.41	15	2589	7721	90618122
Ocular discomfort	46.94	24.41	14	2590	6356	90619487
Eye disorder	45.56	24.41	20	2584	27370	90598473
Visual acuity reduced	45.22	24.41	19	2585	23391	90602452
Multiple use of single-use product	42.59	24.41	10	2594	1813	90624030
Toxic anterior segment syndrome	40.50	24.41	10	2594	2240	90623603
Vitreous floaters	40.46	24.41	13	2591	7536	90618307
Anterior chamber cell	39.52	24.41	8	2596	728	90625115
Ocular hyperaemia	38.54	24.41	19	2585	33779	90592064
Anterior chamber fibrin	38.03	24.41	6	2598	130	90625713
Hypopyon	37.79	24.41	8	2596	906	90624937
Product delivery mechanism issue	36.13	24.41	7	2597	509	90625334
Product container issue	35.78	24.41	9	2595	2172	90623671
Foreign body sensation in eyes	32.09	24.41	9	2595	3291	90622552
Punctate keratitis	27.45	24.41	6	2598	790	90625053
Corneal disorder	26.54	24.41	7	2597	2035	90623808
Sacroiliitis	25.65	24.41	8	2596	4211	90621632
Product administration error	24.71	24.41	13	2591	26410	90599433

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Intraocular pressure increased	96.19	26.03	26	1569	6407	42613333
Corneal oedema	74.08	26.03	16	1579	1532	42618208
Eye pain	63.90	26.03	24	1571	17006	42602734
Visual impairment	59.55	26.03	30	1565	43083	42576657
Toxic anterior segment syndrome	58.64	26.03	13	1582	1403	42618337
Eye irritation	50.01	26.03	18	1577	11300	42608440
Anterior chamber cell	47.22	26.03	9	1586	459	42619281
Cataract	41.36	26.03	21	1574	30583	42589157
Endophthalmitis	39.59	26.03	12	1583	4421	42615319
Product quality issue	38.75	26.03	17	1578	17865	42601875
Eye inflammation	34.34	26.03	10	1585	3208	42616532
Vision blurred	32.78	26.03	22	1573	53677	42566063
Uveitis	27.42	26.03	11	1584	9247	42610493
Anterior chamber fibrin	26.15	26.03	4	1591	53	42619687
Granulocytosis	26.08	26.03	5	1590	263	42619477

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Intraocular pressure increased	128.67	23.05	35	3328	10841	110575095
Endophthalmitis	118.95	23.05	31	3332	8156	110577780
Cataract	116.56	23.05	54	3309	79431	110506505
Corneal oedema	114.12	23.05	25	3338	3148	110582788
Uveitis	104.81	23.05	35	3328	21675	110564261
Toxic anterior segment syndrome	90.43	23.05	21	3342	3433	110582503
Anterior chamber cell	87.23	23.05	17	3346	1204	110584732
Eye inflammation	70.09	23.05	21	3342	9150	110576786
Visual impairment	67.28	23.05	45	3318	134383	110451553
Anterior chamber fibrin	61.84	23.05	10	3353	240	110585696
Eye pain	58.08	23.05	29	3334	50070	110535866
Hypopyon	49.85	23.05	11	3352	1429	110584507
Multiple use of single-use product	45.42	23.05	10	3353	1286	110584650
Corneal epithelium defect	43.08	23.05	9	3354	903	110585033
Glaucoma	41.57	23.05	18	3345	22499	110563437
Visual acuity reduced	41.38	23.05	20	3343	32153	110553783
Vision blurred	41.32	23.05	33	3330	128989	110456947
Corneal disorder	38.51	23.05	10	3353	2587	110583349
Punctate keratitis	35.14	23.05	8	3355	1196	110584740
Paronychia	31.23	23.05	12	3351	11069	110574867
Blindness unilateral	29.02	23.05	11	3352	9775	110576161
Cytomegalovirus chorioretinitis	28.55	23.05	10	3353	7118	110578818
Ulcerative keratitis	28.32	23.05	9	3354	4757	110581179
Aqueous fibrin	28.23	23.05	5	3358	209	110585727
Retinal occlusive vasculitis	27.32	23.05	5	3358	252	110585684
Eye disorder	25.66	23.05	14	3349	28892	110557044
Granulocytosis	24.70	23.05	5	3358	429	110585507
Vitritis	24.33	23.05	7	3356	2646	110583290
Infective keratitis	24.00	23.05	4	3359	116	110585820
Cystoid macular oedema	23.96	23.05	7	3356	2793	110583143
Sacroiliitis	23.90	23.05	8	3355	4970	110580966
Ocular discomfort	23.19	23.05	9	3354	8524	110577412

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	D07AC19	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, potent (group III)
ATC	S01BA16	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Corticosteroids, plain
MeSH PA	D005938	Glucocorticoids
MeSH PA	D006728	Hormones
CHEBI has role	CHEBI:66981	ophthalmology drug
CHEBI has role	CHEBI:67079	anti-inflammatory agent

Related Drugs by ATC class:

D07AC Corticosteroids, potent (group III) 20 drugs

amcinonide beclometasone dipropionate betamethasone budesonide desoximetasone diflorasone diacetate diflucortolone fluclorolone fludroxycortide fluocinolone acetonide fluocinonide fluocortolone show all 20 →

S01BA Corticosteroids, plain 15 drugs

alclometasone dipropionate betamethasone clobetasol propionate clobetasone butyrate desonide dexamethasone fluocinolone acetonide fluorometholone formocortal hydrocortisone loteprednol etabonate medrysone show all 15 →

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	11.49	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST				CHEMBL	CHEMBL

External reference:

ID	Source
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
S8A06QG2QE	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
DUREZOL	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0862	EMULSION	0.50 mg	OPHTHALMIC	NDA	24 sections
Difluprednate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-7518	EMULSION	0.50 mg	OPHTHALMIC	ANDA	24 sections
Difluprednate Ophthalmic	HUMAN PRESCRIPTION DRUG LABEL	1	0781-6000	EMULSION	0.50 mg	OPHTHALMIC	NDA authorized generic	22 sections
Difluprednate	HUMAN PRESCRIPTION DRUG LABEL	1	0832-6054	EMULSION	5 mg	OPHTHALMIC	ANDA	26 sections
Difluprednate	HUMAN PRESCRIPTION DRUG LABEL	1	0832-6054	EMULSION	0.50 mg	OPHTHALMIC	ANDA	26 sections
Difluprednate Ophthalmic Emulsion	HUMAN PRESCRIPTION DRUG LABEL	1	43598-588	EMULSION	0.50 mg	OPHTHALMIC	ANDA	23 sections
Difluprednate	Human Prescription Drug Label	1	46708-750	EMULSION	0.50 mg	OPHTHALMIC	ANDA	24 sections
DUREZOL	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6296	EMULSION	0.50 mg	OPHTHALMIC	NDA	23 sections
Difluprednate	Human Prescription Drug Label	1	62332-750	EMULSION	0.50 mg	OPHTHALMIC	ANDA	24 sections
Difluprednate	Human Prescription Drug Label	1	65145-161	EMULSION	0.50 mg	OPHTHALMIC	ANDA	23 sections
DUREZOL	HUMAN PRESCRIPTION DRUG LABEL	1	66758-086	EMULSION	0.50 mg	OPHTHALMIC	NDA	24 sections
DUREZOL	HUMAN PRESCRIPTION DRUG LABEL	1	66758-086	EMULSION	0.50 mg	OPHTHALMIC	NDA	24 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	22 sections
DIFLUPREDNATE	HUMAN PRESCRIPTION DRUG LABEL	1	69315-329	EMULSION	0.50 mg	OPHTHALMIC	ANDA	22 sections
DIFLUPREDNATE	HUMAN PRESCRIPTION DRUG LABEL	1	76282-708	EMULSION	0.50 mg	OPHTHALMIC	ANDA	20 sections

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General architecture

Using the assistant

difluprednate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

Drug Use | Suggest Off label Use Form| |View source of the data|

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: