All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

difluprednate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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

Drug dosage:

None

ADMET properties:

None

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	115.25	26.48	49	1929	51198	56238891
Eye pain	91.50	26.48	36	1942	30811	56259278
Vision blurred	73.36	26.48	42	1936	82901	56207188
Eye irritation	66.36	26.48	25	1953	19003	56271086
Visual impairment	64.05	26.48	37	1941	74165	56215924
Intraocular pressure increased	62.82	26.48	18	1960	5823	56284266
Uveitis	59.24	26.48	20	1958	11075	56279014
Eye inflammation	57.23	26.48	16	1962	4735	56285354
Corneal oedema	53.86	26.48	12	1966	1410	56288679
Ocular discomfort	46.85	26.48	13	1965	3742	56286347
Anterior chamber fibrin	41.94	26.48	6	1972	52	56290037
Anterior chamber cell	40.67	26.48	8	1970	513	56289576
Endophthalmitis	39.75	26.48	11	1967	3132	56286957
Product delivery mechanism issue	37.68	26.48	7	1971	331	56289758
Product container issue	37.13	26.48	9	1969	1525	56288564
Ocular hyperaemia	36.40	26.48	17	1961	21962	56268127
Toxic anterior segment syndrome	36.31	26.48	9	1969	1673	56288416
Visual acuity reduced	34.22	26.48	16	1962	20710	56269379
Vitreous floaters	29.56	26.48	10	1968	5557	56284532
Product quality issue	27.79	26.48	16	1962	31720	56258369
Glaucoma	27.44	26.48	13	1965	17316	56272773
Hypopyon	26.94	26.48	6	1972	703	56289386

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	102.55	31.69	26	1127	5161	31691030
Corneal oedema	78.09	31.69	16	1137	1225	31694966
Toxic anterior segment syndrome	62.01	31.69	13	1140	1112	31695079
Eye pain	52.82	31.69	19	1134	12285	31683906
Eye irritation	51.74	31.69	16	1137	6502	31689689
Anterior chamber cell	50.07	31.69	9	1144	342	31695849
Visual impairment	47.49	31.69	23	1130	31256	31664935
Eye inflammation	44.99	31.69	11	1142	1872	31694319
Product quality issue	40.95	31.69	17	1136	16094	31680097
Cataract	40.69	31.69	19	1134	23788	31672403
Vision blurred	35.77	31.69	21	1132	41894	31654297

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	131.96	23.81	35	2367	8866	70917176
Corneal oedema	112.12	23.81	24	2378	2436	70923606
Cataract	103.26	23.81	46	2356	55599	70870443
Anterior chamber cell	90.50	23.81	17	2385	888	70925154
Toxic anterior segment syndrome	88.45	23.81	20	2382	2610	70923432
Visual impairment	65.22	23.81	38	2364	80212	70845830
Anterior chamber fibrin	64.28	23.81	10	2392	166	70925876
Endophthalmitis	57.82	23.81	17	2385	6238	70919804
Eye inflammation	55.53	23.81	16	2386	5471	70920571
Eye pain	41.15	23.81	21	2381	34081	70891961
Vision blurred	40.35	23.81	30	2372	94954	70831088
Corneal disorder	39.19	23.81	10	2392	2169	70923873
Paronychia	35.24	23.81	12	2390	7062	70918980
Hypopyon	35.04	23.81	8	2394	1087	70924955
Ulcerative keratitis	30.55	23.81	9	2393	3318	70922724
Aqueous fibrin	29.92	23.81	5	2397	132	70925910
Vitritis	26.90	23.81	7	2395	1639	70924403
Palmar-plantar erythrodysaesthesia syndrome	26.33	23.81	15	2387	30232	70895810
Infective keratitis	26.09	23.81	4	2398	60	70925982
Granulocytosis	25.56	23.81	5	2397	323	70925719
Vitreal cells	25.35	23.81	4	2398	73	70925969
Visual acuity reduced	24.71	23.81	14	2388	27916	70898126

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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|

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

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
DUREZOL	HUMAN PRESCRIPTION DRUG LABEL	1	0065-9240	EMULSION	0.50 mg	OPHTHALMIC	NDA	23 sections
DUREZOL	HUMAN PRESCRIPTION DRUG LABEL	1	0065-9240	EMULSION	0.50 mg	OPHTHALMIC	NDA	23 sections
DUREZOL	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0862	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
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