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 |
|---|---|
|
Synonyms:
|
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 | 117.54 | 25.53 | 51 | 2138 | 57002 | 63429831 |
| Eye pain | 99.34 | 25.53 | 39 | 2150 | 33815 | 63453018 |
| Endophthalmitis | 92.19 | 25.53 | 22 | 2167 | 3570 | 63483263 |
| Uveitis | 85.19 | 25.53 | 27 | 2162 | 12526 | 63474307 |
| Vision blurred | 70.05 | 25.53 | 42 | 2147 | 91882 | 63394951 |
| Eye irritation | 66.83 | 25.53 | 26 | 2163 | 21945 | 63464888 |
| Visual impairment | 62.81 | 25.53 | 38 | 2151 | 84408 | 63402425 |
| Intraocular pressure increased | 62.44 | 25.53 | 18 | 2171 | 6060 | 63480773 |
| Eye inflammation | 59.39 | 25.53 | 17 | 2172 | 5582 | 63481251 |
| Corneal oedema | 53.50 | 25.53 | 12 | 2177 | 1481 | 63485352 |
| Ocular discomfort | 45.55 | 25.53 | 13 | 2176 | 4220 | 63482613 |
| Multiple use of single-use product | 42.77 | 25.53 | 10 | 2179 | 1482 | 63485351 |
| Anterior chamber fibrin | 42.05 | 25.53 | 6 | 2183 | 52 | 63486781 |
| Anterior chamber cell | 40.48 | 25.53 | 8 | 2181 | 536 | 63486297 |
| Product delivery mechanism issue | 37.14 | 25.53 | 7 | 2182 | 365 | 63486468 |
| Visual acuity reduced | 36.81 | 25.53 | 17 | 2172 | 21809 | 63465024 |
| Blindness unilateral | 36.50 | 25.53 | 12 | 2177 | 6229 | 63480604 |
| Toxic anterior segment syndrome | 36.02 | 25.53 | 9 | 2180 | 1762 | 63485071 |
| Glaucoma | 35.92 | 25.53 | 16 | 2173 | 18889 | 63467944 |
| Product container issue | 35.91 | 25.53 | 9 | 2180 | 1784 | 63485049 |
| Ocular hyperaemia | 34.52 | 25.53 | 17 | 2172 | 25127 | 63461706 |
| Vitreous floaters | 29.07 | 25.53 | 10 | 2179 | 5956 | 63480877 |
| Product quality issue | 28.85 | 25.53 | 17 | 2172 | 35848 | 63450985 |
| Hypopyon | 26.86 | 25.53 | 6 | 2183 | 726 | 63486107 |
| Corneal disorder | 26.10 | 25.53 | 7 | 2182 | 1807 | 63485026 |
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 | 102.14 | 27.05 | 26 | 1218 | 5357 | 34950330 |
| Corneal oedema | 77.07 | 27.05 | 16 | 1228 | 1335 | 34954352 |
| Toxic anterior segment syndrome | 61.79 | 27.05 | 13 | 1231 | 1156 | 34954531 |
| Eye pain | 55.27 | 27.05 | 20 | 1224 | 13442 | 34942245 |
| Eye irritation | 49.74 | 27.05 | 16 | 1228 | 7545 | 34948142 |
| Anterior chamber cell | 49.67 | 27.05 | 9 | 1235 | 366 | 34955321 |
| Cataract | 48.67 | 27.05 | 22 | 1222 | 26164 | 34929523 |
| Visual impairment | 47.94 | 27.05 | 24 | 1220 | 35778 | 34919909 |
| Product quality issue | 40.39 | 27.05 | 17 | 1227 | 17018 | 34938669 |
| Eye inflammation | 38.54 | 27.05 | 10 | 1234 | 2208 | 34953479 |
| Endophthalmitis | 38.44 | 27.05 | 11 | 1233 | 3497 | 34952190 |
| Vision blurred | 34.39 | 27.05 | 21 | 1223 | 45942 | 34909745 |
| Retinal occlusive vasculitis | 30.75 | 27.05 | 4 | 1240 | 15 | 34955672 |
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 | 131.17 | 23.41 | 35 | 2635 | 9170 | 79732548 |
| Cataract | 114.71 | 23.41 | 51 | 2619 | 62069 | 79679649 |
| Endophthalmitis | 113.57 | 23.41 | 29 | 2641 | 6399 | 79735319 |
| Corneal oedema | 110.87 | 23.41 | 24 | 2646 | 2596 | 79739122 |
| Anterior chamber cell | 89.89 | 23.41 | 17 | 2653 | 932 | 79740786 |
| Toxic anterior segment syndrome | 87.68 | 23.41 | 20 | 2650 | 2744 | 79738974 |
| Visual impairment | 65.84 | 23.41 | 40 | 2630 | 92091 | 79649627 |
| Anterior chamber fibrin | 64.39 | 23.41 | 10 | 2660 | 166 | 79741552 |
| Eye inflammation | 57.59 | 23.41 | 17 | 2653 | 6396 | 79735322 |
| Uveitis | 48.47 | 23.41 | 19 | 2651 | 16811 | 79724907 |
| Eye pain | 48.12 | 23.41 | 24 | 2646 | 37554 | 79704164 |
| Multiple use of single-use product | 47.83 | 23.41 | 10 | 2660 | 914 | 79740804 |
| Corneal disorder | 38.80 | 23.41 | 10 | 2660 | 2281 | 79739437 |
| Vision blurred | 37.74 | 23.41 | 30 | 2640 | 105868 | 79635850 |
| Hypopyon | 34.80 | 23.41 | 8 | 2662 | 1134 | 79740584 |
| Paronychia | 34.21 | 23.41 | 12 | 2658 | 7796 | 79733922 |
| Aqueous fibrin | 29.94 | 23.41 | 5 | 2665 | 133 | 79741585 |
| Ulcerative keratitis | 29.74 | 23.41 | 9 | 2661 | 3680 | 79738038 |
| Visual acuity reduced | 26.85 | 23.41 | 15 | 2655 | 29454 | 79712264 |
| Vitritis | 26.38 | 23.41 | 7 | 2663 | 1787 | 79739931 |
| Infective keratitis | 26.33 | 23.41 | 4 | 2666 | 57 | 79741661 |
| Blindness unilateral | 26.31 | 23.41 | 10 | 2660 | 8136 | 79733582 |
| Retinal occlusive vasculitis | 25.50 | 23.41 | 4 | 2666 | 71 | 79741647 |
| Granulocytosis | 25.49 | 23.41 | 5 | 2665 | 332 | 79741386 |
| Vitreal cells | 25.34 | 23.41 | 4 | 2666 | 74 | 79741644 |
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 | 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 |
| 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 |
| Difluprednate Ophthalmic Emulsion | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-588 | EMULSION | 0.50 mg | OPHTHALMIC | ANDA | 23 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 |