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

Stem definitionDrug idCAS RN
prednisone and prednisolone derivatives 2247 52-21-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • prednisolone acetate
  • hydroprednisone acetate
  • meticortelone acetate
  • meticotelone acetate
  • Molecular weight: 402.49
  • Formula: C23H30O6
  • CLOGP: 1.96
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 100.90
  • ALOGS: -3.98
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
S (Water solubility) 0.22 mg/mL Bocci G, Oprea TI, Benet LZ
BA (Bioavailability) 82 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,TEK 20
kinase-selectivity-class GRK2,MAP2K6 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 6.577 Moderate 0.77
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 Moderate 0.77
rat-kpuu-brain Rat brain Kpuu 0.053 % Moderate 0.77

Approvals:

DateAgencyCompanyOrphan
May 22, 1955 FDA SCHERING

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 225.53 13.06 109 10854 44059 90573425
Intraocular pressure increased 217.34 13.06 65 10898 7028 90610456
Treatment failure 211.91 13.06 220 10743 303708 90313776
Corneal epithelium defect 188.38 13.06 35 10928 456 90617028
Endophthalmitis 183.68 13.06 52 10911 4633 90612851
Eye irritation 182.99 13.06 87 10876 33891 90583593
Corneal oedema 177.03 13.06 42 10921 1859 90615625
Visual acuity reduced 173.81 13.06 75 10888 23335 90594149
Vision blurred 150.87 13.06 117 10846 110176 90507308
Corneal disorder 143.65 13.06 36 10927 2006 90615478
Corneal opacity 127.20 13.06 28 10935 883 90616601
Ocular hyperaemia 124.64 13.06 67 10896 33731 90583753
Uveitis 111.67 13.06 49 10914 15854 90601630
Punctate keratitis 108.57 13.06 24 10939 772 90616712
Toxic anterior segment syndrome 106.70 13.06 29 10934 2221 90615263
Anterior chamber cell 88.40 13.06 20 10943 716 90616768
Cataract 80.54 13.06 68 10895 72024 90545460
Product delivery mechanism issue 78.40 13.06 17 10946 499 90616985
Eye inflammation 78.04 13.06 31 10932 7820 90609664
Vitritis 72.80 13.06 20 10943 1594 90615890
Keratitis bacterial 70.73 13.06 11 10952 43 90617441
Hypopyon 68.73 13.06 17 10946 897 90616587
Glaucoma 62.43 13.06 36 10927 20719 90596765
Photophobia 58.98 13.06 35 10928 21234 90596250
Cystoid macular oedema 58.96 13.06 18 10945 2082 90615402
Foreign body sensation in eyes 58.70 13.06 20 10943 3280 90614204
Product container issue 58.29 13.06 18 10945 2163 90615321
Corneal infiltrates 58.07 13.06 11 10952 160 90617324
Iridocyclitis 56.67 13.06 20 10943 3641 90613843
Corneal transplant 55.38 13.06 12 10951 351 90617133
Keratitis 54.91 13.06 20 10943 3986 90613498
Infective keratitis 48.32 13.06 8 10955 50 90617434
Visual impairment 47.93 13.06 69 10894 132296 90485188
Rhegmatogenous retinal detachment 47.63 13.06 9 10954 129 90617355
Vitreous haemorrhage 47.04 13.06 16 10947 2610 90614874
Cataract subcapsular 47.02 13.06 12 10951 719 90616765
Corneal scar 46.82 13.06 9 10954 142 90617342
Tractional retinal detachment 46.82 13.06 8 10955 62 90617422
Corneal graft rejection 45.75 13.06 8 10955 72 90617412
Corneal deposits 43.88 13.06 10 10953 370 90617114
Ulcerative keratitis 42.76 13.06 16 10947 3437 90614047
Blindness 42.51 13.06 31 10932 26537 90590947
Conjunctival ulcer 42.39 13.06 7 10956 43 90617441
Iritis 41.74 13.06 16 10947 3670 90613814
Retinal detachment 41.43 13.06 19 10944 6803 90610681
Vitreous floaters 39.60 13.06 19 10944 7530 90609954
Hyphaema 38.88 13.06 9 10954 357 90617127
Keratopathy 37.69 13.06 10 10953 698 90616786
Ocular discomfort 36.38 13.06 17 10946 6353 90611131
Eye discharge 35.06 13.06 18 10945 8240 90609244
Corneal perforation 34.27 13.06 9 10954 604 90616880
Infectious crystalline keratopathy 33.43 13.06 5 10958 14 90617470
Conjunctival hyperaemia 33.20 13.06 13 10950 3156 90614328
Complications of transplant surgery 32.77 13.06 7 10956 191 90617293
Off label use 32.57 13.06 236 10727 1102016 89515468
Eye infection toxoplasmal 32.49 13.06 8 10955 414 90617070
Keratitis fungal 32.39 13.06 7 10956 202 90617282
Hypotony of eye 31.79 13.06 7 10956 221 90617263
Blindness unilateral 30.37 13.06 16 10947 7720 90609764
Retinal pigment epitheliopathy 30.23 13.06 7 10956 278 90617206
Liquid product physical issue 29.96 13.06 10 10953 1540 90615944
Fibrous histiocytoma 29.44 13.06 8 10955 612 90616872
Product residue present 29.40 13.06 13 10950 4278 90613206
Ocular hypertension 29.17 13.06 10 10953 1670 90615814
Keratitis viral 28.42 13.06 4 10959 6 90617478
Foreign body in eye 27.35 13.06 6 10957 186 90617298
Eye swelling 27.34 13.06 25 10938 29361 90588123
Immobile 27.32 13.06 14 10949 6384 90611100
Eye disorder 26.86 13.06 24 10939 27366 90590118
Astigmatism 26.84 13.06 9 10954 1405 90616079
Eye operation 24.51 13.06 10 10953 2699 90614785
Angle closure glaucoma 24.28 13.06 10 10953 2765 90614719
Corneal exfoliation 24.06 13.06 3 10960 0 90617484
Corneal endotheliitis 23.89 13.06 4 10959 27 90617457
Ocular lymphoma 23.75 13.06 5 10958 127 90617357
Corneal neovascularisation 23.08 13.06 5 10958 146 90617338
Corneal thinning 22.79 13.06 5 10958 155 90617329
Metamorphopsia 22.70 13.06 8 10955 1449 90616035
Vitreous opacities 22.01 13.06 6 10957 464 90617020
Macular oedema 21.71 13.06 11 10952 4898 90612586
Scleral thinning 21.60 13.06 4 10959 51 90617433
Lacrimation increased 21.32 13.06 21 10942 27041 90590443
Scleritis 21.09 13.06 11 10952 5197 90612287
Lenticular opacities 20.10 13.06 5 10958 270 90617214
Instillation site foreign body sensation 19.66 13.06 3 10960 10 90617474
Corneal abrasion 19.65 13.06 7 10956 1309 90616175
Open angle glaucoma 19.50 13.06 5 10958 305 90617179
Intraocular pressure decreased 18.39 13.06 4 10959 119 90617365
Ocular procedural complication 18.38 13.06 5 10958 384 90617100
Instillation site pain 17.97 13.06 6 10957 924 90616560
Scleral disorder 17.96 13.06 4 10959 133 90617351
Conjunctivitis 17.91 13.06 19 10944 26687 90590797
Immunoglobulin G4 related disease 17.91 13.06 4 10959 135 90617349
Persistent corneal epithelial defect 17.83 13.06 3 10960 21 90617463
Product physical consistency issue 17.82 13.06 6 10957 948 90616536
Conjunctival oedema 17.73 13.06 6 10957 963 90616521
Product complaint 17.72 13.06 14 10949 13486 90603998
Corneal thickening 17.59 13.06 3 10960 23 90617461
Colitis ulcerative 16.99 13.06 28 10935 60238 90557246
Bedridden 16.82 13.06 13 10950 12135 90605349
Drug effective for unapproved indication 16.81 13.06 11 10952 7907 90609577
No adverse event 15.79 13.06 29 10934 67953 90549531
Thrombocytosis 15.54 13.06 10 10953 6991 90610493
Cytomegalovirus chorioretinitis 15.52 13.06 7 10956 2412 90615072
B-cell aplasia 15.24 13.06 4 10959 268 90617216
Pancreatic failure 15.21 13.06 6 10957 1486 90615998
Swelling of eyelid 15.18 13.06 9 10954 5445 90612039
Dry eye 15.11 13.06 26 10937 57905 90559579
Retinal vasculitis 15.02 13.06 6 10957 1535 90615949
Choroidal detachment 15.00 13.06 4 10959 285 90617199
Conjunctival haemorrhage 14.96 13.06 8 10955 3976 90613508
Choroidal effusion 14.89 13.06 5 10958 784 90616700
Periorbital pain 14.62 13.06 4 10959 314 90617170
Keratic precipitates 14.55 13.06 4 10959 319 90617165
Vitreous haze 14.49 13.06 3 10960 70 90617414
Microsporidia infection 14.28 13.06 4 10959 342 90617142
Product substitution issue 14.23 13.06 14 10949 17994 90599490
Haemorrhagic occlusive retinal vasculitis 14.15 13.06 3 10960 79 90617405
Corynebacterium infection 13.89 13.06 5 10958 963 90616521
Macular hole 13.80 13.06 5 10958 980 90616504
Abnormal sensation in eye 13.59 13.06 6 10957 1965 90615519
Corneal erosion 13.54 13.06 4 10959 414 90617070
Anterior chamber inflammation 13.52 13.06 4 10959 416 90617068
Parophthalmia 13.49 13.06 4 10959 419 90617065
Iris adhesions 13.45 13.06 4 10959 423 90617061
Type 2 diabetes mellitus 13.34 13.06 4 10959 203240 90414244

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
Endophthalmitis 275.02 16.93 75 6806 4358 42610096
Intraocular pressure increased 256.02 16.93 77 6804 6356 42608098
Eye pain 255.62 16.93 98 6783 16932 42597522
Treatment failure 220.93 16.93 133 6748 62491 42551963
Visual acuity reduced 164.12 16.93 72 6809 17478 42596976
Corneal oedema 123.60 16.93 32 6849 1516 42612938
Ulcerative keratitis 118.68 16.93 33 6848 2055 42612399
Cataract 115.53 16.93 68 6813 30536 42583918
Corneal epithelium defect 105.21 16.93 22 6859 400 42614054
Choroiditis 88.66 16.93 24 6857 1351 42613103
Corneal opacity 84.68 16.93 20 6861 645 42613809
Ocular hyperaemia 80.72 16.93 43 6838 15920 42598534
Uveitis 76.95 16.93 35 6846 9223 42605231
Keratitis fungal 75.67 16.93 15 6866 206 42614248
Glaucoma 71.14 16.93 32 6849 8216 42606238
Toxic anterior segment syndrome 69.69 16.93 20 6861 1396 42613058
Vision blurred 66.88 16.93 61 6820 53638 42560816
Cystoid macular oedema 61.80 16.93 17 6864 1016 42613438
Corneal perforation 59.01 16.93 13 6868 305 42614149
Eye irritation 55.84 16.93 30 6851 11288 42603166
Corneal scar 52.49 16.93 11 6870 202 42614252
Infectious crystalline keratopathy 51.53 16.93 9 6872 58 42614396
Foreign body sensation in eyes 49.29 16.93 14 6867 941 42613513
Anterior chamber cell 48.90 16.93 12 6869 456 42613998
Corneal infiltrates 48.61 16.93 10 6871 167 42614287
Corneal disorder 47.86 16.93 14 6867 1045 42613409
Flat anterior chamber of eye 44.75 16.93 8 6873 60 42614394
Corneal thinning 43.33 16.93 9 6872 158 42614296
Eye inflammation 42.84 16.93 17 6864 3201 42611253
Hypopyon 42.41 16.93 11 6870 524 42613930
Photophobia 41.39 16.93 22 6859 8097 42606357
Keratitis 40.62 16.93 14 6867 1777 42612677
Astigmatism 40.56 16.93 13 6868 1318 42613136
Visual impairment 40.54 16.93 42 6839 43071 42571383
NPM1 gene mutation 39.82 16.93 8 6873 118 42614336
Iris adhesions 38.73 16.93 9 6872 270 42614184
Vitritis 37.25 16.93 12 6869 1237 42613217
Retinal detachment 37.03 16.93 19 6862 6506 42607948
Eye infection 34.70 16.93 16 6865 4345 42610109
Corneal deposits 34.69 16.93 8 6873 232 42614222
Chimerism 34.11 16.93 8 6873 250 42614204
Bronchiolitis obliterans syndrome 32.62 16.93 8 6873 303 42614151
Necrotising scleritis 30.50 16.93 6 6875 79 42614375
CSF pressure increased 29.71 16.93 5 6876 25 42614429
Iris atrophy 29.65 16.93 6 6875 92 42614362
Retinal tear 26.97 16.93 9 6872 1035 42613419
Corneal graft rejection 26.96 16.93 5 6876 47 42614407
Ocular discomfort 26.80 16.93 12 6869 3045 42611409
Persistent corneal epithelial defect 26.24 16.93 5 6876 55 42614399
Off label use 25.03 16.93 182 6699 638153 41976301
Macular oedema 25.02 16.93 12 6869 3557 42610897
Idiopathic intracranial hypertension 24.85 16.93 8 6873 822 42613632
Vitreous opacities 24.66 16.93 7 6874 469 42613985
Dry eye 24.09 16.93 20 6861 15486 42598968
Blindness 23.49 16.93 21 6860 17957 42596497
Ocular hypertension 22.36 16.93 8 6873 1133 42613321
Eye infection viral 22.14 16.93 4 6877 32 42614422
Pupillary disorder 21.88 16.93 6 6875 354 42614100
Multifocal motor neuropathy 21.81 16.93 5 6876 141 42614313
Ophthalmic herpes simplex 21.53 16.93 6 6875 376 42614078
Iris hypopigmentation 21.25 16.93 4 6877 41 42614413
Steroid diabetes 21.25 16.93 10 6871 2842 42611612
Liquid product physical issue 21.00 16.93 7 6874 802 42613652
Vitreous floaters 20.26 16.93 11 6870 4219 42610235
Conjunctival hyperaemia 20.23 16.93 10 6871 3166 42611288
Eye disorder 20.20 16.93 16 6865 11596 42602858
Mononeuropathy multiplex 19.69 16.93 6 6875 515 42613939
Product delivery mechanism issue 18.83 16.93 5 6876 261 42614193
Blepharitis 18.27 16.93 8 6873 1925 42612529
Corneal transplant 17.99 16.93 4 6877 98 42614356
Radiation pneumonitis 17.98 16.93 9 6872 2924 42611530
Keratopathy 17.97 16.93 6 6875 692 42613762
Product quality issue 17.85 16.93 18 6863 17864 42596590
Eye discharge 17.80 16.93 9 6872 2986 42611468
Hyphaema 17.78 16.93 6 6875 714 42613740
Eye swelling 17.74 16.93 15 6866 11905 42602549
Peripheral venous disease 17.69 16.93 9 6872 3027 42611427
Scleral thinning 17.22 16.93 3 6878 19 42614435
Articular disc disorder 17.22 16.93 3 6878 19 42614435

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
Endophthalmitis 439.15 12.43 119 14840 8068 110566272
Intraocular pressure increased 427.82 12.43 124 14835 10752 110563588
Eye pain 343.95 12.43 157 14802 49942 110524398
Visual acuity reduced 296.19 12.43 124 14835 32049 110542291
Corneal epithelium defect 286.84 12.43 56 14903 856 110573484
Corneal oedema 282.10 12.43 69 14890 3104 110571236
Corneal opacity 184.32 12.43 41 14918 1210 110573130
Uveitis 171.13 12.43 75 14884 21635 110552705
Corneal disorder 164.13 12.43 43 14916 2554 110571786
Toxic anterior segment syndrome 156.52 12.43 44 14915 3410 110570930
Ulcerative keratitis 146.77 12.43 45 14914 4721 110569619
Vision blurred 140.93 12.43 126 14833 128896 110445444
Anterior chamber cell 131.48 12.43 31 14928 1190 110573150
Ocular hyperaemia 129.01 12.43 75 14884 39211 110535129
Cataract 125.17 12.43 96 14863 79389 110494951
Punctate keratitis 116.31 12.43 28 14931 1176 110573164
Keratitis fungal 114.14 12.43 23 14936 416 110573924
Vitritis 107.61 12.43 31 14928 2622 110571718
Hypopyon 106.38 12.43 27 14932 1413 110572927
Eye irritation 102.31 12.43 61 14898 33391 110540949
Cystoid macular oedema 101.57 12.43 30 14929 2770 110571570
Glaucoma 101.53 12.43 53 14906 22464 110551876
Corneal scar 89.41 12.43 18 14941 324 110574016
Choroiditis 89.02 12.43 24 14935 1591 110572749
Corneal infiltrates 82.32 12.43 17 14942 349 110573991
Eye inflammation 79.84 12.43 34 14925 9137 110565203
Infectious crystalline keratopathy 78.11 12.43 13 14946 74 110574266
Corneal perforation 75.95 12.43 19 14940 937 110573403
Astigmatism 73.94 12.43 21 14938 1688 110572652
Foreign body sensation in eyes 71.86 12.43 24 14935 3310 110571030
Keratitis bacterial 70.91 12.43 14 14945 227 110574113
Keratitis 68.86 12.43 26 14933 5118 110569222
Corneal deposits 68.74 12.43 16 14943 580 110573760
Photophobia 68.57 12.43 43 14916 25728 110548612
Vitreous haemorrhage 60.57 12.43 23 14936 4597 110569743
Corneal transplant 57.60 12.43 13 14946 410 110573930
Blindness 57.39 12.43 44 14915 36315 110538025
Iridocyclitis 57.06 12.43 23 14936 5385 110568955
Hypotony of eye 56.10 12.43 13 14946 462 110573878
Retinal detachment 55.45 12.43 28 14931 11072 110563268
Infective keratitis 54.25 12.43 10 14949 110 110574230
Visual impairment 52.43 12.43 77 14882 134351 110439989
Off label use 51.91 12.43 363 14596 1499822 109074518
Corneal thinning 51.39 12.43 11 14948 270 110574070
Hyphaema 49.69 12.43 14 14945 1093 110573247
Conjunctival hyperaemia 48.72 12.43 21 14938 5810 110568530
Vitreous floaters 48.45 12.43 24 14935 9110 110565230
Cataract subcapsular 47.88 12.43 14 14945 1247 110573093
Corneal graft rejection 46.82 12.43 9 14950 126 110574214
Keratopathy 46.71 12.43 14 14945 1359 110572981
NPM1 gene mutation 46.50 12.43 9 14950 131 110574209
Iritis 46.39 12.43 19 14940 4633 110569707
Rhegmatogenous retinal detachment 46.02 12.43 10 14949 264 110574076
Vitreous opacities 43.36 12.43 12 14947 877 110573463
Persistent corneal epithelial defect 42.24 12.43 8 14951 103 110574237
Iris adhesions 42.06 12.43 11 14948 648 110573692
Ocular discomfort 41.09 12.43 21 14938 8512 110565828
Chimerism 39.05 12.43 9 14950 312 110574028
Macular oedema 39.03 12.43 19 14940 6947 110567393
Ocular hypertension 38.98 12.43 14 14945 2394 110571946
Blindness unilateral 38.38 12.43 21 14938 9765 110564575
Eye discharge 37.73 12.43 20 14939 8734 110565606
Complications of transplant surgery 35.64 12.43 10 14949 769 110573571
Tractional retinal detachment 34.87 12.43 7 14952 124 110574216
Necrotising scleritis 34.56 12.43 8 14951 283 110574057
Retinal tear 33.92 12.43 12 14947 1965 110572375
Eye infection 33.13 12.43 22 14937 14496 110559844
Flat anterior chamber of eye 33.01 12.43 7 14952 164 110574176
Bronchiolitis obliterans syndrome 32.22 12.43 9 14950 681 110573659
Iris atrophy 31.42 12.43 7 14952 208 110574132
Lacrimation increased 31.34 12.43 29 14930 30921 110543419
Scleral thinning 31.28 12.43 6 14953 83 110574257
Scleral disorder 30.56 12.43 7 14952 236 110574104
Fibrous histiocytoma 30.48 12.43 9 14950 830 110573510
Corneal abrasion 29.80 12.43 10 14949 1399 110572941
Eye infection toxoplasmal 26.94 12.43 8 14951 752 110573588
No adverse event 26.92 12.43 41 14918 73798 110500542
Corneal exfoliation 26.62 12.43 4 14955 10 110574330
Retinal vasculitis 26.14 12.43 10 14949 2039 110572301
Immobile 26.06 12.43 15 14944 7687 110566653
Eye swelling 26.04 12.43 27 14932 33021 110541319
Idiopathic intracranial hypertension 25.87 12.43 12 14947 3940 110570400
Retinal pigment epitheliopathy 25.14 12.43 7 14952 523 110573817
Open angle glaucoma 24.59 12.43 7 14952 567 110573773
Cytomegalovirus chorioretinitis 24.43 12.43 14 14945 7114 110567226
Pupillary disorder 23.72 12.43 7 14952 644 110573696
Corneal endotheliitis 23.35 12.43 5 14954 123 110574217
Multifocal motor neuropathy 22.87 12.43 5 14954 136 110574204
Corynebacterium infection 22.81 12.43 9 14950 1991 110572349
Choroidal detachment 22.54 12.43 7 14952 765 110573575
Anterior chamber inflammation 22.52 12.43 7 14952 768 110573572
Conjunctivitis 22.06 12.43 25 14934 33767 110540573
Eye disorder 21.68 12.43 23 14936 28883 110545457
Keratoplasty 21.65 12.43 3 14956 3 110574337
Confusional state 21.57 12.43 19 14940 468661 110105679
Intraocular pressure decreased 21.35 12.43 5 14954 186 110574154
Necrotising retinitis 21.12 12.43 8 14951 1588 110572752
Angle closure glaucoma 20.98 12.43 10 14949 3489 110570851
Metamorphopsia 20.94 12.43 8 14951 1625 110572715
Bipolar II disorder 20.82 12.43 6 14953 508 110573832
Corneal neovascularisation 20.77 12.43 5 14954 210 110574130
Ocular lymphoma 20.72 12.43 5 14954 212 110574128
Anterior chamber fibrin 20.02 12.43 5 14954 245 110574095
Iris hypopigmentation 19.97 12.43 4 14955 70 110574270
Conjunctival erosion 19.92 12.43 5 14954 250 110574090
Graft complication 19.91 12.43 7 14952 1125 110573215
Drug effective for unapproved indication 19.88 12.43 16 14943 14151 110560189
Steroid diabetes 19.85 12.43 11 14948 5243 110569097
Posterior capsule opacification 19.71 12.43 5 14954 261 110574079
CSF pressure increased 19.62 12.43 5 14954 266 110574074
Optic nerve cupping 19.61 12.43 4 14955 77 110574263
Scleritis 19.53 12.43 11 14948 5409 110568931
Drug ineffective for unapproved indication 19.47 12.43 43 14916 102795 110471545
Transplant rejection 19.23 12.43 20 14939 24547 110549793
Scleromalacia 19.02 12.43 4 14955 90 110574250
Tuberculosis of eye 18.98 12.43 4 14955 91 110574249
Dry eye 18.97 12.43 30 14929 55763 110518577
Haemorrhagic occlusive retinal vasculitis 18.69 12.43 4 14955 98 110574242
Instillation site pain 18.61 12.43 6 14953 740 110573600
Radiation pneumonitis 18.53 12.43 10 14949 4526 110569814
Keratitis viral 18.35 12.43 3 14956 15 110574325
Microsporidia infection 18.27 12.43 7 14952 1432 110572908
Vitreous haze 17.91 12.43 4 14955 120 110574220
Mononeuropathy multiplex 17.76 12.43 6 14953 857 110573483
Articular disc disorder 17.75 12.43 3 14956 19 110574321
Foreign body in eye 17.75 12.43 5 14954 390 110573950
Ocular vasculitis 17.58 12.43 4 14955 131 110574209
Overdose 17.43 12.43 5 14954 233789 110340551
Acute myeloid leukaemia recurrent 17.36 12.43 10 14949 5129 110569211
Toxicity to various agents 17.15 12.43 24 14935 480531 110093809
Conjunctival bleb 17.08 12.43 4 14955 149 110574191
Blood immunoglobulin G decreased 16.90 12.43 10 14949 5390 110568950
Synovitis 16.84 12.43 8 14951 274084 110300256
Corneal erosion 16.80 12.43 5 14954 474 110573866
Cytomegalovirus infection 16.77 12.43 28 14931 54416 110519924
Corneal thickening 16.72 12.43 3 14956 28 110574312
Glare 16.64 12.43 4 14955 167 110574173
Ocular procedural complication 16.33 12.43 5 14954 522 110573818
Systemic lupus erythematosus 16.28 12.43 7 14952 254331 110320009
Keratic precipitates 16.06 12.43 5 14954 551 110573789
Eye infection viral 15.97 12.43 4 14955 198 110574142
Blepharitis 15.76 12.43 9 14950 4543 110569797
Ciliary body disorder 15.67 12.43 3 14956 41 110574299
Anterior chamber flare 15.67 12.43 4 14955 214 110574126
Injury corneal 15.49 12.43 4 14955 224 110574116
Eye infection fungal 15.49 12.43 5 14954 620 110573720
Colitis ulcerative 15.38 12.43 33 14926 77330 110497010
Epstein-Barr virus associated lymphoproliferative disorder 15.31 12.43 9 14950 4793 110569547
Corneal degeneration 15.22 12.43 4 14955 240 110574100
Product delivery mechanism issue 15.11 12.43 4 14955 247 110574093
Osteoporosis 14.89 12.43 35 14924 87117 110487223
Acute graft versus host disease in skin 14.79 12.43 12 14947 10728 110563612
Macular fibrosis 14.76 12.43 5 14954 719 110573621
Conjunctival retraction 14.70 12.43 3 14956 58 110574282
Diffuse large B-cell lymphoma refractory 14.50 12.43 7 14952 2514 110571826
Bedridden 14.41 12.43 13 14946 13412 110560928
Product container issue 14.22 12.43 6 14953 1574 110572766
Wound 14.16 12.43 7 14952 234430 110339910
Eye operation 14.12 12.43 7 14952 2660 110571680
Staphylococcus test positive 14.06 12.43 10 14949 7360 110566980
Retinal drusen 14 12.43 3 14956 74 110574266
Ciliary hyperaemia 13.92 12.43 3 14956 76 110574264
Ophthalmic herpes simplex 13.62 12.43 5 14954 909 110573431
Corneal decompensation 13.53 12.43 3 14956 87 110574253
Eye abscess 13.51 12.43 4 14955 372 110573968
Vitreous disorder 13.36 12.43 4 14955 387 110573953
Intraocular pressure fluctuation 13.22 12.43 3 14956 97 110574243
Immunosuppression 13.08 12.43 14 14945 17745 110556595
Immunoglobulin G4 related disease 13.08 12.43 4 14955 416 110573924
Macular hole 13.04 12.43 5 14954 1026 110573314
Eye infection bacterial 12.98 12.43 4 14955 426 110573914
Conjunctival disorder 12.96 12.43 4 14955 428 110573912
Mycotic endophthalmitis 12.84 12.43 4 14955 442 110573898
Disability 12.78 12.43 18 14941 30205 110544135
Infective scleritis 12.60 12.43 3 14956 120 110574220
Non-infectious endophthalmitis 12.46 12.43 4 14955 487 110573853

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
FDA EPC N0000175576 Corticosteroid
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D018931 Antineoplastic Agents, Hormonal
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33231 antitubercular agent
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35472 anti-inflammatory drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35816 leprostatic drug
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:37962 adrenergic agent
CHEBI has role CHEBI:39456 antiglaucoma drug
CHEBI has role CHEBI:49103 drug metabolite
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:50671 antithyroid drug
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:53784 antispasmodic drug
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:76595 nephroprotective agent
CHEBI has role CHEBI:77715 nasal decongestant
CHEBI has role CHEBI:78298 environmental contaminant
CHEBI has role CHEBI:231911 renoprotective agent
CHEBI has role CHEBI:233423 antifibrotic agent
CHEBI has role CHEBI:35480 analgesic

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

DiseaseRelationSNOMED_IDDOID
Blepharoconjunctivitis indication 68659002 DOID:2456
Iridocyclitis indication 77971008
Bacterial conjunctivitis indication 128350005 DOID:9700
Uveitis indication 128473001 DOID:13141
Infective blepharitis indication 312219000
Superficial Ocular Infection indication
Ocular hypertension contraindication 4210003 DOID:9282
Herpes simplex keratitis contraindication 9389005
Herpes simplex dendritic keratitis contraindication 29943008
Fungal infection of eye contraindication 31194008
Severe myopia contraindication 34187009
Tuberculosis of eye contraindication 49107007
Diabetes mellitus contraindication 73211009 DOID:9351
Open-angle glaucoma contraindication 84494001 DOID:1067
Krukenberg spindle contraindication 85430004
Anemia due to enzyme deficiency contraindication 111577008
Deficiency of glucose-6-phosphate dehydrogenase contraindication 124134002 DOID:2862
Eye infection contraindication 128351009
Bacterial infection of eye contraindication 128984004
Viral eye infection contraindication 312132001
Vaccinia keratitis contraindication 397552005
Porphyria contraindication 418470004




🐶 Veterinary Drug Use

SpeciesUseRelation
Dogs Conjunctivitis Indication
Dogs Otitis externa Indication
Cats Inflammation Indication
Cats Acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis Indication
Cats Supportive therapy in nonspecific dermatosis such as summer eczema and atopy Indication
Cats Supportive therapy pre- and post-operatively Indication
Cats Infectious allergic keratitis Indication
Cats Traumatic keratitis Indication
Cats Conjunctivitis Indication
Cats Otitis externa Indication
Cats Chronic otitis externa Indication
Dogs Inflammation Indication
Dogs Acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis Indication
Dogs Supportive therapy in nonspecific dermatosis such as summer eczema and atopy Indication
Dogs Supportive therapy pre- and post-operatively Indication
Dogs Infectious allergic keratitis Indication
Dogs Traumatic keratitis Indication
Dogs Chronic otitis externa Indication
Horses Inflammation Indication
Horses Acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis Indication
Horses Supportive therapy in nonspecific dermatosis such as summer eczema and atopy Indication
Horses Supportive therapy pre- and post-operatively Indication
Horses Infectious allergic keratitis Indication
Horses Traumatic keratitis Indication
Horses Conjunctivitis Indication
Horses Otitis externa Indication
Horses Chronic otitis externa Indication

🐶 Veterinary products

ProductApplicantIngredients
Meticortelone Acetate Intervet Inc. 1
Neo-Delta-Cortef with Tetracaine Ointment Zoetis Inc. 3
Neo-Delta Cortef Sterile Solution Zoetis Inc. 2
Surolan Elanco US Inc. 3

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.65 acidic
pKa2 13.36 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 15MG BASE/5ML FLO-PRED SUN PHARMA CANADA N022067 Jan. 17, 2008 DISCN SUSPENSION ORAL 7799331 Oct. 11, 2028 TREATMENT OF ALLERGIC REACTIONS
EQ 15MG BASE/5ML FLO-PRED SUN PHARMA CANADA N022067 Jan. 17, 2008 DISCN SUSPENSION ORAL 7799331 Oct. 11, 2028 TREATMENT OF ASTHMA
EQ 5MG BASE/5ML FLO-PRED SUN PHARMA CANADA N022067 Jan. 17, 2008 DISCN SUSPENSION ORAL 7799331 Oct. 11, 2028 TREATMENT OF ALLERGIC REACTIONS
EQ 5MG BASE/5ML FLO-PRED SUN PHARMA CANADA N022067 Jan. 17, 2008 DISCN SUSPENSION ORAL 7799331 Oct. 11, 2028 TREATMENT OF ASTHMA

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
4017989 VUID
N0000179219 NUI
D00980 KEGG_DRUG
4017988 VANDF
4017989 VANDF
C0071839 UMLSCUI
CHEBI:8380 CHEBI
TUA PDB_CHEM_ID
CHEMBL1152 ChEMBL_ID
DB15566 DRUGBANK_ID
C009935 MESH_SUPPLEMENTAL_RECORD_UI
5834 PUBCHEM_CID
8B2807733D UNII
34372 RXNORM
25176 MMSL
4601 MMSL
5347 MMSL
5348 MMSL
59710 MMSL
d00084 MMSL
002155 NDDF
002156 NDDF
116601002 SNOMEDCT_US
52388000 SNOMEDCT_US
96334000 SNOMEDCT_US
C0032950 UMLSCUI
DB00860 DRUGBANK_ID
5755 PUBCHEM_CID
535 INN_ID
D011239 MESH_DESCRIPTOR_UI
CHEBI:8378 CHEBI
8B2807733D INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PRED MILD HUMAN PRESCRIPTION DRUG LABEL 1 11980-174 SUSPENSION/ DROPS 1.20 mg OPHTHALMIC NDA 18 sections
PRED FORTE HUMAN PRESCRIPTION DRUG LABEL 1 11980-180 SUSPENSION/ DROPS 10 mg OPHTHALMIC NDA 18 sections
Prednisolone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 50090-0559 SUSPENSION/ DROPS 10 mg OPHTHALMIC NDA authorized generic 18 sections
Prednisolone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 50090-0561 SUSPENSION/ DROPS 10 mg OPHTHALMIC NDA authorized generic 17 sections
PREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 50090-1912 SUSPENSION/ DROPS 10 mg OPHTHALMIC NDA authorized generic 18 sections
PREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 50090-5275 SUSPENSION/ DROPS 10 mg OPHTHALMIC NDA authorized generic 18 sections
PREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 50090-7539 SUSPENSION/ DROPS 10 mg OPHTHALMIC ANDA 16 sections
PREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 52959-265 SUSPENSION/ DROPS 10 mg OPHTHALMIC NDA authorized generic 18 sections
BLEPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 2 54868-0634 SUSPENSION/ DROPS 2 mg OPHTHALMIC NDA 21 sections
BLEPHAMIDE HUMAN PRESCRIPTION DRUG LABEL 2 54868-1157 OINTMENT 2 mg OPHTHALMIC ANDA 19 sections
Prednisolone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 54868-4293 SUSPENSION 10 mg OPHTHALMIC NDA authorized generic 17 sections
PRED MILD HUMAN PRESCRIPTION DRUG LABEL 1 54868-6355 SUSPENSION/ DROPS 1.20 mg OPHTHALMIC NDA 18 sections
prednisolone acetate HUMAN PRESCRIPTION DRUG LABEL 1 60219-2550 SUSPENSION/ DROPS 10 mg OPHTHALMIC ANDA 18 sections
prednisolone acetate HUMAN PRESCRIPTION DRUG LABEL 1 60219-2551 SUSPENSION/ DROPS 10 mg OPHTHALMIC ANDA 18 sections
prednisolone acetate HUMAN PRESCRIPTION DRUG LABEL 1 60219-2552 SUSPENSION/ DROPS 10 mg OPHTHALMIC ANDA 18 sections
PREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 60758-119 SUSPENSION/ DROPS 10 mg OPHTHALMIC NDA authorized generic 19 sections
PREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 60758-119 SUSPENSION/ DROPS 10 mg OPHTHALMIC NDA authorized generic 19 sections
Prednisolone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 61314-637 SUSPENSION/ DROPS 10 mg OPHTHALMIC NDA authorized generic 18 sections
Prednisolone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 67296-0775 SUSPENSION/ DROPS 10 mg OPHTHALMIC NDA authorized generic 18 sections
PREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 67296-0872 SUSPENSION/ DROPS 10 mg OPHTHALMIC NDA authorized generic 19 sections
PREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 67296-2176 SUSPENSION/ DROPS 10 mg OPHTHALMIC ANDA 16 sections
PREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 68071-2222 SUSPENSION/ DROPS 10 mg OPHTHALMIC NDA authorized generic 19 sections
Prednisolone Acetate PF HUMAN PRESCRIPTION DRUG LABEL 1 70261-501 SUSPENSION/ DROPS 10 mg OPHTHALMIC unapproved drug other 2 sections
Pred-Gati HUMAN PRESCRIPTION DRUG LABEL 2 70261-502 SUSPENSION 10 mg OPHTHALMIC unapproved drug other 2 sections
Pred-Gati-Brom HUMAN PRESCRIPTION DRUG LABEL 3 70261-504 SUSPENSION/ DROPS 10 mg OPHTHALMIC unapproved drug other 2 sections
Pred-Brom HUMAN PRESCRIPTION DRUG LABEL 2 70261-505 SUSPENSION/ DROPS 10 mg OPHTHALMIC unapproved drug other 2 sections
PREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 70748-332 SUSPENSION/ DROPS 10 mg OPHTHALMIC ANDA 16 sections
PREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 70748-332 SUSPENSION/ DROPS 10 mg OPHTHALMIC ANDA 16 sections
Pred-Brom HUMAN PRESCRIPTION DRUG LABEL 2 71384-505 SUSPENSION/ DROPS 10 mg OPHTHALMIC unapproved drug other 2 sections
PREDNISOLONE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 72189-055 SUSPENSION/ DROPS 10 mg OPHTHALMIC NDA 11 sections