ketorolac ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
anti-inflammatory agents, ibufenac derivatives 1529 74103-06-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ketorolac
  • ketorolac tromethamine
  • ketorolac trometamol
  • trometamol ketorolac
  • (+/-)-Ketorolac
  • keromin
A pyrrolizine carboxylic acid derivative structurally related to INDOMETHACIN. It is a non-steroidal anti-inflammatory agent used for analgesia for postoperative pain and inhibits cyclooxygenase activity.
  • Molecular weight: 255.27
  • Formula: C15H13NO3
  • CLOGP: 1.62
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 59.30
  • ALOGS: -2.70
  • ROTB: 3

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg O
30 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 200 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 58 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 9.79 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.11 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.35 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.10 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,IKBKB,ITK,MAP2K6,MAPK7,MAPKAPK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,TEK,TGFBR1 23
kinase-selectivity-class ACVR2B,AXL,EIF2AK3,GRK2,MAP2K6,STK33 6
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Nov. 30, 1989 FDA

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
Drug hypersensitivity 404.18 12.10 532 21822 463077 90143016
Ulcerative keratitis 126.53 12.10 43 22311 3410 90602683
Anaphylactic reaction 112.84 12.10 123 22231 87401 90518692
Tracheal deviation 99.44 12.10 21 22333 255 90605838
Phrenic nerve paralysis 94.47 12.10 21 22333 329 90605764
Punctate keratitis 82.02 12.10 22 22332 774 90605319
Spinal epidural haematoma 75.02 12.10 23 22331 1311 90604782
Corneal epithelium defect 72.15 12.10 18 22336 473 90605620
Skin papilloma 69.81 12.10 32 22322 5598 90600495
Monocytosis 68.28 12.10 20 22334 974 90605119
Tendon disorder 58.64 12.10 30 22324 6670 90599423
Hand deformity 57.58 12.10 4 22350 296358 90309735
Systemic lupus erythematosus 55.37 12.10 11 22343 361885 90244208
Concussion 54.44 12.10 34 22320 11057 90595036
Pericarditis 54.42 12.10 3 22351 270148 90335945
Eye irritation 53.18 12.10 53 22301 33925 90572168
Aspirin-exacerbated respiratory disease 52.36 12.10 15 22339 675 90605418
Corneal oedema 51.81 12.10 19 22335 1882 90604211
Eye pain 51.62 12.10 59 22295 44109 90561984
Renal infarct 51 12.10 18 22336 1597 90604496
Exposure to SARS-CoV-2 47.11 12.10 19 22335 2433 90603660
Anterior chamber cell 47.02 12.10 14 22340 722 90605371
Torsade de pointes 46.99 12.10 35 22319 15147 90590946
Synovitis 46.48 12.10 12 22342 329740 90276353
Myocardial reperfusion injury 46.44 12.10 10 22344 134 90605959
Hepatic enzyme increased 45.64 12.10 16 22338 360720 90245373
Wound 44.71 12.10 10 22344 302970 90303123
Retinal pigment epitheliopathy 44.66 12.10 11 22343 274 90605819
Eye inflammation 43.48 12.10 26 22328 7825 90598268
Emotional distress 42.88 12.10 49 22305 36613 90569480
Stomatitis 42.74 12.10 8 22346 274690 90331403
Ventricular fibrillation 42.63 12.10 32 22322 14012 90592081
Cardiac arrest 40.85 12.10 84 22270 104851 90501242
Eye disorder 39.71 12.10 41 22313 27349 90578744
Lower respiratory tract infection 39.65 12.10 7 22347 250652 90355441
Swelling 38.92 12.10 28 22326 419030 90187063
Post-traumatic stress disorder 38.82 12.10 23 22331 6805 90599288
Purpura fulminans 37.89 12.10 8 22346 97 90605996
Corneal disorder 36.42 12.10 15 22339 2027 90604066
Ankylosing spondylitis 35.65 12.10 28 22326 13105 90592988
Intraocular pressure increased 35.46 12.10 22 22332 7071 90599022
Duodenal ulcer perforation 35.39 12.10 6 22348 221282 90384811
Immune thrombocytopenia 35.28 12.10 28 22326 13298 90592795
Meniscus injury 34.85 12.10 23 22331 8214 90597879
Uterine perforation 34.18 12.10 22 22332 7532 90598561
Mobility decreased 33.69 12.10 10 22344 250724 90355369
Non-cardiogenic pulmonary oedema 32.50 12.10 12 22342 1212 90604881
Vision blurred 32.48 12.10 79 22275 110214 90495879
Sacroiliitis 31.53 12.10 17 22337 4202 90601891
Type 2 diabetes mellitus 31.44 12.10 6 22348 203238 90402855
Respiratory tract infection viral 30.43 12.10 15 22339 3081 90603012
Foreign body sensation in eyes 29.53 12.10 15 22339 3285 90602808
Musculoskeletal disorder 28.74 12.10 31 22323 21738 90584355
Visual acuity reduced 28.58 12.10 32 22322 23378 90582715
Microsporidia infection 28.41 12.10 8 22346 338 90605755
Ocular hyperaemia 28 12.10 38 22316 33760 90572333
Periumbilical abscess 26.86 12.10 7 22347 220 90605873
SARS-CoV-2 test positive 26.54 12.10 22 22332 11106 90594987
Migraine 26.52 12.10 105 22249 190287 90415806
Nephrolithiasis 26.21 12.10 45 22309 49040 90557053
Catheter site abscess 26.05 12.10 7 22347 248 90605845
Alopecia 25.83 12.10 52 22302 495019 90111074
General physical health deterioration 25.52 12.10 30 22324 355085 90251008
Product use issue 24.66 12.10 27 22327 329892 90276201
Asymptomatic bacteriuria 24.43 12.10 7 22347 315 90605778
Brain injury 24.31 12.10 18 22336 7720 90598373
Corneal thinning 24.19 12.10 6 22348 154 90605939
Respiratory rate decreased 24.18 12.10 14 22340 3969 90602124
Keratitis 24.11 12.10 14 22340 3992 90602101
Fibrosis 23.69 12.10 16 22338 5936 90600157
Chest injury 23.40 12.10 11 22343 2037 90604056
Myelomalacia 23.36 12.10 5 22349 65 90606028
Irritable bowel syndrome 23.30 12.10 11 22343 207437 90398656
Renal ischaemia 23.25 12.10 8 22346 658 90605435
Atrophy 23.07 12.10 11 22343 2101 90603992
Blister 22.42 12.10 18 22336 254980 90351113
Product administration interrupted 22.39 12.10 21 22333 12471 90593622
Angioedema 21.86 12.10 49 22305 64827 90541266
Apallic syndrome 21.86 12.10 8 22346 788 90605305
Intervertebral disc protrusion 21.66 12.10 30 22324 27166 90578927
Expired product administered 21.51 12.10 16 22338 6906 90599187
Arthropathy 21.28 12.10 36 22318 366206 90239887
Nasal disorder 21.13 12.10 12 22342 3280 90602813
Tachypnoea 20.83 12.10 26 22328 21283 90584810
Dystonia 20.55 12.10 23 22331 16796 90589297
Tryptase increased 20.53 12.10 7 22347 560 90605533
Drug-disease interaction 20.48 12.10 8 22346 942 90605151
Cold urticaria 20.33 12.10 6 22348 300 90605793
Symblepharon 20.20 12.10 6 22348 307 90605786
Tuberculin test positive 19.76 12.10 12 22342 3713 90602380
Anxiety 19.49 12.10 137 22217 309635 90296458
Ventricular tachycardia 19.29 12.10 27 22327 24681 90581412
Infusion related reaction 19.09 12.10 47 22307 416733 90189360
Psoriatic arthropathy 18.99 12.10 17 22337 228318 90377775
Opisthotonus 18.94 12.10 6 22348 381 90605712
Corneal dystrophy 18.93 12.10 6 22348 382 90605711
Obstruction gastric 18.32 12.10 8 22346 1248 90604845
Kounis syndrome 18.28 12.10 10 22344 2543 90603550
Endotracheal intubation 18.26 12.10 11 22343 3353 90602740
Pulmonary embolism 18.09 12.10 72 22282 130748 90475345
Pancreatic pseudocyst 18.05 12.10 7 22347 808 90605285
Abdominal discomfort 18.05 12.10 59 22295 477269 90128824
Corneal abrasion 17.96 12.10 8 22346 1308 90604785
Blood immunoglobulin E increased 17.86 12.10 12 22342 4413 90601680
Musculoskeletal pain 17.86 12.10 10 22344 171241 90434852
Allergy to arthropod bite 17.80 12.10 6 22348 464 90605629
Liver injury 17.73 12.10 10 22344 170557 90435536
Vaginal lesion 17.70 12.10 6 22348 472 90605621
Drug ineffective 17.67 12.10 456 21898 1383842 89222251
Pancreatitis relapsing 17.62 12.10 8 22346 1368 90604725
Corectopia 17.53 12.10 3 22351 10 90606083
Back pain 17.51 12.10 136 22218 317039 90289054
Hypoxic-ischaemic encephalopathy 17.28 12.10 12 22342 4656 90601437
Endophthalmitis 17.24 12.10 12 22342 4673 90601420
Depression 17.21 12.10 130 22224 300471 90305622
Wound dehiscence 17.08 12.10 13 22341 5809 90600284
Stridor 17.00 12.10 12 22342 4781 90601312
Herpes simplex reactivation 16.54 12.10 7 22347 1012 90605081
Brain death 16.46 12.10 11 22343 4010 90602083
Renal papillary necrosis 16.41 12.10 5 22349 279 90605814
Corneal perforation 16.24 12.10 6 22348 607 90605486
Dry mouth 16.17 12.10 13 22341 184046 90422047
Stress cardiomyopathy 15.87 12.10 18 22336 13337 90592756
Fascial infection 15.82 12.10 3 22351 20 90606073
Stress 15.72 12.10 50 22304 81345 90524748
Persistent corneal epithelial defect 15.69 12.10 3 22351 21 90606072
Paraplegia 15.59 12.10 10 22344 3402 90602691
Joint range of motion decreased 15.52 12.10 7 22347 135636 90470457
Electrocardiogram QT prolonged 15.38 12.10 46 22308 72410 90533683
Abdominal pain 15.31 12.10 157 22197 395564 90210529
Colitis ischaemic 15.28 12.10 17 22337 12329 90593764
Soliloquy 15.26 12.10 5 22349 354 90605739
Urticaria 15.05 12.10 130 22224 312604 90293489
Spinal pain 15.03 12.10 19 22335 15748 90590345
Small intestinal obstruction 14.82 12.10 22 22332 21212 90584881
Photophobia 14.79 12.10 22 22332 21247 90584846
Pyelonephritis 14.75 12.10 22 22332 21294 90584799
Neurotoxicity 14.64 12.10 22 22332 21445 90584648
Gait inability 14.63 12.10 9 22345 146447 90459646
Endometrial disorder 14.54 12.10 6 22348 815 90605278
Spinal cord compression 14.48 12.10 11 22343 4900 90601193
Coagulation factor X level abnormal 14.32 12.10 3 22351 35 90606058
Polymerase chain reaction positive 14.25 12.10 4 22350 167 90605926
Pancreatic cyst 14.04 12.10 8 22346 2202 90603891
Corneal opacity 13.93 12.10 6 22348 905 90605188
Product administration error 13.81 12.10 24 22330 26399 90579694
Cystocele 13.80 12.10 7 22347 1527 90604566
Depressive symptom 13.77 12.10 11 22343 5274 90600819
Mastocytosis 13.66 12.10 6 22348 950 90605143
Embedded device 13.61 12.10 10 22344 4238 90601855
Hypercholesterolaemia 13.58 12.10 4 22350 100888 90505205
Therapy non-responder 13.44 12.10 68 22286 136636 90469457
Intensive care unit acquired weakness 13.33 12.10 6 22348 1005 90605088
Bursitis 13.28 12.10 8 22346 131646 90474447
Contraindicated product administered 13.21 12.10 38 22316 320101 90285992
Laryngeal dyspnoea 13.08 12.10 4 22350 226 90605867
Death 13.08 12.10 63 22291 456488 90149605
Intervertebral discitis 13.06 12.10 10 22344 4510 90601583
Nightmare 13.05 12.10 21 22333 21704 90584389
Injection site nerve damage 13.00 12.10 3 22351 56 90606037
Dysentery 12.94 12.10 6 22348 1076 90605017
Febrile neutropenia 12.91 12.10 12 22342 158337 90447756
Ill-defined disorder 12.87 12.10 16 22338 184875 90421218
Ligament injury 12.86 12.10 6 22348 1093 90605000
Vulvovaginal discomfort 12.56 12.10 8 22346 2689 90603404
Blood cholesterol increased 12.49 12.10 20 22334 207992 90398101
Joint swelling 12.44 12.10 73 22281 503227 90102866
Confusional state 12.44 12.10 51 22303 386154 90219939
Embolia cutis medicamentosa 12.41 12.10 5 22349 638 90605455
Ligament rupture 12.41 12.10 9 22345 3739 90602354
Dyspareunia 12.33 12.10 8 22346 2778 90603315
Swollen joint count increased 12.32 12.10 6 22348 111200 90494893
Dysphoria 12.31 12.10 11 22343 6143 90599950
Post concussion syndrome 12.30 12.10 5 22349 653 90605440
Atrial fibrillation 12.29 12.10 9 22345 133602 90472491
Somnambulism 12.19 12.10 11 22343 6217 90599876
Lower limb fracture 12.14 12.10 3 22351 85010 90521083

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
Sedation 470.54 16.19 206 11118 30269 42579742
Nightmare 465.36 16.19 193 11131 24819 42585192
Nephrolithiasis 352.32 16.19 179 11145 36651 42573360
Hyperhidrosis 290.52 16.19 219 11105 90293 42519718
Respiratory depression 198.74 16.19 98 11226 18770 42591241
Drug dependence 177.08 16.19 105 11219 28989 42581022
Product use in unapproved indication 159.16 16.19 219 11105 184237 42425774
Epidural lipomatosis 155.52 16.19 44 11280 1756 42608255
Victim of child abuse 149.20 16.19 39 11285 1150 42608861
Drug ineffective 142.27 16.19 426 10898 629771 41980240
Juvenile idiopathic arthritis 138.91 16.19 44 11280 2595 42607416
Product prescribing error 130.19 16.19 83 11241 26029 42583982
Child abuse 110.68 16.19 29 11295 863 42609148
Product used for unknown indication 97.64 16.19 28 11296 1173 42608838
Nausea 95.38 16.19 275 11049 396524 42213487
Drug hypersensitivity 80.96 16.19 115 11209 99274 42510737
Obesity 73.86 16.19 49 11275 16410 42593601
Asthma-chronic obstructive pulmonary disease overlap syndrome 69.83 16.19 23 11301 1536 42608475
Tenderness 67.25 16.19 37 11287 8846 42601165
Off label use 65.97 16.19 338 10986 637997 41972014
Bronchial hyperreactivity 65.03 16.19 23 11301 1906 42608105
Pulmonary function test abnormal 57.55 16.19 23 11301 2671 42607340
Ulcerative keratitis 55.88 16.19 21 11303 2067 42607944
Anaphylactic reaction 54.71 16.19 62 11262 42681 42567330
Cataract 54.57 16.19 53 11271 30551 42579460
Breath sounds abnormal 47.12 16.19 33 11291 12060 42597951
Treatment failure 45.91 16.19 69 11255 62555 42547456
Leukocyturia 44.71 16.19 14 11310 794 42609217
Angioedema 41.90 16.19 54 11270 42423 42567588
Ischaemic cardiomyopathy 40.83 16.19 24 11300 6498 42603513
Drug abuse 40.13 16.19 87 11237 104684 42505327
Product use issue 38.08 16.19 71 11253 76680 42533331
Abdominal mass 36.30 16.19 16 11308 2370 42607641
Renal tubular injury 33.92 16.19 14 11310 1765 42608246
Death 33.41 16.19 46 11278 471139 42138872
Mesangioproliferative glomerulonephritis 33.32 16.19 8 11316 165 42609846
Periorbital swelling 32.27 16.19 13 11311 1540 42608471
Intentional product misuse 31.62 16.19 58 11266 61842 42548169
Burning feet syndrome 31.38 16.19 7 11317 103 42609908
Discoloured vomit 29.08 16.19 10 11314 762 42609249
Heart sounds abnormal 27.47 16.19 10 11314 900 42609111
Keratitis fungal 26.53 16.19 7 11317 214 42609797
Cardiomyopathy 26.51 16.19 29 11295 19181 42590830
Renal ischaemia 24.76 16.19 11 11313 1659 42608352
Measles 23.98 16.19 7 11317 312 42609699
Toxicity to various agents 23.59 16.19 16 11308 229120 42380891
Corneal thinning 23.49 16.19 6 11318 161 42609850
Asthma 22.99 16.19 51 11273 62263 42547748
Corneal oedema 22.33 16.19 10 11314 1538 42608473
Corneal scar 22.04 16.19 6 11318 207 42609804
Ocular hypertension 21.82 16.19 9 11315 1132 42608879
Bronchitis 21.34 16.19 42 11282 47159 42562852
Skin wrinkling 21.14 16.19 7 11317 475 42609536
Eye swelling 20.04 16.19 20 11304 11900 42598111
Aspirin-exacerbated respiratory disease 19.76 16.19 6 11318 307 42609704
Axillary vein thrombosis 19.76 16.19 6 11318 307 42609704
Postoperative delirium 19.64 16.19 7 11317 593 42609418
Gastrointestinal motility disorder 18.95 16.19 11 11313 2910 42607101
Cardiac failure 18.68 16.19 3 11321 106853 42503158
Strabismus 18.37 16.19 10 11314 2338 42607673
Urticaria 18.27 16.19 52 11272 73984 42536027
Corneal epithelium defect 17.99 16.19 6 11318 416 42609595
Punctate keratitis 17.73 16.19 6 11318 435 42609576
Nasal disorder 16.96 16.19 9 11315 2000 42608011
Periorbital oedema 16.51 16.19 12 11312 4645 42605366
Eyelid oedema 16.48 16.19 13 11311 5682 42604329
Non-infectious endophthalmitis 16.35 16.19 5 11319 262 42609749
Obstructive airways disorder 16.33 16.19 26 11298 24733 42585278
Urine analysis abnormal 16.22 16.19 9 11315 2185 42607826

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
Nightmare 434.25 12.38 210 29081 38653 110521355
Sedation 327.08 12.38 213 29078 69470 110490538
Nephrolithiasis 319.64 12.38 206 29085 66006 110494002
Drug hypersensitivity 292.98 12.38 470 28821 453620 110106388
Hyperhidrosis 206.25 12.38 251 29040 187047 110372961
Respiratory depression 204.07 12.38 119 29172 31882 110528126
Anaphylactic reaction 155.68 12.38 171 29120 114129 110445879
Epidural lipomatosis 149.59 12.38 44 29247 2023 110557985
Victim of child abuse 148.57 12.38 39 29252 1172 110558836
Drug ineffective 134.79 12.38 771 28520 1519769 109040239
Drug dependence 134.12 12.38 109 29182 49911 110510097
Ulcerative keratitis 124.31 12.38 47 29244 4719 110555289
Child abuse 110.84 12.38 29 29262 860 110559148
Juvenile idiopathic arthritis 103.69 12.38 44 29247 5963 110554045
Punctate keratitis 97.64 12.38 28 29263 1176 110558832
Tracheal deviation 96.35 12.38 21 29270 277 110559731
Product used for unknown indication 84.15 12.38 28 29263 1935 110558073
Phrenic nerve paralysis 82.19 12.38 21 29270 566 110559442
Corneal epithelium defect 82.04 12.38 23 29268 889 110559119
Product prescribing error 79.03 12.38 82 29209 51249 110508759
Product use in unapproved indication 69.60 12.38 268 29023 447109 110112899
Spinal epidural haematoma 67.60 12.38 23 29268 1702 110558306
Corneal oedema 64.08 12.38 26 29265 3147 110556861
Tendon disorder 63.94 12.38 35 29256 8302 110551706
Skin papilloma 61.47 12.38 32 29259 6864 110553144
Bronchial hyperreactivity 61.31 12.38 26 29265 3518 110556490
Angioedema 56.56 12.38 97 29194 98403 110461605
Monocytosis 55.88 12.38 20 29271 1720 110558288
Eye pain 53.19 12.38 66 29225 50033 110509975
Aspirin-exacerbated respiratory disease 50.73 12.38 16 29275 932 110559076
Anterior chamber cell 50.68 12.38 17 29274 1204 110558804
Nausea 50.58 12.38 524 28767 1235166 109324842
Pulmonary function test abnormal 49.78 12.38 25 29266 4975 110555033
Tenderness 48.89 12.38 49 29242 29388 110530620
Eye inflammation 47.85 12.38 30 29261 9141 110550867
Eye disorder 47.80 12.38 48 29243 28858 110531150
Renal ischaemia 46.79 12.38 19 29272 2304 110557704
Lower respiratory tract infection 46.67 12.38 5 29286 243101 110316907
Myocardial reperfusion injury 45.66 12.38 10 29281 135 110559873
Asthma-chronic obstructive pulmonary disease overlap syndrome 44.19 12.38 25 29266 6319 110553689
Ischaemic cardiomyopathy 43.81 12.38 27 29264 7984 110552024
Drug abuse 43.42 12.38 124 29167 177287 110382721
Pericarditis 43.39 12.38 4 29287 219110 110340898
Foreign body sensation in eyes 43.29 12.38 20 29271 3314 110556694
Synovitis 42.84 12.38 10 29281 274082 110285926
Exposure to SARS-CoV-2 42.61 12.38 19 29272 2900 110557108
Renal tubular injury 41.47 12.38 19 29272 3089 110556919
Hepatic enzyme increased 40.71 12.38 17 29274 320875 110239133
Off label use 40.43 12.38 588 28703 1499597 109060411
Stomatitis 40.04 12.38 11 29280 270231 110289777
Systemic lupus erythematosus 38.35 12.38 10 29281 254328 110305680
Renal infarct 36.84 12.38 18 29273 3377 110556631
Emotional distress 36.69 12.38 52 29239 44795 110515213
Wound 35.76 12.38 9 29282 234428 110325580
Eye irritation 35.40 12.38 44 29247 33408 110526600
Vision blurred 35.35 12.38 94 29197 128928 110431080
Concussion 34.89 12.38 27 29264 11511 110548497
Uterine perforation 34.75 12.38 22 29269 6818 110553190
Torsade de pointes 34.59 12.38 36 29255 22564 110537444
Respiratory rate decreased 33.99 12.38 21 29270 6237 110553771
Post-traumatic stress disorder 32.97 12.38 21 29270 6575 110553433
Immune thrombocytopenia 32.95 12.38 35 29256 22459 110537549
Mobility decreased 32.75 12.38 11 29280 237411 110322597
Ocular hyperaemia 31.32 12.38 45 29246 39241 110520767
General physical health deterioration 31.32 12.38 40 29251 425255 110134753
Leukocyturia 30.50 12.38 14 29277 2286 110557722
Visual acuity reduced 30.39 12.38 40 29251 32133 110527875
Nasal disorder 30.34 12.38 17 29274 4217 110555791
Swelling 30.26 12.38 29 29262 351012 110208996
Mesangioproliferative glomerulonephritis 30.11 12.38 8 29283 252 110559756
Intraocular pressure increased 29.77 12.38 24 29267 10852 110549156
Catheter site abscess 29.58 12.38 8 29283 270 110559738
Corneal thinning 29.50 12.38 8 29283 273 110559735
Breath sounds abnormal 29.46 12.38 35 29256 25369 110534639
Death 28.93 12.38 92 29199 698777 109861231
Type 2 diabetes mellitus 28.63 12.38 6 29285 177226 110382782
Abdominal mass 27.90 12.38 17 29274 4924 110555084
Urticaria 27.43 12.38 161 29130 318696 110241312
Non-cardiogenic pulmonary oedema 26.07 12.38 12 29279 1972 110558036
Corneal disorder 25.90 12.38 13 29278 2584 110557424
Burning feet syndrome 25.56 12.38 7 29284 248 110559760
Back pain 25.53 12.38 177 29114 370819 110189189
Corneal opacity 24.41 12.38 10 29281 1241 110558767
Musculoskeletal disorder 24.28 12.38 30 29261 22634 110537374
Ankylosing spondylitis 24.13 12.38 25 29266 15587 110544421
Periumbilical abscess 24.03 12.38 7 29284 311 110559697
Cardiomyopathy 23.28 12.38 36 29255 33489 110526519
Purpura fulminans 23.07 12.38 7 29284 358 110559650
Meniscus injury 23.05 12.38 18 29273 7775 110552233
Discoloured vomit 22.81 12.38 11 29280 2006 110558002
Heart sounds abnormal 22.77 12.38 10 29281 1472 110558536
Keratitis 22.35 12.38 15 29276 5129 110554879
Strabismus 22.26 12.38 13 29278 3486 110556522
Cardiac arrest 22.14 12.38 107 29184 196646 110363362
Bursitis 21.82 12.38 4 29287 129914 110430094
Keratitis fungal 21.80 12.38 7 29284 432 110559576
Duodenal ulcer perforation 21.60 12.38 10 29281 177690 110382318
Treatment failure 21.53 12.38 25 29266 277209 110282799
Eyelid oedema 21.04 12.38 23 29268 15239 110544769
Intervertebral disc protrusion 21.02 12.38 31 29260 27667 110532341
Eye swelling 20.90 12.38 34 29257 33014 110526994
Cold urticaria 20.90 12.38 6 29285 253 110559755
Cataract 20.85 12.38 57 29234 79428 110480580
SARS-CoV-2 test positive 20.75 12.38 24 29267 16911 110543097
Respiratory tract infection viral 20.54 12.38 15 29276 5863 110554145
Irritable bowel syndrome 20.34 12.38 9 29282 164206 110395802
Postoperative delirium 20.22 12.38 8 29283 907 110559101
Corneal abrasion 20.02 12.38 9 29282 1400 110558608
Expired product administered 19.94 12.38 17 29274 8303 110551705
Corneal perforation 19.88 12.38 8 29283 948 110559060
Corneal scar 19.25 12.38 6 29285 336 110559672
Fibrosis 19.11 12.38 16 29275 7626 110552382
Measles 18.89 12.38 7 29284 664 110559344
Vaginal lesion 18.82 12.38 6 29285 362 110559646
Apallic syndrome 18.75 12.38 8 29283 1098 110558910
Pancreatic pseudocyst 18.62 12.38 9 29282 1649 110558359
Hepatic neoplasm 18.56 12.38 12 29279 3855 110556153
Musculoskeletal pain 18.39 12.38 13 29278 183010 110376998
Blister 18.21 12.38 20 29271 227356 110332652
Umbilical hernia 18.18 12.38 15 29276 7007 110553001
Endophthalmitis 18.15 12.38 16 29275 8171 110551837
Cardiac failure 17.98 12.38 14 29277 187612 110372396
Atrophy 17.95 12.38 10 29281 2454 110557554
Opisthotonus 17.82 12.38 7 29284 779 110559229
Allergy to arthropod bite 17.73 12.38 6 29285 437 110559571
Gastric ulcer 17.54 12.38 35 29256 39792 110520216
Myelomalacia 17.53 12.38 5 29286 206 110559802
Decreased appetite 17.40 12.38 66 29225 475780 110084228
Corectopia 17.31 12.38 3 29288 10 110559998
Symblepharon 17.11 12.38 6 29285 486 110559522
Periorbital oedema 16.99 12.38 17 29274 10175 110549833
Obstruction gastric 16.98 12.38 9 29282 2002 110558006
Microsporidia infection 16.73 12.38 8 29283 1431 110558577
Interstitial lung disease 16.69 12.38 8 29283 139326 110420682
Tuberculin test positive 16.67 12.38 11 29280 3657 110556351
Ventricular fibrillation 16.65 12.38 35 29256 41278 110518730
Tryptase increased 16.58 12.38 7 29284 936 110559072
Infusion related reaction 16.58 12.38 49 29242 381113 110178895
Pancreatitis relapsing 16.26 12.38 8 29283 1524 110558484
Joint range of motion decreased 16.19 12.38 6 29285 121826 110438182
Liver injury 16.03 12.38 10 29281 150403 110409605
Cystocele 15.85 12.38 7 29284 1045 110558963
Sacroiliitis 15.82 12.38 12 29279 4966 110555042
Acute kidney injury 15.78 12.38 246 29045 635184 109924824
Stress cardiomyopathy 15.47 12.38 20 29271 15786 110544222
Ocular hypertension 15.46 12.38 9 29282 2399 110557609
Endometrial disorder 15.12 12.38 6 29285 686 110559322
Chest injury 14.95 12.38 10 29281 3399 110556609
Arthropathy 14.77 12.38 34 29257 287488 110272520
Periorbital swelling 14.75 12.38 12 29279 5493 110554515
Neuromuscular block prolonged 14.71 12.38 7 29284 1240 110558768
Brain injury 14.70 12.38 18 29273 13458 110546550
Axillary vein thrombosis 14.53 12.38 6 29285 760 110559248
C-reactive protein increased 14.52 12.38 22 29269 217897 110342111
Heparin-induced thrombocytopenia test positive 14.51 12.38 4 29287 145 110559863
Sickle cell anaemia with crisis 14.24 12.38 15 29276 9530 110550478
Pancreatic cyst 14.24 12.38 9 29282 2781 110557227
Myocardial infarction 14.19 12.38 18 29273 192065 110367943
Coagulation factor X level abnormal 14.18 12.38 3 29288 34 110559974
Mastocytosis 14.05 12.38 6 29285 826 110559182
Diarrhoea 14.02 12.38 215 29076 1139290 109420718
Renal papillary necrosis 13.81 12.38 5 29286 444 110559564
Vulvovaginal discomfort 13.80 12.38 8 29283 2116 110557892
Asymptomatic bacteriuria 13.76 12.38 5 29286 449 110559559
Herpes simplex reactivation 13.62 12.38 7 29284 1461 110558547
Flank pain 13.56 12.38 23 29268 23107 110536901
Blood immunoglobulin E increased 13.44 12.38 13 29278 7469 110552539
Embedded device 13.44 12.38 10 29281 4023 110555985
Non-infectious endophthalmitis 13.38 12.38 5 29286 486 110559522
Dyspareunia 13.38 12.38 8 29283 2241 110557767
Abdominal pain 13.26 12.38 200 29091 512789 110047219
Skin wrinkling 13.25 12.38 7 29284 1546 110558462
Liver disorder 13.15 12.38 11 29280 142232 110417776
Iris atrophy 13.07 12.38 4 29287 211 110559797
Alopecia 13.06 12.38 51 29240 364702 110195306
Hypercholesterolaemia 12.89 12.38 4 29287 90833 110469175
Febrile neutropenia 12.87 12.38 42 29249 316725 110243283
Wound dehiscence 12.76 12.38 13 29278 7949 110552059
Dermatitis contact 12.64 12.38 17 29274 13936 110546072
Bronchospasm 12.63 12.38 26 29265 30213 110529795
Dry mouth 12.55 12.38 21 29270 199927 110360081
Migraine 12.45 12.38 83 29208 171569 110388439

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC M01AB15 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC S01BC05 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Antiinflammatory agents, non-steroids
ATC S01FB51 SENSORY ORGANS
OPHTHALMOLOGICALS
MYDRIATICS AND CYCLOPLEGICS
Sympathomimetics excl. antiglaucoma preparations
FDA CS M0001335 Anti-Inflammatory Agents, Non-Steroidal
FDA MoA N0000000160 Cyclooxygenase Inhibitors
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drug
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50629 cyclooxygenase 2 inhibitor
CHEBI has role CHEBI:50630 cyclooxygenase 1 inhibitor
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:73336 vulnerary
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug
FDA EPC N0000175939 Cyclooxygenase Inhibitor
MeSH PA D000700 Analgesics
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D018501 Antirheumatic Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D018712 Analgesics, Non-Narcotic

Related Drugs by ATC class:

M01AB Acetic acid derivatives and related substances 16 drugs
S01BC Antiinflammatory agents, non-steroids 10 drugs
S01FB Sympathomimetics excl. antiglaucoma preparations 3 drugs

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

DiseaseRelationSNOMED_IDDOID
Severe pain indication 76948002
Allergic conjunctivitis indication 473460002 DOID:11204
Acute postoperative pain indication 107401000119105
Postoperative Ocular Pain indication
Post-Op Ocular Inflammation indication
Post-Op Photophobia indication
Renal colic off-label use 7093002
Peptic ulcer contraindication 13200003 DOID:750
Disorder of cornea contraindication 15250008 DOID:10124
Acute gastric ulcer with perforation contraindication 19850005
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Hypovolemia contraindication 28560003
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Tear film insufficiency contraindication 46152009
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Corneal erosion contraindication 50792001
Duodenal ulcer disease contraindication 51868009 DOID:1724
Acute nephropathy contraindication 58574008
Blood coagulation disorder contraindication 64779008 DOID:1247
Rheumatoid arthritis contraindication 69896004 DOID:7148
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Hemophilia contraindication 90935002
Corneal degeneration contraindication 111521006 DOID:1237
Perioperative care contraindication 133897009
Asthma contraindication 195967001 DOID:2841
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Cerebral hemorrhage contraindication 274100004
Pregnancy, function contraindication 289908002
Cardiovascular event risk contraindication 395112001
Gastric ulcer contraindication 397825006 DOID:10808
Breastfeeding (mother) contraindication 413712001
Smokes tobacco daily contraindication 449868002
Preoperative Pain Management contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.47 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.4% ACULAR LS ABBVIE N021528 May 30, 2003 RX SOLUTION/DROPS OPHTHALMIC 8008338 May 24, 2027 A METHOD OF TREATING OR PREVENTING OCULAR PAIN IN A PATIENT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 6.90 WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 9.72 WOMBAT-PK CHEMBL
Serine/threonine-protein kinase PAK 1 Kinase IC50 4.44 CHEMBL
Fatty acid-binding protein, liver Cytosolic other Ki 4.94 CHEMBL
Aldose reductase Enzyme IC50 5.21 DRUG MATRIX
Prostaglandin-H2 D-isomerase Enzyme IC50 6.64 CHEMBL

External reference:

IDSource
4028637 VUID
N0000178380 NUI
D00813 KEGG_DRUG
74103-07-4 SECONDARY_CAS_RN
4019510 VANDF
4028637 VANDF
C0073631 UMLSCUI
CHEBI:6129 CHEBI
KTR PDB_CHEM_ID
CHEMBL469 ChEMBL_ID
CHEMBL1201124 ChEMBL_ID
DB00465 DRUGBANK_ID
D020910 MESH_DESCRIPTOR_UI
3826 PUBCHEM_CID
6661 IUPHAR_LIGAND_ID
5558 INN_ID
YZI5105V0L UNII
28200 RXNORM
30341 MMSL
39892 MMSL
4947 MMSL
9780 MMSL
d00273 MMSL
003539 NDDF
004812 NDDF
108512006 SNOMEDCT_US
108513001 SNOMEDCT_US
372501008 SNOMEDCT_US
D020911 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Acular HUMAN PRESCRIPTION DRUG LABEL 1 0023-2181 SOLUTION/ DROPS 5 mg OPHTHALMIC NDA 23 sections
ACUVAIL HUMAN PRESCRIPTION DRUG LABEL 1 0023-3507 SOLUTION/ DROPS 4.50 mg OPHTHALMIC NDA 23 sections
ACULAR LS HUMAN PRESCRIPTION DRUG LABEL 1 0023-9277 SOLUTION/ DROPS 4 mg OPHTHALMIC NDA 22 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-0314 TABLET, FILM COATED 10 mg ORAL ANDA 27 sections
KETOROLAC TROMETHAMINE HUMAN PRESCRIPTION DRUG LABEL 1 0338-0069 INJECTION, SOLUTION 15 mg INTRAMUSCULAR ANDA 27 sections
KETOROLAC TROMETHAMINE HUMAN PRESCRIPTION DRUG LABEL 1 0338-0072 INJECTION, SOLUTION 30 mg INTRAMUSCULAR ANDA 27 sections
KETOROLAC TROMETHAMINE HUMAN PRESCRIPTION DRUG LABEL 1 0338-0076 INJECTION, SOLUTION 15 mg INTRAMUSCULAR ANDA 27 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0378-1134 TABLET, FILM COATED 10 mg ORAL ANDA 18 sections
Ketorolac tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0404-9996 INJECTION, SOLUTION 30 mg INTRAMUSCULAR ANDA 13 sections
Ketorolac tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0404-9997 INJECTION, SOLUTION 30 mg INTRAMUSCULAR ANDA 13 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0404-9998 INJECTION, SOLUTION 15 mg INTRAMUSCULAR ANDA 14 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0409-3793 INJECTION, SOLUTION 15 mg INTRAMUSCULAR ANDA 24 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0409-3795 INJECTION, SOLUTION 30 mg INTRAMUSCULAR ANDA 24 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0409-3796 INJECTION, SOLUTION 60 mg INTRAMUSCULAR ANDA 24 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0487-6232 INJECTION 30 mg INTRAMUSCULAR ANDA 16 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0641-6041 INJECTION 15 mg INTRAMUSCULAR ANDA 17 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0641-6042 INJECTION 30 mg INTRAMUSCULAR ANDA 17 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0641-6043 INJECTION 30 mg INTRAMUSCULAR ANDA 17 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0904-7303 TABLET, FILM COATED 10 mg ORAL ANDA 15 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 10544-222 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 12634-809 TABLET 10 mg ORAL ANDA 13 sections
ACULAR HUMAN PRESCRIPTION DRUG LABEL 1 16590-002 SOLUTION/ DROPS 5 mg OPHTHALMIC NDA 20 sections
KETOROLAC HUMAN PRESCRIPTION DRUG LABEL 1 16590-138 TABLET, FILM COATED 10 mg ORAL ANDA 15 sections
KETOROLAC TROMETHAMINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-376 SOLUTION 5 mg OPHTHALMIC ANDA 18 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 17478-209 SOLUTION 5 mg OPHTHALMIC ANDA 25 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 21695-432 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
ACULAR HUMAN PRESCRIPTION DRUG LABEL 1 21695-463 SOLUTION 5 mg OPHTHALMIC NDA 10 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 21695-588 INJECTION, SOLUTION 30 mg INTRAMUSCULAR ANDA 23 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 21695-624 SOLUTION 4 mg OPHTHALMIC ANDA 22 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 21695-985 SOLUTION 4 mg OPHTHALMIC ANDA 22 sections