indomethacin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
anti-inflammatory, indometacin derivatives 1440 53-86-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • indomethacin hydrochloride
  • indomethacin HCl
  • indocin
  • indomethacin
  • indometacine
  • indomethacine
  • indometacin
  • indomethacin sodium
A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES. Additional data needed to determine whether in vitro activity against SARS-CoV-2 corresponds with clinical efficacy in the treatment of COVID-19.
  • Molecular weight: 357.79
  • Formula: C19H16ClNO4
  • CLOGP: 4.18
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 68.53
  • ALOGS: -5.17
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.10 g O
0.10 g P
0.10 g R
0.10 g O
0.10 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 15 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 7.99 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) 0.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.30 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) 1.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 10, 1965 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
Oligohydramnios 420.57 12.06 134 21589 6232 63461067
Premature delivery 179.68 12.06 118 21605 30163 63437136
Neck deformity 158.19 12.06 49 21674 2072 63465227
Ankylosing spondylitis 150.72 12.06 73 21650 10401 63456898
Neck mass 140.14 12.06 51 21672 3552 63463747
Bone density abnormal 113.46 12.06 43 21680 3355 63463944
Oesophageal spasm 106.01 12.06 40 21683 3083 63464216
Oesophageal pain 95.97 12.06 39 21684 3662 63463637
Exposure during pregnancy 83.31 12.06 172 21551 155375 63311924
Premature baby 81.75 12.06 63 21660 20672 63446627
Disability 72.88 12.06 56 21667 18291 63449008
Premature labour 65.21 12.06 45 21678 12459 63454840
Neonatal disorder 63.25 12.06 18 21705 565 63466734
Lymphoedema 60.79 12.06 42 21681 11650 63455649
Mood swings 60.31 12.06 50 21673 18198 63449101
Maternal exposure during pregnancy 57.78 12.06 186 21537 219876 63247423
Drug hypersensitivity 55.73 12.06 232 21491 310455 63156844
Death 54.77 12.06 30 21693 374351 63092948
Drug ineffective for unapproved indication 53.34 12.06 62 21661 34001 63433298
Drug ineffective 51.19 12.06 563 21160 1044202 62423097
Corneal perforation 46.57 12.06 14 21709 534 63466765
Limb deformity 43.27 12.06 23 21700 3979 63463320
Product use in unapproved indication 42.21 12.06 146 21577 178934 63288365
Glossodynia 39.09 12.06 7 21716 178869 63288430
Hypermobility syndrome 37.10 12.06 13 21710 810 63466489
Low birth weight baby 35.63 12.06 25 21698 7104 63460195
Migraine 35.33 12.06 96 21627 103250 63364049
Maternal drugs affecting foetus 34.95 12.06 22 21701 5220 63462079
Sleep apnoea syndrome 34.34 12.06 46 21677 29087 63438212
Wound 32.37 12.06 8 21715 163255 63304044
Grip strength decreased 32.30 12.06 39 21684 22248 63445051
Bronchopulmonary dysplasia 32.27 12.06 10 21713 423 63466876
Arthralgia 31.93 12.06 316 21407 569394 62897905
Tinnitus 31.39 12.06 49 21674 35579 63431720
Neonatal respiratory distress syndrome 29.91 12.06 16 21707 2802 63464497
Back pain 29.86 12.06 173 21550 263972 63203327
Polyarthritis 29.84 12.06 26 21697 10120 63457179
Pemphigus 29.43 12.06 13 21710 183713 63283586
Musculoskeletal stiffness 29.31 12.06 133 21590 184485 63282814
Joint swelling 29.23 12.06 202 21521 327464 63139835
Serotonin syndrome 28.90 12.06 42 21681 28640 63438659
Joint abscess 28.55 12.06 9 21714 403 63466896
Cellulitis staphylococcal 26.91 12.06 10 21713 738 63466561
Neurodevelopmental disorder 26.16 12.06 7 21716 174 63467125
Joint stiffness 25.61 12.06 49 21674 41820 63425479
Uveitis 25.12 12.06 26 21697 12527 63454772
Vascular rupture 24.91 12.06 12 21711 1688 63465611
Adrenal suppression 24.86 12.06 10 21713 914 63466385
Abdominal discomfort 24.75 12.06 45 21678 320840 63146459
Neuralgia 24.73 12.06 37 21686 25889 63441410
Foetal death 24.27 12.06 24 21699 10956 63456343
Actinomycotic sepsis 24.20 12.06 6 21717 109 63467190
Agitation 24.01 12.06 59 21664 59698 63407601
Preterm premature rupture of membranes 23.89 12.06 11 21712 1398 63465901
Angioedema 23.27 12.06 51 21672 47914 63419385
Medication overuse headache 22.37 12.06 9 21714 823 63466476
Dyspnoea 21.74 12.06 135 21588 661178 62806121
Pulmonary hypertensive crisis 21.72 12.06 7 21716 337 63466962
Foetal exposure during pregnancy 20.28 12.06 38 21685 31924 63435375
Sacroiliitis 20.05 12.06 13 21710 3244 63464055
Serum ferritin decreased 19.88 12.06 11 21712 2059 63465240
Alopecia 19.77 12.06 55 21668 337481 63129818
Therapeutic response unexpected 19.67 12.06 28 21695 18731 63448568
Fibromyalgia 19.29 12.06 66 21657 80354 63386945
Catheter site bruise 19.28 12.06 7 21716 484 63466815
Systemic lupus erythematosus 19.24 12.06 26 21697 208892 63258407
Large intestinal ulcer haemorrhage 19.22 12.06 5 21718 111 63467188
Mycobacterium tuberculosis complex test positive 19.02 12.06 11 21712 2240 63465059
Endothelin increased 18.93 12.06 4 21719 34 63467265
Alpha tumour necrosis factor increased 18.93 12.06 4 21719 34 63467265
Blood pressure diastolic increased 18.72 12.06 20 21703 9990 63457309
Cystitis 18.69 12.06 51 21672 54940 63412359
Oligoarthritis 18.25 12.06 7 21716 564 63466735
Growth retardation 18.25 12.06 9 21714 1332 63465967
Hyperhidrosis 18.08 12.06 79 21644 107757 63359542
Swollen tongue 18.02 12.06 38 21685 34762 63432537
Hydrops foetalis 17.82 12.06 7 21716 601 63466698
Investigation abnormal 17.70 12.06 10 21713 1948 63465351
Atrial fibrillation 17.53 12.06 9 21714 116627 63350672
Tendonitis 17.31 12.06 27 21696 19588 63447711
Hospitalisation 17.19 12.06 4 21719 85077 63382222
Bronchitis 16.91 12.06 86 21637 124849 63342450
Pharyngeal haematoma 16.79 12.06 4 21719 61 63467238
Pharyngitis 16.77 12.06 27 21696 20116 63447183
Impaired work ability 16.75 12.06 25 21698 17450 63449849
Neck pain 16.72 12.06 57 21666 69261 63398038
Oliguria 16.70 12.06 18 21705 9083 63458216
Coccydynia 16.52 12.06 9 21714 1634 63465665
Muscle spasticity 16.51 12.06 28 21695 21766 63445533
Infective myositis 16.50 12.06 4 21719 66 63467233
Ankle fracture 16.35 12.06 25 21698 17830 63449469
Cerebral vasoconstriction 16.12 12.06 8 21715 1200 63466099
Nerve degeneration 16.12 12.06 4 21719 73 63467226
Intervertebral disc protrusion 16.07 12.06 29 21694 23680 63443619
Ear pain 15.95 12.06 37 21686 36081 63431218
Blood pressure fluctuation 15.79 12.06 43 21680 46274 63421025
Fine motor skill dysfunction 15.48 12.06 13 21710 4812 63462487
Benign vaginal neoplasm 15.16 12.06 4 21719 94 63467205
Narcolepsy 15.12 12.06 8 21715 1370 63465929
Pain 15.05 12.06 345 21378 740283 62727016
Hirsutism 15.03 12.06 8 21715 1387 63465912
Skin striae 15.00 12.06 8 21715 1393 63465906
Myoglobin blood increased 14.98 12.06 8 21715 1397 63465902
Visceral leishmaniasis 14.83 12.06 6 21717 557 63466742
Focal nodular hyperplasia 14.74 12.06 6 21717 565 63466734
External ear cellulitis 14.70 12.06 5 21718 285 63467014
Corneal neovascularisation 14.46 12.06 4 21719 113 63467186
Necrotising colitis 14.43 12.06 6 21717 597 63466702
Nephropathy toxic 14.41 12.06 17 21706 9462 63457837
Hypercholesterolaemia 14.34 12.06 26 21697 21308 63445991
Chronic gastritis 14.28 12.06 10 21713 2831 63464468
Mydriasis 14.27 12.06 19 21704 11937 63455362
Arthritis bacterial 14.05 12.06 14 21709 6449 63460850
White blood cell analysis abnormal 14.04 12.06 3 21720 27 63467272
Decreased vibratory sense 13.94 12.06 5 21718 334 63466965
Right ventricular hypertrophy 13.54 12.06 6 21717 697 63466602
Gastroenteritis salmonella 13.51 12.06 6 21717 701 63466598
Alkalosis 13.50 12.06 5 21718 366 63466933
Wheezing 13.46 12.06 8 21715 95587 63371712
Swelling face 13.43 12.06 50 21673 63425 63403874
Apallic syndrome 13.40 12.06 6 21717 715 63466584
Hypopyon 13.31 12.06 6 21717 726 63466573
Hallucination 13.15 12.06 45 21678 54772 63412527
Dysphonia 13.15 12.06 41 21682 47573 63419726
Vision blurred 12.94 12.06 64 21659 91860 63375439
Apgar score low 12.92 12.06 6 21717 778 63466521
Myoclonus 12.84 12.06 21 21702 15847 63451452
Intentional underdose 12.80 12.06 8 21715 1874 63465425
Bradycardia foetal 12.71 12.06 5 21718 431 63466868
Fluid retention 12.62 12.06 47 21676 59639 63407660
Pulmonary valve incompetence 12.33 12.06 7 21716 1376 63465923
Body temperature increased 12.15 12.06 34 21689 37158 63430141

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
Ankylosing spondylitis 155.06 12.89 64 13437 5540 34937890
Ductus arteriosus premature closure 102.01 12.89 23 13478 238 34943192
Gout 54.71 12.89 51 13450 19202 34924228
Sacroiliitis 47.93 12.89 19 13482 1479 34941951
Hepatitis B virus test positive 47.38 12.89 13 13488 314 34943116
Drug ineffective 43.59 12.89 313 13188 456438 34486992
Arthralgia 43.21 12.89 154 13347 169887 34773543
Exostosis 42.29 12.89 25 13476 4698 34938732
Tendon disorder 41.86 12.89 21 13480 2854 34940576
Ankle fracture 40.02 12.89 23 13478 4102 34939328
Premature baby 39.25 12.89 43 13458 19590 34923840
Hypoaldosteronism 38.81 12.89 10 13491 188 34943242
Duodenal perforation 36.71 12.89 15 13486 1263 34942167
Mast cell activation syndrome 36.50 12.89 10 13491 240 34943190
Psoriasis 34.19 12.89 57 13444 38755 34904675
Arthritis 33.07 12.89 50 13451 31296 34912134
Gastrointestinal haemorrhage 32.42 12.89 91 13410 88386 34855044
Joint swelling 31.84 12.89 71 13430 59819 34883611
Chest expansion decreased 31.22 12.89 8 13493 147 34943283
Benign abdominal neoplasm 29.72 12.89 7 13494 89 34943341
Drug hypersensitivity 29.67 12.89 83 13418 80446 34862984
Psoriatic arthropathy 29.02 12.89 37 13464 19761 34923669
Death 28.93 12.89 70 13431 397979 34545451
Synovitis 26.72 12.89 30 13471 14036 34929394
Foot fracture 26.35 12.89 19 13482 4992 34938438
Gouty arthritis 25.36 12.89 11 13490 1075 34942355
Juvenile idiopathic arthritis 25.13 12.89 13 13488 1884 34941546
Gastric haemorrhage 25.03 12.89 25 13476 10236 34933194
Axial spondyloarthritis 24.74 12.89 8 13493 344 34943086
Neonatal disorder 24.73 12.89 10 13491 820 34942610
Xanthelasma 24.26 12.89 6 13495 95 34943335
Foot deformity 23.39 12.89 17 13484 4520 34938910
Osteoarthritis 23.31 12.89 34 13467 20608 34922822
Placental transfusion syndrome 23.05 12.89 4 13497 8 34943422
Coarctation of the aorta 22.39 12.89 8 13493 467 34942963
Back pain 21.81 12.89 99 13402 121690 34821740
Sensitivity to weather change 21.13 12.89 11 13490 1615 34941815
Caesarean section 20.81 12.89 12 13489 2152 34941278
Neonatal respiratory distress syndrome 20.53 12.89 15 13486 4019 34939411
Gastric ulcer 19.47 12.89 27 13474 15623 34927807
Neck pain 19.40 12.89 35 13466 25314 34918116
Water intoxication 19.39 12.89 7 13494 421 34943009
Melaena 18.86 12.89 42 13459 35338 34908092
Enthesopathy 18.75 12.89 15 13486 4598 34938832
Osteopenia 18.09 12.89 15 13486 4834 34938596
Duodenal ulcer 17.87 12.89 21 13480 10311 34933119
Gastric bypass 17.86 12.89 6 13495 291 34943139
Thoracic vertebral fracture 17.73 12.89 10 13491 1720 34941710
Pulmonary sarcoidosis 17.14 12.89 7 13494 589 34942841
Foetal exposure during pregnancy 16.79 12.89 42 13459 38059 34905371
Myofascial pain syndrome 16.46 12.89 6 13495 371 34943059
Erythroblast count increased 16.42 12.89 3 13498 9 34943421
Joint range of motion decreased 16.35 12.89 17 13484 7295 34936135
Stillbirth 16.34 12.89 5 13496 179 34943251
Patent ductus arteriosus 16.01 12.89 12 13489 3342 34940088
Tricuspid valve incompetence 15.51 12.89 19 13482 9741 34933689
Tobacco abuse 15.48 12.89 6 13495 440 34942990
Iridocyclitis 15.46 12.89 9 13492 1643 34941787
Drug tolerance 15.32 12.89 11 13490 2871 34940559
Procedural vomiting 15.26 12.89 5 13496 224 34943206
Gastrointestinal ulcer 15.17 12.89 9 13492 1702 34941728
Musculoskeletal stiffness 15.15 12.89 46 13455 46634 34896796
Spinal deformity 14.87 12.89 6 13495 489 34942941
Oromandibular dystonia 14.80 12.89 6 13495 495 34942935
Sinusitis aspergillus 14.76 12.89 4 13497 92 34943338
Hydrops foetalis 14.62 12.89 7 13494 860 34942570
Pain 14.32 12.89 131 13370 204544 34738886
Intraventricular haemorrhage neonatal 13.73 12.89 5 13496 308 34943122
Neutropenia 13.48 12.89 25 13476 156753 34786677
Faeces discoloured 13.29 12.89 22 13479 14856 34928574
Pain in extremity 13.29 12.89 89 13412 126424 34817006
Adulterated product 13.22 12.89 3 13498 32 34943398
Foetal distress syndrome 13.04 12.89 7 13494 1093 34942337

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
Ankylosing spondylitis 288.77 11.78 123 29245 12082 79702938
Neck deformity 148.81 11.78 46 29322 1791 79713229
Neck mass 119.66 11.78 49 29319 4355 79710665
Oesophageal spasm 109.66 11.78 43 29325 3413 79711607
Bone density abnormal 103.93 11.78 40 29328 3020 79712000
Oesophageal pain 97.48 11.78 42 29326 4237 79710783
Drug ineffective 83.01 11.78 679 28689 1080234 78634786
Sacroiliitis 63.72 11.78 30 29338 3724 79711296
Corneal perforation 61.35 11.78 19 29349 744 79714276
Lymphoedema 60.23 11.78 44 29324 12369 79702651
Arthralgia 58.40 11.78 385 28983 571418 79143602
Back pain 56.71 11.78 242 29126 303938 79411082
Musculoskeletal stiffness 52.86 11.78 163 29205 174845 79540175
Ankle fracture 52.10 11.78 46 29322 16923 79698097
Disability 51.75 11.78 46 29322 17074 79697946
Death 50.33 11.78 82 29286 566432 79148588
Mood swings 49.61 11.78 48 29320 19832 79695188
Joint swelling 48.75 11.78 223 29145 288423 79426597
Drug hypersensitivity 46.15 11.78 225 29143 298691 79416329
Drug ineffective for unapproved indication 46.04 11.78 74 29294 51164 79663856
Sleep apnoea syndrome 44.77 11.78 61 29307 36417 79678603
Hepatitis B virus test positive 42.55 11.78 13 29355 486 79714534
Hypermobility syndrome 41.50 11.78 13 29355 529 79714491
Pain 38.07 11.78 411 28957 703391 79011629
Migraine 36.80 11.78 92 29276 87401 79627619
Limb deformity 35.66 11.78 20 29348 3570 79711450
Gout 32.84 11.78 43 29325 24706 79690314
Hypoaldosteronism 32.68 11.78 10 29358 376 79714644
Tinnitus 30.62 11.78 57 29311 44276 79670744
Neck pain 30.36 11.78 78 29290 75339 79639681
Chest expansion decreased 29.78 11.78 8 29360 187 79714833
Tendon disorder 29.39 11.78 23 29345 7163 79707857
Gastrointestinal haemorrhage 28.62 11.78 119 29249 147600 79567420
Premature delivery 28.43 11.78 39 29329 23428 79691592
Arthritis 28.39 11.78 100 29268 114780 79600240
Gastric haemorrhage 27.92 11.78 31 29337 15019 79700001
Gastric ulcer 27.81 11.78 47 29321 33858 79681162
Right ventricular hypertension 27.63 11.78 4 29364 0 79715020
Psoriatic arthropathy 26.71 11.78 76 29292 77923 79637097
Fibromyalgia 26.37 11.78 67 29301 64273 79650747
Neuralgia 25.70 11.78 45 29323 33339 79681681
Joint abscess 25.48 11.78 9 29359 533 79714487
Investigation abnormal 24.66 11.78 13 29355 2053 79712967
Actinomycotic sepsis 24.19 11.78 6 29362 101 79714919
Duodenal perforation 24.05 11.78 13 29355 2159 79712861
Joint stiffness 23.94 11.78 49 29319 40781 79674239
Large intestinal ulcer 23.26 11.78 17 29351 4780 79710240
Ductus arteriosus premature closure 23.24 11.78 5 29363 43 79714977
Psoriasis 23.01 11.78 79 29289 89508 79625512
Neutropenia 22.48 11.78 45 29323 287665 79427355
Benign abdominal neoplasm 22.48 11.78 7 29361 279 79714741
Dysstasia 22.14 11.78 38 29330 27708 79687312
Uveitis 21.96 11.78 29 29339 16801 79698219
Blood pressure fluctuation 21.62 11.78 64 29304 67081 79647939
Xanthelasma 21.40 11.78 6 29362 165 79714855
Vascular rupture 21.25 11.78 11 29357 1674 79713346
Axial spondyloarthritis 21.12 11.78 8 29360 578 79714442
Intestinal diaphragm disease 21.09 11.78 7 29361 343 79714677
Duodenal ulcer 21.04 11.78 28 29340 16341 79698679
Glossodynia 20.99 11.78 6 29362 103331 79611689
Blood pressure diastolic increased 20.44 11.78 26 29342 14516 79700504
Neonatal disorder 20.15 11.78 4 29364 22 79714998
Gouty arthritis 19.76 11.78 10 29358 1451 79713569
Malignant neoplasm progression 19.57 11.78 13 29355 135977 79579043
Tendonitis 19.49 11.78 33 29335 23797 79691223
Oligoarthritis 19.48 11.78 8 29360 716 79714304
Myocardial infarction 19.32 11.78 125 29243 184004 79531016
Catheter site bruise 19.25 11.78 7 29361 451 79714569
Juvenile idiopathic arthritis 18.95 11.78 15 29353 4748 79710272
Ear pain 18.75 11.78 39 29329 32830 79682190
Right ventricular hypertrophy 18.69 11.78 10 29358 1627 79713393
Osteopenia 18.55 11.78 28 29340 18336 79696684
Wound 18.27 11.78 10 29358 116169 79598851
Alpha tumour necrosis factor increased 17.88 11.78 4 29364 42 79714978
Hyperhidrosis 17.87 11.78 106 29262 151386 79563634
Cystitis 17.68 11.78 51 29317 52681 79662339
Exostosis 17.45 11.78 26 29342 16832 79698188
Large intestinal ulcer haemorrhage 17.45 11.78 6 29362 328 79714692
Adrenal suppression 17.26 11.78 9 29359 1390 79713630
Hypotension 16.98 11.78 94 29274 440223 79274797
Angioedema 16.93 11.78 64 29304 75971 79639049
Fluid retention 16.58 11.78 60 29308 69749 79645271
Febrile neutropenia 16.49 11.78 38 29330 230961 79484059
Bronchitis 16.44 11.78 93 29275 130551 79584469
Hand deformity 16.26 11.78 9 29359 103910 79611110
Gastrointestinal ulcer 16.23 11.78 12 29356 3434 79711586
Mast cell activation syndrome 16.18 11.78 7 29361 713 79714307
Trigger finger 16.10 11.78 13 29355 4232 79710788
Mycobacterium tuberculosis complex test positive 16.10 11.78 11 29357 2781 79712239
Cellulitis staphylococcal 15.78 11.78 8 29360 1165 79713855
Water intoxication 15.69 11.78 7 29361 767 79714253
Muscle spasticity 15.31 11.78 28 29340 21447 79693573
Stress 15.30 11.78 64 29304 79548 79635472
Benign vaginal neoplasm 15.30 11.78 4 29364 84 79714936
Grip strength decreased 14.95 11.78 28 29340 21841 79693179
Exposure during pregnancy 14.77 11.78 75 29293 101057 79613963
Serotonin syndrome 14.57 11.78 43 29325 44984 79670036
Hirsutism 14.55 11.78 8 29360 1374 79713646
Pharyngitis 14.50 11.78 28 29340 22347 79692673
Product dose omission issue 14.43 11.78 45 29323 247492 79467528
Coccydynia 14.18 11.78 9 29359 2012 79713008
Melaena 14.18 11.78 52 29316 60838 79654182
Cerebral vasoconstriction 14.09 11.78 8 29360 1462 79713558
Arthritis bacterial 13.86 11.78 17 29351 9149 79705871
Endothelin increased 13.82 11.78 3 29365 27 79714993
White blood cell analysis abnormal 13.82 11.78 3 29365 27 79714993
Vision blurred 13.73 11.78 76 29292 105822 79609198
Episcleritis 13.63 11.78 7 29361 1048 79713972
Fine motor skill dysfunction 13.49 11.78 13 29355 5344 79709676
Intervertebral disc protrusion 13.44 11.78 28 29340 23593 79691427
Urticaria 13.32 11.78 115 29253 185086 79529934
Pharyngeal haematoma 13.29 11.78 4 29364 142 79714878
Leukopenia 13.24 11.78 14 29354 116499 79598521
Drug intolerance 13.17 11.78 152 29216 263967 79451053
Swollen tongue 13.15 11.78 40 29328 42530 79672490
Facial paresis 13.14 11.78 13 29355 5513 79709507
Premature baby 13.13 11.78 11 29357 3769 79711251
Secondary adrenocortical insufficiency 13.09 11.78 10 29358 3004 79712016
Dizziness 13.07 11.78 269 29099 526172 79188848
Hyponatraemia 12.89 11.78 29 29339 177819 79537201
Treatment failure 12.86 11.78 107 29261 170379 79544641
Corneal neovascularisation 12.83 11.78 4 29364 160 79714860
Focal nodular hyperplasia 12.81 11.78 6 29362 736 79714284
Hypercholesterolaemia 12.70 11.78 27 29341 23068 79691952
Synovitis 12.68 11.78 97 29271 150637 79564383
Infective myositis 12.60 11.78 4 29364 170 79714850
Myoclonus 12.60 11.78 30 29338 27630 79687390
Procedural vomiting 12.44 11.78 6 29362 785 79714235
Prostate cancer recurrent 12.25 11.78 6 29362 812 79714208
Skin striae 12.24 11.78 8 29360 1880 79713140
Wheezing 12.19 11.78 15 29353 116649 79598371
Enthesopathy 12.16 11.78 18 29350 11590 79703430
Alopecia 12.16 11.78 44 29324 231311 79483709
Genital hypoaesthesia 12.03 11.78 4 29364 197 79714823
Oligohydramnios 12 11.78 10 29358 3402 79711618
Neuropathy peripheral 12.00 11.78 21 29347 141284 79573736
Anxiety 11.94 11.78 142 29226 248370 79466650
Pulmonary sarcoidosis 11.88 11.78 7 29361 1370 79713650
Depression 11.83 11.78 127 29241 216663 79498357

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C01EB03 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
OTHER CARDIAC PREPARATIONS
Other cardiac preparations
ATC M01AB01 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC M01AB51 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC M02AA23 MUSCULO-SKELETAL SYSTEM
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Antiinflammatory preparations, non-steroids for topical use
ATC S01BC01 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Antiinflammatory agents, non-steroids
ATC S01CC02 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Antiinflammatory agents, non-steroids and antiinfectives in combination
FDA CS M0001335 Anti-Inflammatory Agents, Non-Steroidal
FDA MoA N0000000160 Cyclooxygenase Inhibitors
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006074 Gout Suppressants
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D012102 Reproductive Control Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D015149 Tocolytic Agents
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:35544 cyclooxygenase inhibitors
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:35845 gout suppressants
CHEBI has role CHEBI:49103 drug metabolites
CHEBI has role CHEBI:76206 xenobiotic metabolites
CHEBI has role CHEBI:78298 environmental contaminants

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

DiseaseRelationSNOMED_IDDOID
Ankylosing spondylitis indication 9631008 DOID:7147
Tendinitis indication 34840004 DOID:971
Tenosynovitis indication 67801009 DOID:970
Rheumatoid arthritis indication 69896004 DOID:7148
Patent ductus arteriosus indication 83330001 DOID:13832
Bursitis indication 84017003 DOID:2965
Gout indication 90560007 DOID:13189
Bursitis of shoulder indication 239961006
Osteoarthritis indication 396275006
Synovitis indication 416209007 DOID:2703
Shoulder Tendonitis indication
Pericarditis off-label use 3238004 DOID:1787
Premature labor off-label use 6383007
Renal colic off-label use 7093002
Pseudoprimary hyperaldosteronism off-label use 71275003
Nephrogenic diabetes insipidus off-label use 111395007 DOID:12387
Dysmenorrhea off-label use 266599000
Fever off-label use 386661006
Twin reversal arterial perfusion syndrome off-label use 417006004
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Proctitis contraindication 3951002 DOID:3127
Acute hemorrhage contraindication 8573003
Rectal hemorrhage contraindication 12063002
Hyperkalemia contraindication 14140009
Myocardial infarction contraindication 22298006 DOID:5844
Parkinsonism contraindication 32798002
Dehydration contraindication 34095006
Depressive disorder contraindication 35489007
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Duodenal ulcer disease contraindication 51868009 DOID:1724
Gastrointestinal perforation contraindication 51875005
Stomatitis contraindication 61170000 DOID:9637
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Hemorrhoids contraindication 70153002 DOID:9746
Corneal deposit contraindication 74460005 DOID:11547
Gastrointestinal hemorrhage contraindication 74474003
Heart failure contraindication 84114007 DOID:6000
Epilepsy contraindication 84757009 DOID:1826
Bacterial infectious disease contraindication 87628006
Hyponatremia contraindication 89627008
Kidney disease contraindication 90708001 DOID:557
Blurring of visual image contraindication 111516008
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Asthma contraindication 195967001 DOID:2841
Sepsis of the newborn contraindication 206376005
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Esophageal dysmotility contraindication 266434009 DOID:9192
Cerebral hemorrhage contraindication 274100004
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Malignant tumor of colon contraindication 363406005 DOID:219
Cardiovascular event risk contraindication 395112001
Gastric ulcer contraindication 397825006 DOID:10808
Diverticular disease contraindication 397881000
Smokes tobacco daily contraindication 449868002
Psychiatric Disturbance contraindication
Intraventricular Hemorrhage In Newborn contraindication
Congenital Heart Defect Requiring Open Patent Ductus Arteriosus 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 4.45 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
20MG TIVORBEX GENUS N204768 Feb. 24, 2014 DISCN CAPSULE ORAL 9089471 April 23, 2030 TREATMENT OF PAIN
40MG TIVORBEX GENUS N204768 Feb. 24, 2014 DISCN CAPSULE ORAL 9089471 April 23, 2030 TREATMENT OF PAIN

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
50MG INDOMETHACIN ZYDUS A216184 Aug. 2, 2023 RX SUPPOSITORY RECTAL Jan. 30, 2024 COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 7.21 WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 6.33 WOMBAT-PK CHEMBL
Multidrug resistance-associated protein 1 Transporter IC50 4.92 CHEMBL
Androgen receptor Nuclear hormone receptor EC50 9.85 CHEMBL
Prostaglandin D2 receptor 2 GPCR Ki 6.53 WOMBAT-PK
Dehydrogenase/reductase SDR family member 9 Enzyme IC50 4.85 CHEMBL
Aldose reductase Enzyme IC50 5.22 CHEMBL
Aldo-keto reductase family 1 member C2 Enzyme IC50 4.44 CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 7 CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor AGONIST Kd 7.38 IUPHAR
Prostaglandin E2 receptor EP2 subtype GPCR Ki 7.69 PDSP
Lactoylglutathione lyase Enzyme Ki 4.74 CHEMBL
Cytochrome c oxidase subunit 2 Enzyme IC50 6.21 CHEMBL
Interleukin-8 Cytokine IC50 7.30 CHEMBL
Potassium voltage-gated channel subfamily A member 7 Ion channel Ki 7.50 WOMBAT-PK
Prostaglandin E synthase Enzyme IC50 4.39 CHEMBL
Aldo-keto reductase family 1 member C4 Enzyme IC50 4.27 CHEMBL
Nicotinate phosphoribosyltransferase Enzyme Ki 9.82 CHEMBL
Multidrug resistance protein 1 Transporter IC50 4.49 CHEMBL
Aldose reductase Enzyme IC50 5.44 DRUG MATRIX
Prostaglandin G/H synthase 2 Enzyme IC50 8.19 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 8.70 CHEMBL
Aldose reductase Enzyme IC50 5.30 CHEMBL
Prostaglandin G/H synthase 1 Enzyme Ki 5.10 CHEMBL
Prostaglandin-H2 D-isomerase Enzyme IC50 6.30 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 8.22 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 6.47 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 8.39 CHEMBL
Cyclooxygenase Enzyme IC50 6.37 CHEMBL
Cyclooxygenase Enzyme IC50 7 CHEMBL
Prostaglandin G/H synthase (cyclooxygenase) Enzyme IC50 6.82 CHEMBL
Nitric oxide synthase, inducible Enzyme IC50 4.70 CHEMBL
Prostaglandin D2 receptor 2 GPCR AGONIST Ki 6 IUPHAR
Prostaglandin G/H synthase 2 Enzyme IC50 8 CHEMBL

External reference:

IDSource
D00141 KEGG_DRUG
74252-25-8 SECONDARY_CAS_RN
4017890 VANDF
4017891 VANDF
C0021246 UMLSCUI
CHEBI:49662 CHEBI
IMN PDB_CHEM_ID
CHEMBL6 ChEMBL_ID
CHEMBL3989410 ChEMBL_ID
DB00328 DRUGBANK_ID
D007213 MESH_DESCRIPTOR_UI
3715 PUBCHEM_CID
1909 IUPHAR_LIGAND_ID
1524 INN_ID
XXE1CET956 UNII
1294612 RXNORM
2387 MMSL
2393 MMSL
4877 MMSL
d00039 MMSL
002373 NDDF
002374 NDDF
373513008 SNOMEDCT_US
60149003 SNOMEDCT_US
783274005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 0409-1113 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 mg INTRAVENOUS ANDA 13 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 0409-1113 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 mg INTRAVENOUS ANDA 13 sections
INDOMETHACIN HUMAN PRESCRIPTION DRUG LABEL 1 0713-0176 SUPPOSITORY 50 mg RECTAL ANDA 14 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-083 CAPSULE 50 mg ORAL ANDA 27 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-919 CAPSULE, EXTENDED RELEASE 75 mg ORAL ANDA 12 sections
Indomethacin Human Prescription Drug Label 1 10544-935 CAPSULE, EXTENDED RELEASE 75 mg ORAL ANDA 24 sections
INDOMETHACIN HUMAN PRESCRIPTION DRUG LABEL 1 10702-016 CAPSULE, EXTENDED RELEASE 75 mg ORAL ANDA 28 sections
INDOMETHACIN ER HUMAN PRESCRIPTION DRUG LABEL 1 12634-160 CAPSULE 75 mg ORAL ANDA 14 sections
INDOMETHACIN ER HUMAN PRESCRIPTION DRUG LABEL 1 12634-838 CAPSULE 75 mg ORAL ANDA 14 sections
INDOMETHACIN HUMAN PRESCRIPTION DRUG LABEL 1 16590-130 CAPSULE 50 mg ORAL ANDA 24 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 21695-522 CAPSULE 25 mg ORAL ANDA 27 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 21695-523 CAPSULE 50 mg ORAL ANDA 23 sections
Indomethacin Human Prescription Drug Label 1 31722-542 CAPSULE 25 mg ORAL ANDA 27 sections
Indomethacin Human Prescription Drug Label 1 31722-542 CAPSULE 25 mg ORAL ANDA 27 sections
Indomethacin Human Prescription Drug Label 1 31722-543 CAPSULE 50 mg ORAL ANDA 27 sections
Indomethacin Human Prescription Drug Label 1 31722-543 CAPSULE 50 mg ORAL ANDA 27 sections
Indomethacin Human Prescription Drug Label 1 31722-565 CAPSULE, EXTENDED RELEASE 75 mg ORAL ANDA 24 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 35356-697 CAPSULE 50 mg ORAL ANDA 27 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 35356-697 CAPSULE 50 mg ORAL ANDA 27 sections
INDOCIN HUMAN PRESCRIPTION DRUG LABEL 1 42211-101 SUSPENSION 25 mg ORAL NDA 28 sections
INDOCIN HUMAN PRESCRIPTION DRUG LABEL 1 42211-102 SUPPOSITORY 50 mg RECTAL ANDA 29 sections
Tivorbex HUMAN PRESCRIPTION DRUG LABEL 1 42211-201 CAPSULE 20 mg ORAL NDA 28 sections
Tivorbex HUMAN PRESCRIPTION DRUG LABEL 1 42211-202 CAPSULE 40 mg ORAL NDA 28 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 42254-081 CAPSULE 50 mg ORAL ANDA 27 sections
INDOMETHACIN HUMAN PRESCRIPTION DRUG LABEL 1 42254-237 CAPSULE 25 mg ORAL ANDA 25 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 43063-368 CAPSULE 25 mg ORAL ANDA 27 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 43063-368 CAPSULE 25 mg ORAL ANDA 27 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 43063-773 CAPSULE 25 mg ORAL ANDA 27 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 43063-773 CAPSULE 25 mg ORAL ANDA 27 sections
Indomethacin HUMAN PRESCRIPTION DRUG LABEL 1 43063-773 CAPSULE 25 mg ORAL ANDA 27 sections