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

Stem definitionDrug idCAS RN
selective cyclo-oxygenase inhibitors 568 169590-42-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • celecoxib
  • celebrex
  • celecox
  • celocoxib
  • onsenal
A pyrazole derivative and selective CYCLOOXYGENASE 2 INHIBITOR that is used to treat symptoms associated with RHEUMATOID ARTHRITIS; OSTEOARTHRITIS and JUVENILE ARTHRITIS, as well as the management of ACUTE PAIN.
  • Molecular weight: 381.37
  • Formula: C17H14F3N3O2S
  • CLOGP: 4.57
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 77.98
  • ALOGS: -4.88
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.20 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.01 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 17.49 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Dec. 31, 1998 FDA GD SEARLE

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 1664.90 9.69 2957 162725 248053 50191389
Drug ineffective 471.98 9.69 4406 161276 814927 49624515
Rheumatoid arthritis 444.39 9.69 1565 164117 200985 50238457
Arthralgia 393.02 9.69 2616 163066 436086 50003356
Musculoskeletal stiffness 296.37 9.69 1010 164672 127471 50311971
Death 289.86 9.69 385 165297 324994 50114448
Maternal exposure during pregnancy 284.24 9.69 85 165597 159693 50279749
Loss of personal independence in daily activities 227.39 9.69 621 165061 69429 50370013
Toxicity to various agents 220.82 9.69 222 165460 212277 50227165
Pain in extremity 198.75 9.69 1550 164132 271315 50168127
Pemphigus 196.09 9.69 74 165608 120092 50319350
Completed suicide 188.81 9.69 98 165584 131791 50307651
Ankylosing spondylitis 178.44 9.69 164 165518 7001 50432441
Therapeutic product effect incomplete 176.55 9.69 679 165003 90836 50348606
Exposure during pregnancy 170.15 9.69 92 165590 120923 50318519
Neutropenia 152.00 9.69 156 165526 147809 50291633
C-reactive protein abnormal 147.71 9.69 299 165383 27510 50411932
Glossodynia 146.88 9.69 99 165583 115470 50323972
Fibromyalgia 140.22 9.69 393 165289 44585 50394857
Condition aggravated 137.64 9.69 1532 164150 295526 50143916
Pain 135.60 9.69 2651 163031 576252 49863190
Osteoarthritis 133.07 9.69 510 165172 68096 50371346
Psoriatic arthropathy 131.27 9.69 395 165287 46637 50392805
Rheumatoid nodule 130.92 9.69 184 165498 12551 50426891
Drug abuse 130.39 9.69 20 165662 59826 50379616
Febrile neutropenia 129.09 9.69 80 165602 97587 50341855
Systemic lupus erythematosus 125.32 9.69 166 165516 140456 50298986
Gait inability 124.85 9.69 333 165349 36694 50402748
Therapeutic product effect decreased 121.41 9.69 812 164870 135238 50304204
Bedridden 117.24 9.69 149 165533 9218 50430224
Foot deformity 115.95 9.69 218 165464 18992 50420450
Pharyngitis 111.13 9.69 203 165479 17300 50422142
Toothache 109.88 9.69 198 165484 16696 50422746
Intentional overdose 107.92 9.69 35 165647 62469 50376973
Drug intolerance 107.83 9.69 1144 164538 217960 50221482
Arthritis 105.89 9.69 562 165120 86159 50353283
Gait disturbance 104.49 9.69 844 164838 149161 50290281
Thrombocytopenia 100.76 9.69 164 165518 127509 50311933
Osteoporosis 99.97 9.69 349 165333 44530 50394912
Wound 99.32 9.69 120 165562 105674 50333768
International normalised ratio fluctuation 96.68 9.69 70 165612 2120 50437322
Anti-cyclic citrullinated peptide antibody positive 95.82 9.69 56 165626 70531 50368911
Hypoaesthesia 93.54 9.69 725 164957 126532 50312910
Myocardial infarction 93.47 9.69 554 165128 88473 50350969
Pericarditis 92.68 9.69 73 165609 78616 50360826
Confusional state 91.17 9.69 308 165374 185620 50253822
Red blood cell sedimentation rate increased 88.71 9.69 254 165428 29162 50410280
White blood cell count abnormal 88.65 9.69 99 165583 5341 50434101
Dyspnoea 88.62 9.69 1262 164420 546346 49893096
Hyponatraemia 86.12 9.69 113 165569 96026 50343416
Pleural fibrosis 85.32 9.69 78 165604 3306 50436136
Hypotension 85.06 9.69 439 165243 235030 50204412
Immobile 84.12 9.69 93 165589 4961 50434481
Thyroid neoplasm 82.94 9.69 78 165604 3429 50436013
Electrocardiogram QT prolonged 82.86 9.69 33 165649 51853 50387589
Presbyacusis 82.00 9.69 70 165612 2706 50436736
Nerve injury 81.93 9.69 118 165564 8232 50431210
Muscle injury 81.76 9.69 12 165670 37099 50402343
Gastric disorder 81.34 9.69 247 165435 29301 50410141
Device expulsion 81.04 9.69 3 165679 28819 50410623
Neoplasm malignant 80.66 9.69 214 165468 23501 50415941
Lower limb fracture 79.03 9.69 156 165526 14090 50425352
Bone swelling 78.21 9.69 49 165633 1161 50438281
Joint swelling 77.99 9.69 1181 164501 244105 50195337
Red blood cell sedimentation rate abnormal 77.76 9.69 168 165514 16175 50423267
Foot fracture 77.36 9.69 190 165492 19901 50419541
C-reactive protein increased 75.87 9.69 423 165259 66051 50373391
Acute kidney injury 75.86 9.69 437 165245 227621 50211821
Ulcer 75.64 9.69 189 165493 20011 50419431
Pulmonary toxicity 75.25 9.69 92 165590 5470 50433972
Blood magnesium increased 73.82 9.69 67 165615 2813 50436629
Foetal exposure during pregnancy 73.16 9.69 4 165678 27355 50412087
Pyrexia 72.55 9.69 846 164836 379357 50060085
Pleural thickening 71.64 9.69 63 165619 2536 50436906
Joint injury 68.49 9.69 191 165491 21598 50417844
Drug tolerance 68.45 9.69 83 165599 4893 50434549
Musculoskeletal pain 65.04 9.69 432 165250 71745 50367697
Alopecia 64.72 9.69 503 165179 244544 50194898
Drug eruption 64.66 9.69 197 165485 23409 50416033
Hand deformity 63.96 9.69 146 165536 100053 50339389
Anaemia 62.64 9.69 527 165155 251929 50187513
Folliculitis 62.54 9.69 25 165657 39200 50400242
Bloody discharge 62.28 9.69 42 165640 1132 50438310
Nephrolithiasis 61.66 9.69 251 165431 34442 50405000
Overdose 60.71 9.69 149 165533 99578 50339864
Mobility decreased 60.67 9.69 459 165223 79489 50359953
Deafness neurosensory 60.16 9.69 74 165608 4427 50435015
Contraindicated product administered 59.83 9.69 748 164934 148210 50291232
Enthesopathy 59.68 9.69 94 165588 7099 50432343
Deformity 59.39 9.69 99 165583 7841 50431601
Epigastric discomfort 59.13 9.69 84 165598 5786 50433656
Hypermobility syndrome 57.52 9.69 34 165648 723 50438719
Psoriasis 57.43 9.69 405 165277 68595 50370847
Disability 57.02 9.69 128 165554 12647 50426795
Sleep disorder due to general medical condition, insomnia type 55.36 9.69 17 165665 31430 50408012
Suicide attempt 54.84 9.69 53 165629 51679 50387763
Bunion operation 54.01 9.69 38 165644 1099 50438343
Seizure 53.91 9.69 201 165481 117673 50321769
Osteopenia 53.31 9.69 149 165533 16869 50422573
Hypoglycaemia 53.27 9.69 58 165624 53523 50385919
Blood parathyroid hormone decreased 52.28 9.69 88 165594 7026 50432416
Joint stiffness 52.07 9.69 217 165465 30091 50409351
Intervertebral disc protrusion 51.08 9.69 165 165517 20228 50419214
Disease progression 51.01 9.69 153 165529 95713 50343729
Dry eye 50.67 9.69 224 165458 31871 50407571
Abortion spontaneous 50.13 9.69 38 165644 41734 50397708
Intentional self-injury 49.71 9.69 8 165674 23104 50416338
Tenosynovitis 49.57 9.69 108 165574 10457 50428985
Interstitial lung disease 49.56 9.69 321 165361 52855 50386587
Sepsis 49.55 9.69 245 165437 132680 50306762
Systemic lupus erythematosus rash 49.30 9.69 43 165639 1712 50437730
Premature delivery 49.11 9.69 9 165673 23654 50415788
Product use in unapproved indication 48.82 9.69 204 165478 115615 50323827
Burning mouth syndrome 48.72 9.69 25 165657 398 50439044
Intervertebral disc degeneration 48.37 9.69 124 165558 13337 50426105
Duodenal ulcer perforation 48.03 9.69 47 165635 45564 50393878
Fine motor skill dysfunction 47.80 9.69 63 165619 4040 50435402
Arthropathy 47.32 9.69 753 164929 157153 50282289
Cardio-respiratory arrest 46.57 9.69 65 165617 53827 50385615
Hypokalaemia 46.41 9.69 141 165541 87851 50351591
Movement disorder 46.30 9.69 145 165537 17487 50421955
Impaired work ability 46.30 9.69 123 165559 13517 50425925
Bone cyst 45.93 9.69 44 165638 1980 50437462
Panniculitis 45.82 9.69 92 165590 8411 50431031
Anaphylactic reaction 45.40 9.69 318 165364 53737 50385705
Sopor 44.79 9.69 6 165676 19873 50419569
Lyme disease 44.42 9.69 48 165634 2495 50436947
Helicobacter infection 43.90 9.69 59 165623 49643 50389799
Mucosal inflammation 43.87 9.69 40 165642 40102 50399340
Investigation abnormal 43.84 9.69 35 165647 1230 50438212
Off label use 43.74 9.69 1201 164481 473225 49966217
Syncope 43.67 9.69 181 165501 102821 50336621
Rotator cuff syndrome 43.21 9.69 108 165574 11436 50428006
Osteosclerosis 43.15 9.69 55 165627 3412 50436030
Dehydration 42.06 9.69 309 165373 152140 50287302
Inflammation 41.63 9.69 324 165358 56588 50382854
Fear of injection 41.57 9.69 73 165609 6030 50433412
Musculoskeletal disorder 41.32 9.69 138 165544 17211 50422231
Stress 40.89 9.69 309 165373 53484 50385958
Tachycardia 40.64 9.69 178 165504 99585 50339857
Pancytopenia 40.59 9.69 140 165542 83890 50355552
Granuloma skin 40.16 9.69 70 165612 5748 50433694
Neck pain 39.62 9.69 321 165361 56746 50382696
Pharyngeal oedema 39.03 9.69 113 165569 13052 50426390
Epicondylitis 38.66 9.69 39 165643 1870 50437572
Cyst 38.46 9.69 107 165575 12080 50427362
Fatigue 38.30 9.69 1911 163771 705690 49733752
Spinal osteoarthritis 38.03 9.69 117 165565 13975 50425467
Gastric ulcer 37.74 9.69 154 165528 21151 50418291
Fracture 37.55 9.69 131 165551 16702 50422740
Tendonitis 37.27 9.69 130 165552 16575 50422867
Leukopenia 37.21 9.69 106 165576 67422 50372020
Alanine aminotransferase abnormal 36.84 9.69 56 165626 4100 50435342
Metabolic acidosis 36.46 9.69 44 165638 38781 50400661
Hospitalisation 36.44 9.69 108 165574 67829 50371613
Antinuclear antibody positive 36.39 9.69 70 165612 6202 50433240
Encephalopathy 36.35 9.69 34 165648 33677 50405765
Irritable bowel syndrome 36.12 9.69 71 165611 51370 50388072
Cardiac arrest 36.08 9.69 146 165536 83505 50355937
Premature baby 35.92 9.69 8 165674 18329 50421113
Multiple organ dysfunction syndrome 35.76 9.69 69 165613 50268 50389174
Therapeutic response decreased 35.72 9.69 271 165411 46960 50392482
Discomfort 35.27 9.69 209 165473 108171 50331271
Malignant neoplasm progression 34.62 9.69 111 165571 68013 50371429
Red blood cell sedimentation rate 34.19 9.69 50 165632 3536 50435906
Multiple sclerosis relapse 34.04 9.69 55 165627 42909 50396533
Right ventricular failure 33.08 9.69 6 165676 15887 50423555
Pregnancy 32.88 9.69 29 165653 29548 50409894
Dermatitis allergic 32.84 9.69 104 165578 12616 50426826
Muscle spasticity 32.66 9.69 8 165674 17176 50422266
Meniscus injury 32.55 9.69 67 165615 6235 50433207
Tongue disorder 32.19 9.69 84 165598 9132 50430310
Neuropathy peripheral 31.80 9.69 186 165496 96571 50342871
Respiratory failure 31.74 9.69 172 165510 91009 50348433
Hunger 31.68 9.69 53 165629 4210 50435232
Spinal stenosis 31.58 9.69 107 165575 13443 50425999
Loss of employment 31.39 9.69 32 165650 1554 50437888
Platelet count decreased 31.33 9.69 197 165485 100529 50338913
Skin necrosis 30.99 9.69 92 165590 10775 50428667
Respiratory tract congestion 30.39 9.69 109 165573 14090 50425352
Bradycardia 30.00 9.69 109 165573 64317 50375125
Hypoxia 29.85 9.69 78 165604 51045 50388397
Exostosis 29.83 9.69 95 165587 11558 50427884
Device dislocation 29.36 9.69 17 165665 21529 50417913
Pulmonary arterial hypertension 29.19 9.69 15 165667 20304 50419138
Joint range of motion decreased 29.07 9.69 129 165553 18383 50421059
Neutrophil count decreased 28.60 9.69 68 165614 45958 50393484
Hypervolaemia 28.35 9.69 25 165657 25474 50413968
Multiple fractures 28.13 9.69 65 165617 6546 50432896
Vomiting 28.11 9.69 1228 164454 459530 49979912
Torsade de pointes 28.08 9.69 3 165679 11832 50427610
Neutropenic sepsis 28.06 9.69 6 165676 14141 50425301
Joint effusion 27.90 9.69 100 165582 12921 50426521
Somnolence 27.88 9.69 349 165333 154636 50284806
Blood pressure systolic increased 27.71 9.69 205 165477 35244 50404198
Pulmonary congestion 27.63 9.69 111 165571 15136 50424306
Cognitive disorder 27.57 9.69 65 165617 44058 50395384
Skin ulcer 27.47 9.69 204 165478 35114 50404328
Tooth infection 27.41 9.69 105 165577 14007 50425435
White blood cell count decreased 27.41 9.69 247 165435 116475 50322967
Sedation 27.37 9.69 36 165646 30574 50408868
Bursitis 27.36 9.69 144 165538 21991 50417451
Paranasal sinus inflammation 27.24 9.69 17 165665 400 50439042
Gastric ulcer haemorrhage 27.20 9.69 51 165631 4433 50435009
Treatment failure 26.96 9.69 615 165067 137022 50302420
Gastrointestinal toxicity 26.89 9.69 52 165630 4625 50434817
Basal cell carcinoma 26.21 9.69 148 165534 23208 50416234
Asthenia 25.99 9.69 821 164861 318221 50121221
Upper limb fracture 25.98 9.69 112 165570 15761 50423681
Blood calcium decreased 25.93 9.69 18 165664 20688 50418754
Plasma cell myeloma 25.86 9.69 39 165643 31283 50408159
Tuberculosis 25.63 9.69 82 165600 10001 50429441
Rheumatoid factor positive 25.50 9.69 81 165601 49778 50389664
Synovial cyst 25.09 9.69 71 165611 8095 50431347
Acute myeloid leukaemia 25.04 9.69 9 165673 15065 50424377
Bronchitis 24.82 9.69 479 165203 103680 50335762
Pruritus allergic 24.76 9.69 24 165658 1096 50438346
Cytomegalovirus infection 24.72 9.69 14 165668 17948 50421494
Cholestasis 24.69 9.69 28 165654 25373 50414069
Premature labour 24.62 9.69 4 165678 11472 50427970
Drug resistance 24.46 9.69 16 165666 18973 50420469
Nodule 24.11 9.69 115 165567 16888 50422554
Epistaxis 23.74 9.69 118 165564 63836 50375606
Decreased appetite 23.29 9.69 491 165191 200432 50239010
Septic shock 23.28 9.69 102 165580 57073 50382369
Palmar-plantar erythrodysaesthesia syndrome 23.21 9.69 19 165663 20079 50419363
Back disorder 23.04 9.69 75 165607 9230 50430212
International normalised ratio increased 22.85 9.69 69 165613 43083 50396359
Clostridium difficile colitis 22.79 9.69 15 165667 17727 50421715
Limb discomfort 22.66 9.69 147 165535 24210 50415232
Joint prosthesis user 22.53 9.69 8 165674 47 50439395
Hyperglycaemia 21.67 9.69 55 165627 36350 50403092
Sacroiliitis 21.63 9.69 34 165648 2563 50436879
Hepatic failure 21.44 9.69 46 165636 32237 50407205
Mental status changes 21.43 9.69 55 165627 36217 50403225
Orthostatic hypotension 21.30 9.69 40 165642 29441 50410001
Peripheral swelling 21.24 9.69 850 164832 205086 50234356
Medication error 21.14 9.69 55 165627 36049 50403393
Malignant melanoma 21.12 9.69 77 165605 10031 50429411
Respiratory arrest 20.57 9.69 42 165640 29967 50409475
Oesophageal spasm 20.44 9.69 31 165651 2265 50437177
Radiculopathy 20.39 9.69 48 165634 4893 50434549
Gelatinous transformation of the bone marrow 20.18 9.69 5 165677 5 50439437
Breast cyst excision 20.12 9.69 8 165674 67 50439375
Constipation 20.03 9.69 459 165223 185249 50254193
Femur fracture 19.97 9.69 199 165483 37265 50402177
Ascites 19.96 9.69 56 165626 35805 50403637
Gamma-glutamyltransferase increased 19.85 9.69 42 165640 29581 50409861
Neoplasm progression 19.82 9.69 41 165641 29116 50410326
COVID-19 19.77 9.69 82 165600 46580 50392862
Insomnia 19.74 9.69 729 164953 174136 50265306
Poisoning 19.68 9.69 8 165674 12421 50427021
Epilepsy 19.66 9.69 25 165657 21542 50417900
Synovial rupture 19.17 9.69 10 165672 165 50439277
Acute hepatic failure 19.14 9.69 14 165668 15663 50423779
Tuberculin test positive 19.03 9.69 36 165646 3150 50436292
Foot operation 19.02 9.69 50 165632 5460 50433982
Emphysema 18.78 9.69 69 165613 9024 50430418
Dysstasia 18.75 9.69 111 165571 17708 50421734
Body height decreased 18.73 9.69 68 165614 8840 50430602
Amblyopia 18.65 9.69 11 165671 233 50439209
Blood potassium increased 18.46 9.69 104 165578 16294 50423148
Full blood count decreased 18.27 9.69 28 165654 22318 50417124
Carpal tunnel syndrome 18.27 9.69 106 165576 16787 50422655
Diabetic ketoacidosis 18.15 9.69 19 165663 17853 50421589
Hepatocellular injury 18.05 9.69 36 165646 25911 50413531
Tremor 18.03 9.69 266 165416 114637 50324805
Osteomyelitis 17.89 9.69 130 165552 22223 50417219
Infection 17.62 9.69 713 164969 172241 50267201
Limb injury 17.51 9.69 120 165562 20130 50419312
Angina unstable 17.47 9.69 55 165627 6651 50432791
Oral herpes 17.44 9.69 122 165560 20603 50418839
Blister 17.43 9.69 187 165495 85231 50354211
Metabolic surgery 17.41 9.69 19 165663 999 50438443
Injection related reaction 17.39 9.69 15 165667 588 50438854
Cardiac failure 17.37 9.69 162 165520 75878 50363564
Device issue 17.34 9.69 24 165658 19948 50419494
Progressive multifocal leukoencephalopathy 17.15 9.69 8 165674 11449 50427993
Hip surgery 17.09 9.69 31 165651 2627 50436815
Axial spondyloarthritis 17.03 9.69 10 165672 210 50439232
Inflammatory bowel disease 17.03 9.69 36 165646 3414 50436028
Spondylolisthesis 16.97 9.69 34 165648 3103 50436339
Myofascial pain syndrome 16.97 9.69 27 165655 2056 50437386
Back pain 16.78 9.69 881 164801 219149 50220293
Spinal pain 16.75 9.69 75 165607 10728 50428714
Hypersensitivity vasculitis 16.56 9.69 39 165643 3976 50435466
Malaise 16.56 9.69 1294 164388 334238 50105204
Cardiogenic shock 16.51 9.69 16 165666 15583 50423859
Dactylitis 16.39 9.69 25 165657 1836 50437606
Neuralgia 16.28 9.69 125 165557 21738 50417704
Clostridium difficile infection 16.27 9.69 37 165645 25402 50414040
Eye disorder 16.17 9.69 111 165571 18628 50420814
Rheumatoid lung 16.17 9.69 29 165653 2436 50437006
Infusion related reaction 16.13 9.69 427 165255 169130 50270312
Acute respiratory failure 15.98 9.69 45 165637 28737 50410705
Malignant polyp 15.85 9.69 9 165673 177 50439265
Contusion 15.82 9.69 265 165417 111918 50327524
Coma 15.81 9.69 115 165567 56764 50382678
Post procedural haemorrhage 15.72 9.69 56 165626 7214 50432228
Respiratory depression 15.63 9.69 10 165672 12000 50427442
Gluten sensitivity 15.57 9.69 13 165669 487 50438955
Chondropathy 15.46 9.69 26 165656 2074 50437368
Creatinine renal clearance decreased 15.32 9.69 10 165672 11871 50427571
Vitamin K deficiency 15.30 9.69 12 165670 411 50439031
Migraine 15.24 9.69 338 165344 74942 50364500
Flushing 15.21 9.69 143 165539 66872 50372570
Foetal death 15.18 9.69 4 165678 8176 50431266
Bone erosion 15.12 9.69 77 165605 11610 50427832
Posterior reversible encephalopathy syndrome 15.01 9.69 16 165666 14912 50424530
Ligament sprain 14.79 9.69 71 165611 10454 50428988
Groin pain 14.75 9.69 63 165619 8828 50430614
Haemodynamic instability 14.74 9.69 4 165678 8020 50431422
Product dose omission issue 14.72 9.69 474 165208 183364 50256078
Diarrhoea 14.56 9.69 1696 163986 586780 49852662
Parotid gland enlargement 14.52 9.69 15 165667 740 50438702
Fracture pain 14.48 9.69 11 165671 359 50439083
Infective pulmonary exacerbation of cystic fibrosis 14.43 9.69 4 165678 7905 50431537
Caesarean section 14.39 9.69 18 165664 15621 50423821
Tenosynovitis stenosans 14.38 9.69 26 165656 2198 50437244
Bronchomalacia 14.37 9.69 9 165673 213 50439229
Myelodysplastic syndrome 14.36 9.69 17 165665 15115 50424327
Patellofemoral pain syndrome 14.30 9.69 13 165669 547 50438895
Dressler's syndrome 14.18 9.69 3 165679 0 50439442
Immunoglobulins decreased 14.14 9.69 17 165665 993 50438449
Therapy non-responder 14.03 9.69 240 165442 50782 50388660
Transplant rejection 13.94 9.69 7 165675 9602 50429840
Respiratory distress 13.92 9.69 52 165630 30437 50409005
Status epilepticus 13.90 9.69 14 165668 13392 50426050
Agitation 13.86 9.69 110 165572 53274 50386168
Kidney infection 13.86 9.69 107 165575 18639 50420803
Hyperbilirubinaemia 13.84 9.69 7 165675 9563 50429879
Abdominal pain upper 13.83 9.69 646 165036 158663 50280779
Blood bilirubin increased 13.76 9.69 56 165626 31982 50407460
Tenderness 13.74 9.69 106 165576 18459 50420983
Psychotic disorder 13.73 9.69 32 165650 21780 50417662
Lethargy 13.71 9.69 100 165582 49332 50390110
Wrist fracture 13.70 9.69 74 165608 11413 50428029
Glomerulonephritis minimal lesion 13.66 9.69 9 165673 233 50439209
Red blood cell count decreased 13.60 9.69 170 165512 33665 50405777
Hepatic enzyme increased 13.58 9.69 344 165338 137036 50302406
Ill-defined disorder 13.56 9.69 114 165568 54540 50384902
Tooth disorder 13.55 9.69 130 165552 24098 50415344
Oculomucocutaneous syndrome 13.39 9.69 7 165675 116 50439326
Tubo-ovarian abscess 13.39 9.69 10 165672 318 50439124
Finger deformity 13.36 9.69 45 165637 5637 50433805
Swollen tongue 13.34 9.69 148 165534 28482 50410960
Presyncope 13.31 9.69 38 165644 24160 50415282
Gastric perforation 13.30 9.69 20 165662 1450 50437992
Abortion induced 13.27 9.69 7 165675 9337 50430105
Pulmonary fibrosis 13.12 9.69 130 165552 24307 50415135
Surgery 13.11 9.69 154 165528 30051 50409391
Product complaint 13.09 9.69 73 165609 11393 50428049
Drug-induced liver injury 12.99 9.69 145 165537 27950 50411492
Tendon rupture 12.94 9.69 52 165630 7092 50432350
Prescribed overdose 12.91 9.69 87 165595 14513 50424929
Pneumonia aspiration 12.81 9.69 55 165627 30949 50408493
Road traffic accident 12.81 9.69 129 165553 24223 50415219
Mass excision 12.80 9.69 9 165673 260 50439182
Wrist deformity 12.79 9.69 22 165660 1787 50437655
Pulmonary hypertension 12.78 9.69 61 165621 33356 50406086
Exposure via skin contact 12.75 9.69 8 165674 190 50439252
Adrenal suppression 12.74 9.69 15 165667 857 50438585
Lithotripsy 12.72 9.69 4 165678 15 50439427
Musculoskeletal discomfort 12.71 9.69 88 165594 14810 50424632
Body temperature increased 12.70 9.69 56 165626 31285 50408157
Electrolyte imbalance 12.66 9.69 23 165659 17146 50422296
Drug reaction with eosinophilia and systemic symptoms 12.64 9.69 49 165633 28375 50411067
Pulmonary oedema 12.63 9.69 101 165581 48837 50390605
Genital haemorrhage 12.61 9.69 3 165679 6571 50432871
Depressed level of consciousness 12.60 9.69 109 165573 51844 50387598
Lymphocyte count decreased 12.58 9.69 44 165638 26263 50413179
Tongue cancer recurrent 12.52 9.69 4 165678 16 50439426
Klebsiella infection 12.46 9.69 4 165678 7190 50432252
Paradoxical psoriasis 12.31 9.69 7 165675 138 50439304
Rhabdomyolysis 12.30 9.69 76 165606 38951 50400491
Nail injury 12.30 9.69 11 165671 453 50438989
Metastases to liver 12.25 9.69 30 165652 20074 50419368
Toe operation 12.25 9.69 13 165669 662 50438780
Pulmonary embolism 12.23 9.69 247 165435 101457 50337985
Suicidal ideation 12.22 9.69 119 165563 55266 50384176
Uterine perforation 12.17 9.69 3 165679 6412 50433030
Sciatic nerve neuropathy 12.11 9.69 9 165673 284 50439158
Neuroprosthesis implantation 12.11 9.69 3 165679 3 50439439
Disability assessment scale score increased 12.10 9.69 25 165657 2333 50437109
Dermatitis 12.05 9.69 84 165598 14167 50425275
Eosinophilia 12.04 9.69 27 165655 18625 50420817
Cystitis 12.03 9.69 209 165473 44355 50395087
Stenosis 12.02 9.69 17 165665 1166 50438276
Coronary artery stenosis 11.94 9.69 36 165646 4253 50435189
Generalised tonic-clonic seizure 11.93 9.69 45 165637 26265 50413177
Meningitis streptococcal 11.92 9.69 7 165675 147 50439295
Interferon gamma release assay positive 11.89 9.69 5 165677 49 50439393
Thrombotic microangiopathy 11.89 9.69 7 165675 8784 50430658
Miosis 11.87 9.69 3 165679 6307 50433135
Neuroma 11.84 9.69 10 165672 381 50439061
Device related infection 11.82 9.69 32 165650 20703 50418739
Knee operation 11.82 9.69 39 165643 4834 50434608
Urticaria 11.81 9.69 528 165154 129033 50310409
Ejection fraction decreased 11.79 9.69 27 165655 18493 50420949
Mania 11.78 9.69 11 165671 10905 50428537
Vertebral foraminal stenosis 11.77 9.69 14 165668 809 50438633
Transfusion 11.72 9.69 15 165667 12890 50426552
Gastritis 11.70 9.69 162 165520 32821 50406621
Bone disorder 11.69 9.69 103 165579 18649 50420793
Synovial fluid analysis 11.69 9.69 20 165662 1618 50437824
Spinal deformity 11.66 9.69 15 165667 939 50438503
Cartilage injury 11.65 9.69 20 165662 1622 50437820
Spinal cord injury cervical 11.64 9.69 4 165678 21 50439421
Brain oedema 11.63 9.69 14 165668 12356 50427086
Pleural effusion 11.62 9.69 192 165490 81262 50358180
Tooth abscess 11.59 9.69 77 165605 12783 50426659
Periarticular disorder 11.54 9.69 5 165677 53 50439389
Coronary artery surgery 11.54 9.69 5 165677 53 50439389
Necrotising fasciitis 11.52 9.69 26 165656 2578 50436864
Gestational diabetes 11.51 9.69 5 165677 7460 50431982
Anuria 11.36 9.69 12 165670 11232 50428210
Erythema multiforme 11.27 9.69 59 165623 8991 50430451
Hepatic encephalopathy 11.26 9.69 9 165673 9627 50429815
Urinary tract infection 11.26 9.69 609 165073 223411 50216031
Musculoskeletal chest pain 11.25 9.69 101 165581 18385 50421057
Balance disorder 11.21 9.69 163 165519 70427 50369015
Euglycaemic diabetic ketoacidosis 11.21 9.69 27 165655 2792 50436650
Pneumonitis 11.21 9.69 54 165628 29456 50409986
Spondylitis 11.18 9.69 27 165655 2798 50436644
Cerebral haemorrhage 11.17 9.69 48 165634 27004 50412438
Coeliac artery compression syndrome 11.14 9.69 6 165676 106 50439336
Mydriasis 11.13 9.69 11 165671 10616 50428826
Polyneuropathy 11.12 9.69 14 165668 12117 50427325
Localised infection 11.09 9.69 130 165552 25355 50414087
Blastomycosis 11.09 9.69 8 165674 241 50439201
Purpura senile 11.07 9.69 11 165671 518 50438924
Underdose 11.04 9.69 32 165650 20246 50419196
Granuloma 11.00 9.69 38 165644 4820 50434622
Walking aid user 11.00 9.69 46 165636 6387 50433055
Ventricular fibrillation 10.98 9.69 11 165671 10548 50428894
Tumour necrosis factor receptor-associated periodic syndrome 10.93 9.69 4 165678 26 50439416
Iritis 10.91 9.69 25 165657 2503 50436939
Joint noise 10.84 9.69 31 165651 3556 50435886
Spondyloarthropathy 10.82 9.69 13 165669 759 50438683
Hyperkalaemia 10.75 9.69 103 165579 47986 50391456
Cardiac disorder 10.69 9.69 199 165483 42780 50396662
Perseveration 10.69 9.69 8 165674 255 50439187
Parkinsonism 10.67 9.69 8 165674 8839 50430603
Device leakage 10.67 9.69 3 165679 5875 50433567
Disease risk factor 10.64 9.69 5 165677 65 50439377
Blood cholesterol increased 10.58 9.69 246 165436 54969 50384473
Uveitis 10.45 9.69 59 165623 9251 50430191
Cell marker increased 10.43 9.69 8 165674 265 50439177
Extrapyramidal disorder 10.36 9.69 14 165668 11756 50427686
Coeliac disease 10.29 9.69 8 165674 8677 50430765
Bone marrow oedema 10.27 9.69 13 165669 801 50438641
Oesophageal pain 10.26 9.69 26 165656 2776 50436666
Cutaneous symptom 10.24 9.69 7 165675 193 50439249
Bone marrow failure 10.23 9.69 51 165631 27573 50411869
Medulloblastoma 10.22 9.69 4 165678 32 50439410
Pathogen resistance 10.15 9.69 3 165679 5686 50433756
Temporomandibular joint syndrome 10.13 9.69 30 165652 3509 50435933
Renal tubular necrosis 10.11 9.69 11 165671 10157 50429285
Uterine disorder 10.10 9.69 25 165657 2630 50436812
Back injury 10.10 9.69 48 165634 7037 50432405
Iron deficiency 10.09 9.69 42 165640 5820 50433622
Urinary tract pain 10.08 9.69 7 165675 198 50439244
Pneumonia 10.05 9.69 1085 164597 377316 50062126
Enterococcal infection 10.05 9.69 5 165677 6893 50432549
Depression 10.04 9.69 649 165033 164774 50274668
Carotid artery disease 9.96 9.69 18 165664 1521 50437921
Breast cyst 9.92 9.69 18 165664 1526 50437916
Delusion 9.90 9.69 12 165670 10557 50428885
Weight fluctuation 9.89 9.69 48 165634 7100 50432342
Pneumonia viral 9.88 9.69 5 165677 6829 50432613
Circulatory collapse 9.87 9.69 33 165649 19967 50419475
Aspergillus infection 9.85 9.69 5 165677 6816 50432626
Accidental overdose 9.80 9.69 32 165650 19501 50419941
Left ventricular dysfunction 9.76 9.69 12 165670 10494 50428948
No adverse event 9.76 9.69 67 165615 33511 50405931
Dystonia 9.70 9.69 15 165667 11911 50427531

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 331.33 10.26 161 56196 4015 29514155
Drug hypersensitivity 301.05 10.26 498 55859 67908 29450262
Psoriatic arthropathy 188.78 10.26 183 56174 14508 29503662
Arthralgia 138.95 10.26 580 55777 139037 29379133
Toxicity to various agents 128.23 10.26 87 56270 173574 29344596
Pain 124.81 10.26 650 55707 170782 29347388
Death 121.73 10.26 298 56059 341786 29176384
Myocardial infarction 98.72 10.26 444 55913 109852 29408318
Psoriasis 95.37 10.26 198 56159 32029 29486141
Arthritis 92.67 10.26 169 56188 24850 29493320
Osteoarthritis 81.06 10.26 133 56224 17970 29500200
Neck pain 72.10 10.26 139 56218 21308 29496862
Rheumatoid arthritis 71.10 10.26 176 56181 31976 29486194
Back pain 69.59 10.26 381 55976 101903 29416267
Musculoskeletal stiffness 65.57 10.26 188 56169 37270 29480900
Febrile neutropenia 63.67 10.26 72 56285 112168 29406002
Completed suicide 62.85 10.26 48 56309 90198 29427972
Arthropathy 62.08 10.26 131 56226 21423 29496747
Drug ineffective 61.00 10.26 1000 55357 362170 29156000
Drug interaction 60.19 10.26 185 56172 197200 29320970
Victim of child abuse 59.36 10.26 30 56327 815 29517355
Knee arthroplasty 55.91 10.26 62 56295 5747 29512423
Drug abuse 54.97 10.26 43 56314 79840 29438330
Therapeutic product effect incomplete 49.35 10.26 176 56181 39129 29479041
Acute kidney injury 49.34 10.26 300 56057 264967 29253203
Axial spondyloarthritis 46.19 10.26 18 56339 257 29517913
Joint swelling 45.97 10.26 202 56155 49428 29468742
Brain scan abnormal 45.04 10.26 25 56332 825 29517345
Intervertebral disc protrusion 44.76 10.26 68 56289 8602 29509568
Coronary artery disease 44.12 10.26 184 56173 44006 29474164
General physical health deterioration 43.54 10.26 81 56276 102776 29415394
Drug dependence 43.40 10.26 112 56245 20869 29497301
Hypotension 43.17 10.26 207 56150 194147 29324023
Cerebral artery thrombosis 42.57 10.26 23 56334 719 29517451
Sacroiliitis 40.99 10.26 26 56331 1101 29517069
Thrombocytopenia 39.89 10.26 128 56229 134695 29383475
Off label use 39.87 10.26 374 55983 300426 29217744
Neutropenia 38.99 10.26 125 56232 131586 29386584
Muscle swelling 38.63 10.26 17 56340 335 29517835
Sepsis 34.63 10.26 147 56210 142535 29375635
Pleural thickening 34.06 10.26 15 56342 296 29517874
Fibromyalgia 32.36 10.26 32 56325 2597 29515573
Exostosis 32.31 10.26 37 56320 3552 29514618
Anxiety 32.17 10.26 275 56082 85090 29433080
Hyperhidrosis 31.60 10.26 221 56136 64319 29453851
Juvenile idiopathic arthritis 31.49 10.26 24 56333 1370 29516800
Hypoglycaemia 30.82 10.26 28 56329 48318 29469852
Pancytopenia 30.54 10.26 71 56286 83097 29435073
Cardio-respiratory arrest 30.29 10.26 31 56326 50570 29467600
Multiple organ dysfunction syndrome 30.11 10.26 46 56311 63070 29455100
Inflammatory pain 30.10 10.26 11 56346 130 29518040
Therapeutic product effect decreased 29.68 10.26 123 56234 29328 29488842
Leukopenia 28.54 10.26 38 56319 55165 29463005
Transposition of the great vessels 28.48 10.26 15 56342 445 29517725
Cytomegalovirus infection 28.35 10.26 5 56352 23210 29494960
Pain in extremity 28.13 10.26 328 56029 110105 29408065
Hernia 27.87 10.26 54 56303 8304 29509866
Intentional overdose 27.44 10.26 20 56337 38508 29479662
Epidural lipomatosis 27.36 10.26 17 56340 694 29517476
Oesophageal fibrosis 27.14 10.26 11 56346 175 29517995
Coronary artery stenosis 26.91 10.26 54 56303 8519 29509651
Lactic acidosis 26.83 10.26 12 56345 30235 29487935
Emotional distress 26.52 10.26 72 56285 13823 29504347
Blood cholesterol increased 26.05 10.26 77 56280 15518 29502652
Oesophagogastric fundoplasty 25.72 10.26 6 56351 10 29518160
Synovitis 25.54 10.26 61 56296 10829 29507341
Intervertebral disc degeneration 25.37 10.26 40 56317 5224 29512946
Heart rate decreased 25.06 10.26 104 56253 24808 29493362
Cerebrovascular accident 25.01 10.26 240 56117 76671 29441499
Hypoaesthesia 24.95 10.26 181 56176 53286 29464884
Depression 24.93 10.26 260 56097 84887 29433283
Foetal exposure during pregnancy 24.88 10.26 17 56340 33850 29484320
Xyphoid retraction 24.45 10.26 10 56347 163 29518007
Coronary artery occlusion 24.17 10.26 57 56300 10037 29508133
Nasopharyngitis 23.95 10.26 195 56162 59470 29458700
Joint range of motion decreased 23.82 10.26 42 56315 6012 29512158
Hypokalaemia 23.55 10.26 37 56320 50166 29468004
Nephrolithiasis 22.60 10.26 102 56255 25232 29492938
Bradycardia 22.54 10.26 58 56299 65571 29452599
Anaemia 22.01 10.26 261 56096 200690 29317480
Osteopenia 21.95 10.26 33 56324 4135 29514035
Blood pressure increased 21.91 10.26 226 56131 73577 29444593
Musculoskeletal pain 21.80 10.26 111 56246 28842 29489328
Electrocardiogram QT prolonged 21.78 10.26 22 56335 36115 29482055
Overdose 21.40 10.26 79 56278 79740 29438430
Product prescribing error 21.29 10.26 79 56278 17897 29500273
Platelet count decreased 21.20 10.26 115 56242 104557 29413613
Gait disturbance 21.01 10.26 223 56134 73126 29445044
Investigation abnormal 20.98 10.26 12 56345 420 29517750
Splenic embolism 20.94 10.26 9 56348 167 29518003
Spinal stenosis 20.81 10.26 33 56324 4330 29513840
Blood pressure fluctuation 20.76 10.26 84 56273 19810 29498360
Arachnoiditis 20.65 10.26 11 56346 334 29517836
Diarrhoea 20.64 10.26 480 55877 332218 29185952
Abdominal discomfort 20.56 10.26 159 56198 47744 29470426
Coma 20.55 10.26 27 56330 39423 29478747
Premature baby 20.50 10.26 4 56353 17276 29500894
Rotator cuff syndrome 20.23 10.26 35 56322 4935 29513235
Chest pain 20.01 10.26 312 56045 111661 29406509
Rhabdomyolysis 19.92 10.26 55 56302 60753 29457417
Inflammation 19.90 10.26 91 56266 22637 29495533
Road traffic accident 19.79 10.26 70 56287 15491 29502679
Cardiogenic shock 19.73 10.26 6 56351 19184 29498986
Septic shock 19.46 10.26 58 56299 62502 29455668
Grip strength decreased 19.46 10.26 23 56334 2284 29515886
Angina unstable 19.45 10.26 55 56302 10810 29507360
Periarthritis 19.32 10.26 15 56342 880 29517290
Gastric ulcer haemorrhage 19.21 10.26 34 56323 4880 29513290
Sideroblastic anaemia 19.10 10.26 9 56348 209 29517961
Loss of personal independence in daily activities 18.78 10.26 97 56260 25343 29492827
Hip arthroplasty 18.73 10.26 29 56328 3729 29514441
Benign abdominal neoplasm 18.70 10.26 7 56350 89 29518081
Chest expansion decreased 18.69 10.26 8 56349 147 29518023
Agitation 18.66 10.26 44 56313 51260 29466910
Joint injury 18.65 10.26 41 56316 6892 29511278
Child abuse 18.60 10.26 9 56348 222 29517948
Hepatic cirrhosis 18.39 10.26 65 56292 14379 29503791
Spinal pain 18.18 10.26 33 56324 4831 29513339
Carpal tunnel syndrome 18.10 10.26 30 56327 4084 29514086
Nightmare 17.78 10.26 55 56302 11362 29506808
Vitamin B1 decreased 17.72 10.26 9 56348 247 29517923
Interstitial lung disease 17.72 10.26 178 56179 57540 29460630
Spinal disorder 17.70 10.26 28 56329 3667 29514503
Energy increased 17.67 10.26 16 56341 1162 29517008
Spinal osteoarthritis 17.57 10.26 38 56319 6318 29511852
Pyrexia 17.53 10.26 416 55941 287206 29230964
Lumbar spinal stenosis 17.46 10.26 22 56335 2333 29515837
Intervertebral disc disorder 17.44 10.26 19 56338 1726 29516444
Enthesopathy 17.43 10.26 28 56329 3715 29514455
Drug tolerance 17.40 10.26 21 56336 2132 29516038
Transient ischaemic attack 17.37 10.26 89 56268 23181 29494989
Cardiac arrest 17.34 10.26 94 56263 85497 29432673
Mucosal inflammation 17.10 10.26 21 56336 31574 29486596
Impaired work ability 17.08 10.26 35 56322 5605 29512565
Dyspepsia 17.06 10.26 107 56250 30018 29488152
Oesophageal infection 17.02 10.26 9 56348 269 29517901
Hypomagnesaemia 17.01 10.26 6 56351 17462 29500708
Drug resistance 16.93 10.26 10 56347 21530 29496640
Mass 16.86 10.26 40 56317 7071 29511099
Diaphragmatic injury 16.64 10.26 7 56350 123 29518047
Peptic ulcer 16.53 10.26 22 56335 2463 29515707
Fracture 16.51 10.26 36 56321 6017 29512153
Drug withdrawal syndrome 16.49 10.26 73 56284 17911 29500259
Confusional state 16.43 10.26 160 56197 127717 29390453
Diverticulitis 16.33 10.26 72 56285 17632 29500538
Areflexia 16.24 10.26 23 56334 2731 29515439
Neurotoxicity 16.09 10.26 4 56353 14609 29503561
Gastric ulcer 15.99 10.26 61 56296 14000 29504170
Foot deformity 15.98 10.26 28 56329 3987 29514183
Small intestine ulcer 15.92 10.26 10 56347 416 29517754
Joint space narrowing 15.90 10.26 6 56351 78 29518092
Injury 15.75 10.26 75 56282 18971 29499199
Respiratory depression 15.65 10.26 59 56298 13464 29504706
Hyperkalaemia 15.65 10.26 62 56295 61330 29456840
Orchitis noninfective 15.54 10.26 4 56353 12 29518158
Gastrooesophageal reflux disease 15.49 10.26 108 56249 31388 29486782
Nervousness 15.37 10.26 52 56305 11254 29506916
Bronchial wall thickening 15.22 10.26 14 56343 1038 29517132
Neuroleptic malignant syndrome 14.97 10.26 6 56351 16142 29502028
Seizure 14.89 10.26 110 56247 93013 29425157
Facet joint syndrome 14.87 10.26 8 56349 248 29517922
Mobility decreased 14.86 10.26 92 56265 25688 29492482
Ankle fracture 14.83 10.26 25 56332 3451 29514719
Medulloblastoma 14.71 10.26 5 56352 47 29518123
Inflammatory bowel disease 14.67 10.26 20 56337 2291 29515879
Knee operation 14.67 10.26 16 56341 1456 29516714
Chronic idiopathic pain syndrome 14.65 10.26 4 56353 16 29518154
Drug level increased 14.38 10.26 9 56348 18778 29499392
Gastrointestinal haemorrhage 14.34 10.26 222 56135 79311 29438859
Hypoxia 13.97 10.26 45 56312 47334 29470836
Marrow hyperplasia 13.97 10.26 13 56344 978 29517192
Inadequate analgesia 13.96 10.26 21 56336 2633 29515537
Metabolic acidosis 13.94 10.26 32 56325 37630 29480540
Palpitations 13.86 10.26 108 56249 32496 29485674
Hyponatraemia 13.85 10.26 74 56283 67559 29450611
Hyperlipidaemia 13.81 10.26 54 56303 12536 29505634
Arteriosclerosis 13.79 10.26 47 56310 10209 29507961
Granulomatous liver disease 13.74 10.26 10 56347 532 29517638
Chronic tonsillitis 13.72 10.26 3 56354 3 29518167
Granuloma 13.68 10.26 20 56337 2444 29515726
Cytokine release syndrome 13.67 10.26 4 56353 13115 29505055
Epstein-Barr virus infection reactivation 13.57 10.26 10 56347 542 29517628
Gingival ulceration 13.56 10.26 8 56349 297 29517873
Generalised tonic-clonic seizure 13.54 10.26 10 56347 19129 29499041
Intermittent claudication 13.44 10.26 18 56339 2027 29516143
Brain neoplasm malignant 13.37 10.26 10 56347 555 29517615
Upper-airway cough syndrome 13.35 10.26 22 56335 2981 29515189
Pregnancy of partner 13.20 10.26 8 56349 312 29517858
Myalgia intercostal 13.18 10.26 4 56353 25 29518145
Tumour lysis syndrome 13.13 10.26 5 56352 13879 29504291
Hyperbilirubinaemia 13.12 10.26 6 56351 14928 29503242
Iritis 13.11 10.26 14 56343 1244 29516926
Drug abuser 13.10 10.26 25 56332 3802 29514368
Sciatica 12.99 10.26 29 56328 4925 29513245
Mitral valve incompetence 12.98 10.26 55 56302 13238 29504932
Insomnia 12.81 10.26 239 56118 88522 29429648
Product use in unapproved indication 12.77 10.26 105 56252 86770 29431400
Rib fracture 12.71 10.26 53 56304 12665 29505505
Agranulocytosis 12.70 10.26 12 56345 20328 29497842
Hypervolaemia 12.63 10.26 9 56348 17536 29500634
Suicide attempt 12.61 10.26 29 56328 34081 29484089
Renal failure 12.59 10.26 155 56202 118444 29399726
Uveitis 12.55 10.26 32 56325 5915 29512255
Aggression 12.51 10.26 31 56326 35510 29482660
Hepatitis chronic persistent 12.51 10.26 3 56354 6 29518164
Therapy non-responder 12.49 10.26 25 56332 30886 29487284
Herpes zoster 12.48 10.26 99 56258 29953 29488217
Post procedural infection 12.20 10.26 26 56331 4279 29513891
Rebound psychosis 12.18 10.26 6 56351 154 29518016
Nerve compression 12.04 10.26 20 56337 2728 29515442
Blood creatinine increased 12.00 10.26 104 56253 84998 29433172
Hyperglycaemia 12.00 10.26 30 56327 34257 29483913
Influenza 11.83 10.26 127 56230 41754 29476416
Status epilepticus 11.80 10.26 3 56354 10791 29507379
Red blood cell sedimentation rate increased 11.67 10.26 36 56321 7425 29510745
Back disorder 11.45 10.26 31 56326 5942 29512228
Hypercholesterolaemia 11.39 10.26 35 56322 7203 29510967
Hospitalisation 11.37 10.26 47 56310 45941 29472229
Duodenal ulcer 11.27 10.26 41 56316 9197 29508973
Cyst 11.25 10.26 24 56333 3953 29514217
Cardiac failure 11.13 10.26 97 56260 79190 29438980
Body temperature decreased 11.10 10.26 45 56312 10619 29507551
Sinusitis 11.06 10.26 107 56250 34243 29483927
Spinal compression fracture 11.06 10.26 31 56326 6063 29512107
Product use issue 11.02 10.26 148 56209 51296 29466874
Postoperative delirium 10.97 10.26 4 56353 47 29518123
Nasal dryness 10.92 10.26 11 56346 913 29517257
Myofascial pain syndrome 10.90 10.26 7 56350 303 29517867
Blood bilirubin increased 10.84 10.26 31 56326 33862 29484308
Pulmonary granuloma 10.82 10.26 13 56344 1313 29516857
Vomiting 10.79 10.26 315 56042 211945 29306225
Bronchopulmonary aspergillosis 10.78 10.26 5 56352 12339 29505831
Nerve block 10.74 10.26 4 56353 50 29518120
Application site rash 10.73 10.26 10 56347 754 29517416
Cardiac disorder 10.52 10.26 113 56244 37150 29481020
Hemiplegia 10.48 10.26 32 56325 6562 29511608
Carotid artery stenosis 10.44 10.26 25 56332 4444 29513726
Swelling 10.44 10.26 108 56249 35175 29482995
Scoliosis 10.43 10.26 17 56340 2283 29515887
Tachycardia 10.42 10.26 88 56269 72322 29445848
Inappropriate schedule of product administration 10.39 10.26 130 56227 44342 29473828
Epistaxis 10.35 10.26 57 56300 51647 29466523
Retro-orbital neoplasm 10.29 10.26 3 56354 16 29518154
Syndesmophyte 10.29 10.26 3 56354 16 29518154
Cellulitis 10.28 10.26 133 56224 45707 29472463

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
Drug hypersensitivity 1895.97 9.63 2781 175859 235034 64085058
Rheumatoid arthritis 558.00 9.63 1334 177306 162960 64157132
Drug ineffective 535.77 9.63 4061 174579 836186 63483906
Arthralgia 505.16 9.63 2489 176151 439771 63880321
Ankylosing spondylitis 386.01 9.63 256 178384 7978 64312114
Toxicity to various agents 373.83 9.63 277 178363 363236 63956856
Death 342.23 9.63 505 178135 482200 63837892
Pain 309.73 9.63 2600 176040 550911 63769181
Musculoskeletal stiffness 294.76 9.63 879 177761 122327 64197765
Completed suicide 279.55 9.63 136 178504 224278 64095814
Psoriatic arthropathy 270.76 9.63 454 178186 42827 64277265
Therapeutic product effect incomplete 243.41 9.63 734 177906 102748 64217344
Pain in extremity 232.86 9.63 1536 177104 301549 64018543
Therapeutic product effect decreased 219.52 9.63 761 177879 114590 64205502
Drug abuse 207.57 9.63 55 178585 132319 64187773
Febrile neutropenia 204.53 9.63 134 178506 187523 64132569
Neutropenia 178.03 9.63 242 178398 239382 64080710
Acute kidney injury 177.79 9.63 643 177997 448597 63871495
Osteoarthritis 175.84 9.63 477 178163 62859 64257233
Arthritis 166.46 9.63 561 178079 83253 64236839
Joint swelling 163.06 9.63 1088 177552 214294 64105798
Fibromyalgia 161.75 9.63 326 178314 35405 64284687
Loss of personal independence in daily activities 160.14 9.63 503 178137 71951 64248141
Arthropathy 158.66 9.63 710 177930 120257 64199835
Rheumatoid nodule 157.92 9.63 185 178455 12466 64307626
Thrombocytopenia 156.37 9.63 236 178404 223565 64096527
Foot deformity 145.43 9.63 203 178437 16301 64303791
Drug intolerance 141.26 9.63 948 177692 187044 64133048
Contraindicated product administered 140.72 9.63 632 178008 107197 64212895
Hypotension 137.30 9.63 566 178074 380408 63939684
Psoriasis 131.11 9.63 467 178173 71236 64248856
Condition aggravated 126.08 9.63 1580 177060 370846 63949246
Intentional overdose 120.55 9.63 49 178591 89895 64230197
Myocardial infarction 115.55 9.63 821 177819 165000 64155092
Maternal exposure during pregnancy 113.49 9.63 62 178578 95822 64224270
C-reactive protein abnormal 110.60 9.63 247 178393 28800 64291292
Sepsis 108.94 9.63 304 178336 230037 64090055
Electrocardiogram QT prolonged 106.93 9.63 43 178597 79405 64240687
Hyponatraemia 102.04 9.63 158 178482 148181 64171911
Confusional state 100.98 9.63 377 178263 260767 64059325
Red blood cell sedimentation rate increased 100.82 9.63 249 178391 30986 64289106
Foot fracture 99.87 9.63 180 178460 17977 64302115
Thyroid neoplasm 97.31 9.63 71 178569 2586 64317506
Anaemia 96.67 9.63 633 178007 378047 63942045
Red blood cell sedimentation rate abnormal 96.60 9.63 167 178473 16139 64303953
Pleural thickening 96.05 9.63 71 178569 2639 64317453
International normalised ratio fluctuation 94.81 9.63 73 178567 2888 64317204
Drug tolerance 93.16 9.63 99 178541 5986 64314106
Ulcer 90.35 9.63 198 178442 22792 64297300
Pyrexia 90.10 9.63 1052 177588 557592 63762500
Pancytopenia 89.01 9.63 163 178477 143146 64176946
Presbyacusis 88.00 9.63 66 178574 2509 64317583
Lower limb fracture 87.24 9.63 144 178496 13401 64306691
Hypoglycaemia 85.28 9.63 74 178566 89818 64230274
Osteoporosis 84.69 9.63 283 178357 41797 64278295
Mobility decreased 84.16 9.63 464 178176 85376 64234716
Hypoaesthesia 84.01 9.63 666 177974 138442 64181650
Overdose 83.54 9.63 200 178440 159366 64160726
Bone swelling 82.87 9.63 48 178592 1169 64318923
Cardio-respiratory arrest 81.80 9.63 91 178549 98302 64221790
Neck pain 80.49 9.63 361 178279 61172 64258920
Dyspnoea 79.08 9.63 1459 177181 717215 63602877
Multiple organ dysfunction syndrome 78.74 9.63 99 178541 101314 64218778
Exposure during pregnancy 78.59 9.63 60 178580 77615 64242477
Gastric disorder 78.12 9.63 217 178423 28980 64291112
Cardiac arrest 77.59 9.63 197 178443 153867 64166225
Deformity 76.79 9.63 91 178549 6206 64313886
Impaired work ability 76.32 9.63 145 178495 15074 64305018
Gait disturbance 75.61 9.63 769 177871 171386 64148706
Osteopenia 75.40 9.63 146 178494 15394 64304698
Pleural fibrosis 74.96 9.63 73 178567 3977 64316115
Nerve injury 74.48 9.63 99 178541 7586 64312506
Gait inability 73.24 9.63 271 178369 42097 64277995
Enthesopathy 72.48 9.63 110 178530 9528 64310564
Drug eruption 70.93 9.63 241 178399 35895 64284197
Musculoskeletal pain 70.27 9.63 425 178215 80869 64239223
Inflammation 68.77 9.63 360 178280 64940 64255152
Seizure 68.41 9.63 235 178405 166657 64153435
Leukopenia 67.55 9.63 110 178530 101132 64218960
Mucosal inflammation 66.36 9.63 46 178594 62538 64257554
Bradycardia 65.23 9.63 144 178496 118075 64202017
Joint injury 64.83 9.63 174 178466 22773 64297319
Toothache 64.83 9.63 147 178493 17312 64302780
Intervertebral disc protrusion 63.10 9.63 159 178481 20032 64300060
Drug interaction 62.53 9.63 671 177969 361412 63958680
Tachycardia 62.40 9.63 209 178431 149370 64170722
Blood magnesium increased 61.23 9.63 59 178581 3172 64316920
Blood parathyroid hormone decreased 61.05 9.63 88 178552 7278 64312814
C-reactive protein increased 60.94 9.63 461 178179 94448 64225644
Tenosynovitis 60.90 9.63 114 178526 11719 64308373
Neoplasm malignant 60.71 9.63 178 178462 24510 64295582
Hypokalaemia 60.51 9.63 157 178483 121746 64198346
Bedridden 60.49 9.63 104 178536 10005 64310087
Bloody discharge 59.91 9.63 42 178598 1435 64318657
Systemic lupus erythematosus rash 58.92 9.63 41 178599 1384 64318708
Back pain 58.57 9.63 996 177644 249175 64070917
Septic shock 58.53 9.63 128 178512 105309 64214783
Dry eye 58.24 9.63 195 178445 28824 64291268
Sopor 57.93 9.63 7 178633 29654 64290438
Neurotoxicity 57.31 9.63 5 178635 27399 64292693
Deafness neurosensory 57.05 9.63 79 178561 6295 64313797
Metabolic acidosis 56.41 9.63 68 178572 70890 64249202
Peripheral swelling 55.80 9.63 851 177789 208302 64111790
Cytomegalovirus infection 55.42 9.63 17 178623 37182 64282910
Product use in unapproved indication 55.34 9.63 276 178364 176342 64143750
Musculoskeletal disorder 54.91 9.63 140 178500 17766 64302326
Pharyngitis 54.43 9.63 145 178495 18894 64301198
Suicide attempt 54.40 9.63 70 178570 70937 64249155
Lyme disease 53.29 9.63 48 178592 2367 64317725
Nephrolithiasis 53.21 9.63 251 178389 43432 64276660
Syncope 53.10 9.63 240 178400 157395 64162697
Panniculitis 52.67 9.63 91 178549 8788 64311304
Stress 52.64 9.63 317 178323 60217 64259875
Nasopharyngitis 52 9.63 797 177843 195276 64124816
Disability 51.47 9.63 108 178532 12064 64308028
Platelet count decreased 50.33 9.63 266 178374 167445 64152647
Epigastric discomfort 50.18 9.63 77 178563 6734 64313358
Intentional self-injury 49.61 9.63 10 178630 29034 64291058
Victim of child abuse 48.03 9.63 30 178610 841 64319251
Fine motor skill dysfunction 47.81 9.63 62 178578 4637 64315455
Hypermobility syndrome 47.79 9.63 25 178615 495 64319597
Off label use 47.62 9.63 1362 177278 631444 63688648
Axial spondyloarthritis 47.44 9.63 23 178617 385 64319707
Multiple fractures 46.93 9.63 70 178570 5970 64314122
Agitation 46.83 9.63 110 178530 88257 64231835
Device expulsion 46.64 9.63 3 178637 21133 64298959
Burning mouth syndrome 46.12 9.63 24 178616 470 64319622
Intervertebral disc degeneration 45.99 9.63 108 178532 13012 64307080
Hypoxia 45.70 9.63 111 178529 88038 64232054
Pericarditis 45.49 9.63 64 178576 62452 64257640
Cyst 45.47 9.63 102 178538 11925 64308167
Bunion operation 45.47 9.63 28 178612 765 64319327
Gastric ulcer 45.41 9.63 185 178455 30049 64290043
Bone cyst 45.23 9.63 42 178598 2155 64317937
Granuloma skin 45.22 9.63 69 178571 6005 64314087
Encephalopathy 45.04 9.63 58 178582 58761 64261331
Respiratory failure 44.89 9.63 262 178378 160921 64159171
Exostosis 44.36 9.63 98 178542 11340 64308752
Spinal osteoarthritis 43.84 9.63 112 178528 14229 64305863
Osteosclerosis 43.54 9.63 51 178589 3435 64316657
Rhabdomyolysis 43.35 9.63 121 178519 91605 64228487
Epicondylitis 43.25 9.63 38 178602 1813 64318279
Cytokine release syndrome 43.02 9.63 4 178636 20825 64299267
Gastric ulcer haemorrhage 42.59 9.63 79 178561 8064 64312028
Treatment failure 42.59 9.63 503 178137 116313 64203779
Drug resistance 42.55 9.63 22 178618 35080 64285012
Muscle injury 41.38 9.63 11 178629 26426 64293666
Tendonitis 41.33 9.63 137 178503 20145 64299947
Red blood cell sedimentation rate 40.94 9.63 51 178589 3663 64316429
Bronchitis 40.87 9.63 471 178169 108272 64211820
Therapeutic response decreased 40.82 9.63 266 178374 51922 64268170
Hypervolaemia 40.77 9.63 28 178612 38257 64281835
Rotator cuff syndrome 40.65 9.63 98 178542 12009 64308083
Joint range of motion decreased 40.62 9.63 132 178508 19211 64300881
Pemphigus 40.44 9.63 66 178574 60635 64259457
Pharyngeal oedema 40.14 9.63 114 178526 15417 64304675
Anti-cyclic citrullinated peptide antibody positive 39.92 9.63 47 178593 49515 64270577
Cardiogenic shock 39.79 9.63 20 178620 32407 64287685
Neutropenic sepsis 39.77 9.63 8 178632 23264 64296828
Sacroiliitis 39.19 9.63 45 178595 2967 64317125
Hyperglycaemia 39.04 9.63 68 178572 60900 64259192
Epistaxis 38.97 9.63 140 178500 97991 64222101
Somnolence 38.57 9.63 369 178271 203276 64116816
Dehydration 38.46 9.63 399 178241 216364 64103728
Hyperkalaemia 38.37 9.63 147 178493 100982 64219110
Back disorder 38.08 9.63 85 178555 9905 64310187
Eye disorder 38.05 9.63 127 178513 18742 64301350
Joint stiffness 37.98 9.63 176 178464 30228 64289864
Blood cholesterol increased 37.84 9.63 253 178387 49813 64270279
Cholestasis 37.83 9.63 41 178599 44831 64275261
Coma 37.50 9.63 121 178519 87494 64232598
Inflammatory bowel disease 37.29 9.63 54 178586 4484 64315608
Spinal stenosis 36.73 9.63 103 178537 13828 64306264
Ascites 36.30 9.63 73 178567 61928 64258164
Synovitis 36.26 9.63 427 178213 98663 64221429
Interstitial lung disease 36.14 9.63 422 178218 97310 64222782
Spinal pain 35.95 9.63 96 178544 12525 64307567
Orthostatic hypotension 35.88 9.63 46 178594 46692 64273400
Mental status changes 35.82 9.63 72 178568 61090 64259002
Tooth infection 35.64 9.63 105 178535 14496 64305596
Disease progression 35.47 9.63 238 178402 141442 64178650
Upper limb fracture 35.42 9.63 106 178534 14760 64305332
Cardiac failure 34.84 9.63 219 178421 132154 64187938
Clostridium difficile colitis 34.61 9.63 16 178624 27207 64292885
Poisoning 34.44 9.63 9 178631 21870 64298222
Hepatic failure 34.37 9.63 63 178577 55331 64264761
Rash 34.04 9.63 1574 177066 456975 63863117
Blood pressure systolic increased 33.89 9.63 244 178396 49209 64270883
Hunger 33.82 9.63 50 178590 4231 64315861
Right ventricular failure 33.48 9.63 9 178631 21462 64298630
Malaise 33.13 9.63 1377 177263 394870 63925222
Meniscus injury 33.04 9.63 59 178581 5848 64314244
Loss of employment 32.75 9.63 33 178607 1874 64318218
Bursitis 32.69 9.63 132 178508 21353 64298739
Premature delivery 32.59 9.63 6 178634 18583 64301509
Carpal tunnel syndrome 32.33 9.63 107 178533 15721 64304371
Pulmonary arterial hypertension 32.11 9.63 15 178625 25352 64294740
Neutrophil count decreased 32.08 9.63 108 178532 77088 64243004
Folliculitis 32.02 9.63 22 178618 30055 64290037
Respiratory tract congestion 31.88 9.63 108 178532 16057 64304035
General physical health deterioration 31.27 9.63 389 178251 204036 64116056
Blood bilirubin increased 31.00 9.63 71 178569 57482 64262610
Limb discomfort 30.82 9.63 153 178487 27022 64293070
Skin ulcer 30.73 9.63 218 178422 43756 64276336
Respiratory arrest 30.50 9.63 63 178577 52922 64267170
Coronary artery stenosis 30.48 9.63 84 178556 11164 64308928
Fear of injection 30.48 9.63 57 178583 5855 64314237
Renal failure 30.38 9.63 339 178301 181349 64138743
Movement disorder 30.22 9.63 131 178509 21869 64298223
Aggression 30.12 9.63 51 178589 46181 64273911
Migraine 29.92 9.63 285 178355 62392 64257700
Acute respiratory failure 29.92 9.63 58 178582 49876 64270216
Immobile 29.78 9.63 57 178583 5958 64314134
Bronchopulmonary aspergillosis 29.76 9.63 8 178632 19077 64301015
Body height decreased 29.61 9.63 65 178575 7489 64312603
Blood calcium decreased 29.54 9.63 17 178623 25537 64294555
Nodule 29.52 9.63 113 178527 17834 64302258
Inflammatory pain 29.38 9.63 22 178618 834 64319258
Road traffic accident 29.32 9.63 165 178475 30580 64289512
Joint effusion 29.25 9.63 93 178547 13380 64306712
Status epilepticus 28.69 9.63 12 178628 21651 64298441
Glossodynia 28.63 9.63 88 178552 64608 64255484
Depression 28.59 9.63 687 177953 182604 64137488
Investigation abnormal 28.26 9.63 26 178614 1318 64318774
Plasma cell myeloma 28.06 9.63 53 178587 46022 64274070
Acute hepatic failure 27.93 9.63 19 178621 26093 64293999
Transplant rejection 27.69 9.63 7 178633 17394 64302698
Hyperbilirubinaemia 27.68 9.63 12 178628 21193 64298899
Neuropathy peripheral 27.65 9.63 201 178439 117324 64202768
Skin necrosis 27.62 9.63 95 178545 14234 64305858
Localised infection 27.54 9.63 160 178480 30001 64290091
Brain scan abnormal 27.33 9.63 24 178616 1144 64318948
Aspergillus infection 27.23 9.63 6 178634 16373 64303719
Myofascial pain syndrome 27.08 9.63 29 178611 1769 64318323
Posterior reversible encephalopathy syndrome 26.90 9.63 15 178625 22931 64297161
Poisoning deliberate 26.72 9.63 3 178637 13455 64306637
Femur fracture 26.70 9.63 174 178466 33961 64286131
Alanine aminotransferase abnormal 26.70 9.63 59 178581 6829 64313263
Eosinophilia 26.69 9.63 40 178600 38036 64282056
Synovial cyst 26.53 9.63 63 178577 7644 64312448
Lactic acidosis 26.15 9.63 85 178555 61325 64258767
Vomiting 26.11 9.63 1254 177386 549863 63770229
Wound 26.00 9.63 116 178524 76361 64243731
Antinuclear antibody positive 25.90 9.63 55 178585 6195 64313897
Tongue disorder 25.88 9.63 83 178557 11997 64308095
Torsade de pointes 25.75 9.63 8 178632 17355 64302737
Systemic lupus erythematosus 25.62 9.63 119 178521 77493 64242599
Coronary artery disease 25.56 9.63 268 178372 60165 64259927
Diabetic ketoacidosis 25.46 9.63 27 178613 29818 64290274
Oesophageal spasm 25.20 9.63 33 178607 2492 64317600
Cerebral haemorrhage 25.18 9.63 66 178574 51024 64269068
Paranasal sinus inflammation 25.12 9.63 12 178628 194 64319898
Brain oedema 25.07 9.63 15 178625 22060 64298032
Medication error 25.05 9.63 64 178576 49902 64270190
Osteomyelitis 24.96 9.63 146 178494 27441 64292651
Grip strength decreased 24.61 9.63 80 178560 11644 64308448
Pathogen resistance 24.40 9.63 3 178637 12540 64307552
Acute myeloid leukaemia 24.39 9.63 24 178616 27439 64292653
Cognitive disorder 24.33 9.63 75 178565 55012 64265080
Angina unstable 24.31 9.63 96 178544 15371 64304721
Progressive multifocal leukoencephalopathy 24.31 9.63 10 178630 18222 64301870
International normalised ratio increased 24.05 9.63 125 178515 79042 64241050
Asthenia 23.96 9.63 956 177684 427088 63893004
Klebsiella infection 23.91 9.63 4 178636 13277 64306815
Hospitalisation 23.84 9.63 117 178523 75090 64245002
Benign abdominal neoplasm 23.77 9.63 12 178628 220 64319872
Product complaint 23.69 9.63 80 178560 11874 64308218
Muscle swelling 23.38 9.63 18 178622 712 64319380
Cerebral artery thrombosis 23.27 9.63 21 178619 1038 64319054
Oesophageal fibrosis 23.19 9.63 11 178629 175 64319917
Tuberculin test positive 23.05 9.63 35 178605 3033 64317059
Dyspepsia 23.03 9.63 331 178309 79981 64240111
Haematotoxicity 22.96 9.63 4 178636 12892 64307200
Gamma-glutamyltransferase increased 22.91 9.63 64 178576 48446 64271646
Tremor 22.68 9.63 282 178358 147948 64172144
Psychotic disorder 22.65 9.63 38 178602 34540 64285552
Hepatocellular injury 22.63 9.63 58 178582 45177 64274915
Rheumatoid lung 22.60 9.63 31 178609 2448 64317644
Pneumonia aspiration 22.58 9.63 86 178554 59185 64260907
Palmar-plantar erythrodysaesthesia syndrome 22.50 9.63 28 178612 28791 64291301
Generalised tonic-clonic seizure 22.43 9.63 48 178592 39809 64280283
Tumour lysis syndrome 22.37 9.63 13 178627 19427 64300665
Hernia 22.14 9.63 85 178555 13433 64306659
Foot operation 22.04 9.63 41 178599 4194 64315898
Neuroleptic malignant syndrome 22.02 9.63 22 178618 24974 64295118
Finger deformity 21.91 9.63 46 178594 5140 64314952
Swelling 21.88 9.63 590 178050 159628 64160464
Tooth disorder 21.87 9.63 121 178519 22281 64297811
Miosis 21.77 9.63 5 178635 13261 64306831
Drug reaction with eosinophilia and systemic symptoms 21.75 9.63 77 178563 54140 64265952
Device related infection 21.64 9.63 32 178608 30594 64289498
Blood pressure increased 21.49 9.63 628 178012 171924 64148168
Infection 21.45 9.63 667 177973 184213 64135879
COVID-19 21.43 9.63 100 178540 65040 64255052
Kidney infection 21.35 9.63 102 178538 17736 64302356
Diarrhoea 21.35 9.63 1718 176922 720986 63599106
White blood cell count decreased 21.34 9.63 308 178332 157529 64162563
Amblyopia 21.25 9.63 11 178629 213 64319879
Bacteraemia 21.16 9.63 26 178614 26885 64293207
Spinal compression fracture 21.08 9.63 89 178551 14686 64305406
Sleep disorder due to general medical condition, insomnia type 21.06 9.63 25 178615 26245 64293847
Impaired healing 20.98 9.63 258 178382 60215 64259877
Burning sensation 20.89 9.63 220 178420 49444 64270648
Xyphoid retraction 20.86 9.63 10 178630 163 64319929
Fracture 20.85 9.63 105 178535 18650 64301442
Drug tolerance decreased 20.72 9.63 54 178586 6944 64313148
Gastrooesophageal reflux disease 20.51 9.63 334 178306 82809 64237283
Granuloma 20.44 9.63 52 178588 6589 64313503
Medulloblastoma 20.35 9.63 8 178632 78 64320014
Musculoskeletal discomfort 20.16 9.63 94 178546 16183 64303909
Epilepsy 20.04 9.63 39 178601 33492 64286600
Bone marrow failure 19.98 9.63 67 178573 47885 64272207
Emotional distress 19.82 9.63 169 178471 35869 64284223
Anaphylactic reaction 19.69 9.63 283 178357 68381 64251711
Joint prosthesis user 19.58 9.63 7 178633 51 64320041
Enterococcal infection 19.49 9.63 7 178633 13859 64306233
Sciatica 19.48 9.63 109 178531 20155 64299937
Mydriasis 19.46 9.63 9 178631 15303 64304789
Device dislocation 19.40 9.63 18 178622 21160 64298932
Drug level increased 19.39 9.63 41 178599 34155 64285937
Influenza 19.33 9.63 408 178232 106123 64213969
Coronary artery occlusion 19.30 9.63 83 178557 13808 64306284
Drug dependence 19.27 9.63 158 178482 33154 64286938
Presyncope 19.13 9.63 43 178597 35046 64285046
Limb injury 19.11 9.63 121 178519 23384 64296708
Feeling abnormal 19.11 9.63 495 178145 133107 64186985
Radiculopathy 19.10 9.63 46 178594 5632 64314460
COVID-19 pneumonia 19.05 9.63 11 178629 16493 64303599
Blood lactic acid increased 19.02 9.63 3 178637 10398 64309694
Neuralgia 18.99 9.63 131 178509 26053 64294039
Febrile bone marrow aplasia 18.96 9.63 4 178636 11251 64308841
Herpes zoster 18.75 9.63 316 178324 78871 64241221
Wrist deformity 18.70 9.63 24 178616 1776 64318316
Extrapyramidal disorder 18.65 9.63 16 178624 19536 64300556
Iritis 18.57 9.63 32 178608 3084 64317008
Tenderness 18.56 9.63 105 178535 19497 64300595
Hyperlipidaemia 18.51 9.63 118 178522 22858 64297234
Epidural lipomatosis 18.51 9.63 17 178623 860 64319232
Ligament sprain 18.40 9.63 69 178571 10783 64309309
Nephropathy toxic 18.39 9.63 13 178627 17501 64302591
Knee arthroplasty 18.37 9.63 133 178507 26866 64293226
Myelodysplastic syndrome 18.35 9.63 30 178610 27549 64292543
Infective pulmonary exacerbation of cystic fibrosis 18.29 9.63 5 178635 11791 64308301
Decreased appetite 18.24 9.63 617 178023 280672 64039420
Exposure via skin contact 18.13 9.63 9 178631 159 64319933
Walking aid user 18.12 9.63 48 178592 6233 64313859
Abortion spontaneous 18.03 9.63 26 178614 25117 64294975
Muscle spasticity 18.00 9.63 12 178628 16657 64303435
Insomnia 18.00 9.63 694 177946 197142 64122950
Dysstasia 17.95 9.63 118 178522 23097 64296995
Cataract 17.91 9.63 219 178421 51043 64269049
Sideroblastic anaemia 17.89 9.63 10 178630 227 64319865
Depressed level of consciousness 17.86 9.63 142 178498 81294 64238798
Blood pressure fluctuation 17.86 9.63 221 178419 51650 64268442
Hyperammonaemia 17.79 9.63 3 178637 9901 64310191
Knee operation 17.62 9.63 39 178601 4518 64315574
Abdominal pain upper 17.62 9.63 621 178019 174409 64145683
Clostridium difficile infection 17.61 9.63 47 178593 36116 64283976
Dactylitis 17.31 9.63 24 178616 1914 64318178
Electrolyte imbalance 17.23 9.63 27 178613 25216 64294876
Splenic embolism 17.17 9.63 9 178631 179 64319913
Blood pressure diastolic abnormal 17.17 9.63 72 178568 11845 64308247
Tenosynovitis stenosans 17.10 9.63 24 178616 1936 64318156
Post procedural infection 17.10 9.63 62 178578 9535 64310557
Lumbar spinal stenosis 17.09 9.63 39 178601 4611 64315481
Pulmonary congestion 17.04 9.63 119 178521 23761 64296331
Injection site reaction 17.02 9.63 201 178439 46463 64273629
Cytopenia 16.90 9.63 11 178629 15460 64304632
Pulmonary oedema 16.88 9.63 138 178502 78536 64241556
Delusion 16.87 9.63 15 178625 17999 64302093
Multiple sclerosis relapse 16.78 9.63 58 178582 41077 64279015
Bone disorder 16.68 9.63 91 178549 16668 64303424
Tachypnoea 16.68 9.63 30 178610 26541 64293551
Cardiotoxicity 16.61 9.63 4 178636 10270 64309822
Tooth abscess 16.51 9.63 79 178561 13747 64306345
Wrist fracture 16.47 9.63 63 178577 9938 64310154
Dyskinesia 16.43 9.63 55 178585 39333 64280759
Epstein-Barr virus infection 16.41 9.63 7 178633 12481 64307611
Cardiac disorder 16.39 9.63 231 178409 55585 64264507
Patellofemoral pain syndrome 16.35 9.63 12 178628 441 64319651
Back injury 16.34 9.63 53 178587 7704 64312388
Fracture pain 16.30 9.63 11 178629 353 64319739
Gelatinous transformation of the bone marrow 16.27 9.63 5 178635 21 64320071
Metabolic surgery 16.26 9.63 16 178624 883 64319209
Injection related reaction 16.20 9.63 14 178626 653 64319439
Sensitivity to weather change 16.12 9.63 48 178592 6666 64313426
Left ventricular dysfunction 16.02 9.63 14 178626 16940 64303152
Nerve block 16.00 9.63 11 178629 364 64319728
Haematuria 15.93 9.63 100 178540 60371 64259721
Orchitis noninfective 15.92 9.63 4 178636 6 64320086
Musculoskeletal chest pain 15.90 9.63 108 178532 21371 64298721
Hepatic encephalopathy 15.89 9.63 21 178619 21045 64299047
Child abuse 15.84 9.63 9 178631 211 64319881
Rash pruritic 15.83 9.63 235 178405 57169 64262923
Acute respiratory distress syndrome 15.81 9.63 55 178585 38880 64281212
Helicobacter infection 15.71 9.63 54 178586 38308 64281784
Transfusion 15.66 9.63 16 178624 17978 64302114
Agranulocytosis 15.53 9.63 54 178586 38175 64281917
Tubo-ovarian abscess 15.53 9.63 10 178630 296 64319796
Pneumonia 15.46 9.63 1337 177303 558239 63761853
Uveitis 15.45 9.63 73 178567 12635 64307457
Thrombotic microangiopathy 15.44 9.63 14 178626 16641 64303451
Duodenal ulcer perforation 15.39 9.63 47 178593 34578 64285514
Accidental overdose 15.31 9.63 45 178595 33512 64286580
Gastritis 15.29 9.63 183 178457 42435 64277657
Tuberculosis 15.21 9.63 74 178566 12964 64307128
Cystitis 15.21 9.63 183 178457 42492 64277600
Bone erosion 15.13 9.63 68 178572 11527 64308565
Malignant polyp 15.13 9.63 8 178632 162 64319930
Disability assessment scale score increased 15.10 9.63 26 178614 2504 64317588
Joint destruction 15.07 9.63 32 178608 3604 64316488
Inappropriate antidiuretic hormone secretion 15.06 9.63 24 178616 22265 64297827
Oral herpes 15.00 9.63 109 178531 22043 64298049
Ventricular fibrillation 14.92 9.63 27 178613 23833 64296259
Ventricular tachycardia 14.88 9.63 47 178593 34218 64285874
Synovial fluid analysis 14.88 9.63 20 178620 1549 64318543
Chills 14.88 9.63 279 178361 136985 64183107
Periarthritis 14.82 9.63 26 178614 2541 64317551
Swollen tongue 14.77 9.63 155 178485 34799 64285293
Renal tubular necrosis 14.76 9.63 24 178616 22086 64298006
Peripheral vascular disorder 14.75 9.63 49 178591 7212 64312880
Suspected suicide 14.74 9.63 3 178637 8651 64311441
Device issue 14.73 9.63 25 178615 22623 64297469
Ankle fracture 14.73 9.63 80 178560 14630 64305462
Muscle rigidity 14.69 9.63 16 178624 17457 64302635
Bronchial wall thickening 14.67 9.63 22 178618 1885 64318207
Parkinsonism 14.66 9.63 11 178629 14362 64305730
Neoplasm progression 14.61 9.63 61 178579 40903 64279189
Basal cell carcinoma 14.60 9.63 140 178500 30698 64289394
Hallucination 14.58 9.63 130 178510 72658 64247434
Haemodynamic instability 14.47 9.63 12 178628 14900 64305192
Vertebral foraminal stenosis 14.42 9.63 16 178624 1016 64319076
Serotonin syndrome 14.32 9.63 58 178582 39224 64280868
Product prescribing error 14.26 9.63 155 178485 35114 64284978
Anuria 14.21 9.63 19 178621 18945 64301147
Erythema multiforme 14.14 9.63 83 178557 15618 64304474
Diaphragmatic injury 14.13 9.63 7 178633 123 64319969
Chest expansion decreased 14.10 9.63 8 178632 187 64319905
Salivary hypersecretion 14.08 9.63 8 178632 12105 64307987
Sleep disorder 14.04 9.63 238 178402 59471 64260621
Dystonia 14.03 9.63 19 178621 18846 64301246
Abnormal behaviour 13.99 9.63 47 178593 33575 64286517
Pancreatitis acute 13.97 9.63 66 178574 42789 64277303
Abdominal discomfort 13.94 9.63 628 178012 181694 64138398
Small intestine ulcer 13.87 9.63 13 178627 675 64319417
Oesophageal pain 13.85 9.63 29 178611 3234 64316858
Torticollis 13.82 9.63 23 178617 2154 64317938
Intervertebral disc disorder 13.82 9.63 35 178605 4422 64315670
Dysarthria 13.78 9.63 102 178538 59304 64260788
Transaminases increased 13.77 9.63 70 178570 44524 64275568
Spinal disorder 13.60 9.63 54 178586 8668 64311424
Leukocytosis 13.58 9.63 56 178584 37684 64282408
Creatinine renal clearance decreased 13.51 9.63 12 178628 14409 64305683
Inappropriate schedule of product administration 13.50 9.63 343 178297 91943 64228149
Joint dislocation 13.32 9.63 65 178575 11400 64308692
Paradoxical psoriasis 13.32 9.63 7 178633 140 64319952
Constipation 13.28 9.63 510 178130 228827 64091265
Product use issue 13.27 9.63 530 178110 151185 64168907
Haemorrhage intracranial 13.24 9.63 29 178611 23855 64296237
Tongue cancer recurrent 13.17 9.63 4 178636 16 64320076
Toe operation 13.07 9.63 11 178629 495 64319597
Pericardial effusion 13.06 9.63 60 178580 39194 64280898
Cystitis haemorrhagic 13.05 9.63 3 178637 7953 64312139
Colitis 13.01 9.63 102 178538 58572 64261520
Pneumonitis 12.90 9.63 84 178556 50281 64269811
Toxic epidermal necrolysis 12.85 9.63 56 178584 37110 64282982
Haemophagocytic lymphohistiocytosis 12.83 9.63 18 178622 17591 64302501
Suicidal ideation 12.82 9.63 120 178520 66422 64253670
Pregnancy 12.70 9.63 24 178616 20841 64299251
Facial paralysis 12.66 9.63 93 178547 18873 64301219
Transient ischaemic attack 12.63 9.63 182 178458 44000 64276092
Vitamin B1 decreased 12.62 9.63 9 178631 316 64319776
Spondylitis 12.60 9.63 27 178613 3059 64317033
Sciatic nerve neuropathy 12.57 9.63 9 178631 318 64319774
Chondropathy 12.55 9.63 23 178617 2326 64317766
Aplastic anaemia 12.55 9.63 12 178628 13908 64306184
Wrong product administered 12.49 9.63 3 178637 7717 64312375
Chronic idiopathic pain syndrome 12.46 9.63 4 178636 20 64320072
Ingrowing nail 12.40 9.63 22 178618 2169 64317923
Pulmonary fibrosis 12.40 9.63 132 178508 29746 64290346
Scleritis 12.17 9.63 26 178614 2940 64317152
Immune reconstitution inflammatory syndrome 12.15 9.63 10 178630 12460 64307632
Limb deformity 12.15 9.63 28 178612 3333 64316759
Meningitis streptococcal 12.14 9.63 7 178633 169 64319923
Vitamin K deficiency 12.12 9.63 12 178628 667 64319425
Inadequate analgesia 12.09 9.63 31 178609 3947 64316145
Coeliac artery compression syndrome 12.08 9.63 6 178634 106 64319986
Pulmonary hypertension 12.06 9.63 70 178570 43069 64277023
Spondylolisthesis 12.06 9.63 25 178615 2769 64317323
Heart rate decreased 12.05 9.63 217 178423 54850 64265242
Diverticulum 12.04 9.63 70 178570 13128 64306964
Gluten sensitivity 12.00 9.63 9 178631 342 64319750
Nervousness 11.99 9.63 130 178510 29426 64290666
Peritonitis bacterial 11.99 9.63 5 178635 9038 64311054
Malignant melanoma 11.98 9.63 69 178571 12895 64307197
Breast cyst 11.95 9.63 15 178625 1086 64319006
Cardiolipin antibody positive 11.92 9.63 7 178633 175 64319917
Irritable bowel syndrome 11.92 9.63 58 178582 37311 64282781
Failure to thrive 11.91 9.63 7 178633 10397 64309695
Joint noise 11.88 9.63 27 178613 3184 64316908
Staphylococcal sepsis 11.77 9.63 11 178629 12888 64307204
Pleurisy 11.76 9.63 54 178586 9237 64310855
Breast cyst excision 11.71 9.63 4 178636 25 64320067
Myalgia intercostal 11.71 9.63 4 178636 25 64320067
Blood potassium decreased 11.59 9.63 65 178575 40334 64279758
Hypernatraemia 11.59 9.63 10 178630 12179 64307913
Aspiration 11.58 9.63 18 178622 16867 64303225
Intestinal ischaemia 11.58 9.63 9 178631 11540 64308552
Gingival ulceration 11.57 9.63 13 178627 837 64319255
Duodenal ulcer 11.54 9.63 74 178566 14361 64305731
Prescribed overdose 11.53 9.63 96 178544 20235 64299857
Mania 11.52 9.63 17 178623 16269 64303823
Cervical radiculopathy 11.51 9.63 14 178626 981 64319111
Muscle twitching 11.44 9.63 22 178618 18976 64301116
Groin pain 11.43 9.63 62 178578 11331 64308761
Hepatitis chronic persistent 11.40 9.63 3 178637 6 64320086
Viral upper respiratory tract infection 11.34 9.63 49 178591 8166 64311926
Fracture delayed union 11.33 9.63 20 178620 1965 64318127
Cardiac stress test abnormal 11.33 9.63 12 178628 723 64319369
Uterine disorder 11.28 9.63 19 178621 1798 64318294
Labelled drug-drug interaction medication error 11.26 9.63 28 178612 22034 64298058
Dermatitis 11.24 9.63 87 178553 17942 64302150
Hyperthermia 11.23 9.63 16 178624 15534 64304558
Adrenal suppression 11.21 9.63 16 178624 1311 64318781
Polyneuropathy 11.16 9.63 24 178616 19870 64300222
Pleural effusion 11.15 9.63 266 178374 126293 64193799
Malignant neoplasm progression 11.15 9.63 233 178407 112638 64207454
Weight fluctuation 11.13 9.63 49 178591 8233 64311859
Respiratory distress 11.13 9.63 92 178548 52239 64267853
Blood pressure diastolic increased 11.12 9.63 59 178581 10693 64309399
Hypovolaemia 11.12 9.63 16 178624 15470 64304622
Pelvic adhesions 11.07 9.63 8 178632 287 64319805
Disorientation 11.05 9.63 100 178540 55728 64264364
Blood glucose increased 11.04 9.63 198 178442 97875 64222217
Skin texture abnormal 11.02 9.63 9 178631 388 64319704
Unresponsive to stimuli 10.99 9.63 88 178552 50305 64269787
Purpura senile 10.97 9.63 10 178630 501 64319591
Hypercalcaemia 10.88 9.63 134 178506 31282 64288810
Lymphocyte count decreased 10.87 9.63 67 178573 40632 64279460
Schizophrenia 10.82 9.63 9 178631 11159 64308933
Urticaria 10.73 9.63 505 178135 146812 64173280
Nerve compression 10.69 9.63 45 178595 7416 64312676
Spondyloarthropathy 10.66 9.63 12 178628 774 64319318
Infective tenosynovitis 10.65 9.63 8 178632 305 64319787
Product dispensing error 10.62 9.63 61 178579 11389 64308703
Haemolysis 10.57 9.63 9 178631 11030 64309062
Juvenile idiopathic arthritis 10.54 9.63 29 178611 3850 64316242
Subdural haematoma 10.49 9.63 41 178599 28013 64292079
Oculomucocutaneous syndrome 10.47 9.63 8 178632 313 64319779
Catatonia 10.45 9.63 4 178636 7616 64312476
Lethargy 10.40 9.63 140 178500 72454 64247638
Urinary tract pain 10.33 9.63 7 178633 226 64319866
Oesophageal infection 10.29 9.63 10 178630 543 64319549
Device leakage 10.29 9.63 5 178635 8261 64311831
Drug level decreased 10.27 9.63 10 178630 11493 64308599
Hypomagnesaemia 10.26 9.63 61 178579 37315 64282777
Rebound psychosis 10.25 9.63 6 178634 149 64319943
Ovarian cystectomy 10.19 9.63 5 178635 86 64320006
Glomerulonephritis minimal lesion 10.12 9.63 11 178629 682 64319410
Arteriosclerosis 10.11 9.63 77 178563 15800 64304292
Aphasia 10.09 9.63 69 178571 40837 64279255
Paraesthesia mucosal 10.00 9.63 4 178636 41 64320051
Atrioventricular block first degree 9.98 9.63 9 178631 10725 64309367
Drug abuser 9.91 9.63 37 178603 5771 64314321
Pregnancy of partner 9.89 9.63 7 178633 243 64319849
Blood creatine phosphokinase increased 9.88 9.63 109 178531 58449 64261643
Peptic ulcer 9.85 9.63 35 178605 5328 64314764
Circulatory collapse 9.83 9.63 54 178586 33678 64286414
Splenomegaly 9.80 9.63 22 178618 17939 64302153
Pallor 9.77 9.63 65 178575 38716 64281376
Apathy 9.76 9.63 10 178630 11222 64308870
Scoliosis 9.76 9.63 38 178602 6044 64314048
Cervicobrachial syndrome 9.68 9.63 13 178627 1006 64319086
Sinus tachycardia 9.67 9.63 51 178589 32137 64287955
Respiratory syncytial virus infection 9.67 9.63 4 178636 7264 64312828
Plantar fasciitis 9.65 9.63 23 178617 2797 64317295
Fluid retention 9.64 9.63 112 178528 59494 64260598

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C08CA51 CARDIOVASCULAR SYSTEM
CALCIUM CHANNEL BLOCKERS
SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
Dihydropyridine derivatives
ATC L01XX33 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Other antineoplastic agents
ATC M01AH01 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Coxibs
ATC N02AJ16 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
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 D052246 Cyclooxygenase 2 Inhibitors
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:50629 COX-2 inhibitor
CHEBI has role CHEBI:176497 geroprotectors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Ankylosing spondylitis indication 9631008 DOID:7147
Rheumatoid arthritis indication 69896004 DOID:7148
Dysmenorrhea indication 266599000
Osteoarthritis indication 396275006
Juvenile rheumatoid arthritis indication 410795001
Acute postoperative pain indication 107401000119105
Alcoholism contraindication 7200002
Peptic ulcer contraindication 13200003 DOID:750
Myocardial infarction contraindication 22298006 DOID:5844
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Gastrointestinal perforation contraindication 51875005
Acute nephropathy contraindication 58574008
Gastrointestinal hemorrhage contraindication 74474003
Kidney disease contraindication 90708001 DOID:557
Liver function tests abnormal contraindication 166603001
Asthma contraindication 195967001 DOID:2841
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thromboembolic disorder contraindication 371039008
Cardiovascular event risk contraindication 395112001
Smokes tobacco daily contraindication 449868002




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 9.79 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 10MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9662315 May 22, 2029 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 2.5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9662315 May 22, 2029 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9662315 May 22, 2029 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 10MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9408837 Feb. 28, 2030 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 2.5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9408837 Feb. 28, 2030 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9408837 Feb. 28, 2030 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
56MG;44MG SEGLENTIS KOWA PHARMS N213426 Oct. 15, 2021 RX TABLET ORAL 10238668 April 19, 2030 A METHOD FOR TREATMENT OF PAIN IN ADULTS USING TRAMADOL HYDROCHLORIDE AND CELECOXIB
56MG;44MG SEGLENTIS KOWA PHARMS N213426 Oct. 15, 2021 RX TABLET ORAL 10548909 April 19, 2030 A METHOD FOR TREATMENT OF PAIN IN ADULTS USING TRAMADOL HYDROCHLORIDE AND CELECOXIB
25MG/ML ELYXYB BDSI N212157 May 5, 2020 RX SOLUTION ORAL 10376527 May 27, 2036 ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
25MG/ML ELYXYB BDSI N212157 May 5, 2020 RX SOLUTION ORAL 10722456 May 27, 2036 ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
25MG/ML ELYXYB BDSI N212157 May 5, 2020 RX SOLUTION ORAL 10799517 May 27, 2036 ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
25MG/ML ELYXYB BDSI N212157 May 5, 2020 RX SOLUTION ORAL 9572819 May 27, 2036 ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
25MG/ML ELYXYB BDSI N212157 May 5, 2020 RX SOLUTION ORAL 9795620 May 27, 2036 ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
25MG/ML ELYXYB BDSI N212157 May 5, 2020 RX SOLUTION ORAL 9949990 May 27, 2036 ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
EQ 10MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 10925835 June 14, 2038 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 2.5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 10925835 June 14, 2038 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 10925835 June 14, 2038 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
25MG/ML ELYXYB BDSI N212157 May 5, 2020 RX SOLUTION ORAL May 5, 2023 NEW PRODUCT
56MG;44MG SEGLENTIS KOWA PHARMS N213426 Oct. 15, 2021 RX TABLET ORAL Oct. 15, 2024 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 7.24 WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 7.30 CHEMBL
D(1A) dopamine receptor GPCR Ki 4.85 DRUG MATRIX
Sodium-dependent serotonin transporter Transporter Ki 5.48 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 5.14 DRUG MATRIX
Alpha-2B adrenergic receptor GPCR Ki 6.16 DRUG MATRIX
Beta-3 adrenergic receptor GPCR Ki 4.92 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 6.18 WOMBAT-PK
Cytochrome P450 2D6 Enzyme IC50 6 DRUG MATRIX
Adenosine receptor A3 GPCR Ki 4.86 DRUG MATRIX
Carbonic anhydrase 2 Enzyme IC50 7.68 WOMBAT-PK
Carbonic anhydrase 1 Enzyme Ki 4.30 CHEMBL
Carbonic anhydrase 4 Enzyme Ki 6.06 CHEMBL
Carbonic anhydrase 9 Enzyme Ki 4.80 CHEMBL
Carbonic anhydrase 12 Enzyme Ki 7.74 CHEMBL
Arachidonate 5-lipoxygenase Enzyme IC50 5.76 CHEMBL
Carbonic anhydrase 5A, mitochondrial Enzyme Ki 6.10 CHEMBL
Carbonic anhydrase 5B, mitochondrial Enzyme Ki 7.03 CHEMBL
Carbonic anhydrase 7 Enzyme Ki 5.66 CHEMBL
cGMP-specific 3',5'-cyclic phosphodiesterase Enzyme IC50 4.44 CHEMBL
cAMP-specific 3',5'-cyclic phosphodiesterase 4A Enzyme IC50 5.03 DRUG MATRIX
Histone deacetylase 1 Enzyme IC50 5.93 CHEMBL
Histone deacetylase 6 Enzyme IC50 6.19 CHEMBL
Carbonic anhydrase 3 Enzyme Ki 5.13 CHEMBL
Carbonic anhydrase 6 Enzyme Ki 7.03 CHEMBL
Carbonic anhydrase 14 Enzyme Ki 6.16 CHEMBL
Mitogen-activated protein kinase 14 Kinase IC50 6.09 CHEMBL
Cytochrome c oxidase subunit 2 Enzyme IC50 6.27 CHEMBL
3-phosphoinositide-dependent protein kinase 1 Kinase IC50 4.32 CHEMBL
Carbonic anhydrase 13 Enzyme Ki 7.01 CHEMBL
Prostaglandin E synthase Enzyme IC50 6.37 CHEMBL
Progesterone receptor Transcription factor Ki 5.63 DRUG MATRIX
Prostaglandin G/H synthase 2 Enzyme IC50 9.29 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 9.15 CHEMBL
Cyclooxygenase 2; Prostaglandin G/H synthase-2; Uncharacterized protein Enzyme IC50 6.05 CHEMBL
Carbonic anhydrase 4 Enzyme Ki 6.54 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 7.24 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 5.96 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 4.85 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 5.25 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 7.40 CHEMBL
Carbonic anhydrase Enzyme Ki 6.85 CHEMBL
Carbonic anhydrase Enzyme Ki 4.41 CHEMBL
Carbonic anhydrase 15 Enzyme Ki 7.35 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 5.11 CHEMBL
Carbonic anhydrase Enzyme Ki 6.97 CHEMBL
Carbonic anhydrase Enzyme Ki 7.68 CHEMBL
Probable transmembrane carbonic anhydrase (Carbonate dehydratase) (Carbonic dehydratase); Transmembrane carbonic anhydrase Enzyme Ki 5.11 CHEMBL
Carbonic anhydrase Enzyme Ki 6.94 CHEMBL
Alpha carbonic anhydrase Enzyme Ki 7.47 CHEMBL
Cytochrome c oxidase subunit 2 Enzyme IC50 7.22 CHEMBL
Carbonic anhydrase Enzyme Ki 6.16 CHEMBL
Carbonic anhydrase 2 Enzyme Ki 5.51 CHEMBL
Astrosclerin-3 Enzyme Ki 6.14 CHEMBL
Beta-carbonic anhydrase 1 Enzyme Ki 4.99 CHEMBL
Delta carbonic anhydrase Unclassified Ki 6.58 CHEMBL
Carbonic anhydrase 2 Enzyme Ki 6.15 CHEMBL
Cytochrome c oxidase subunit 1 Enzyme IC50 4.61 CHEMBL
Carbonic anhydrase Enzyme Ki 6.76 CHEMBL
Carbonic anhydrase, alpha family Unclassified Ki 6.01 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 8.43 CHEMBL
Carbonate dehydratase Enzyme Ki 8.16 CHEMBL

External reference:

IDSource
4021143 VUID
N0000148596 NUI
D00567 KEGG_DRUG
140587 RXNORM
4021143 VANDF
C0538927 UMLSCUI
CHEBI:41423 CHEBI
CEL PDB_CHEM_ID
CHEMBL118 ChEMBL_ID
DB00482 DRUGBANK_ID
D000068579 MESH_DESCRIPTOR_UI
2662 PUBCHEM_CID
2892 IUPHAR_LIGAND_ID
7767 INN_ID
JCX84Q7J1L UNII
14020 MMSL
174627 MMSL
7872 MMSL
d04380 MMSL
007731 NDDF
116081000 SNOMEDCT_US
370187009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
CELEBREX HUMAN PRESCRIPTION DRUG LABEL 1 0025-1515 CAPSULE 50 mg ORAL NDA 31 sections
CELEBREX HUMAN PRESCRIPTION DRUG LABEL 1 0025-1520 CAPSULE 100 mg ORAL NDA 31 sections
CELEBREX HUMAN PRESCRIPTION DRUG LABEL 1 0025-1525 CAPSULE 200 mg ORAL NDA 31 sections
CELEBREX HUMAN PRESCRIPTION DRUG LABEL 1 0025-1530 CAPSULE 400 mg ORAL NDA 31 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0093-7165 CAPSULE 100 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0093-7166 CAPSULE 200 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0093-7170 CAPSULE 400 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0093-7306 CAPSULE 50 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0378-7150 CAPSULE 200 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0378-7160 CAPSULE 100 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0378-7165 CAPSULE 50 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0378-7170 CAPSULE 400 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0591-3982 CAPSULE 50 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0591-3982 CAPSULE 50 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0591-3983 CAPSULE 100 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0591-3983 CAPSULE 100 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0591-3984 CAPSULE 200 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0591-3984 CAPSULE 200 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0591-3985 CAPSULE 400 mg ORAL ANDA 30 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0591-3985 CAPSULE 400 mg ORAL ANDA 30 sections
celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0615-8338 CAPSULE 200 mg ORAL ANDA 26 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0904-6502 CAPSULE 100 mg ORAL ANDA 31 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 0904-6503 CAPSULE 200 mg ORAL ANDA 31 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 10544-917 CAPSULE 200 mg ORAL NDA authorized generic 33 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 10544-918 CAPSULE 200 mg ORAL NDA authorized generic 33 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 10544-929 CAPSULE 200 mg ORAL NDA authorized generic 33 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 10544-953 CAPSULE 200 mg ORAL ANDA 33 sections
Celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 10544-967 CAPSULE 200 mg ORAL NDA authorized generic 33 sections
celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 13668-307 CAPSULE 50 mg ORAL ANDA 29 sections
celecoxib HUMAN PRESCRIPTION DRUG LABEL 1 13668-307 CAPSULE 50 mg ORAL ANDA 29 sections