tofacitinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
Janus kinase inhibitors, antineoplastics 4713 477600-75-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • tasocitinib
  • xeljanz
  • CP 690550
  • tofacitinib citrate
  • tofacitinib
  • CP-690550
Tofacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression. Tofacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs.
  • Molecular weight: 312.38
  • Formula: C16H20N6O
  • CLOGP: 2.03
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 88.91
  • ALOGS: -3.02
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 1.24 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.88 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.60 % Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 25, 2013 PMDA Pfizer Japan Inc.
Nov. 6, 2012 FDA PF PRISM CV
March 22, 2017 EMA PFIZER EUROPE MA EEIG

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 ineffective 8011.25 16.79 20352 423291 1024413 62020966
Condition aggravated 3236.14 16.79 8025 435618 394192 62651187
Joint swelling 3173.66 16.79 7032 436611 320634 62724745
Arthralgia 2884.30 16.79 9619 434024 560091 62485288
Drug intolerance 2749.27 16.79 6410 437233 302251 62743128
Synovitis 2745.16 16.79 4783 438860 182135 62863244
Therapeutic product effect incomplete 2347.84 16.79 3578 440065 121478 62923901
Musculoskeletal stiffness 2344.03 16.79 4436 439207 180182 62865197
Treatment failure 2327.66 16.79 4619 439024 194424 62850955
Pain 2249.01 16.79 10655 432988 729973 62315406
Contraindicated product administered 1955.26 16.79 4539 439104 213109 62832270
Therapeutic product effect decreased 1925.11 16.79 4199 439444 188988 62856391
Product dose omission in error 1871.45 16.79 960 442683 6652 63038727
Discouragement 1707.56 16.79 544 443099 718 63044661
Arthropathy 1653.92 16.79 4464 439179 230328 62815051
Hand deformity 1446.49 16.79 3340 440303 156117 62889262
Acute kidney injury 1345.85 16.79 139 443504 263276 62782103
Swelling 1340.47 16.79 4599 439044 270779 62774600
Abdominal discomfort 1333.40 16.79 5089 438554 315796 62729583
Hypotension 1230.65 16.79 212 443431 272392 62772987
Toxicity to various agents 1168.59 16.79 169 443474 247081 62798298
Blood cholesterol increased 1159.76 16.79 2234 441409 91798 62953581
Hepatic enzyme increased 1131.77 16.79 3544 440099 198784 62846595
Anti-cyclic citrullinated peptide antibody positive 1058.40 16.79 2439 441204 113773 62931606
Rheumatoid arthritis 1010.33 16.79 3973 439670 249846 62795533
Completed suicide 998.60 16.79 3 443640 145670 62899709
Peripheral swelling 967.32 16.79 4048 439595 261894 62783485
Alopecia 962.42 16.79 4781 438862 332755 62712624
Glossodynia 941.44 16.79 3069 440574 175807 62869572
Death 939.28 16.79 745 442898 373636 62671743
Sensitivity to weather change 927.64 16.79 597 443046 6640 63038739
Loss of personal independence in daily activities 926.94 16.79 2079 441564 95211 62950168
Pemphigus 920.39 16.79 3100 440543 180626 62864753
Product dose omission issue 904.34 16.79 3633 440010 230680 62814699
Wound 882.43 16.79 2827 440816 160436 62884943
Drug interaction 876.00 16.79 257 443386 228874 62816505
Systemic lupus erythematosus 851.02 16.79 3295 440348 205623 62839756
Pericarditis 849.80 16.79 2426 441217 129153 62916226
Discomfort 849.63 16.79 2837 440806 164537 62880842
Rheumatoid factor positive 780.88 16.79 1783 441860 82623 62962756
Anaemia 754.48 16.79 569 443074 292861 62752518
Febrile neutropenia 745.38 16.79 17 443626 118432 62926947
COVID-19 731.77 16.79 2087 441556 111016 62934363
Pain in extremity 718.72 16.79 4360 439283 327126 62718253
Infection 702.39 16.79 3316 440327 225857 62819522
Dehydration 693.20 16.79 178 443465 173176 62872203
C-reactive protein abnormal 684.16 16.79 1187 442456 44909 63000470
Illness 681.30 16.79 1227 442416 47832 62997547
Helicobacter infection 656.38 16.79 1769 441874 91016 62954363
Neutropenia 649.37 16.79 207 443436 174798 62870581
Herpes zoster 646.60 16.79 1634 442009 80828 62964551
Hyponatraemia 645.11 16.79 33 443610 111867 62933512
Joint stiffness 642.17 16.79 1094 442549 40775 63004604
Duodenal ulcer perforation 614.14 16.79 1660 441983 85549 62959830
Dyspnoea 606.58 16.79 2474 441169 658839 62386540
Seizure 574.66 16.79 114 443529 132520 62912859
Vomiting 568.20 16.79 2008 441635 557609 62487770
Product use issue 558.86 16.79 3025 440618 217495 62827884
Hypersensitivity 547.78 16.79 3710 439933 288975 62756404
Malignant neoplasm progression 545.49 16.79 5 443638 82116 62963263
Inflammation 526.95 16.79 1513 442130 80760 62964619
Joint range of motion decreased 508.75 16.79 856 442787 31572 63013807
Tachycardia 504.70 16.79 105 443538 118051 62927328
Cardiac arrest 498.57 16.79 39 443604 92506 62952873
Nasopharyngitis 489.42 16.79 3246 440397 251011 62794368
Injection site pain 485.93 16.79 151 443492 129649 62915730
Drug abuse 483.65 16.79 4 443639 72514 62972865
Intentional overdose 477.08 16.79 8 443635 74144 62971235
Pancytopenia 474.77 16.79 59 443584 96874 62948505
Somnolence 468.55 16.79 339 443304 178346 62867033
Thrombocytopenia 458.40 16.79 242 443401 150915 62894464
Red blood cell sedimentation rate increased 449.26 16.79 967 442676 43015 63002364
Drug hypersensitivity 444.15 16.79 3696 439947 306991 62738388
Therapy interrupted 439.43 16.79 803 442840 31652 63013727
Asthenia 436.15 16.79 1308 442335 382296 62663083
Rash 435.08 16.79 5895 437748 554976 62490403
Respiratory failure 427.89 16.79 94 443549 101764 62943615
Hypokalaemia 419.79 16.79 104 443539 103700 62941679
Bradycardia 417.61 16.79 23 443620 73204 62972175
Disease progression 414.80 16.79 169 443474 122589 62922790
Overdose 412.95 16.79 144 443499 114934 62930445
Infusion related reaction 412.71 16.79 3033 440610 242488 62802891
Platelet count decreased 398.68 16.79 156 443487 115966 62929413
Tremor 397.58 16.79 214 443429 132025 62913354
Depressed level of consciousness 390.11 16.79 9 443634 62069 62983310
Mobility decreased 388.11 16.79 1777 441866 119382 62925997
Sepsis 386.63 16.79 302 443341 152821 62892558
Suicide attempt 386.08 16.79 8 443635 60910 62984469
Oxygen saturation decreased 386.04 16.79 75 443568 88510 62956869
Therapeutic response unexpected 378.67 16.79 556 443087 18203 63027176
Renal failure 369.18 16.79 180 443463 117472 62927907
Weight decreased 367.19 16.79 874 442769 275924 62769455
Haemoglobin decreased 360.94 16.79 292 443351 145193 62900186
Drug effective for unapproved indication 359.89 16.79 248 443395 3116 63042263
Arthritis 357.15 16.79 1681 441962 114240 62931139
Red blood cell sedimentation rate abnormal 352.12 16.79 553 443090 19229 63026150
Coma 349.84 16.79 26 443617 64338 62981041
Gastrointestinal haemorrhage 342.79 16.79 74 443569 81102 62964277
Hyperkalaemia 340.05 16.79 8 443635 54195 62991184
Rheumatic fever 336.42 16.79 853 442790 42258 63003121
Oedema peripheral 336.07 16.79 502 443141 189009 62856370
Cardiac failure 322.47 16.79 110 443533 89032 62956347
Chest discomfort 320.38 16.79 185 443458 109784 62935595
Hypoglycaemia 318.81 16.79 27 443616 60038 62985341
Tuberculin test positive 318.32 16.79 234 443409 3277 63042102
Hypoxia 317.02 16.79 27 443616 59765 62985614
Pleural effusion 315.38 16.79 128 443515 93082 62952297
Rheumatoid nodule 312.91 16.79 485 443158 16670 63028709
Syncope 307.21 16.79 223 443420 117162 62928217
Multiple sclerosis relapse 300.91 16.79 8 443635 48470 62996909
Atrial fibrillation 300.81 16.79 225 443418 116411 62928968
Dizziness 294.77 16.79 1779 441864 428146 62617233
Intentional dose omission 293.57 16.79 321 443322 7754 63037625
International normalised ratio increased 290.67 16.79 7 443636 46418 62998961
Agitation 288.65 16.79 38 443605 59719 62985660
Hallucination 287.25 16.79 26 443617 54791 62990588
Multiple organ dysfunction syndrome 286.70 16.79 31 443612 56721 62988658
Liver function test increased 282.28 16.79 674 442969 32137 63013242
Neutrophil count decreased 281.95 16.79 32 443611 56374 62989005
Metabolic acidosis 277.65 16.79 8 443635 45061 63000318
Cardiac failure congestive 277.17 16.79 150 443493 92283 62953096
Constipation 271.38 16.79 745 442898 224198 62821181
Impaired healing 267.67 16.79 1419 442224 101123 62944256
Blood pressure decreased 265.09 16.79 64 443579 64958 62980421
Swollen joint count increased 263.42 16.79 696 442947 35358 63010021
Neuropathy peripheral 261.45 16.79 245 443398 113422 62931957
Rhabdomyolysis 259.59 16.79 11 443632 43940 63001439
Fibromyalgia 259.26 16.79 1182 442461 79238 62966141
Cognitive disorder 254.56 16.79 42 443601 55773 62989606
Folliculitis 253.68 16.79 1069 442574 69248 62976131
Muscle injury 253.56 16.79 1016 442627 64329 62981050
Gastrointestinal disorder 253.54 16.79 1678 441965 129561 62915818
Knee arthroplasty 251.09 16.79 892 442751 53314 62992065
Fatigue 250.93 16.79 8037 435606 879991 62165388
Decreased appetite 250.43 16.79 906 442737 250146 62795233
Flushing 246.17 16.79 108 443535 74979 62970400
Foot deformity 245.94 16.79 578 443065 27275 63018104
Pyrexia 244.33 16.79 2108 441535 468370 62577009
Sinusitis 241.74 16.79 2534 441109 224119 62821260
Suicidal ideation 240.10 16.79 69 443574 62352 62983027
Irritable bowel syndrome 239.22 16.79 1175 442468 81237 62964142
Hyperglycaemia 239.17 16.79 13 443630 41854 63003525
Lactic acidosis 238.83 16.79 6 443637 38281 63007098
Bone erosion 238.08 16.79 437 443206 17280 63028099
Encephalopathy 237.38 16.79 7 443636 38613 63006766
Musculoskeletal pain 235.40 16.79 1269 442374 91008 62954371
Sleep disorder due to general medical condition, insomnia type 234.81 16.79 851 442792 51366 62994013
Wrong technique in product usage process 234.16 16.79 72 443571 62268 62983111
Ascites 231.56 16.79 13 443630 40715 63004664
Grip strength decreased 230.97 16.79 493 443150 21794 63023585
Injection site erythema 230.96 16.79 148 443495 83026 62962353
Headache 230.40 16.79 5919 437724 627322 62418057
Osteoarthritis 223.78 16.79 1282 442361 94061 62951318
Balance disorder 222.67 16.79 159 443484 84263 62961116
Blister 219.65 16.79 1607 442036 128207 62917172
Fall 218.99 16.79 1724 441919 390610 62654769
Osteonecrosis of jaw 217.23 16.79 6 443637 35117 63010262
Incorrect dose administered 211.72 16.79 77 443566 59891 62985488
Neoplasm progression 205.96 16.79 12 443631 36416 63008963
White blood cell count decreased 205.87 16.79 413 443230 138691 62906688
Dysarthria 204.28 16.79 28 443615 42683 63002696
Mental status changes 204.24 16.79 20 443623 39579 63005800
Abdominal pain 204.17 16.79 1208 442435 292248 62753131
Abortion spontaneous 203.40 16.79 41 443602 47154 62998225
Pulmonary oedema 203.19 16.79 65 443578 54808 62990571
Lethargy 202.73 16.79 69 443574 55938 62989441
Blood bilirubin increased 201.83 16.79 15 443628 37125 63008254
Unresponsive to stimuli 201.27 16.79 8 443635 33808 63011571
Vision blurred 200.02 16.79 208 443435 91716 62953663
Angioedema 199.90 16.79 45 443598 47920 62997459
Plasma cell myeloma 199.48 16.79 13 443630 35892 63009487
Dysphagia 196.66 16.79 197 443446 88388 62956991
Foetal exposure during pregnancy 195.69 16.79 6 443637 31956 63013423
C-reactive protein increased 194.54 16.79 1230 442413 93477 62951902
Respiratory arrest 193.37 16.79 8 443635 32637 63012742
Nausea 191.33 16.79 4533 439110 849938 62195441
Hip arthroplasty 190.60 16.79 748 442895 46898 62998481
Cholestasis 190.04 16.79 3 443640 29431 63015948
Respiratory distress 189.49 16.79 12 443631 33939 63011440
Drug reaction with eosinophilia and systemic symptoms 188.72 16.79 12 443631 33824 63011555
Anxiety 187.20 16.79 832 442811 216709 62828670
Generalised tonic-clonic seizure 187.16 16.79 3 443640 29013 63016366
Disorientation 186.02 16.79 27 443616 39425 63005954
Palpitations 185.34 16.79 314 443329 112456 62932923
Pulmonary hypertension 183.19 16.79 22 443621 37101 63008278
Tenderness 180.57 16.79 451 443192 22127 63023252
Dyspnoea exertional 179.10 16.79 99 443544 60203 62985176
Acute respiratory failure 178.95 16.79 17 443626 34468 63010911
Heart rate increased 175.46 16.79 241 443402 93997 62951382
Mycobacterium tuberculosis complex test positive 175.28 16.79 137 443506 2114 63043265
Loss of consciousness 174.52 16.79 351 443292 117770 62927609
Pallor 173.03 16.79 10 443633 30558 63014821
Hepatocellular injury 171.90 16.79 4 443639 27377 63018002
Joint injury 171.27 16.79 525 443118 29047 63016332
Orthostatic hypotension 169.90 16.79 25 443618 36135 63009244
Hepatic failure 169.05 16.79 24 443619 35632 63009747
Hypophagia 168.80 16.79 13 443630 31246 63014133
Accidental exposure to product 168.31 16.79 5 443638 27400 63017979
Pulmonary embolism 166.24 16.79 354 443289 116330 62929049
Intentional self-injury 164.25 16.79 3 443640 25684 63019695
Haematoma 163.78 16.79 24 443619 34796 63010583
Cerebrovascular accident 163.03 16.79 317 443326 107707 62937672
Hepatic function abnormal 162.72 16.79 31 443612 37111 63008268
Drug tolerance decreased 162.38 16.79 370 443273 17103 63028276
Pneumonia aspiration 162.01 16.79 24 443619 34516 63010863
Mucosal inflammation 161.07 16.79 63 443580 46865 62998514
Injection site pruritus 160.84 16.79 57 443586 45059 63000320
Agranulocytosis 160.45 16.79 3 443640 25131 63020248
Adverse drug reaction 159.81 16.79 1029 442614 78685 62966694
Hypervolaemia 158.70 16.79 10 443633 28403 63016976
Chest pain 157.62 16.79 875 442768 215084 62830295
Hyperhidrosis 157.12 16.79 323 443320 107513 62937866
Heart rate decreased 156.64 16.79 61 443582 45499 62999880
Nodule 155.71 16.79 408 443235 20618 63024761
Injection site swelling 155.01 16.79 69 443574 47503 62997876
Urinary retention 154.45 16.79 16 443627 30285 63015094
Type 2 diabetes mellitus 153.91 16.79 865 442778 63003 62982376
Psychotic disorder 153.31 16.79 6 443637 25706 63019673
Blood parathyroid hormone decreased 152.91 16.79 258 443385 9533 63035846
Device issue 151.16 16.79 3 443640 23778 63021601
Product quality issue 150.76 16.79 33 443610 35832 63009547
Coronary artery disease 150.71 16.79 23 443620 32354 63013025
Granuloma skin 150.34 16.79 236 443407 8201 63037178
Blood glucose increased 150.16 16.79 220 443423 83536 62961843
Diarrhoea 148.95 16.79 3835 439808 711531 62333848
Bone marrow failure 147.93 16.79 16 443627 29274 63016105
Aphasia 147.90 16.79 26 443617 32974 63012405
Pneumonia 147.76 16.79 2274 441369 454493 62590886
Adverse event 147.24 16.79 891 442752 66668 62978711
Cholelithiasis 145.83 16.79 62 443581 43863 63001516
Jaundice 145.16 16.79 17 443626 29234 63016145
Myocardial infarction 144.86 16.79 300 443343 99593 62945786
Eosinophilia 144.13 16.79 3 443640 22753 63022626
Injection site haemorrhage 143.87 16.79 6 443637 24308 63021071
Blood alkaline phosphatase increased 143.69 16.79 60 443583 42907 63002472
Sinus tachycardia 143.56 16.79 6 443637 24262 63021117
Pericardial effusion 143.05 16.79 20 443623 30038 63015341
Blood calcium decreased 140.05 16.79 12 443631 26439 63018940
Ill-defined disorder 138.17 16.79 1012 442631 80743 62964636
Panniculitis 137.09 16.79 268 443375 11117 63034262
Arrhythmia 136.28 16.79 48 443595 38092 63007287
Blood pressure fluctuation 136.16 16.79 77 443566 46240 62999139
Melaena 135.92 16.79 24 443619 30341 63015038
Stevens-Johnson syndrome 135.79 16.79 10 443633 24940 63020439
Dyskinesia 135.43 16.79 29 443614 31973 63013406
Altered state of consciousness 134.81 16.79 11 443632 25219 63020160
Chills 134.73 16.79 378 443265 113000 62932379
Ejection fraction decreased 133.87 16.79 5 443638 22327 63023052
Off label use 133.40 16.79 5871 437772 668591 62376788
Deep vein thrombosis 132.53 16.79 239 443404 83561 62961818
Gastric disorder 132.31 16.79 565 443078 36804 63008575
Cerebral haemorrhage 131.78 16.79 27 443616 30702 63014677
Lower respiratory tract infection 131.48 16.79 1459 442184 130848 62914531
Blood potassium decreased 130.70 16.79 65 443578 41961 63003418
Hemiparesis 130.62 16.79 8 443635 23274 63022105
Gamma-glutamyltransferase increased 130.16 16.79 38 443605 33993 63011386
Drug level increased 130.04 16.79 7 443636 22729 63022650
Upper respiratory tract infection 129.84 16.79 1000 442643 81047 62964332
Septic shock 129.52 16.79 165 443478 66464 62978915
Osteoporosis 129.29 16.79 763 442880 56575 62988804
Chronic kidney disease 128.47 16.79 79 443564 45319 63000060
Maternal exposure during pregnancy 127.96 16.79 2205 441438 217857 62827522
Circulatory collapse 127.88 16.79 6 443637 21932 63023447
Obstructive airways disorder 126.31 16.79 4 443639 20695 63024684
Restlessness 126.06 16.79 26 443617 29427 63015952
Haematemesis 125.79 16.79 29 443614 30383 63014996
Finger deformity 124.84 16.79 207 443436 7538 63037841
Pulmonary fibrosis 124.45 16.79 580 443063 39229 63006150
Transient ischaemic attack 124.20 16.79 54 443589 37699 63007680
Disturbance in attention 123.47 16.79 56 443587 38133 63007246
Shock 123.26 16.79 11 443632 23452 63021927
Pulmonary arterial hypertension 123.01 16.79 9 443634 22568 63022811
Erythema 122.33 16.79 723 442920 175028 62870351
Chronic obstructive pulmonary disease 122.10 16.79 155 443488 62531 62982848
Electrolyte imbalance 122.08 16.79 4 443639 20072 63025307
Epistaxis 121.78 16.79 200 443443 72525 62972854
Metastases to liver 121.74 16.79 12 443631 23627 63021752
Pancreatitis acute 120.45 16.79 22 443621 27144 63018235
Face oedema 119.55 16.79 5 443638 20207 63025172
Joint effusion 118.21 16.79 323 443320 16737 63028642
Ventricular tachycardia 117.98 16.79 5 443638 19974 63025405
Vaginal haemorrhage 116.13 16.79 25 443618 27462 63017917
Mitral valve incompetence 115.39 16.79 5 443638 19589 63025790
Acne 114.50 16.79 391 443252 22902 63022477
Intentional product use issue 114.42 16.79 1382 442261 126510 62918869
Blood urea increased 113.49 16.79 23 443620 26356 63019023
Full blood count decreased 113.41 16.79 22 443621 26002 63019377
Hallucination, visual 113.39 16.79 5 443638 19293 63026086
Inappropriate schedule of product administration 112.47 16.79 362 443281 103603 62941776
Emotional distress 111.20 16.79 44 443599 32505 63012874
Aggression 110.97 16.79 16 443627 23482 63021897
Acute myocardial infarction 110.45 16.79 43 443600 32081 63013298
Metastases to bone 110.03 16.79 10 443633 21009 63024370
Abnormal behaviour 110.02 16.79 11 443632 21415 63023964
Depressed mood 109.49 16.79 563 443080 39628 63005751
Acute respiratory distress syndrome 108.89 16.79 17 443626 23517 63021862
Product administration error 108.73 16.79 14 443629 22383 63022996
Cardiogenic shock 107.54 16.79 4 443639 17928 63027451
Upper gastrointestinal haemorrhage 107.22 16.79 6 443637 18846 63026533
Tachypnoea 106.83 16.79 3 443640 17299 63028080
Hospitalisation 106.08 16.79 277 443366 84804 62960575
Injection site mass 105.91 16.79 6 443637 18650 63026729
Angina pectoris 105.52 16.79 39 443604 30039 63015340
Memory impairment 105.07 16.79 1153 442490 103105 62942274
Asthma 104.80 16.79 496 443147 127065 62918314
Neurotoxicity 104.70 16.79 3 443640 16987 63028392
Intentional product misuse 104.02 16.79 756 442887 60161 62985218
Therapeutic product effect delayed 102.88 16.79 104 443539 2287 63043092
Skin exfoliation 102.52 16.79 90 443553 43012 63002367
Haematuria 101.96 16.79 38 443605 29119 63016260
Intestinal obstruction 101.96 16.79 44 443599 30855 63014524
Urinary incontinence 101.86 16.79 48 443595 31966 63013413
Dysgeusia 101.24 16.79 106 443537 46604 62998775
Device malfunction 100.59 16.79 6 443637 17851 63027528
Cerebral infarction 100.39 16.79 22 443621 23871 63021508
Renal impairment 98.13 16.79 304 443339 88051 62957328
Fear of injection 97.88 16.79 178 443465 6986 63038393
Blood lactate dehydrogenase increased 97.71 16.79 21 443622 23095 63022284
Leukocytosis 97.30 16.79 30 443613 25905 63019474
Diabetic ketoacidosis 96.74 16.79 14 443629 20491 63024888
Disseminated intravascular coagulation 94.71 16.79 11 443632 19040 63026339
Myoclonus 93.61 16.79 4 443639 15864 63029515
Blood pressure systolic increased 93.55 16.79 116 443527 47281 62998098
Haemoptysis 93.06 16.79 42 443601 28684 63016695
Stomatitis 92.86 16.79 1423 442220 137302 62908077
Blood creatinine increased 92.16 16.79 310 443333 87534 62957845
Injection site bruising 92.08 16.79 94 443549 41816 63003563
Epilepsy 91.78 16.79 37 443606 27028 63018351
Irritability 91.29 16.79 54 443589 31640 63013739
Product substitution issue 91.25 16.79 5 443638 15991 63029388
Bronchospasm 91.05 16.79 8 443635 17272 63028107
Deformity 90.92 16.79 231 443412 11453 63033926
Coagulopathy 90.30 16.79 17 443626 20527 63024852
Ischaemic stroke 90.20 16.79 10 443633 17947 63027432
Vertigo 90.10 16.79 176 443467 59711 62985668
Visual acuity reduced 89.90 16.79 21 443622 21805 63023574
Onychomycosis 89.83 16.79 182 443461 7750 63037629
Malnutrition 89.77 16.79 4 443639 15294 63030085
Lip swelling 89.37 16.79 53 443590 31010 63014369
Ileus 89.30 16.79 3 443640 14722 63030657
Joint dislocation 89.28 16.79 312 443331 18488 63026891
Ataxia 89.08 16.79 4 443639 15191 63030188
Neck pain 88.93 16.79 806 442837 68512 62976867
Body temperature increased 88.05 16.79 78 443565 37114 63008265
Ulcer 87.28 16.79 388 443255 25719 63019660
Subdural haematoma 86.61 16.79 3 443640 14325 63031054
Diplopia 86.26 16.79 29 443614 23699 63021680
Cyanosis 86.16 16.79 9 443634 16926 63028453
Dry eye 85.90 16.79 533 443110 40228 63005151
Exposure during pregnancy 85.85 16.79 685 442958 154862 62890517
Blood pressure diastolic decreased 85.66 16.79 26 443617 22680 63022699
Pulmonary toxicity 85.41 16.79 198 443445 9257 63036122
Tricuspid valve incompetence 85.22 16.79 4 443639 14617 63030762
Withdrawal syndrome 84.86 16.79 18 443625 19979 63025400
Creatinine renal clearance decreased 84.72 16.79 8 443635 16300 63029079
Musculoskeletal disorder 84.09 16.79 326 443317 20318 63025061
Rash erythematous 83.94 16.79 104 443539 42406 63002973
Lymphocyte count decreased 83.75 16.79 54 443589 30203 63015176
Swollen tongue 83.57 16.79 72 443571 34728 63010651
Right ventricular failure 82.82 16.79 11 443632 17177 63028202
Dry skin 82.32 16.79 171 443472 56716 62988663
Macular degeneration 81.57 16.79 34 443609 24342 63021037
Hypothermia 81.55 16.79 3 443640 13578 63031801
Prescribed overdose 81.23 16.79 461 443182 33692 63011687
Tenosynovitis 79.96 16.79 245 443398 13550 63031829
Gait inability 79.64 16.79 638 443005 52321 62993058
Myelosuppression 79.41 16.79 33 443610 23670 63021709
Immune system disorder 79.22 16.79 197 443446 9637 63035742
Complication associated with device 79.16 16.79 12 443631 16966 63028413
Cardiomegaly 78.66 16.79 14 443629 17600 63027779
Metastases to central nervous system 78.33 16.79 3 443640 13102 63032277
Skin necrosis 78.30 16.79 245 443398 13705 63031674
Acute myeloid leukaemia 77.96 16.79 13 443630 17134 63028245
Sleep apnoea syndrome 77.94 16.79 54 443589 29079 63016300
Myelodysplastic syndrome 77.75 16.79 12 443631 16742 63028637
Blood sodium decreased 77.72 16.79 36 443607 24216 63021163
Therapy non-responder 77.65 16.79 842 442801 75059 62970320
Pruritus 77.48 16.79 1928 441715 359525 62685854
Bacteraemia 77.02 16.79 14 443629 17334 63028045
Haematocrit decreased 76.89 16.79 97 443546 39243 63006136
Tubulointerstitial nephritis 76.52 16.79 22 443621 19881 63025498
Coordination abnormal 76.46 16.79 5 443638 13768 63031611
Brain oedema 76.37 16.79 6 443637 14189 63031190
Gastritis 76.06 16.79 89 443554 37214 63008165
Full blood count abnormal 75.71 16.79 66 443577 31651 63013728
Joint laxity 74.42 16.79 89 443554 2375 63043004
Joint noise 74.33 16.79 120 443523 4272 63041107
Pancreatitis 73.94 16.79 144 443499 48911 62996468
Contusion 73.41 16.79 1464 442179 148580 62896799
Hypocalcaemia 73.30 16.79 68 443575 31645 63013734
Hallucination, auditory 73.18 16.79 4 443639 12820 63032559
Poisoning 73.12 16.79 6 443637 13694 63031685
Device related infection 73.01 16.79 36 443607 23356 63022023
Rhinorrhoea 72.98 16.79 740 442903 64837 62980542
Blood creatine phosphokinase increased 71.82 16.79 64 443579 30366 63015013
Progressive multifocal leukoencephalopathy 71.16 16.79 5 443638 12966 63032413
Labelled drug-drug interaction medication error 71.15 16.79 6 443637 13393 63031986
Delusion 70.98 16.79 3 443640 12014 63033365
Extrapyramidal disorder 70.40 16.79 6 443637 13278 63032101
Impaired work ability 70.39 16.79 275 443368 17200 63028179
Osteonecrosis 70.36 16.79 42 443601 24488 63020891
X-ray abnormal 70.17 16.79 167 443476 7943 63037436
Mania 70.13 16.79 4 443639 12363 63033016
Drug effect less than expected 70.01 16.79 72 443571 1617 63043762
Diabetes mellitus inadequate control 69.82 16.79 11 443632 15115 63030264
Presyncope 69.80 16.79 55 443588 27730 63017649
Speech disorder 69.64 16.79 110 443533 40519 63004860
Psoriatic arthropathy 69.61 16.79 960 442683 90560 62954819
Paraesthesia oral 69.20 16.79 24 443619 19232 63026147
Small intestinal obstruction 69.17 16.79 21 443622 18316 63027063
Lymphopenia 69.11 16.79 21 443622 18306 63027073
Hypothyroidism 68.82 16.79 120 443523 42512 63002867
Abdominal pain lower 68.16 16.79 48 443595 25630 63019749
Fluid retention 67.95 16.79 203 443440 59483 62985896
Exostosis 67.87 16.79 276 443367 17586 63027793
Wrist deformity 67.75 16.79 79 443564 2051 63043328
Colitis 67.61 16.79 149 443494 48379 62997000
Delirium 67.32 16.79 159 443484 50382 62994997
Cellulitis 67.10 16.79 319 443324 81639 62963740
Haemorrhage 66.31 16.79 212 443431 60810 62984569
Procedural pain 66.11 16.79 34 443609 21535 63023844
Haemorrhage intracranial 66.09 16.79 8 443635 13411 63031968
Transfusion 66.02 16.79 13 443630 15204 63030175
Adverse reaction 65.60 16.79 188 443455 10015 63035364
White blood cell count increased 65.30 16.79 152 443491 48409 62996970
Gastrooesophageal reflux disease 65.15 16.79 396 443247 95243 62950136
Lower limb fracture 65.07 16.79 338 443305 23883 63021496
Cytomegalovirus infection 64.26 16.79 33 443610 20919 63024460
Oral mucosal exfoliation 64.07 16.79 68 443575 1586 63043793
Accidental overdose 63.97 16.79 42 443601 23267 63022112
Lung infiltration 63.50 16.79 12 443631 14451 63030928
Poor venous access 63.38 16.79 13 443630 14772 63030607
Rash maculo-papular 63.01 16.79 78 443565 31818 63013561
Cholecystitis 62.93 16.79 15 443628 15362 63030017
Multiple sclerosis 62.81 16.79 47 443596 24325 63021054
Bone pain 62.81 16.79 185 443458 54456 62990923
Unevaluable event 62.75 16.79 169 443474 51217 62994162
Infusion site erythema 62.65 16.79 5 443638 11674 63033705
Myocardial ischaemia 62.51 16.79 8 443635 12851 63032528
Heavy menstrual bleeding 62.42 16.79 23 443620 17750 63027629
Productive cough 62.31 16.79 229 443414 62979 62982400
Incorrect product administration duration 61.78 16.79 5 443638 11541 63033838
Acute generalised exanthematous pustulosis 61.70 16.79 4 443639 11095 63034284
Central nervous system lesion 61.69 16.79 3 443640 10632 63034747
Immune thrombocytopenia 61.16 16.79 3 443640 10553 63034826
Nail disorder 60.95 16.79 215 443428 12800 63032579
Rheumatoid lung 60.89 16.79 102 443541 3746 63041633
Anhedonia 60.88 16.79 4 443639 10970 63034409
Malaise 60.84 16.79 3519 440124 412435 62632944
Mental disorder 60.58 16.79 55 443588 25864 63019515
Aspiration 60.06 16.79 4 443639 10847 63034532
Blood magnesium decreased 60.02 16.79 10 443633 13188 63032191
Pseudomonas infection 59.60 16.79 5 443638 11208 63034171
Myopathy 59.46 16.79 5 443638 11186 63034193
Blood albumin decreased 59.26 16.79 15 443628 14751 63030628
Throat tightness 59.14 16.79 52 443591 24835 63020544
Muscle twitching 58.81 16.79 32 443611 19636 63025743
Muscle rigidity 58.80 16.79 6 443637 11494 63033885
Hyperthyroidism 58.71 16.79 15 443628 14658 63030721
Spinal stenosis 58.61 16.79 233 443410 14692 63030687
Acute coronary syndrome 58.28 16.79 3 443640 10123 63035256
Polyneuropathy 58.21 16.79 15 443628 14574 63030805
Pre-existing condition improved 58.03 16.79 157 443486 8087 63037292
Clostridium difficile colitis 57.90 16.79 36 443607 20533 63024846
Neoplasm malignant 57.70 16.79 382 443261 29479 63015900
Dialysis 57.26 16.79 4 443639 10423 63034956
Contrast media allergy 57.11 16.79 77 443566 2324 63043055
Device breakage 56.55 16.79 7 443636 11535 63033844
Panic attack 56.36 16.79 44 443599 22287 63023092
Muscle spasticity 56.20 16.79 42 443601 21752 63023627
Hypovolaemia 56.07 16.79 5 443638 10668 63034711
Gastroenteritis 55.77 16.79 62 443581 26528 63018851
Erythema multiforme 55.55 16.79 4 443639 10165 63035214
Alanine aminotransferase increased 55.39 16.79 461 443182 103309 62942070
Aspartate aminotransferase increased 54.80 16.79 387 443256 89890 62955489
Hepatitis B virus test positive 54.56 16.79 28 443615 194 63045185
Feeling cold 54.29 16.79 52 443591 23836 63021543
Schizophrenia 54.12 16.79 4 443639 9948 63035431
Petechiae 54.10 16.79 15 443628 13882 63031497
Influenza 53.89 16.79 1063 442580 107659 62937720
Hydronephrosis 53.39 16.79 6 443637 10656 63034723
Injection site urticaria 53.29 16.79 16 443627 14057 63031322
Hemiplegia 52.92 16.79 3 443640 9320 63036059
Injection site rash 52.84 16.79 33 443610 18776 63026603
Injection site warmth 52.80 16.79 20 443623 15175 63030204
Subarachnoid haemorrhage 52.72 16.79 17 443626 14266 63031113
Rales 52.72 16.79 12 443631 12685 63032694
Breast cancer metastatic 52.71 16.79 10 443633 12008 63033371
Hypotonia 52.66 16.79 3 443640 9282 63036097
Pre-eclampsia 51.65 16.79 3 443640 9130 63036249
Sleep disorder 50.88 16.79 827 442816 80739 62964640
Blood loss anaemia 50.77 16.79 3 443640 8998 63036381
Abortion induced 50.70 16.79 6 443637 10236 63035143
Tuberculosis 50.62 16.79 183 443460 11028 63034351
Cardiomyopathy 50.58 16.79 30 443613 17554 63027825
Confusional state 50.54 16.79 1261 442382 235119 62810260
Eosinophil count increased 50.32 16.79 8 443635 10920 63034459
Atrial flutter 50.22 16.79 5 443638 9767 63035612
Dermatitis atopic 49.91 16.79 5 443638 9719 63035660
Anti-cyclic citrullinated peptide antibody 49.89 16.79 131 443512 6627 63038752
Synovial disorder 49.28 16.79 66 443577 1979 63043400
Supraventricular tachycardia 49.23 16.79 19 443624 14252 63031127
Foot operation 49.19 16.79 136 443507 7095 63038284
Swelling face 49.11 16.79 252 443391 63223 62982156
Liver injury 48.96 16.79 642 443001 59878 62985501
Dry mouth 48.77 16.79 790 442853 77073 62968306
Red blood cell sedimentation rate 48.71 16.79 106 443537 4748 63040631
Urosepsis 48.68 16.79 35 443608 18489 63026890
Ventricular extrasystoles 48.62 16.79 11 443632 11676 63033703
Generalised oedema 48.38 16.79 25 443618 15793 63029586
Escherichia urinary tract infection 48.30 16.79 12 443631 11950 63033429
Disability 47.89 16.79 254 443389 18093 63027286
Troponin increased 47.54 16.79 7 443636 10114 63035265
Blood pressure diastolic abnormal 47.51 16.79 21 443622 14521 63030858
Dermatitis bullous 47.50 16.79 3 443640 8505 63036874
Splenomegaly 47.43 16.79 10 443633 11147 63034232
Systemic lupus erythematosus rash 47.26 16.79 68 443575 2184 63043195
Therapeutic response decreased 47.03 16.79 646 442997 60879 62984500
Peritonitis 46.95 16.79 31 443612 17123 63028256
Psychomotor hyperactivity 46.49 16.79 9 443634 10654 63034725
Muscular weakness 46.19 16.79 590 443053 121763 62923616
Pyelonephritis 46.18 16.79 34 443609 17744 63027635
Lipase increased 46.15 16.79 7 443636 9893 63035486
Anticipatory anxiety 45.94 16.79 50 443593 1201 63044178
Eczema 45.93 16.79 98 443545 32193 63013186
Pruritus allergic 45.92 16.79 56 443587 1526 63043853
Blood pressure systolic abnormal 45.88 16.79 18 443625 13368 63032011
Bursitis 45.62 16.79 427 443216 36614 63008765
Renal injury 45.58 16.79 6 443637 9433 63035946
Paraesthesia 45.43 16.79 797 442846 156169 62889210
Fear 45.21 16.79 27 443616 15739 63029640
Sudden death 45.18 16.79 9 443634 10440 63034939
Transplant rejection 45.14 16.79 10 443633 10770 63034609
Blood glucose decreased 44.89 16.79 48 443595 20904 63024475
Urine output decreased 44.77 16.79 12 443631 11358 63034021
Myocarditis 44.42 16.79 9 443634 10316 63035063
Anaphylactic shock 44.41 16.79 60 443583 23573 63021806
Nervousness 44.08 16.79 94 443549 30885 63014494
Metastases to lung 43.94 16.79 17 443626 12733 63032646
Hypoaesthesia oral 43.89 16.79 18 443625 13015 63032364
Intermenstrual bleeding 43.64 16.79 3 443640 7923 63037456
Hepatitis acute 43.56 16.79 6 443637 9114 63036265
Synovial cyst 43.51 16.79 166 443477 10267 63035112
Treatment noncompliance 42.44 16.79 127 443516 37198 63008181
Acute pulmonary oedema 42.38 16.79 4 443639 8154 63037225
Renal tubular necrosis 42.34 16.79 15 443628 11863 63033516
Skin laceration 42.32 16.79 58 443585 22650 63022729
Proteinuria 41.98 16.79 43 443600 19102 63026277
Joint destruction 41.95 16.79 117 443526 6135 63039244
Multiple fractures 41.77 16.79 144 443499 8474 63036905
Therapeutic product effect variable 41.67 16.79 47 443596 1176 63044203
Cardiac failure acute 41.60 16.79 8 443635 9515 63035864
Elbow deformity 41.36 16.79 52 443591 1463 63043916
Purpura 41.24 16.79 14 443629 11371 63034008
Urticaria 41.20 16.79 864 442779 164938 62880441
Haemolytic anaemia 41.19 16.79 10 443633 10115 63035264
Coeliac disease 41.13 16.79 188 443455 12609 63032770
Prescribed underdose 41.06 16.79 351 443292 29338 63016041
Anger 40.68 16.79 18 443625 12438 63032941
Feeling hot 40.62 16.79 197 443446 50157 62995222
Bronchopulmonary aspergillosis 40.49 16.79 6 443637 8629 63036750
Drug resistance 40.34 16.79 61 443582 22872 63022507
Weight increased 40.32 16.79 2218 441425 258574 62786805
Sensory loss 39.95 16.79 11 443632 10227 63035152
Head injury 39.93 16.79 82 443561 27314 63018065
Spinal operation 39.91 16.79 138 443505 8133 63037246
Injection site induration 39.78 16.79 8 443635 9218 63036161
Peptic ulcer haemorrhage 39.77 16.79 43 443600 1025 63044354
Blood pressure increased 39.54 16.79 847 442796 161215 62884164
Pneumonitis 39.23 16.79 121 443522 35101 63010278
Inflammatory marker increased 39.20 16.79 121 443522 6718 63038661
Stress cardiomyopathy 39.10 16.79 9 443634 9441 63035938
Gestational diabetes 38.99 16.79 6 443637 8390 63036989
Arteriosclerosis 38.93 16.79 11 443632 10055 63035324
Arteriosclerosis coronary artery 38.85 16.79 6 443637 8367 63037012
Body temperature decreased 38.78 16.79 51 443592 20268 63025111
Neck deformity 38.72 16.79 60 443583 2061 63043318
Product storage error 38.34 16.79 29 443614 14927 63030452
Erysipelas 38.23 16.79 5 443638 7900 63037479
Dysuria 38.22 16.79 115 443528 33623 63011756
Lower gastrointestinal haemorrhage 38.13 16.79 5 443638 7885 63037494
Crepitations 37.80 16.79 133 443510 7907 63037472
Eyelid oedema 37.76 16.79 13 443630 10466 63034913
Incontinence 37.69 16.79 17 443626 11615 63033764
Oropharyngeal pain 37.58 16.79 895 442748 93592 62951787
Arthrodesis 37.51 16.79 69 443574 2732 63042647
Electrocardiogram abnormal 37.47 16.79 9 443634 9170 63036209
Pneumothorax 37.42 16.79 35 443608 16226 63029153
Lipids increased 37.42 16.79 44 443599 1153 63044226
Soft tissue disorder 37.12 16.79 90 443553 4332 63041047
Aspergillus infection 37.09 16.79 6 443637 8087 63037292
Restless legs syndrome 36.94 16.79 45 443598 18486 63026893
Gait disturbance 36.92 16.79 1599 442044 181579 62863800
Breast cancer stage I 36.81 16.79 3 443640 6886 63038493
Nightmare 36.81 16.79 48 443595 19146 63026233
Salivary hypersecretion 36.71 16.79 5 443638 7661 63037718
Enthesopathy 36.70 16.79 138 443505 8476 63036903
Eyelid ptosis 36.62 16.79 4 443639 7263 63038116
Nodal osteoarthritis 36.41 16.79 37 443606 819 63044560
Dysphonia 36.29 16.79 190 443453 47424 62997955
Heart rate irregular 36.29 16.79 63 443580 22358 63023021
Hereditary angioedema 36.05 16.79 5 443638 7557 63037822
Dementia 36.04 16.79 47 443596 18747 63026632
Cardiac disorder 35.87 16.79 208 443435 50608 62994771
Limb discomfort 35.82 16.79 341 443302 29375 63016004
Encephalitis 35.68 16.79 9 443634 8871 63036508
Nephropathy toxic 35.49 16.79 11 443632 9468 63035911
Intestinal ischaemia 35.46 16.79 5 443638 7463 63037916
Eye swelling 35.36 16.79 71 443572 23847 63021532
Metastases to lymph nodes 35.33 16.79 7 443636 8151 63037228
Brain injury 35.18 16.79 4 443639 7039 63038340
No adverse event 35.16 16.79 159 443484 41246 63004133
Knee operation 35.04 16.79 107 443536 5906 63039473
Hypertransaminasaemia 34.98 16.79 3 443640 6606 63038773
Pelvic pain 34.93 16.79 26 443617 13493 63031886
Personality change 34.73 16.79 4 443639 6969 63038410
Epstein-Barr virus infection 34.67 16.79 7 443636 8043 63037336
Leukopenia 34.50 16.79 359 443284 76931 62968448
Facet joint syndrome 34.43 16.79 172 443471 11966 63033413
Retching 34.32 16.79 31 443612 14614 63030765
Drug use disorder 34.16 16.79 94 443549 4890 63040489
Onychomadesis 34.11 16.79 104 443539 5736 63039643
Diastolic dysfunction 34.08 16.79 3 443640 6468 63038911
Cholecystitis acute 33.91 16.79 8 443635 8252 63037127
Toothache 33.76 16.79 240 443403 18959 63026420
SLE arthritis 33.74 16.79 32 443611 649 63044730
Blood thyroid stimulating hormone increased 33.73 16.79 5 443638 7189 63038190
Ovarian cyst 33.64 16.79 37 443606 15908 63029471
Deep vein thrombosis postoperative 33.60 16.79 163 443480 11206 63034173
Enterocolitis 33.49 16.79 7 443636 7851 63037528
Sleep disorder due to a general medical condition 33.39 16.79 22 443621 12166 63033213
Lacrimation increased 33.36 16.79 58 443585 20573 63024806
Tooth infection 33.27 16.79 227 443416 17693 63027686
Ecchymosis 33.24 16.79 18 443625 11076 63034303
Haematotoxicity 33.15 16.79 12 443631 9364 63036015
Retinitis 33.11 16.79 107 443536 6089 63039290
Therapy cessation 33.07 16.79 342 443301 30115 63015264
Blood lactic acid increased 33.05 16.79 5 443638 7081 63038298
Lip dry 33.03 16.79 203 443440 15267 63030112
Diverticulitis 32.99 16.79 422 443221 39135 63006244
Dermatitis 32.94 16.79 42 443601 16916 63028463
Drug tolerance 32.71 16.79 115 443528 6834 63038545
Cold sweat 32.66 16.79 22 443621 12025 63033354
Aortic arteriosclerosis 32.37 16.79 3 443640 6206 63039173
Rhinitis allergic 32.36 16.79 21 443622 11706 63033673
Gastrointestinal toxicity 32.14 16.79 123 443520 7618 63037761
Trigger finger 32.09 16.79 85 443558 4323 63041056
Staphylococcal infection 31.79 16.79 164 443479 41092 63004287
Hyperventilation 31.77 16.79 3 443640 6113 63039266
Throat irritation 31.71 16.79 145 443498 37502 63007877
Injection site reaction 31.66 16.79 580 443063 57944 62987435
Cardiovascular disorder 31.45 16.79 22 443621 11790 63033589
Pulmonary haemorrhage 31.44 16.79 6 443637 7175 63038204
Blood calcium increased 31.35 16.79 13 443630 9337 63036042
Medication error 31.30 16.79 225 443418 52059 62993320
Nasal polyps 31.27 16.79 3 443640 6036 63039343
Device failure 31.09 16.79 3 443640 6008 63039371
Mucous stools 31.01 16.79 82 443561 4166 63041213
Limb deformity 31.01 16.79 79 443564 3923 63041456
Glomerular filtration rate decreased 30.85 16.79 29 443614 13412 63031967
End stage renal disease 30.59 16.79 5 443638 6688 63038691
Breast cancer 30.55 16.79 205 443438 48178 62997201
Hepatomegaly 30.54 16.79 23 443620 11866 63033513
Nasal congestion 30.54 16.79 636 443007 65024 62980355
Vaginal discharge 30.50 16.79 13 443630 9185 63036194
Immobile 30.30 16.79 101 443542 5842 63039537
Extremity contracture 30.25 16.79 41 443602 1244 63044135
Partial seizures 29.99 16.79 3 443640 5839 63039540
Hypersomnia 29.89 16.79 50 443593 18005 63027374
Apathy 29.85 16.79 12 443631 8782 63036597
Amenorrhoea 29.83 16.79 16 443627 9898 63035481
Investigation abnormal 29.79 16.79 51 443592 1907 63043472
Visual field defect 29.77 16.79 5 443638 6556 63038823
Unintended pregnancy 29.66 16.79 4 443639 6175 63039204
Hiatus hernia 29.51 16.79 67 443576 21527 63023852
Staphylococcal sepsis 29.43 16.79 10 443633 8118 63037261
Basal cell carcinoma 29.30 16.79 312 443331 27679 63017700
Haemorrhoids 29.24 16.79 70 443573 22080 63023299
Peripheral sensory neuropathy 29.08 16.79 8 443635 7443 63037936
Immune reconstitution inflammatory syndrome 29.06 16.79 4 443639 6080 63039299
Synovial fluid analysis 28.96 16.79 57 443586 2376 63043003
Haemolysis 28.91 16.79 6 443637 6762 63038617
Radiculopathy 28.83 16.79 12 443631 8599 63036780
Blood pressure systolic decreased 28.76 16.79 8 443635 7389 63037990
Frequent bowel movements 28.65 16.79 266 443377 22756 63022623
Oral candidiasis 28.57 16.79 74 443569 22724 63022655
Atrioventricular block 28.41 16.79 9 443634 7638 63037741
Back disorder 28.39 16.79 152 443491 10865 63034514
Atelectasis 28.28 16.79 68 443575 21415 63023964
Sputum discoloured 28.26 16.79 44 443599 16303 63029076
Bone swelling 28.20 16.79 46 443597 1652 63043727
Therapy partial responder 28.18 16.79 20 443623 10638 63034741
Fistula 28.15 16.79 19 443624 10374 63035005
Facial paralysis 28.09 16.79 34 443609 14007 63031372
Burning sensation 27.99 16.79 244 443399 54163 62991216
Chromaturia 27.95 16.79 46 443597 16671 63028708
Female genital tract fistula 27.90 16.79 9 443634 7550 63037829
Refusal of treatment by patient 27.76 16.79 3 443640 5494 63039885
Joint arthroplasty 27.67 16.79 60 443583 2681 63042698
Mental impairment 27.54 16.79 35 443608 14116 63031263
Faeces discoloured 27.31 16.79 55 443588 18454 63026925
Duodenal ulcer 27.30 16.79 10 443633 7746 63037633
Metabolic disorder 27.30 16.79 6 443637 6497 63038882
Loss of employment 27.23 16.79 53 443590 2191 63043188
Eye pruritus 27.11 16.79 56 443587 18615 63026764
Rheumatoid factor negative 27.07 16.79 27 443616 584 63044795
Transaminases increased 26.91 16.79 120 443523 31247 63014132
Product complaint 26.72 16.79 30 443613 12779 63032600
Rotator cuff repair 26.63 16.79 51 443592 2083 63043296
Diverticulum intestinal 26.59 16.79 7 443636 6706 63038673
Hydrocephalus 26.50 16.79 3 443640 5297 63040082
Hair growth abnormal 26.46 16.79 62 443581 2919 63042460
Seborrhoea 26.46 16.79 24 443619 459 63044920
Lupus vulgaris 26.35 16.79 97 443546 5897 63039482
Amylase increased 26.34 16.79 6 443637 6339 63039040
Oesophagitis 26.32 16.79 40 443603 14968 63030411
Aortic valve incompetence 26.22 16.79 5 443638 5983 63039396
Wheezing 26.19 16.79 490 443153 95105 62950274
Abnormal dreams 26.18 16.79 21 443622 10495 63034884
Ankle arthroplasty 25.99 16.79 46 443597 1767 63043612
Humerus fracture 25.95 16.79 15 443628 8901 63036478
Hypertriglyceridaemia 25.82 16.79 6 443637 6253 63039126
Loose body in joint 25.78 16.79 38 443605 1248 63044131
Root canal infection 25.71 16.79 22 443621 388 63044991
Hypovolaemic shock 25.71 16.79 6 443637 6235 63039144
Skin ulcer 25.56 16.79 433 443210 42612 63002767
Major depression 25.54 16.79 12 443631 8006 63037373
Fine motor skill dysfunction 25.49 16.79 83 443560 4742 63040637
Polyuria 25.39 16.79 14 443629 8528 63036851
Neutrophil count increased 25.35 16.79 48 443595 16479 63028900
Cardiac murmur 25.32 16.79 39 443604 14513 63030866
Blindness 25.27 16.79 73 443570 21626 63023753
Red blood cell count decreased 25.27 16.79 173 443470 40472 63004907
Peripheral venous disease 25.22 16.79 190 443453 15287 63030092
Angina unstable 25.22 16.79 9 443634 7086 63038293
Discontinued product administered 25.08 16.79 12 443631 70 63045309
Lupus-like syndrome 25.06 16.79 188 443455 15107 63030272
Bundle branch block left 25.02 16.79 9 443634 7050 63038329
Gangrene 25.00 16.79 6 443637 6117 63039262
Protein urine present 24.98 16.79 6 443637 6114 63039265
Post procedural complication 24.97 16.79 51 443592 17023 63028356
Coronary artery occlusion 24.97 16.79 13 443630 8178 63037201
Maternal exposure timing unspecified 24.96 16.79 107 443536 6980 63038399
Abnormal loss of weight 24.96 16.79 5 443638 5777 63039602
Motor dysfunction 24.95 16.79 23 443620 10738 63034641
Embolism 24.93 16.79 12 443631 7894 63037485
Skin cancer 24.64 16.79 151 443492 11344 63034035
Infiltration anaesthesia 24.63 16.79 16 443627 181 63045198
Tenosynovitis stenosans 24.62 16.79 65 443578 3299 63042080
Tongue disorder 24.62 16.79 142 443501 10438 63034941
Pulse absent 24.60 16.79 4 443639 5370 63040009
Retinal toxicity 24.59 16.79 37 443606 1238 63044141
Laryngeal oedema 24.57 16.79 5 443638 5713 63039666
Antibiotic therapy 24.41 16.79 34 443609 1059 63044320
Periorbital oedema 24.36 16.79 5 443638 5679 63039700
Rectal haemorrhage 24.30 16.79 222 443421 48808 62996571
Odynophagia 24.16 16.79 11 443632 7475 63037904
Dermatitis contact 23.83 16.79 25 443618 10983 63034396
Glycosylated haemoglobin increased 23.78 16.79 31 443612 12367 63033012
Chronic sinusitis 23.73 16.79 33 443610 12810 63032569
Autoimmune disorder 23.71 16.79 203 443440 16974 63028405
Foetal death 23.69 16.79 25 443618 10955 63034424
Aphthous ulcer 23.63 16.79 38 443605 13900 63031479
Clostridium difficile infection 23.59 16.79 118 443525 29804 63015575
Metastasis 23.49 16.79 4 443639 5193 63040186
Sensory disturbance 23.44 16.79 37 443606 13635 63031744
Myalgia 23.44 16.79 813 442830 145716 62899663
Staphylococcal bacteraemia 23.42 16.79 5 443638 5525 63039854
Skin burning sensation 23.25 16.79 33 443610 12701 63032678
Adjustment disorder with depressed mood 23.13 16.79 136 443507 10068 63035311
Abdominal distension 23.10 16.79 446 443197 86169 62959210
Bowel movement irregularity 22.98 16.79 85 443558 5179 63040200
Eating disorder 22.87 16.79 63 443580 18953 63026426
Dyspepsia 22.84 16.79 902 442741 101294 62944085
Candida infection 22.82 16.79 111 443532 28240 63017139
Invasive ductal breast carcinoma 22.81 16.79 10 443633 6948 63038431
Endocarditis 22.77 16.79 6 443637 5744 63039635
Hunger 22.77 16.79 86 443557 5293 63040086
Kidney infection 22.73 16.79 255 443388 22921 63022458
Granulomatous rosacea 22.46 16.79 8 443635 18 63045361
Pulmonary alveolar haemorrhage 22.46 16.79 3 443640 4665 63040714
Injection site hypersensitivity 22.43 16.79 47 443596 2050 63043329
Left ventricular failure 22.40 16.79 6 443637 5681 63039698
Scleritis 22.35 16.79 75 443568 4353 63041026
Oesophageal candidiasis 22.26 16.79 6 443637 5657 63039722
Thirst 22.23 16.79 40 443603 14001 63031378
Bunion operation 22.21 16.79 36 443607 1286 63044093
Lung neoplasm 22.20 16.79 7 443636 5959 63039420
Ear infection 22.19 16.79 383 443260 37830 63007549
Endometriosis 22.15 16.79 5 443638 5315 63040064
Feeding disorder 22.12 16.79 37 443606 13325 63032054
Eye pain 22.10 16.79 142 443501 33712 63011667
Drug level decreased 22.10 16.79 14 443629 7905 63037474
Bacterial test positive 22.07 16.79 5 443638 5302 63040077
Vitamin B12 deficiency 22.04 16.79 5 443638 5298 63040081
Tinnitus 21.97 16.79 152 443491 35476 63009903
Tongue oedema 21.94 16.79 3 443640 4583 63040796
Blood glucose fluctuation 21.88 16.79 3 443640 4573 63040806
Pharyngitis 21.78 16.79 226 443417 19917 63025462
Venous thrombosis 21.67 16.79 4 443639 4898 63040481
Renal cyst 21.63 16.79 24 443619 10278 63035101
Laryngitis 21.60 16.79 197 443446 16770 63028609
Intracranial pressure increased 21.58 16.79 5 443638 5222 63040157
Somnambulism 21.55 16.79 6 443637 5537 63039842
Peripheral ischaemia 21.52 16.79 4 443639 4874 63040505
C-reactive protein decreased 21.48 16.79 30 443613 937 63044442
Wrong product administered 21.48 16.79 8 443635 6133 63039246
Bradyphrenia 21.39 16.79 11 443632 6969 63038410
Hepatic enzyme abnormal 21.36 16.79 95 443548 6297 63039082
Insurance issue 21.36 16.79 8 443635 6113 63039266
Skin irritation 21.22 16.79 22 443621 9719 63035660
Live birth 21.19 16.79 273 443370 25357 63020022
Blood potassium increased 21.03 16.79 62 443581 18247 63027132
Drug eruption 21.00 16.79 299 443344 28395 63016984
Neck mass 20.89 16.79 64 443579 3539 63041840
Cardiac tamponade 20.88 16.79 4 443639 4771 63040608
Cardiac failure chronic 20.88 16.79 3 443640 4415 63040964
Dislocation of vertebra 20.82 16.79 117 443526 8518 63036861
Neutrophilia 20.80 16.79 3 443640 4403 63040976
Skin discolouration 20.65 16.79 167 443476 37661 63007718
Dizziness postural 20.64 16.79 13 443630 7363 63038016
Product prescribing issue 20.62 16.79 53 443590 2646 63042733
Musculoskeletal discomfort 20.58 16.79 204 443439 17763 63027616
Escherichia infection 20.49 16.79 36 443607 12718 63032661
Diabetic eye disease 20.47 16.79 13 443630 141 63045238
Bursitis infective 20.46 16.79 35 443608 1308 63044071
Cytomegalovirus viraemia 20.37 16.79 7 443636 5642 63039737
Anal incontinence 20.33 16.79 40 443603 13536 63031843
Skin plaque 20.24 16.79 17 443626 8303 63037076
Systemic inflammatory response syndrome 20.21 16.79 7 443636 5614 63039765
Product physical issue 20.10 16.79 5 443638 4975 63040404
Retinal haemorrhage 20.03 16.79 5 443638 4964 63040415
Nerve block 20.02 16.79 26 443617 756 63044623
Mood altered 19.94 16.79 46 443597 14697 63030682
Taste disorder 19.82 16.79 41 443602 13621 63031758
C-reactive protein 19.80 16.79 77 443566 4805 63040574
Spinal compression fracture 19.77 16.79 44 443599 14239 63031140
Mean cell haemoglobin concentration abnormal 19.71 16.79 12 443631 120 63045259
Vasculitic rash 19.69 16.79 35 443608 1349 63044030
Haemorrhagic stroke 19.51 16.79 8 443635 5784 63039595
Mass 19.49 16.79 43 443600 13957 63031422
Decubitus ulcer 19.47 16.79 27 443616 10493 63034886
Incoherent 19.38 16.79 4 443639 4526 63040853
Limb operation 19.23 16.79 67 443576 3964 63041415
Hyperlipidaemia 19.22 16.79 71 443572 19500 63025879
Spinal cord compression 19.18 16.79 3 443640 4145 63041234
Hepatic lesion 19.17 16.79 5 443638 4820 63040559
Maternal exposure before pregnancy 19.16 16.79 15 443628 7588 63037791
Enterococcal infection 19.13 16.79 16 443627 7832 63037547
Papule 18.94 16.79 8 443635 5683 63039696
Blood phosphorus decreased 18.91 16.79 4 443639 4449 63040930
Walking aid user 18.86 16.79 134 443509 10583 63034796
Allergic oedema 18.86 16.79 26 443617 802 63044577
Viral upper respiratory tract infection 18.85 16.79 105 443538 7619 63037760
Head discomfort 18.84 16.79 41 443602 13374 63032005
Gastric ulcer 18.83 16.79 95 443548 23942 63021437
Lung disorder 18.80 16.79 569 443074 61692 62983687
Hyperuricaemia 18.77 16.79 7 443636 5363 63040016
Aortic stenosis 18.48 16.79 6 443637 5014 63040365
Spinal osteoarthritis 18.45 16.79 55 443588 16131 63029248
Cytopenia 18.41 16.79 33 443610 11568 63033811
Affective disorder 18.37 16.79 10 443633 6136 63039243
Tooth extraction 18.35 16.79 27 443616 10237 63035142
Palindromic rheumatism 18.18 16.79 14 443629 211 63045168
Hypogammaglobulinaemia 18.18 16.79 14 443629 7141 63038238
Dysphoria 18.17 16.79 6 443637 4960 63040419
Hypertensive crisis 18.12 16.79 51 443592 15235 63030144
Dyslipidaemia 18.11 16.79 15 443628 7378 63038001
Intestinal sepsis 18.07 16.79 16 443627 296 63045083
Injection site discomfort 18.02 16.79 5 443638 4625 63040754
Obliterative bronchiolitis 17.97 16.79 43 443600 2052 63043327
Hypercholesterolaemia 17.96 16.79 228 443415 21106 63024273
Metastatic neoplasm 17.95 16.79 4 443639 4291 63041088
Myositis 17.95 16.79 23 443620 9243 63036136
Rash macular 17.93 16.79 93 443550 23271 63022108
Lymphadenopathy 17.83 16.79 177 443466 38281 63007098
Supraventricular extrasystoles 17.78 16.79 5 443638 4584 63040795
Carpal tunnel syndrome 17.75 16.79 223 443420 20594 63024785
Euphoric mood 17.72 16.79 6 443637 4881 63040498
Dental caries 17.71 16.79 30 443613 10749 63034630
Uterine leiomyoma 17.64 16.79 23 443620 9175 63036204
Transplant dysfunction 17.63 16.79 6 443637 4866 63040513
Apnoea 17.61 16.79 18 443625 8004 63037375
Extrasystoles 17.58 16.79 7 443636 5153 63040226
Overwork 17.58 16.79 9 443634 62 63045317
Hip fracture 17.56 16.79 127 443516 29347 63016032
Procedural complication 17.54 16.79 8 443635 5431 63039948
Pneumocystis jirovecii pneumonia 17.52 16.79 60 443583 16854 63028525
Latent tuberculosis 17.47 16.79 49 443594 2578 63042801
Foot fracture 17.42 16.79 249 443394 23665 63021714
Polyarthritis 17.36 16.79 126 443517 10020 63035359
Iron deficiency 17.31 16.79 15 443628 7215 63038164
Musculoskeletal chest pain 17.28 16.79 82 443561 21001 63024378
Overlap syndrome 17.28 16.79 26 443617 870 63044509
Blood pressure diastolic increased 17.25 16.79 27 443616 9983 63035396
Laryngeal pain 17.24 16.79 5 443638 4493 63040886
Panic reaction 17.22 16.79 4 443639 4170 63041209
Skin abrasion 17.21 16.79 24 443619 9305 63036074
Compression fracture 17.18 16.79 12 443631 6436 63038943
Pseudopolyp 17.14 16.79 15 443628 273 63045106
Dysaesthesia 17.12 16.79 5 443638 4473 63040906
Salt craving 17.11 16.79 11 443632 122 63045257
Dermatitis exfoliative generalised 17.06 16.79 3 443640 3804 63041575
Jaw disorder 17.05 16.79 8 443635 5341 63040038
Hot flush 17.03 16.79 253 443390 50906 62994473

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
Drug ineffective 3523.45 20.11 4294 62265 452457 34437915
Joint swelling 1500.95 20.11 1094 65465 58796 34831576
Therapeutic product effect incomplete 1320.06 20.11 947 65612 49594 34840778
Arthralgia 1303.87 20.11 1607 64952 168434 34721938
Musculoskeletal stiffness 1126.35 20.11 834 65725 45846 34844526
Condition aggravated 1106.72 20.11 1579 64980 190617 34699755
Product dose omission in error 1074.92 20.11 323 66236 1951 34888421
Pain 1030.72 20.11 1579 64980 203096 34687276
Rheumatoid arthritis 890.32 20.11 669 65890 37569 34852803
Therapeutic product effect decreased 756.10 20.11 584 65975 34159 34856213
Drug intolerance 688.16 20.11 699 65860 58871 34831501
Product dose omission issue 684.49 20.11 982 65577 118729 34771643
Treatment failure 642.21 20.11 603 65956 46094 34844278
Synovitis 592.64 20.11 356 66203 13710 34876662
Discouragement 539.76 20.11 128 66431 239 34890133
Contraindicated product administered 524.50 20.11 387 66172 21094 34869278
Arthropathy 484.52 20.11 405 66154 26502 34863870
Peripheral swelling 444.20 20.11 633 65926 75908 34814464
Herpes zoster 401.06 20.11 406 66153 33993 34856379
Acute kidney injury 388.85 20.11 59 66500 304929 34585443
Drug hypersensitivity 373.44 20.11 600 65959 79929 34810443
Frequent bowel movements 373.42 20.11 257 66302 12530 34877842
Loss of personal independence in daily activities 358.58 20.11 376 66183 32803 34857569
Pain in extremity 358.48 20.11 762 65797 125751 34764621
Toxicity to various agents 339.82 20.11 9 66550 200353 34690019
C-reactive protein abnormal 337.45 20.11 209 66350 8501 34881871
Sensitivity to weather change 325.75 20.11 121 66438 1505 34888867
Hypotension 311.24 20.11 31 66528 221618 34668754
Red blood cell sedimentation rate abnormal 295.80 20.11 142 66417 3447 34886925
Bone erosion 289.48 20.11 145 66414 3870 34886502
COVID-19 270.80 20.11 510 66049 77040 34813332
Illness 269.35 20.11 216 66343 13313 34877059
Drug interaction 265.21 20.11 54 66505 225892 34664480
Red blood cell sedimentation rate increased 253.09 20.11 178 66381 8984 34881388
Joint range of motion decreased 244.75 20.11 160 66399 7152 34883220
Febrile neutropenia 244.67 20.11 3 66556 136846 34753526
Arthritis 242.92 20.11 299 66260 31047 34859325
Swelling 241.94 20.11 348 66211 42018 34848354
Joint stiffness 238.88 20.11 184 66375 10689 34879683
Drug effective for unapproved indication 217.62 20.11 104 66455 2498 34887874
Haematochezia 214.45 20.11 346 66213 46188 34844184
Abdominal discomfort 213.14 20.11 397 66162 59438 34830934
Neutropenia 204.80 20.11 28 66531 156750 34733622
Vomiting 193.77 20.11 116 66443 247505 34642867
Thrombocytopenia 190.27 20.11 34 66525 156213 34734159
Mobility decreased 186.07 20.11 257 66302 29871 34860501
Rheumatoid factor negative 184.12 20.11 68 66491 831 34889541
Disability 183.68 20.11 114 66445 4651 34885721
Therapeutic response unexpected 179.92 20.11 149 66410 9608 34880764
Gastric disorder 169.46 20.11 160 66399 12281 34878091
Completed suicide 167.79 20.11 4 66555 98164 34792208
Anaemia 161.53 20.11 125 66434 233210 34657162
Headache 161.45 20.11 782 65777 199853 34690519
Blood cholesterol increased 155.96 20.11 194 66365 20349 34870023
C-reactive protein increased 152.97 20.11 326 66233 53772 34836600
Dehydration 150.36 20.11 32 66527 129937 34760435
Memory impairment 149.93 20.11 284 66275 43034 34847338
Inflammation 147.86 20.11 223 66336 28072 34862300
Confusional state 146.71 20.11 46 66513 144114 34746258
Intentional dose omission 143.23 20.11 87 66472 3413 34886959
Death 141.88 20.11 346 66213 397703 34492669
Onychoclasis 141.04 20.11 70 66489 1830 34888542
Nasopharyngitis 138.53 20.11 367 66192 69601 34820771
Hand deformity 138.24 20.11 87 66472 3638 34886734
Joint lock 134.90 20.11 60 66499 1215 34889157
Off label use 133.34 20.11 1299 65260 418225 34472147
Chondropathy 130.14 20.11 54 66505 916 34889456
Pyrexia 129.47 20.11 276 66283 332737 34557635
Acne 125.90 20.11 129 66430 10937 34879435
Osteoarthritis 122.82 20.11 173 66386 20469 34869903
Knee arthroplasty 121.52 20.11 106 66453 7338 34883034
Seizure 120.88 20.11 26 66533 104831 34785541
Disease progression 120.19 20.11 29 66530 108048 34782324
Liver function test increased 119.39 20.11 143 66416 14422 34875950
Therapy interrupted 118.10 20.11 138 66421 13559 34876813
Hyperkalaemia 117.89 20.11 3 66556 69386 34820986
Drug tolerance decreased 115.78 20.11 62 66497 1905 34888467
Rhabdomyolysis 115.60 20.11 3 66556 68160 34822212
Bradycardia 112.64 20.11 8 66551 75410 34814962
Cardiac arrest 110.51 20.11 24 66535 96135 34794237
Lymphoma 109.48 20.11 127 66432 12380 34877992
Acne cystic 109.41 20.11 40 66519 474 34889898
General physical health deterioration 109.01 20.11 54 66505 128215 34762157
Syncope 108.88 20.11 21 66538 91430 34798942
Tachycardia 108.59 20.11 16 66543 84756 34805616
Bowel movement irregularity 108.55 20.11 69 66490 2936 34887436
Multiple organ dysfunction syndrome 106.49 20.11 11 66548 76555 34813817
Respiratory failure 104.57 20.11 38 66521 108534 34781838
Apparent death 101.09 20.11 71 66488 3573 34886799
Hip arthroplasty 101.00 20.11 77 66482 4402 34885970
Atlantoaxial instability 100.85 20.11 34 66525 311 34890061
Platelet count decreased 99.33 20.11 52 66507 119665 34770707
Physical disability 99.30 20.11 50 66509 1349 34889023
Spinal instability 98.97 20.11 34 66525 331 34890041
Musculoskeletal pain 98.96 20.11 200 66359 31763 34858609
Mycobacterium tuberculosis complex test positive 98.65 20.11 49 66510 1283 34889089
Mineral metabolism disorder 98.34 20.11 34 66525 338 34890034
Impaired work ability 97.96 20.11 91 66468 6839 34883533
Dislocation of vertebra 96.71 20.11 35 66524 402 34889970
Dyspnoea 96.15 20.11 381 66178 376401 34513971
Pancytopenia 95.62 20.11 31 66528 95126 34795246
Agitation 95.59 20.11 3 66556 57396 34832976
Decreased appetite 94 20.11 107 66452 166285 34724087
Anti-cyclic citrullinated peptide antibody positive 91.71 20.11 52 66507 1791 34888581
Cardio-respiratory arrest 91.65 20.11 3 66556 55270 34835102
Diverticulitis 91.06 20.11 148 66411 19856 34870516
Tooth loss 90.70 20.11 68 66491 3790 34886582
Limb discomfort 88.15 20.11 107 66452 10940 34879432
Tuberculin test positive 86.64 20.11 43 66516 1124 34889248
Alopecia 85.87 20.11 161 66398 24194 34866178
Terminal state 85.13 20.11 66 66493 3868 34886504
Hypokalaemia 84.59 20.11 7 66552 58207 34832165
Overdose 84.14 20.11 34 66525 91025 34799347
Ill-defined disorder 81.89 20.11 116 66443 13793 34876579
Gastrointestinal haemorrhage 81.80 20.11 33 66526 88444 34801928
Sleep disorder due to general medical condition, insomnia type 81.75 20.11 43 66516 1273 34889099
Hypoglycaemia 80.99 20.11 6 66553 54634 34835738
Rheumatoid factor positive 80.58 20.11 35 66524 668 34889704
Pulmonary thrombosis 78.25 20.11 83 66476 7324 34883048
Cytology abnormal 77.25 20.11 29 66530 372 34890000
Neoplasm malignant 77.02 20.11 137 66422 19768 34870604
Product use issue 76.11 20.11 279 66280 62937 34827435
Intestinal sepsis 75.59 20.11 33 66526 638 34889734
Hallucination 75.36 20.11 6 66553 51492 34838880
Depressed mood 74.81 20.11 133 66426 19184 34871188
Septic shock 74.67 20.11 22 66537 71812 34818560
Neutrophil count decreased 74.65 20.11 6 66553 51098 34839274
Blood creatinine increased 73.38 20.11 45 66514 94931 34795441
Loss of consciousness 72.96 20.11 33 66526 82634 34807738
Polyarthritis 72.79 20.11 64 66495 4476 34885896
Ascites 72.33 20.11 4 66555 46567 34843805
Hypoxia 71.47 20.11 10 66549 55085 34835287
Infection 71.17 20.11 352 66207 90563 34799809
Fall 70.71 20.11 178 66381 202707 34687665
Sarcoidosis 70.34 20.11 52 66507 2836 34887536
Haematuria 70.11 20.11 7 66552 50059 34840313
Joint arthroplasty 69.63 20.11 34 66525 857 34889515
Depressed level of consciousness 68.71 20.11 3 66556 42838 34847534
Blood pressure decreased 67.65 20.11 9 66550 51506 34838866
Delirium 67.64 20.11 4 66555 43987 34846385
Seronegative arthritis 67.55 20.11 35 66524 1004 34889368
Mass 67.06 20.11 79 66480 7826 34882546
Asthenia 65.62 20.11 243 66316 245008 34645364
Steroid dependence 65.41 20.11 39 66520 1478 34888894
Colitis ulcerative 64.30 20.11 114 66445 16406 34873966
Intervertebral disc space narrowing 64.20 20.11 34 66525 1021 34889351
Plasma cell myeloma 64.10 20.11 4 66555 42033 34848339
Lipids increased 64.05 20.11 34 66525 1026 34889346
Joint noise 62.54 20.11 29 66530 649 34889723
Cardiac failure congestive 62.20 20.11 41 66518 83229 34807143
Somnolence 61.03 20.11 73 66486 111043 34779329
Atrial fibrillation 60.48 20.11 87 66472 122306 34768066
Photosensitivity reaction 60.37 20.11 87 66472 10507 34879865
Osteosclerosis 59.60 20.11 35 66524 1289 34889083
Infusion related reaction 59.41 20.11 14 66545 53043 34837329
Gastrointestinal disorder 58.15 20.11 169 66390 33779 34856593
Coma 57.60 20.11 9 66550 45669 34844703
Dizziness 57.46 20.11 218 66341 218303 34672069
Defaecation urgency 57.26 20.11 44 66515 2545 34887827
Oxygen saturation decreased 56.82 20.11 16 66543 53802 34836570
Hyperglycaemia 56.66 20.11 5 66554 39475 34850897
Pneumonia aspiration 55.79 20.11 7 66552 41896 34848476
Angioedema 55.68 20.11 4 66555 37370 34853002
Rhinorrhoea 54.18 20.11 138 66421 25530 34864842
Oral surgery 53.73 20.11 25 66534 564 34889808
Nipple swelling 53.51 20.11 21 66538 306 34890066
Skin laceration 53.50 20.11 90 66469 12419 34877953
Hepatic enzyme increased 51.74 20.11 178 66381 38902 34851470
Sinusitis 51.73 20.11 185 66374 41217 34849155
Mental status changes 51.59 20.11 6 66553 38077 34852295
Tooth fracture 51.33 20.11 48 66511 3637 34886735
Dysphagia 50.38 20.11 28 66531 62353 34828019
Sepsis 49.95 20.11 157 66402 166404 34723968
Coronary artery disease 49.82 20.11 15 66544 48290 34842082
Cardiac failure 48.99 20.11 61 66498 91187 34799185
Psoriasis 48.98 20.11 174 66385 38638 34851734
Tenderness 48.67 20.11 63 66496 6871 34883501
Aspartate aminotransferase increased 48.46 20.11 35 66524 67748 34822624
Dysarthria 48.34 20.11 5 66554 34777 34855595
Nasal congestion 47.67 20.11 123 66436 22934 34867438
Drug ineffective for unapproved indication 47.48 20.11 125 66434 23590 34866782
Fear of injection 47.19 20.11 32 66527 1520 34888852
Pre-existing condition improved 46.56 20.11 39 66520 2553 34887819
Pleural effusion 46.46 20.11 52 66507 81494 34808878
Skin mass 46.31 20.11 47 66512 3938 34886434
Hypoacusis 45.75 20.11 98 66461 16203 34874169
Rheumatoid factor increased 45.36 20.11 22 66537 546 34889826
Prerenal failure 45.17 20.11 35 66524 2049 34888323
Respiratory distress 45.03 20.11 7 66552 35658 34854714
Knee operation 44.98 20.11 35 66524 2062 34888310
Lymph node calcification 43.94 20.11 15 66544 143 34890229
Rectal haemorrhage 43.76 20.11 172 66387 40077 34850295
Mucosal inflammation 43.62 20.11 10 66549 38612 34851760
Hair growth abnormal 43.26 20.11 24 66535 792 34889580
Pneumonia 43.23 20.11 462 66097 362165 34528207
Epistaxis 43.06 20.11 29 66530 58222 34832150
Fine motor skill dysfunction 42.89 20.11 32 66527 1770 34888602
Melaena 42.35 20.11 8 66551 35372 34855000
Spinal operation 42.27 20.11 39 66520 2905 34887467
Feeling abnormal 41.99 20.11 234 66325 63001 34827371
Nodule 41.81 20.11 58 66501 6761 34883611
Blood glucose increased 40.87 20.11 40 66519 66678 34823694
Jaundice 40.84 20.11 6 66553 31876 34858496
Upper respiratory tract infection 40.68 20.11 147 66412 32912 34857460
Therapeutic product effect delayed 40.03 20.11 27 66532 1271 34889101
Cerebral haemorrhage 39.54 20.11 9 66550 34928 34855444
Joint effusion 39.33 20.11 49 66510 5144 34885228
Cardiogenic shock 39.22 20.11 3 66556 26615 34863757
Ventricular tachycardia 39.15 20.11 3 66556 26576 34863796
Suicidal ideation 39.08 20.11 14 66545 40374 34849998
Hepatic function abnormal 38.67 20.11 18 66541 44345 34846027
Dyspnoea exertional 38.60 20.11 17 66542 43262 34847110
Neck pain 37.60 20.11 120 66439 25229 34865143
Blood alkaline phosphatase increased 37.42 20.11 7 66552 31168 34859204
Bone cyst 37.16 20.11 28 66531 1572 34888800
Hepatic failure 36.94 20.11 10 66549 34521 34855851
Disorientation 36.67 20.11 9 66550 33179 34857193
Grip strength decreased 36.14 20.11 37 66522 3132 34887240
Joint ankylosis 35.38 20.11 27 66532 1545 34888827
Intentional product misuse 35.22 20.11 176 66383 45435 34844937
Renal impairment 35.18 20.11 80 66479 94433 34795939
Upper gastrointestinal haemorrhage 34.61 20.11 4 66555 25514 34864858
Renal failure 34.42 20.11 130 66429 130427 34759945
Agranulocytosis 34.22 20.11 3 66556 23818 34866554
Bone marrow failure 34.20 20.11 7 66552 29246 34861126
Musculoskeletal disorder 33.97 20.11 50 66509 6154 34884218
Eosinophilia 33.44 20.11 5 66554 26217 34864155
Psoriatic arthropathy 33.35 20.11 98 66461 19700 34870672
Fibromyalgia 33.21 20.11 35 66524 3065 34887307
Influenza 33.10 20.11 184 66375 49482 34840890
Intestinal polyp 33.07 20.11 22 66537 1012 34889360
Urinary retention 32.77 20.11 14 66545 36274 34854098
Nipple pain 32.57 20.11 21 66538 916 34889456
Chills 32.31 20.11 66 66493 80977 34809395
Restlessness 32.17 20.11 5 66554 25477 34864895
Blood urea increased 32.09 20.11 9 66550 30355 34860017
Malaise 31.96 20.11 514 66045 185311 34705061
Metabolic acidosis 31.94 20.11 22 66537 43658 34846714
Finger deformity 31.91 20.11 25 66534 1488 34888884
Pulmonary fibrosis 31.89 20.11 92 66467 18304 34872068
Flushing 31.78 20.11 11 66548 32409 34857963
Dyskinesia 31.72 20.11 3 66556 22410 34867962
Colectomy 31.47 20.11 27 66532 1827 34888545
Dyspepsia 31.44 20.11 146 66413 36586 34853786
Hepatocellular injury 31.36 20.11 3 66556 22208 34868164
Alanine aminotransferase increased 31.22 20.11 67 66492 80748 34809624
Abnormal faeces 31.18 20.11 35 66524 3290 34887082
Drug level increased 31.16 20.11 3 66556 22093 34868279
Immune system disorder 30.61 20.11 43 66516 5072 34885300
Localised infection 30.54 20.11 88 66471 17499 34872873
Mucous stools 30.39 20.11 26 66533 1752 34888620
Adverse reaction 30.32 20.11 33 66526 2998 34887374
Gamma-glutamyltransferase increased 30.28 20.11 9 66550 29222 34861150
Therapy non-responder 30.19 20.11 151 66408 38995 34851377
Stress 30.05 20.11 126 66433 30221 34860151
Anaphylactic reaction 29.91 20.11 12 66547 32289 34858083
Oedema peripheral 29.85 20.11 122 66437 119690 34770682
Acute myocardial infarction 29.78 20.11 35 66524 53684 34836688
Therapy cessation 29.54 20.11 85 66474 16888 34873484
Drug effect less than expected 29.45 20.11 22 66537 1219 34889153
Impaired quality of life 29.16 20.11 45 66514 5773 34884599
Heart rate decreased 29.06 20.11 12 66547 31733 34858639
Injection site pain 28.05 20.11 20 66539 38985 34851387
Haemoptysis 27.84 20.11 16 66543 34990 34855382
Pneumonitis 27.64 20.11 15 66544 33863 34856509
Arrhythmia 27.59 20.11 17 66542 35791 34854581
Aphasia 27.57 20.11 4 66555 21450 34868922
Oral disorder 27.35 20.11 37 66522 4212 34886160
Hernia 27.33 20.11 58 66501 9525 34880847
Loss of therapeutic response 27.03 20.11 16 66543 598 34889774
Skin ulcer 26.66 20.11 98 66461 22118 34868254
Trigger finger 26.51 20.11 18 66541 857 34889515
Arthritis bacterial 26.31 20.11 40 66519 5066 34885306
Intentional overdose 25.81 20.11 27 66532 43647 34846725
Blood bilirubin increased 25.80 20.11 21 66538 38275 34852097
Subdural haematoma 25.79 20.11 4 66555 20417 34869955
Hepatic enzyme abnormal 25.74 20.11 29 66530 2737 34887635
Tooth extraction 25.73 20.11 38 66521 4690 34885682
Rheumatoid lung 25.31 20.11 18 66541 924 34889448
Pancreatitis acute 25.18 20.11 11 66548 28130 34862242
Thrombosis 24.87 20.11 173 66386 50285 34840087
Heart rate increased 24.84 20.11 31 66528 46312 34844060
Urinary tract infection 24.64 20.11 80 66479 84001 34806371
Alanine aminotransferase abnormal 24.54 20.11 37 66522 4651 34885721
Hypothyroidism 24.44 20.11 5 66554 20897 34869475
Nausea 24.26 20.11 479 66080 339429 34550943
Myelosuppression 23.83 20.11 4 66555 19261 34871111
Hypophagia 23.80 20.11 8 66551 24014 34866358
Rheumatoid factor 23.65 20.11 8 66551 74 34890298
Physical deconditioning 23.49 20.11 20 66539 1339 34889033
Urinary incontinence 23.16 20.11 4 66555 18870 34871502
Oedema 23.08 20.11 32 66527 45709 34844663
Fatigue 22.93 20.11 892 65667 369761 34520611
Haematoma 22.92 20.11 10 66549 25595 34864777
Abdominal pain upper 22.77 20.11 222 66337 71268 34819104
Constipation 22.71 20.11 160 66399 136822 34753550
Chronic kidney disease 22.68 20.11 27 66532 41183 34849189
White blood cell count decreased 22.65 20.11 99 66460 95346 34795026
Cerebral infarction 22.63 20.11 12 66547 27443 34862929
Coagulopathy 22.59 20.11 5 66554 19784 34870588
Skin injury 22.53 20.11 25 66534 2320 34888052
Nodal osteoarthritis 22.52 20.11 9 66550 138 34890234
Back pain 22.48 20.11 341 66218 121448 34768924
Tumour lysis syndrome 22.34 20.11 3 66556 17056 34873316
Cutaneous symptom 22.25 20.11 11 66548 285 34890087
Intentional product use issue 22.21 20.11 192 66367 59624 34830748
Hospitalisation 22.12 20.11 47 66512 56855 34833517
Disseminated intravascular coagulation 22.08 20.11 7 66552 21809 34868563
Musculoskeletal discomfort 22.06 20.11 48 66511 8020 34882352
Acute respiratory failure 22.05 20.11 16 66543 30912 34859460
Interstitial lung disease 21.91 20.11 205 66354 65077 34825295
Full blood count decreased 21.84 20.11 4 66555 18084 34872288
Diabetic ketoacidosis 21.74 20.11 4 66555 18028 34872344
Angina pectoris 21.37 20.11 17 66542 31346 34859026
Immune recovery uveitis 21.07 20.11 6 66553 29 34890343
Blood creatine phosphokinase increased 21.05 20.11 33 66526 44824 34845548
Faecal calprotectin increased 20.88 20.11 25 66534 2519 34887853
Hepatic fibrosis 20.84 20.11 34 66525 4573 34885799
Ankle operation 20.81 20.11 10 66549 243 34890129
Dry eye 20.74 20.11 52 66507 9523 34880849
Pulmonary hypertension 20.68 20.11 7 66552 20917 34869455
Feeding disorder 20.66 20.11 43 66516 6967 34883405
Blood lactate dehydrogenase increased 20.55 20.11 9 66550 22981 34867391
Sinus disorder 20.34 20.11 43 66516 7042 34883330
Carbon dioxide abnormal 20.29 20.11 9 66550 181 34890191

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 ineffective 8728.44 16.91 17805 390330 1063108 78273145
Condition aggravated 4236.21 16.91 8453 399682 492671 78843582
Joint swelling 3793.73 16.91 5916 402219 282730 79053523
Pain 3765.61 16.91 9905 398230 693897 78642356
Arthralgia 3547.65 16.91 8518 399617 563285 78772968
Product dose omission in error 3185.05 16.91 1275 406860 6513 79329740
Drug intolerance 2961.13 16.91 5040 403095 259079 79077174
Therapeutic product effect incomplete 2909.28 16.91 3603 404532 138042 79198211
Synovitis 2898.64 16.91 3710 404425 147024 79189229
Product dose omission issue 2506.53 16.91 4518 403617 243019 79093234
Musculoskeletal stiffness 2421.06 16.91 3677 404458 171331 79164922
Contraindicated product administered 2277.19 16.91 3379 404756 154159 79182094
Discouragement 2273.76 16.91 671 407464 979 79335274
Treatment failure 2150.02 16.91 3433 404702 167053 79169200
Arthropathy 2126.87 16.91 3488 404647 173623 79162630
Acute kidney injury 2025.76 16.91 171 407964 519233 78817020
Therapeutic product effect decreased 1972.49 16.91 3231 404904 160632 79175621
Abdominal discomfort 1658.07 16.91 3838 404297 246889 79089364
Toxicity to various agents 1599.23 16.91 155 407980 421385 78914868
Hypotension 1522.13 16.91 222 407913 440095 78896158
Swelling 1519.76 16.91 3396 404739 213315 79122938
Peripheral swelling 1513.62 16.91 3875 404260 265742 79070511
Hand deformity 1444.69 16.91 2190 405945 101729 79234524
Blood cholesterol increased 1440.79 16.91 1953 406182 81767 79254486
Illness 1354.02 16.91 1419 406716 45092 79291161
Sensitivity to weather change 1330.50 16.91 702 407433 7345 79328908
Drug interaction 1275.56 16.91 283 407852 414900 78921353
Alopecia 1259.60 16.91 3288 404847 228067 79108186
Completed suicide 1221.70 16.91 6 408129 245761 79090492
Hepatic enzyme increased 1167.40 16.91 2760 405375 179850 79156403
COVID-19 1159.00 16.91 2519 405616 155155 79181098
Rheumatoid arthritis 1140.92 16.91 2969 405166 205501 79130752
Loss of personal independence in daily activities 1121.79 16.91 1939 406196 100641 79235612
Anti-cyclic citrullinated peptide antibody positive 1112.79 16.91 1722 406413 81421 79254832
Pemphigus 1100.31 16.91 1891 406244 97691 79238562
Systemic lupus erythematosus 1093.10 16.91 2107 406028 119042 79217211
Febrile neutropenia 1090.60 16.91 18 408117 230981 79105272
Pain in extremity 1090.30 16.91 4212 403923 360326 78975927
Glossodynia 1052.03 16.91 1893 406242 101444 79234809
Nasopharyngitis 1051.14 16.91 3269 404866 250612 79085641
Herpes zoster 1031.53 16.91 1770 406365 91313 79244940
C-reactive protein abnormal 961.87 16.91 1212 406923 47155 79289098
Neutropenia 928.98 16.91 174 407961 287536 79048717
Anaemia 898.23 16.91 587 407548 444428 78891825
Infection 895.79 16.91 2997 405138 238715 79097538
Rheumatoid factor positive 860.93 16.91 1282 406853 58557 79277696
Death 824.50 16.91 1014 407121 565500 78770753
Drug abuse 797.90 16.91 6 408129 162685 79173568
Hyponatraemia 785.71 16.91 28 408107 177820 79158433
Pericarditis 777.66 16.91 1676 406459 102560 79233693
Sinusitis 748.05 16.91 2451 405684 193050 79143203
Wound 735.32 16.91 1750 406385 114429 79221824
Inflammation 731.17 16.91 1535 406600 92218 79244035
Therapy interrupted 721.73 16.91 846 407289 30495 79305758
Dehydration 716.88 16.91 192 407943 247995 79088258
Helicobacter infection 701.62 16.91 1271 406864 68433 79267820
Thrombocytopenia 701.53 16.91 241 407894 265018 79071235
Arthritis 700.81 16.91 1706 406429 113174 79223079
Red blood cell sedimentation rate increased 677.67 16.91 996 407139 44946 79291307
Discomfort 676.16 16.91 1779 406356 123838 79212415
Malignant neoplasm progression 662.07 16.91 6 408129 135984 79200269
Cardiac arrest 660.43 16.91 60 408075 172036 79164217
Headache 655.13 16.91 5636 402499 648136 78688117
Duodenal ulcer perforation 647.03 16.91 1192 406943 65019 79271234
Drug hypersensitivity 627.17 16.91 3107 405028 295809 79040444
Therapeutic response unexpected 624.45 16.91 633 407502 19313 79316940
Joint stiffness 623.74 16.91 900 407235 39930 79296323
Hypersensitivity 617.84 16.91 2819 405316 259420 79076833
Pancytopenia 601.91 16.91 71 408064 165674 79170579
Seizure 601.20 16.91 118 408017 188716 79147537
Respiratory failure 576.04 16.91 113 408022 180798 79155455
Tachycardia 574.59 16.91 107 408028 177661 79158592
Bradycardia 560.82 16.91 33 408102 135524 79200729
Dyspnoea 559.88 16.91 2374 405761 854651 78481602
Red blood cell sedimentation rate abnormal 550.79 16.91 606 407529 20357 79315896
Product use issue 549.06 16.91 2328 405807 207494 79128759
Mobility decreased 533.49 16.91 1604 406531 120571 79215682
Hyperkalaemia 531.18 16.91 11 408124 114387 79221866
Cardio-respiratory arrest 527.18 16.91 5 408130 108505 79227748
Vomiting 517.31 16.91 1717 406418 664111 78672142
Sepsis 509.10 16.91 381 407754 269047 79067206
Disease progression 507.56 16.91 156 407979 184206 79152047
Platelet count decreased 507.41 16.91 181 407954 194483 79141770
Overdose 505.10 16.91 157 407978 184049 79152204
Intentional dose omission 502.87 16.91 393 407742 8424 79327829
Intentional overdose 481.15 16.91 13 408122 105947 79230306
Drug effective for unapproved indication 474.90 16.91 326 407809 5675 79330578
Rhabdomyolysis 470.75 16.91 12 408123 103119 79233134
Gastrointestinal haemorrhage 468.69 16.91 93 408042 147626 79188627
Multiple organ dysfunction syndrome 466.49 16.91 40 408095 120206 79216047
Depressed level of consciousness 445.94 16.91 10 408125 96642 79239611
Osteoarthritis 431.98 16.91 1199 406936 86110 79250143
Syncope 426.56 16.91 192 407943 179257 79156996
Fibromyalgia 425.17 16.91 986 407149 63354 79272899
Hypokalaemia 422.25 16.91 108 408027 143932 79192321
Irritable bowel syndrome 420.29 16.91 962 407173 61279 79274974
Knee arthroplasty 419.16 16.91 776 407359 42472 79293781
Cardiac failure 417.31 16.91 136 407999 154706 79181547
Renal failure 417.27 16.91 256 407879 200712 79135541
Joint range of motion decreased 414.10 16.91 667 407468 32615 79303638
Impaired healing 411.41 16.91 1181 406954 86474 79249779
Somnolence 409.23 16.91 372 407763 238609 79097644
Hypoglycaemia 407.55 16.91 29 408106 101565 79234688
Atrial fibrillation 405.42 16.91 256 407879 197630 79138623
Hypoxia 398.69 16.91 35 408100 103208 79233045
Bone erosion 396.36 16.91 473 407662 17374 79318879
Muscle injury 395.89 16.91 810 407325 47751 79288502
Oxygen saturation decreased 395.50 16.91 88 408047 128959 79207294
Sleep disorder due to general medical condition, insomnia type 394.19 16.91 759 407376 42797 79293456
Coma 391.73 16.91 33 408102 100616 79235637
International normalised ratio increased 389.95 16.91 9 408126 84712 79251541
Folliculitis 389.57 16.91 870 407265 54510 79281743
Tuberculin test positive 388.47 16.91 233 407902 3175 79333078
Memory impairment 381.35 16.91 1349 406786 110385 79225868
Agitation 379.17 16.91 36 408099 99679 79236574
Fatigue 377.25 16.91 6761 401374 922966 78413287
Metabolic acidosis 371.47 16.91 11 408124 82518 79253735
Rheumatoid nodule 365.81 16.91 449 407686 16989 79319264
Gastrointestinal disorder 363.99 16.91 1412 406723 120793 79215460
Rash 363.26 16.91 4536 403599 573822 78762431
Injection site pain 362.49 16.91 107 408028 129731 79206522
Neutrophil count decreased 357.06 16.91 34 408101 93925 79242328
Suicide attempt 356.20 16.91 16 408119 82916 79253337
Asthenia 348.33 16.91 1393 406742 510296 78825957
Pleural effusion 342.73 16.91 157 407978 145105 79191148
Hallucination 334.00 16.91 28 408107 85717 79250536
Hip arthroplasty 328.37 16.91 627 407508 35129 79301124
Lactic acidosis 325.67 16.91 7 408128 70352 79265901
Gastric disorder 320.15 16.91 637 407498 36796 79299457
Ascites 319.94 16.91 16 408119 75546 79260707
Pyrexia 318.61 16.91 2101 406034 676608 78659645
Oedema peripheral 318.57 16.91 499 407636 251789 79084464
Blister 314.81 16.91 1329 406806 118147 79218106
Blood pressure decreased 312.60 16.91 64 408071 99402 79236851
Cardiac failure congestive 311.75 16.91 170 407965 142232 79194021
Encephalopathy 306.97 16.91 8 408127 67389 79268864
Rheumatic fever 293.09 16.91 525 407610 28000 79308253
Drug reaction with eosinophilia and systemic symptoms 291.20 16.91 8 408127 64236 79272017
Tremor 288.40 16.91 267 407868 169816 79166437
Hyperglycaemia 288.20 16.91 18 408117 70317 79265936
Foot deformity 273.28 16.91 463 407672 23611 79312642
Acne 269.90 16.91 493 407642 26697 79309556
Haemoglobin decreased 269.43 16.91 451 407684 221668 79114585
C-reactive protein increased 268.45 16.91 1339 406796 127688 79208565
Mental status changes 260.42 16.91 22 408113 66937 79269316
Angioedema 258.30 16.91 40 408095 75995 79260258
Respiratory arrest 254.25 16.91 9 408126 57541 79278712
Grip strength decreased 250.11 16.91 422 407713 21447 79314806
Sedation 249.24 16.91 3 408132 51892 79284361
Infusion related reaction 249.04 16.91 2022 406113 228215 79108038
Dysarthria 247.81 16.91 28 408107 67594 79268659
Cholestasis 245.98 16.91 4 408131 52105 79284148
Unresponsive to stimuli 245.51 16.91 9 408126 55779 79280474
Upper respiratory tract infection 244.70 16.91 1020 407115 90148 79246105
Depressed mood 242.90 16.91 669 407466 47811 79288442
Septic shock 241.76 16.91 166 407969 122635 79213618
Decreased appetite 239.20 16.91 922 407213 341496 78994757
Malaise 237.63 16.91 3671 404464 486198 78850055
Pneumonia aspiration 237.37 16.91 31 408104 66936 79269317
Chest discomfort 237.22 16.91 214 407921 137830 79198423
Weight decreased 236.98 16.91 974 407161 354224 78982029
Hepatic function abnormal 236.12 16.91 44 408091 73063 79263190
Ill-defined disorder 233.02 16.91 805 407330 65070 79271183
Blood creatinine increased 232.83 16.91 270 407865 154787 79181466
Joint injury 232.49 16.91 503 407632 30832 79305421
Blood bilirubin increased 231.57 16.91 32 408103 66200 79270053
Respiratory distress 230.12 16.91 18 408117 58321 79277932
Frequent bowel movements 229.34 16.91 483 407652 29056 79307197
Musculoskeletal pain 227.07 16.91 1082 407053 101272 79234981
Hypomagnesaemia 224.01 16.91 3 408132 46908 79289345
Liver function test increased 223.74 16.91 573 407562 39200 79297053
Haematuria 223.24 16.91 41 408094 68795 79267458
Hepatic failure 222.67 16.91 26 408109 61186 79275067
Disorientation 220.26 16.91 30 408105 62746 79273507
Mycobacterium tuberculosis complex test positive 219.33 16.91 151 407984 2641 79333612
Swollen joint count increased 219.14 16.91 409 407726 22518 79313735
Coronary artery disease 218.90 16.91 36 408099 65438 79270815
Loss of consciousness 218.80 16.91 325 407810 167618 79168635
Hepatocellular injury 215.43 16.91 6 408129 47587 79288666
Orthostatic hypotension 211.59 16.91 21 408114 56143 79280110
Melaena 211.52 16.91 30 408105 60860 79275393
Plasma cell myeloma 211.30 16.91 16 408119 53243 79283010
Pallor 210.66 16.91 11 408124 50051 79286202
Agranulocytosis 210.31 16.91 4 408131 45026 79291227
Serotonin syndrome 210.30 16.91 4 408131 45023 79291230
Acute myocardial infarction 208.66 16.91 67 408068 76969 79259284
Neuropathy peripheral 207.92 16.91 250 407885 141055 79195198
Pulmonary oedema 207.17 16.91 96 408039 88158 79248095
Multiple sclerosis relapse 206.53 16.91 7 408128 46526 79289727
Nodule 205.94 16.91 399 407736 22595 79313658
Suicidal ideation 205.70 16.91 67 408068 76273 79259980
Dyspnoea exertional 205.51 16.91 94 408041 86979 79249274
Drug tolerance decreased 205.38 16.91 291 407844 12687 79323566
Cognitive disorder 203.77 16.91 53 408082 69873 79266380
Urinary retention 203.66 16.91 25 408110 56605 79279648
Jaundice 203.48 16.91 19 408116 53330 79282923
Dysphagia 202.00 16.91 196 407939 121940 79214313
Generalised tonic-clonic seizure 200.77 16.91 5 408130 43905 79292348
Acute respiratory failure 200.71 16.91 32 408103 59509 79276744
Eosinophilia 200.63 16.91 7 408128 45338 79290915
Aggression 200.22 16.91 16 408119 50942 79285311
Pneumonia 199.25 16.91 2291 405844 657955 78678298
Mucosal inflammation 199.00 16.91 69 408066 75511 79260742
White blood cell count decreased 196.06 16.91 419 407716 187869 79148384
Bone marrow failure 195.47 16.91 18 408117 51089 79285164
Psychotic disorder 192.07 16.91 4 408131 41398 79294855
Dizziness 191.56 16.91 1747 406388 524694 78811559
Maternal exposure during pregnancy 190.91 16.91 1275 406860 135263 79200990
Rhinorrhoea 190.90 16.91 834 407301 75240 79261013
Constipation 190.69 16.91 773 407362 282277 79053976
Osteonecrosis of jaw 190.12 16.91 7 408128 43219 79293034
Flushing 189.35 16.91 108 408027 88160 79248093
Heart rate decreased 187.20 16.91 63 408072 70253 79266000
Cardiogenic shock 187.11 16.91 6 408129 41908 79294345
Osteoporosis 185.95 16.91 655 407480 53457 79282796
Cerebral haemorrhage 185.63 16.91 35 408100 57638 79278615
Lethargy 182.36 16.91 94 408041 81198 79255055
Off label use 182.07 16.91 5994 402141 901221 78435032
Hypervolaemia 180.84 16.91 9 408126 42681 79293572
Ventricular tachycardia 180.36 16.91 8 408127 41927 79294326
Hypophagia 178.93 16.91 14 408121 45353 79290900
Shock 178.84 16.91 11 408124 43537 79292716
Stomatitis 178.61 16.91 1325 406810 145432 79190821
Neoplasm progression 178.27 16.91 26 408109 51656 79284597
Drug level increased 175.86 16.91 6 408129 39645 79296608
Blood parathyroid hormone decreased 175.30 16.91 242 407893 10294 79325959
Altered state of consciousness 174.31 16.91 13 408122 43809 79292444
Renal impairment 172.83 16.91 341 407794 157442 79178811
Influenza 171.50 16.91 1194 406941 128412 79207841
Upper gastrointestinal haemorrhage 171.31 16.91 10 408125 41370 79294883
Disability 170.65 16.91 311 407824 16809 79319444
Circulatory collapse 169.57 16.91 5 408130 37663 79298590
Blood urea increased 169.56 16.91 24 408111 48766 79287487
Pulmonary hypertension 168.62 16.91 23 408112 48057 79288196
Granuloma skin 168.32 16.91 221 407914 8953 79327300
Blood alkaline phosphatase increased 167.82 16.91 58 408077 63606 79272647
Haematoma 167.30 16.91 32 408103 52163 79284090
Adverse event 166.51 16.91 680 407455 59534 79276719
Sinus tachycardia 165.78 16.91 5 408130 36903 79299350
Abdominal pain 165.60 16.91 1240 406895 388329 78947924
Pancreatitis acute 164.21 16.91 28 408107 49576 79286677
Stevens-Johnson syndrome 163.57 16.91 9 408126 39157 79297096
Incorrect dose administered 162.61 16.91 95 408040 76535 79259718
Drug withdrawal syndrome 162.48 16.91 3 408132 34715 79301538
Epistaxis 161.18 16.91 200 407935 111315 79224938
Psoriatic arthropathy 161.12 16.91 808 407327 77191 79259062
Lower respiratory tract infection 160.27 16.91 1172 406963 128048 79208205
Panniculitis 159.45 16.91 252 407883 12119 79324134
Myocardial infarction 159.32 16.91 451 407684 183678 79152575
Arrhythmia 157.79 16.91 58 408077 61214 79275039
Pericardial effusion 157.77 16.91 24 408111 46213 79290040
Gamma-glutamyltransferase increased 154.52 16.91 44 408091 54636 79281617
Restlessness 154.44 16.91 26 408109 46466 79289787
Ejection fraction decreased 154.17 16.91 5 408130 34572 79301681
Chills 153.47 16.91 373 407762 159861 79176392
Abnormal behaviour 153.26 16.91 8 408127 36413 79299840
Balance disorder 151.78 16.91 169 407966 98688 79237565
Aphasia 151.17 16.91 28 408107 46704 79289549
Intentional self-injury 150.92 16.91 3 408132 32416 79303837
Pre-existing condition improved 149.90 16.91 163 407972 5400 79330853
Immune system disorder 149.58 16.91 230 407905 10799 79325454
Blood glucose increased 149.23 16.91 223 407912 114752 79221501
Ventricular fibrillation 148.44 16.91 3 408132 31923 79304330
Haemoptysis 145.92 16.91 52 408083 55947 79280306
Blood creatine phosphokinase increased 145.90 16.91 78 408057 66012 79270241
Wrong technique in product usage process 145.19 16.91 100 408035 73775 79262478
Impaired work ability 144.93 16.91 315 407820 19366 79316887
Chronic kidney disease 144.69 16.91 79 408056 66075 79270178
Therapeutic product effect delayed 144.61 16.91 122 408013 2924 79333329
Heart rate increased 144.57 16.91 247 407888 120477 79215776
Cerebral infarction 142.23 16.91 30 408105 45646 79290607
Rheumatoid factor negative 141.01 16.91 83 408052 1090 79335163
Dyskinesia 140.25 16.91 29 408106 44744 79291509
Adverse drug reaction 139.41 16.91 691 407444 65701 79270552
Acute hepatic failure 139.33 16.91 3 408132 30110 79306143
Obstructive airways disorder 138.68 16.91 5 408130 31454 79304799
Chest pain 138.56 16.91 861 407274 281443 79054810
Joint effusion 138.03 16.91 293 407842 17721 79318532
Accidental exposure to product 138.00 16.91 5 408130 31317 79304936
Weight increased 137.73 16.91 2088 406047 275298 79060955
Haematemesis 137.09 16.91 48 408087 52216 79284037
Contusion 135.85 16.91 1259 406876 147517 79188736
Hemiparesis 134.19 16.91 10 408125 33723 79302530
Acute respiratory distress syndrome 133.06 16.91 31 408104 44036 79292217
Electrolyte imbalance 132.45 16.91 6 408129 30875 79305378
Leukocytosis 132.35 16.91 30 408105 43425 79292828
Subdural haematoma 131.97 16.91 7 408128 31427 79304826
Limb discomfort 131.81 16.91 419 407716 32431 79303822
Cerebrovascular accident 130.21 16.91 386 407749 154906 79181347
Delirium 129.55 16.91 145 407990 84482 79251771
Finger deformity 129.38 16.91 175 407960 7299 79328954
Intentional product misuse 128.99 16.91 882 407253 94283 79241970
Injection site erythema 128.69 16.91 126 408009 78071 79258182
Pulmonary fibrosis 128.22 16.91 506 407629 43606 79292647
Angina pectoris 128.19 16.91 52 408083 51680 79284573
Lower limb fracture 124.95 16.91 329 407806 22886 79313367
Fall 124.86 16.91 1751 406384 485878 78850375
Mitral valve incompetence 124.34 16.91 5 408130 28560 79307693
Disseminated intravascular coagulation 123.69 16.91 18 408117 35824 79300429
Diabetic ketoacidosis 122.85 16.91 15 408120 34107 79302146
Coagulopathy 122.15 16.91 19 408116 35987 79300266
Hyperhidrosis 121.71 16.91 384 407751 151108 79185145
Drug effect less than expected 121.24 16.91 94 408041 1990 79334263
Injection site haemorrhage 120.91 16.91 5 408130 27865 79308388
Ulcer 120.91 16.91 383 407752 29589 79306664
Tubulointerstitial nephritis 119.28 16.91 25 408110 38210 79298043
Hepatic cytolysis 117.36 16.91 5 408130 27146 79309107
Device issue 117.15 16.91 5 408130 27103 79309150
Blood calcium decreased 117.02 16.91 13 408122 31806 79304447
Vision blurred 116.69 16.91 228 407907 105670 79230583
Myoclonus 116.62 16.91 6 408129 27654 79308599
Face oedema 115.86 16.91 7 408128 28129 79308124
Ischaemic stroke 115.82 16.91 16 408119 33115 79303138
Musculoskeletal disorder 115.48 16.91 304 407831 21144 79315109
Blood lactate dehydrogenase increased 115.44 16.91 29 408106 39141 79297112
Nasal congestion 114.97 16.91 728 407407 75824 79260429
Device dislocation 114.92 16.91 4 408131 25966 79310287
Transient ischaemic attack 113.69 16.91 64 408071 52631 79283622
Oropharyngeal pain 113.58 16.91 952 407183 108401 79227852
Acute myeloid leukaemia 112.62 16.91 13 408122 30872 79305381
Bacteraemia 112.08 16.91 17 408118 32807 79303446
Disturbance in attention 112.07 16.91 60 408075 50741 79285512
Ataxia 110.30 16.91 4 408131 25035 79311218
Neoplasm malignant 110.09 16.91 386 407749 31424 79304829
Rash maculo-papular 110.08 16.91 76 408059 56002 79280251
Blood pressure fluctuation 109.56 16.91 109 408026 67036 79269217
Injection site swelling 109.47 16.91 52 408083 47080 79289173
Pulmonary arterial hypertension 108.45 16.91 10 408125 28356 79307897
Tumour lysis syndrome 108.41 16.91 3 408132 23936 79312317
Myelosuppression 107.43 16.91 36 408099 40260 79295993
Confusional state 107.05 16.91 1075 407060 316922 79019331
Sleep disorder 106.72 16.91 778 407357 84899 79251354
Palpitations 106.64 16.91 314 407821 126296 79209957
Cholelithiasis 106.57 16.91 69 408066 52595 79283658
Ileus 106.50 16.91 7 408128 26204 79310049
Spinal operation 105.82 16.91 164 407971 7753 79328500
Diverticulitis 105.03 16.91 490 407645 45446 79290807
Haemorrhage intracranial 103.53 16.91 8 408127 26185 79310068
Rheumatoid lung 103.41 16.91 118 408017 4127 79332126
Product administration error 103.18 16.91 19 408116 31827 79304426
Myelodysplastic syndrome 102.76 16.91 16 408119 30285 79305968
Hypothermia 102.46 16.91 3 408132 22743 79313510
Brain oedema 101.90 16.91 7 408128 25256 79310997
Prescribed overdose 101.71 16.91 424 407711 37459 79298794
Anxiety 101.71 16.91 799 407336 247713 79088540
Pulmonary embolism 100.31 16.91 494 407641 171160 79165093
Urinary incontinence 99.94 16.91 42 408093 40867 79295386
Labelled drug-drug interaction medication error 99.92 16.91 12 408123 27638 79308615
Abdominal pain upper 99.79 16.91 1655 406480 222164 79114089
Dry eye 99.67 16.91 414 407721 36517 79299736
Bowel movement irregularity 98.71 16.91 141 407994 6193 79330060
Epilepsy 98.14 16.91 43 408092 40817 79295436
Emotional distress 97.70 16.91 41 408094 39928 79296325
Hypocalcaemia 97.54 16.91 68 408067 49856 79286397
Joint laxity 97.38 16.91 87 408048 2257 79333996
Presyncope 97.36 16.91 44 408091 41010 79295243
Bronchospasm 97.11 16.91 8 408127 24851 79311402
Visual acuity reduced 96.74 16.91 17 408118 29452 79306801
Poisoning 96.37 16.91 9 408126 25263 79310990
Injection site pruritus 96.16 16.91 48 408087 42235 79294018
Type 2 diabetes mellitus 94.48 16.91 557 407578 56565 79279688
Onychomycosis 93.91 16.91 159 407976 8102 79328151
Tenderness 93.44 16.91 300 407835 23342 79312911
Extrapyramidal disorder 92.31 16.91 6 408129 22673 79313580
Joint dislocation 92.12 16.91 241 407894 16698 79319555
Alanine aminotransferase increased 92.06 16.91 473 407662 162097 79174156
Aspartate aminotransferase increased 91.77 16.91 381 407754 138260 79197993
Cardiomegaly 91.48 16.91 13 408122 26339 79309914
Bursitis 91.45 16.91 395 407740 35449 79300804
Anaphylactic shock 91.13 16.91 35 408100 35961 79300292
Product quality issue 91.05 16.91 30 408105 33910 79302343
Leukopenia 91.02 16.91 299 407836 116214 79220039
Delusion 90.89 16.91 3 408132 20420 79315833
Cyanosis 90.83 16.91 11 408124 25171 79311082
Diplopia 90.80 16.91 29 408106 33437 79302816
Foot operation 89.90 16.91 128 408007 5605 79330648
Aspiration 89.57 16.91 3 408132 20155 79316098
Device malfunction 89.34 16.91 5 408130 21443 79314810
Cytomegalovirus infection 88.87 16.91 54 408081 42590 79293663
Blood potassium decreased 88.71 16.91 65 408070 46447 79289806
Gait inability 88.28 16.91 560 407575 58357 79277896
Spinal stenosis 88.28 16.91 227 407908 15564 79320689
Acidosis 87.60 16.91 3 408132 19759 79316494
Metastases to bone 87.30 16.91 11 408124 24416 79311837
Oral mucosal exfoliation 86.43 16.91 67 408068 1418 79334835
Paranoia 85.96 16.91 3 408132 19429 79316824
Left ventricular dysfunction 85.61 16.91 3 408132 19358 79316895
Lymphopenia 85.58 16.91 25 408110 30532 79305721
Lymphocyte count decreased 85.22 16.91 70 408065 47219 79289034
Haematochezia 85.22 16.91 752 407383 86893 79249360
Ear infection 85.22 16.91 376 407759 34056 79302197
Joint lock 84.30 16.91 93 408042 3132 79333121
Pneumonitis 83.96 16.91 113 408022 60747 79275506
Fear of injection 83.83 16.91 143 407992 7331 79328922
Intentional product use issue 83.30 16.91 1165 406970 150947 79185306
Deformity 82.76 16.91 164 407971 9441 79326812
Haematocrit decreased 82.41 16.91 116 408019 61196 79275057
Knee operation 81.91 16.91 124 408011 5742 79330511
Muscle rigidity 81.70 16.91 5 408130 19877 79316376
Polyneuropathy 81.34 16.91 13 408122 24138 79312115
Dialysis 81.15 16.91 3 408132 18459 79317794
Tricuspid valve incompetence 80.88 16.91 5 408130 19707 79316546
Right ventricular failure 80.62 16.91 12 408123 23485 79312768
Tenosynovitis 80.24 16.91 217 407918 15337 79320916
Mania 80.15 16.91 3 408132 18257 79317996
Neck pain 80.13 16.91 660 407475 74757 79261496
Acute coronary syndrome 79.34 16.91 8 408127 21125 79315128
Abortion spontaneous 79.30 16.91 26 408109 29481 79306772
Myopathy 79.28 16.91 7 408128 20556 79315697
Myocardial ischaemia 78.96 16.91 17 408118 25502 79310751
Full blood count decreased 78.76 16.91 20 408115 26799 79309454
Synovial cyst 78.61 16.91 165 407970 9900 79326353
Pancreatitis 77.85 16.91 145 407990 68430 79267823
Chronic obstructive pulmonary disease 77.75 16.91 204 407931 85215 79251038
Injection site mass 77.47 16.91 7 408128 20177 79316076
Skin necrosis 77.46 16.91 236 407899 17851 79318402
Creatinine renal clearance decreased 77.42 16.91 5 408130 18997 79317256
Withdrawal syndrome 77.01 16.91 21 408114 26833 79309420
White blood cell count increased 76.86 16.91 167 407968 74466 79261787
Joint arthroplasty 76.84 16.91 82 408053 2658 79333595
Renal tubular necrosis 76.83 16.91 17 408118 25022 79311231
Progressive multifocal leukoencephalopathy 76.81 16.91 8 408127 20592 79315661
Sudden death 76.08 16.91 12 408123 22499 79313754
Malnutrition 76.04 16.91 12 408123 22490 79313763
Troponin increased 75.77 16.91 6 408129 19249 79317004
Blood pressure diastolic decreased 75.47 16.91 30 408105 30186 79306067
Aspergillus infection 75.31 16.91 6 408129 19155 79317098
Anti-cyclic citrullinated peptide antibody 75.13 16.91 119 408016 5733 79330520
Atrial flutter 74.29 16.91 11 408124 21614 79314639
Apparent death 73.82 16.91 82 408053 2783 79333470
Blood sodium decreased 73.76 16.91 39 408096 33216 79303037
Lung infiltration 73.52 16.91 14 408121 22898 79313355
Intestinal obstruction 73.49 16.91 67 408068 42953 79293300
Prothrombin time prolonged 73.41 16.91 3 408132 16896 79319357
Pseudomonas infection 73.29 16.91 10 408125 20893 79315360
Tooth infection 72.64 16.91 237 407898 18595 79317658
Atlantoaxial instability 72.32 16.91 34 408101 271 79335982
Dysgeusia 72.15 16.91 113 408022 57064 79279189
Nausea 71.44 16.91 4091 404044 953105 78383148
Transplant rejection 71.33 16.91 8 408127 19429 79316824
Rash erythematous 71.17 16.91 116 408019 57653 79278600
Metastases to liver 70.90 16.91 28 408107 28286 79307967
Erythema multiforme 70.88 16.91 5 408130 17646 79318607
Mineral metabolism disorder 70.86 16.91 34 408101 285 79335968
Accidental overdose 70.82 16.91 59 408076 39522 79296731
Transfusion 70.68 16.91 12 408123 21318 79314935
Blood pressure systolic increased 70.56 16.91 148 407987 66838 79269415
Oliguria 70.50 16.91 3 408132 16306 79319947
Exostosis 70.37 16.91 218 407917 16640 79319613
Hyperthyroidism 70.36 16.91 14 408121 22195 79314058
Myocarditis 70.34 16.91 13 408122 21720 79314533
Product substitution issue 70.30 16.91 10 408125 20246 79316007
Splenomegaly 70.29 16.91 11 408124 20743 79315510
Hydronephrosis 69.92 16.91 5 408130 17449 79318804
Small intestinal obstruction 69.90 16.91 26 408109 27246 79309007
Cardiomyopathy 69.55 16.91 30 408105 28744 79307509
Rales 69.12 16.91 10 408125 19991 79316262
Nephropathy toxic 68.75 16.91 11 408124 20408 79315845
Joint destruction 68.63 16.91 115 408020 5810 79330443
Subarachnoid haemorrhage 68.54 16.91 20 408115 24445 79311808
Dry skin 68.50 16.91 154 407981 67841 79268412
Dislocation of vertebra 68.45 16.91 135 408000 7745 79328508
Hypovolaemia 68.27 16.91 6 408129 17685 79318568
Sinus disorder 67.98 16.91 261 407874 22203 79314050
Proteinuria 67.95 16.91 41 408094 32461 79303792
Lip swelling 67.21 16.91 66 408069 40845 79295408
Nail disorder 66.90 16.91 171 407964 11681 79324572
Polyarthritis 66.76 16.91 174 407961 12028 79324225
Chondropathy 66.63 16.91 73 408062 2439 79333814
Device related infection 66.61 16.91 47 408088 34247 79302006
Blood loss anaemia 66.50 16.91 3 408132 15495 79320758
Coordination abnormal 66.46 16.91 6 408129 17306 79318947
Atrioventricular block complete 65.85 16.91 5 408130 16605 79319648
Facet joint syndrome 65.81 16.91 165 407970 11137 79325116
Skin exfoliation 65.70 16.91 113 408022 54987 79281266
Back disorder 65.30 16.91 167 407968 11411 79324842
Erythema 65.05 16.91 780 407355 222510 79113743
Hepatitis B virus test positive 64.47 16.91 37 408098 462 79335791
Liver injury 64.24 16.91 503 407632 56111 79280142
Full blood count abnormal 63.42 16.91 68 408067 40406 79295847
Ventricular extrasystoles 63.31 16.91 12 408123 19692 79316561
Kidney infection 62.97 16.91 250 407885 21601 79314652
Irritability 62.41 16.91 71 408064 41073 79295180
Gastritis 62.34 16.91 93 408042 47900 79288353
Cardiac failure acute 61.96 16.91 11 408124 18918 79317335
Body temperature increased 61.75 16.91 82 408053 44338 79291915
Contrast media allergy 61.26 16.91 70 408065 2452 79333801
Swollen tongue 60.81 16.91 77 408058 42493 79293760
Hepatitis acute 60.72 16.91 5 408130 15537 79320716
Clostridium difficile colitis 60.42 16.91 46 408089 32237 79304016
Urosepsis 60.36 16.91 30 408105 26465 79309788
Lip dry 60.34 16.91 195 407940 15223 79321030
Supraventricular tachycardia 60.31 16.91 17 408118 21253 79315000
Schizophrenia 60.23 16.91 5 408130 15435 79320818
Generalised oedema 60.10 16.91 23 408112 23686 79312567
Onychomadesis 59.73 16.91 101 408034 5141 79331112
X-ray abnormal 59.71 16.91 107 408028 5706 79330547
Spinal instability 59.70 16.91 34 408101 418 79335835
Deep vein thrombosis 59.66 16.91 368 407767 120551 79215702
Pemphigoid 59.63 16.91 5 408130 15310 79320943
Renal injury 59.58 16.91 8 408127 16919 79319334
Metastases to central nervous system 59.44 16.91 7 408128 16368 79319885
Cataract 59.35 16.91 531 407604 61589 79274664
Speech disorder 59.29 16.91 118 408017 54327 79281926
Bronchopulmonary aspergillosis 59.29 16.91 20 408115 22274 79313979
Red blood cell sedimentation rate 59.18 16.91 104 408031 5461 79330792
Petechiae 59.12 16.91 16 408119 20549 79315704
Haemolytic anaemia 59.11 16.91 10 408125 17810 79318443
Arteriosclerosis coronary artery 59.09 16.91 10 408125 17806 79318447
Cholecystitis 58.94 16.91 20 408115 22192 79314061
Neck deformity 58.77 16.91 59 408076 1778 79334475
Anticipatory anxiety 58.76 16.91 49 408086 1155 79335098
Deep vein thrombosis postoperative 58.50 16.91 153 407982 10599 79325654
Purpura 58.43 16.91 14 408121 19513 79316740
Transaminases increased 58.21 16.91 110 408025 51633 79284620
Coeliac disease 58.19 16.91 158 407977 11193 79325060
Eosinophil count increased 58.08 16.91 9 408126 17096 79319157
Hemiplegia 57.83 16.91 5 408130 14934 79321319
Intestinal sepsis 57.70 16.91 43 408092 856 79335397
Acute pulmonary oedema 57.23 16.91 4 408131 14226 79322027
Systemic lupus erythematosus rash 56.33 16.91 58 408077 1802 79334451
Inappropriate schedule of product administration 56.33 16.91 426 407709 133202 79203051
Central nervous system lesion 56.04 16.91 3 408132 13365 79322888
Hypothyroidism 55.82 16.91 115 408020 52277 79283976
Therapeutic response decreased 55.67 16.91 555 407580 66298 79269955
Vaginal haemorrhage 55.58 16.91 21 408114 21796 79314457
Angina unstable 55.43 16.91 9 408126 16518 79319735
Lipase increased 55.15 16.91 9 408126 16457 79319796
Foot fracture 55.13 16.91 241 407894 21740 79314513
Unevaluable event 55.09 16.91 127 408008 55458 79280795
Concomitant disease aggravated 55.06 16.91 3 408132 13164 79323089
Peritonitis 55.01 16.91 38 408097 27998 79308255
Skin ulcer 54.92 16.91 469 407666 53681 79282572
Post procedural haemorrhage 54.88 16.91 4 408131 13740 79322513
Psychomotor hyperactivity 54.70 16.91 10 408125 16839 79319414
Autoimmune disorder 54.42 16.91 198 407937 16414 79319839
Encephalitis 54.35 16.91 6 408129 14754 79321499
Sleep apnoea syndrome 54.20 16.91 64 408071 36414 79299839
Electrocardiogram abnormal 54.19 16.91 10 408125 16727 79319526
Pulmonary haemorrhage 54.15 16.91 6 408129 14711 79321542
Urine output decreased 53.77 16.91 13 408122 18009 79318244
Cellulitis 53.75 16.91 332 407803 108728 79227525
Hypotonia 53.61 16.91 3 408132 12867 79323386
Complication associated with device 53.44 16.91 12 408123 17484 79318769
Hospitalisation 53.43 16.91 274 407861 93962 79242291
Dyspepsia 53.40 16.91 817 407318 107870 79228383
Mucous stools 53.00 16.91 95 408040 5067 79331186
Blood albumin decreased 52.93 16.91 29 408106 24214 79312039
Arteriosclerosis 52.74 16.91 14 408121 18213 79318040
Maternal exposure timing unspecified 52.46 16.91 101 408034 5691 79330562
Poor venous access 52.40 16.91 14 408121 18135 79318118
Lipids increased 52.23 16.91 53 408082 1618 79334635
Drug tolerance 51.94 16.91 128 408007 8547 79327706
Dermatitis bullous 51.93 16.91 6 408129 14239 79322014
Sciatica 51.78 16.91 319 407816 32903 79303350
Coronary artery stenosis 51.72 16.91 3 408132 12481 79323772
Laryngitis 51.56 16.91 190 407945 15849 79320404
Trigger finger 51.32 16.91 84 408051 4161 79332092
Osteonecrosis 51.27 16.91 50 408085 31045 79305208
Heart rate irregular 51.10 16.91 55 408080 32624 79303629
Hepatic enzyme abnormal 50.80 16.91 119 408016 7691 79328562
Enterocolitis 50.75 16.91 7 408128 14505 79321748
End stage renal disease 50.44 16.91 3 408132 12217 79324036
Seborrhoea 50.35 16.91 31 408104 444 79335809
Elbow deformity 50.07 16.91 50 408085 1497 79334756
Gastroenteritis viral 49.69 16.91 255 407880 24576 79311677
Salivary hypersecretion 49.41 16.91 7 408128 14217 79322036
Fine motor skill dysfunction 49.24 16.91 94 408041 5263 79330990
Blood magnesium decreased 49.09 16.91 12 408123 16500 79319753
Drug resistance 49.03 16.91 88 408047 42125 79294128
Wrist deformity 48.47 16.91 57 408078 2060 79334193
Fear 48.44 16.91 26 408109 21960 79314293
Gait disturbance 48.43 16.91 1398 406737 206108 79130145
Gastroenteritis 48.32 16.91 62 408073 34020 79302233
Body temperature decreased 48.18 16.91 56 408079 32089 79304164
Myositis 47.92 16.91 19 408116 19149 79317104
Hair growth abnormal 47.90 16.91 65 408070 2719 79333534
Blood lactic acid increased 47.39 16.91 5 408130 12739 79323514
Hypertriglyceridaemia 47.37 16.91 5 408130 12735 79323518
Pneumothorax 47.33 16.91 45 408090 28278 79307975
Muscle twitching 46.72 16.91 35 408100 24729 79311524
Prostate cancer 46.67 16.91 61 408074 33207 79303046
Psoriasis 46.57 16.91 680 407455 88907 79247346
Multiple fractures 46.55 16.91 117 408018 7909 79328344
Seronegative arthritis 46.46 16.91 85 408050 4607 79331646
Antibiotic therapy 46.21 16.91 37 408098 822 79335431
Diabetes mellitus inadequate control 46.15 16.91 34 408101 24230 79312023
Productive cough 46.12 16.91 264 407871 88067 79248186
Stress 46.11 16.91 616 407519 78996 79257257
Dry mouth 46.11 16.91 669 407466 87350 79248903
Limb deformity 46.08 16.91 73 408062 3517 79332736
Treatment noncompliance 45.92 16.91 127 408008 52141 79284112
Peripheral venous disease 45.83 16.91 182 407953 15727 79320526
Bundle branch block right 45.72 16.91 3 408132 11248 79325005
Pathogen resistance 45.52 16.91 9 408126 14333 79321920
Congestive cardiomyopathy 45.44 16.91 4 408131 11776 79324477
Metastases to lung 45.41 16.91 18 408117 18145 79318108
Ecchymosis 45.31 16.91 11 408124 15195 79321058
Intestinal ischaemia 45.01 16.91 7 408128 13263 79322990
Vertigo 44.98 16.91 191 407944 68891 79267362
Musculoskeletal discomfort 44.91 16.91 211 407924 19624 79316629
Erectile dysfunction 44.90 16.91 10 408125 14654 79321599
Skin cancer 44.90 16.91 174 407961 14866 79321387
Haematotoxicity 44.75 16.91 12 408123 15507 79320746
Injection site bruising 44.53 16.91 89 408046 40913 79295340
Neutrophil count increased 44.29 16.91 51 408084 29345 79306908
Brain injury 44.19 16.91 4 408131 11513 79324740
Physical disability 43.64 16.91 68 408067 3230 79333023
Retinitis 43.48 16.91 92 408043 5551 79330702
Blood pressure diastolic abnormal 43.36 16.91 22 408113 19180 79317073
Steroid dependence 43.14 16.91 60 408075 2570 79333683
Carpal tunnel syndrome 42.95 16.91 206 407929 19322 79316931
Hypovolaemic shock 42.74 16.91 6 408129 12270 79323983
Eyelid oedema 42.59 16.91 9 408126 13678 79322575
Paraesthesia oral 42.54 16.91 26 408109 20445 79315808
Muscular weakness 42.49 16.91 573 407562 160156 79176097
Cardiac failure chronic 42.37 16.91 4 408131 11131 79325122
Bone disorder 42.31 16.91 202 407933 18911 79317342
Tuberculosis 42.29 16.91 172 407963 15026 79321227
Hepatomegaly 42.06 16.91 22 408113 18852 79317401
Femur fracture 41.98 16.91 340 407795 38312 79297941
Haemorrhage 41.54 16.91 284 407851 90834 79245419
Bronchitis 41.36 16.91 917 407218 129727 79206526
Anger 41.31 16.91 18 408117 17144 79319109
Duodenal ulcer 41.29 16.91 16 408119 16353 79319900
Hunger 41.25 16.91 88 408047 5340 79330913
Hernia 41.24 16.91 185 407950 16874 79319379
Dysuria 41.00 16.91 129 408006 50822 79285431
Product prescribing issue 40.97 16.91 74 408061 3971 79332282
Abdominal pain lower 40.87 16.91 62 408073 31720 79304533
Fluid retention 40.69 16.91 201 407934 69608 79266645
Pulmonary toxicity 40.69 16.91 152 407983 12762 79323491
Synovial fluid analysis 40.47 16.91 55 408080 2304 79333949
Limb operation 40.35 16.91 67 408068 3359 79332894
Adjustment disorder with depressed mood 40.27 16.91 120 408015 8966 79327287
Tenosynovitis stenosans 40.08 16.91 63 408072 3015 79333238
Nephrotic syndrome 40.01 16.91 5 408130 11169 79325084
Cold sweat 39.92 16.91 23 408112 18676 79317577
Head injury 39.83 16.91 82 408053 37287 79298966
Peripheral sensory neuropathy 39.68 16.91 9 408126 13024 79323229
Immune reconstitution inflammatory syndrome 39.36 16.91 11 408124 13830 79322423
Pulmonary alveolar haemorrhage 38.96 16.91 6 408129 11451 79324802
Hypertransaminasaemia 38.87 16.91 7 408128 11917 79324336
Injection site induration 38.80 16.91 3 408132 9816 79326437
Panic attack 38.71 16.91 40 408095 24176 79312077
Lower gastrointestinal haemorrhage 38.68 16.91 17 408118 16108 79320145
Cholangitis 38.54 16.91 9 408126 12767 79323486
Enterococcal infection 38.37 16.91 16 408119 15644 79320609
Scleritis 38.29 16.91 75 408060 4281 79331972
Injection site warmth 38.14 16.91 14 408121 14793 79321460
Arthrodesis 38.12 16.91 54 408081 2353 79333900
Injection site extravasation 38.08 16.91 3 408132 9666 79326587
Therapy non-responder 37.98 16.91 674 407461 91631 79244622
Cytology abnormal 37.74 16.91 23 408112 323 79335930
Mental disorder 37.49 16.91 64 408071 31238 79305015
Pulse absent 37.47 16.91 4 408131 10099 79326154
Benign prostatic hyperplasia 37.46 16.91 7 408128 11605 79324648
Rotator cuff repair 37.37 16.91 47 408088 1823 79334430
Throat tightness 37.30 16.91 53 408082 27854 79308399
SLE arthritis 37.25 16.91 28 408107 565 79335688
Colitis 37.25 16.91 221 407914 73086 79263167
Eyelid ptosis 37.07 16.91 6 408129 11038 79325215
Blood glucose decreased 36.90 16.91 48 408087 26186 79310067
Terminal state 36.85 16.91 79 408056 4810 79331443
Systemic inflammatory response syndrome 36.80 16.91 7 408128 11458 79324795
Haemolysis 36.77 16.91 10 408125 12802 79323451
Ankle arthroplasty 36.49 16.91 42 408093 1483 79334770
Prostatic specific antigen increased 36.34 16.91 5 408130 10381 79325872
Hyperuricaemia 36.22 16.91 8 408127 11791 79324462
Erysipelas 36.18 16.91 6 408129 10844 79325409
Staphylococcal sepsis 36.16 16.91 15 408120 14711 79321542
Eczema 35.99 16.91 99 408036 40719 79295534
Cardiovascular disorder 35.94 16.91 24 408111 18001 79318252
Procedural pain 35.93 16.91 39 408096 23045 79313208
Cholecystitis acute 35.88 16.91 12 408123 13439 79322814
Polyuria 35.74 16.91 16 408119 14998 79321255
Adverse reaction 35.73 16.91 117 408018 9197 79327056
Blood thyroid stimulating hormone increased 35.61 16.91 4 408131 9704 79326549
Device breakage 35.38 16.91 6 408129 10669 79325584
Nerve injury 35.15 16.91 117 408018 9275 79326978
Bladder cancer 35.06 16.91 29 408106 19497 79316756
Staphylococcal infection 35.05 16.91 166 407969 58129 79278124
Loose body in joint 34.99 16.91 38 408097 1257 79334996
Atrioventricular block 34.97 16.91 14 408121 14027 79322226
Orthopnoea 34.89 16.91 5 408130 10068 79326185
Injection site hypersensitivity 34.74 16.91 46 408089 1879 79334374
Circumstance or information capable of leading to medication error 34.73 16.91 68 408067 3880 79332373
Embolism 34.72 16.91 14 408121 13968 79322285
Therapeutic product effect variable 34.71 16.91 47 408088 1962 79334291
Oesophagitis 34.62 16.91 44 408091 24245 79312008
Colectomy 34.52 16.91 62 408073 3312 79332941
Aortic arteriosclerosis 34.48 16.91 3 408132 8915 79327338
Inflammatory marker increased 34.33 16.91 127 408008 10613 79325640
Pruritus allergic 34.27 16.91 39 408096 1360 79334893
Nipple swelling 34.15 16.91 21 408114 300 79335953
Hypoaesthesia 34.12 16.91 1179 406956 178173 79158080
Blood uric acid increased 33.80 16.91 13 408122 13347 79322906
Carotid artery stenosis 33.71 16.91 3 408132 8755 79327498
C-reactive protein 33.63 16.91 77 408058 4902 79331351
Amylase increased 33.61 16.91 8 408127 11201 79325052
Cardiac tamponade 33.58 16.91 4 408131 9272 79326981
Drug level above therapeutic 33.55 16.91 3 408132 8720 79327533
Glomerular filtration rate decreased 33.54 16.91 40 408095 22662 79313591
Incorrect product administration duration 33.36 16.91 10 408125 12012 79324241
Localised infection 33.27 16.91 316 407819 37259 79298994
Injection site urticaria 33.26 16.91 12 408123 12814 79323439
Blood potassium increased 33.13 16.91 62 408073 29213 79307040
Bunion operation 33.10 16.91 32 408103 920 79335333
Personality change 33.09 16.91 6 408129 10164 79326089
Injection site rash 33.07 16.91 26 408109 17928 79318325
Blood pressure systolic decreased 33.03 16.91 8 408127 11068 79325185
Blood pressure systolic abnormal 33.02 16.91 24 408111 17223 79319030
Bundle branch block left 33.02 16.91 9 408126 11504 79324749
Neck mass 33.01 16.91 71 408064 4333 79331920
Feeling abnormal 32.96 16.91 1057 407078 158142 79178111
Dermatitis atopic 32.57 16.91 6 408129 10050 79326203
Atelectasis 32.53 16.91 73 408062 32184 79304069
Loss of employment 32.38 16.91 52 408083 2535 79333718
Therapy partial responder 32.29 16.91 25 408110 17372 79318881
Partial seizures 32.19 16.91 4 408131 8974 79327279
Multiple sclerosis 32.14 16.91 40 408095 22242 79314011
Rheumatoid factor increased 32.07 16.91 43 408092 1778 79334475
Infusion site erythema 32.07 16.91 5 408130 9455 79326798
Hyperreflexia 31.94 16.91 3 408132 8382 79327871
Epstein-Barr virus infection 31.83 16.91 17 408118 14399 79321854
Pulmonary thrombosis 31.71 16.91 135 408000 12036 79324217
Dyslipidaemia 31.70 16.91 10 408125 11623 79324630
Walking aid user 31.60 16.91 119 408016 10029 79326224
Basal cell carcinoma 31.46 16.91 311 407824 37064 79299189
Pyelonephritis 31.12 16.91 35 408100 20353 79315900
Hip surgery 31.02 16.91 58 408077 3197 79333056
Haemorrhagic stroke 31.00 16.91 9 408126 11037 79325216
Oesophageal candidiasis 30.96 16.91 5 408130 9213 79327040
Movement disorder 30.82 16.91 242 407893 27017 79309236
Investigation abnormal 30.75 16.91 45 408090 2021 79334232
Hypoaesthesia oral 30.69 16.91 17 408118 14107 79322146
Extremity contracture 30.66 16.91 41 408094 1691 79334562
Muscle spasticity 30.51 16.91 39 408096 21436 79314817
Oral surgery 30.47 16.91 33 408102 1088 79335165
Left ventricular failure 30.43 16.91 6 408129 9575 79326678
Drug level decreased 30.34 16.91 18 408117 14384 79321869
Facial paralysis 30.21 16.91 38 408097 21034 79315219
Post procedural complication 30.15 16.91 47 408088 23782 79312471
Faeces discoloured 30.13 16.91 65 408070 29062 79307191
Bone cyst 30.04 16.91 59 408076 3374 79332879
Cytomegalovirus viraemia 29.99 16.91 14 408121 12807 79323446
Myalgia 29.95 16.91 722 407413 184919 79151334
Viral upper respiratory tract infection 29.92 16.91 108 408027 8918 79327335
Localised oedema 29.88 16.91 3 408132 7949 79328304
Stress cardiomyopathy 29.72 16.91 10 408125 11156 79325097
Adenovirus infection 29.71 16.91 4 408131 8443 79327810
Joint noise 29.71 16.91 64 408071 3910 79332343
Chromaturia 29.61 16.91 54 408081 25692 79310561
Hydrocephalus 29.51 16.91 5 408130 8895 79327358
Periorbital oedema 29.50 16.91 4 408131 8398 79327855
Shoulder arthroplasty 29.44 16.91 57 408078 3225 79333028
Tooth abscess 29.38 16.91 162 407973 16048 79320205
Staphylococcal bacteraemia 29.12 16.91 13 408122 12205 79324048
Nightmare 29.07 16.91 55 408080 25806 79310447
Shoulder operation 28.71 16.91 51 408084 2701 79333552
Haemophagocytic lymphohistiocytosis 28.66 16.91 42 408093 21795 79314458
Ischaemic cardiomyopathy 28.66 16.91 3 408132 7692 79328561
Retinal haemorrhage 28.65 16.91 4 408131 8213 79328040
Metabolic disorder 28.59 16.91 6 408129 9164 79327089
Therapy cessation 28.50 16.91 306 407829 37256 79298997
Immunodeficiency 28.44 16.91 200 407935 21568 79314685
Glycosylated haemoglobin increased 28.39 16.91 34 408101 19226 79317027
Colorectal cancer 28.36 16.91 5 408130 8642 79327611
Appendicitis 28.28 16.91 39 408096 20755 79315498
Visual field defect 28.04 16.91 6 408129 9039 79327214
Necrosis 28.03 16.91 7 408128 9486 79326767
Immobile 28.02 16.91 89 408046 6884 79329369
Bone swelling 27.96 16.91 39 408096 1675 79334578
Cytopenia 27.95 16.91 38 408097 20345 79315908
Hepatitis C 27.93 16.91 13 408122 11912 79324341
Nephrolithiasis 27.88 16.91 405 407730 52886 79283367
Peripheral ischaemia 27.87 16.91 7 408128 9450 79326803
Renal cyst 27.56 16.91 21 408114 14711 79321542
Hypogammaglobulinaemia 27.55 16.91 16 408119 12935 79323318
Drug ineffective for unapproved indication 27.45 16.91 391 407744 50847 79285406
Neutrophilia 27.42 16.91 4 408131 7947 79328306
Enthesopathy 27.40 16.91 125 408010 11483 79324770
Latent tuberculosis 27.40 16.91 56 408079 3297 79332956
Coronary artery occlusion 27.19 16.91 23 408112 15292 79320961
Abnormal loss of weight 27.13 16.91 5 408130 8371 79327882
Toothache 26.99 16.91 185 407950 19785 79316468
Discontinued product administered 26.96 16.91 12 408123 83 79336170
Intracranial pressure increased 26.88 16.91 5 408130 8317 79327936
Decreased immune responsiveness 26.86 16.91 75 408060 5400 79330853
Lupus-like syndrome 26.82 16.91 141 407994 13716 79322537
Frustration tolerance decreased 26.79 16.91 92 408043 7410 79328843
Escherichia urinary tract infection 26.78 16.91 19 408116 13806 79322447
Hepatitis 26.75 16.91 171 407964 55556 79280697
Soft tissue disorder 26.73 16.91 57 408078 3458 79332795
Gastritis erosive 26.71 16.91 11 408124 10836 79325417
Hiccups 26.67 16.91 9 408126 10022 79326231
Respiratory tract congestion 26.46 16.91 184 407951 19770 79316483
Sputum discoloured 26.46 16.91 44 408091 21699 79314554
Paradoxical drug reaction 26.26 16.91 3 408132 7182 79329071
Apathy 26.25 16.91 17 408118 12960 79323293
Laryngeal oedema 26.01 16.91 5 408130 8124 79328129
Pulmonary function test decreased 25.97 16.91 4 408131 7633 79328620
Tongue oedema 25.94 16.91 3 408132 7114 79329139
Hypoacusis 25.92 16.91 252 407883 29898 79306355
Defaecation urgency 25.89 16.91 77 408058 5747 79330506
Escherichia sepsis 25.65 16.91 6 408129 8502 79327751
Mental impairment 25.59 16.91 36 408099 19000 79317253
Pre-eclampsia 25.58 16.91 3 408132 7038 79329215
Tongue disorder 25.55 16.91 140 407995 13835 79322418
Odynophagia 25.54 16.91 13 408122 11314 79324939
Nodal osteoarthritis 25.51 16.91 23 408112 604 79335649
Glaucoma 25.49 16.91 181 407954 19580 79316673
Infiltration anaesthesia 25.46 16.91 14 408121 160 79336093
Asthma 25.34 16.91 513 407622 134582 79201671
Hypertensive crisis 25.31 16.91 42 408093 20728 79315525
Thirst 25.24 16.91 35 408100 18584 79317669
Dermatitis 25.16 16.91 44 408091 21277 79314976
Pneumonia fungal 25.08 16.91 13 408122 11197 79325056
Tendonitis 25.01 16.91 208 407927 23622 79312631
Spinal fusion surgery 24.96 16.91 71 408064 5167 79331086
Drug use disorder 24.94 16.91 99 408036 8552 79327701
Metastases to lymph nodes 24.87 16.91 11 408124 10386 79325867
Nerve block 24.86 16.91 24 408111 689 79335564
Anal incontinence 24.78 16.91 34 408101 18134 79318119
Intervertebral disc space narrowing 24.69 16.91 37 408098 1698 79334555
Embolic stroke 24.65 16.91 5 408130 7821 79328432
Aortic valve incompetence 24.57 16.91 9 408126 9521 79326732
Oral candidiasis 24.56 16.91 74 408061 29554 79306699
Eye disorder 24.38 16.91 204 407931 23208 79313045
Ankle operation 24.36 16.91 29 408106 1062 79335191
Bradyphrenia 24.31 16.91 12 408123 10628 79325625
Gastric ulcer haemorrhage 24.17 16.91 8 408127 9019 79327234
Vitamin B12 deficiency 24.16 16.91 4 408131 7237 79329016
Endocarditis 24.14 16.91 12 408123 10585 79325668
Rebound effect 24.09 16.91 4 408131 7222 79329031
Suspected COVID-19 24.05 16.91 51 408084 3082 79333171
Breast cancer stage I 23.98 16.91 3 408132 6697 79329556
Blood glucose fluctuation 23.90 16.91 3 408132 6679 79329574
Heavy menstrual bleeding 23.72 16.91 22 408113 13989 79322264
Rhinitis allergic 23.58 16.91 17 408118 12252 79324001
Portal hypertension 23.55 16.91 4 408131 7104 79329149
Sleep disorder due to a general medical condition 23.49 16.91 23 408112 14254 79321999
Renal cancer 23.42 16.91 17 408118 12209 79324044
Fracture delayed union 23.18 16.91 40 408095 2070 79334183
Root canal infection 23.14 16.91 18 408117 383 79335870
Incontinence 23.09 16.91 23 408112 14141 79322112
Limb injury 23.08 16.91 242 407893 29286 79306967
Feeling cold 22.93 16.91 73 408062 28656 79307597
Tachyarrhythmia 22.89 16.91 4 408131 6958 79329295
Blood cholesterol abnormal 22.84 16.91 52 408083 3298 79332955
Bone density abnormal 22.55 16.91 49 408086 3011 79333242
Metastasis 22.51 16.91 4 408131 6876 79329377
Sensory loss 22.47 16.91 20 408115 12971 79323282
Nasal polyps 22.43 16.91 5 408130 7322 79328931
Pneumocystis jirovecii pneumonia 22.34 16.91 88 408047 32420 79303833
Synovial disorder 22.32 16.91 38 408097 1945 79334308
Medication error 22.24 16.91 234 407901 68408 79267845
Euphoric mood 22.23 16.91 6 408129 7720 79328533
Furuncle 22.23 16.91 87 408048 7467 79328786
Gangrene 22.22 16.91 9 408126 8955 79327298
Protein urine present 22.22 16.91 12 408123 10100 79326153
Muscle haemorrhage 22.12 16.91 3 408132 6297 79329956
Incoherent 22.08 16.91 6 408129 7686 79328567
Live birth 22.07 16.91 168 407967 18576 79317677
Alanine aminotransferase abnormal 22.07 16.91 97 408038 8770 79327483
Device failure 21.94 16.91 3 408132 6258 79329995
Oral herpes 21.93 16.91 226 407909 27228 79309025
Bacterial infection 21.93 16.91 84 408051 31196 79305057
Gastric ulcer 21.91 16.91 94 408041 33811 79302442
Drug dose omission by device 21.89 16.91 3 408132 6247 79330006
Diarrhoea 21.88 16.91 4072 404063 876417 78459836
Skin abrasion 21.77 16.91 22 408113 13434 79322819
Pruritus 21.66 16.91 1732 406403 392916 78943337
Night sweats 21.64 16.91 381 407754 51714 79284539
Potentiating drug interaction 21.63 16.91 9 408126 8810 79327443
Retching 21.58 16.91 35 408100 17432 79318821
Blood phosphorus decreased 21.55 16.91 4 408131 6664 79329589
Restless legs syndrome 21.48 16.91 44 408091 20048 79316205
Body height decreased 21.46 16.91 94 408041 8486 79327767
Escherichia infection 21.43 16.91 37 408098 17980 79318273
Overwork 21.42 16.91 9 408126 53 79336200
Product use in unapproved indication 21.35 16.91 1055 407080 249304 79086949
Polydipsia 21.27 16.91 4 408131 6601 79329652
Protein total decreased 21.16 16.91 10 408125 9082 79327171
Allergic oedema 21.00 16.91 23 408112 768 79335485
Product residue present 20.98 16.91 52 408083 3484 79332769
Nervous system disorder 20.90 16.91 69 408066 26787 79309466
Wrong product administered 20.84 16.91 10 408125 9002 79327251
Hepatic lesion 20.80 16.91 5 408130 6954 79329299
Bedridden 20.76 16.91 119 408016 11960 79324293
Breast cancer metastatic 20.74 16.91 9 408126 8593 79327660
Major depression 20.71 16.91 10 408125 8970 79327283
Bacterial sepsis 20.70 16.91 8 408127 8190 79328063
Gastric haemorrhage 20.70 16.91 28 408107 15022 79321231
Intestinal polyp 20.69 16.91 38 408097 2066 79334187
Myasthenia gravis 20.53 16.91 14 408121 10385 79325868
Spondylitis 20.51 16.91 62 408073 4669 79331584
Drooling 20.43 16.91 3 408132 5931 79330322
Liver disorder 20.35 16.91 500 407635 71917 79264336
Sinus node dysfunction 20.32 16.91 7 408128 7694 79328559
Apnoea 20.26 16.91 18 408117 11686 79324567
Energy increased 20.26 16.91 49 408086 3233 79333020
Lung disorder 20.24 16.91 548 407587 80009 79256244
Dementia 20.14 16.91 62 408073 24597 79311656
Wheezing 20.13 16.91 449 407686 116215 79220038
Pneumonia bacterial 20.11 16.91 43 408092 19288 79316965
Osteosclerosis 20.08 16.91 55 408080 3916 79332337
Transplant dysfunction 20.05 16.91 6 408129 7215 79329038
No adverse event 20.04 16.91 110 408025 37082 79299171
Optic neuritis 19.91 16.91 12 408123 9508 79326745
Paraesthesia 19.87 16.91 720 407415 175603 79160650
Haemarthrosis 19.87 16.91 3 408132 5809 79330444
Swelling face 19.86 16.91 251 407884 70961 79265292
Dizziness postural 19.71 16.91 18 408117 11531 79324722
Abdominal distension 19.66 16.91 464 407671 119186 79217067
Hyperlipidaemia 19.66 16.91 68 408067 26025 79310228
Venous thrombosis 19.60 16.91 6 408129 7110 79329143
Affective disorder 19.59 16.91 9 408126 8310 79327943
Abortion induced 19.57 16.91 6 408129 7103 79329150
Candida infection 19.52 16.91 115 408020 38099 79298154
Anaphylactic reaction 19.52 16.91 306 407829 83437 79252816
Insurance issue 19.50 16.91 3 408132 5730 79330523
Wound infection 19.40 16.91 198 407937 23793 79312460
Lung neoplasm 19.40 16.91 6 408129 7063 79329190
General physical health deterioration 19.37 16.91 1182 406953 274056 79062197
Neck surgery 19.35 16.91 34 408101 1785 79334468
Pulmonary tuberculosis 19.33 16.91 8 408127 7857 79328396
Brain death 19.24 16.91 3 408132 5674 79330579
Blood calcium increased 19.23 16.91 15 408120 10385 79325868
Dysphonia 19.20 16.91 192 407943 56680 79279573
Extrasystoles 19.14 16.91 7 408128 7412 79328841
Papule 19.09 16.91 7 408128 7400 79328853
Supraventricular extrasystoles 19.05 16.91 6 408129 6981 79329272
Decubitus ulcer 18.85 16.91 32 408103 15655 79320598
Drug-induced liver injury 18.83 16.91 232 407903 65885 79270368
Hiatus hernia 18.77 16.91 59 408076 23253 79313000
Colitis ischaemic 18.77 16.91 31 408104 15328 79320925
Skin hyperpigmentation 18.65 16.91 7 408128 7296 79328957
Hyperaesthesia 18.63 16.91 21 408114 12201 79324052
Eye swelling 18.60 16.91 71 408064 26397 79309856
Lupus vulgaris 18.60 16.91 48 408087 3298 79332955
Areflexia 18.59 16.91 3 408132 5531 79330722
Bacterial vulvovaginitis 18.57 16.91 19 408116 586 79335667
Facial paresis 18.55 16.91 3 408132 5523 79330730
Skin tightness 18.53 16.91 3 408132 5519 79330734
Bone pain 18.48 16.91 189 407946 55553 79280700
Ocular icterus 18.43 16.91 3 408132 5497 79330756
Cytomegalovirus test positive 18.32 16.91 4 408131 5943 79330310
Macular oedema 18.31 16.91 3 408132 5471 79330782
Prescribed underdose 18.19 16.91 231 407904 29283 79306970
Mass excision 18.12 16.91 15 408120 350 79335903
Diabetic eye disease 18.08 16.91 11 408124 154 79336099
Thiopurine methyltransferase decreased 18.08 16.91 15 408120 351 79335902
Conjunctival haemorrhage 17.96 16.91 4 408131 5861 79330392
Nerve compression 17.88 16.91 94 408041 9145 79327108
Aortic stenosis 17.82 16.91 8 408127 7487 79328766
Breast cancer stage III 17.68 16.91 98 408037 9728 79326525
Mean cell haemoglobin concentration abnormal 17.66 16.91 11 408124 161 79336092
Bacterial test positive 17.63 16.91 8 408127 7441 79328812
Gallbladder adenocarcinoma 17.55 16.91 10 408125 123 79336130
Microcytic anaemia 17.40 16.91 3 408132 5271 79330982
Loss of therapeutic response 17.32 16.91 22 408113 862 79335391
Allergy to chemicals 17.31 16.91 40 408095 2562 79333691
Blood thyroid stimulating hormone decreased 17.30 16.91 4 408131 5712 79330541
Nocturia 17.29 16.91 27 408108 13654 79322599
Respiratory rate decreased 17.26 16.91 3 408132 5240 79331013
Laryngeal pain 17.12 16.91 5 408130 6109 79330144
Neurological symptom 17.11 16.91 12 408123 8771 79327482
Pseudopolyp 17.05 16.91 16 408119 443 79335810
Dyspnoea at rest 17.04 16.91 8 408127 7294 79328959
Subileus 17.02 16.91 4 408131 5650 79330603
Sensory disturbance 17.00 16.91 32 408103 15045 79321208
Osteoporotic fracture 16.93 16.91 54 408081 4186 79332067
Occult blood positive 16.92 16.91 7 408128 6876 79329377

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AA29 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D000075242 Janus Kinase Inhibitors
MeSH PA D047428 Protein Kinase Inhibitors
FDA MoA N0000190857 Janus Kinase Inhibitors
FDA EPC N0000190858 Janus Kinase Inhibitor
CHEBI has role CHEBI:35842 anti-rheumatic drugs
CHEBI has role CHEBI:76617 BTK inhibitor

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

DiseaseRelationSNOMED_IDDOID
Ulcerative colitis indication 64766004 DOID:8577
Rheumatoid arthritis indication 69896004 DOID:7148
Psoriatic arthritis indication 156370009 DOID:9008
Juvenile psoriatic arthritis indication 239802003
Juvenile idiopathic arthritis, extended oligoarthritis indication 410800006
Polyarticular juvenile idiopathic arthritis indication 16044800000000000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.27 acidic
pKa2 6.48 Basic
pKa3 0.91 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 11MG BASE XELJANZ XR PFIZER N208246 Feb. 23, 2016 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING ANKYLOSING SPONDYLITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-43, 45, 47, 49, 50, 54, 59, 63, 68-71, 73, 77, 82-84, AND 87-98
EQ 11MG BASE XELJANZ XR PFIZER N208246 Feb. 23, 2016 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING PSORIATIC ARTHRITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-44, 46, 48, 50, 53, 59, 62, 68-71, 73, 76, 82-84, AND 87-98
EQ 11MG BASE XELJANZ XR PFIZER N208246 Feb. 23, 2016 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING RHEUMATOID ARTHRITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 2, 8, 9, 15-21, 27-31, 34-43, 50, 51, 59, 60, 68-71, 73, 74, 82-84 AND 87-98
EQ 11MG BASE XELJANZ XR PFIZER N208246 Feb. 23, 2016 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING ULCERATIVE COLITIS, BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 3, 8, 10, 15-20, 22, 27-31, 34-43, 50, 52, 59, 61, 68-71, 73, 75, 82-84 AND 87-98
EQ 22MG BASE XELJANZ XR PFIZER N208246 Dec. 12, 2019 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING ANKYLOSING SPONDYLITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-43, 45, 47, 49, 50, 54, 59, 63, 68-71, 73, 77, 82-84, AND 87-98
EQ 22MG BASE XELJANZ XR PFIZER N208246 Dec. 12, 2019 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING PSORIATIC ARTHRITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-44, 46, 48, 50, 53, 59, 62, 68-71, 73, 76, 82-84, AND 87-98
EQ 22MG BASE XELJANZ XR PFIZER N208246 Dec. 12, 2019 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING RHEUMATOID ARTHRITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 2, 8, 9, 15-21, 27-31, 34-43, 50, 51, 59, 60, 68-71, 73, 74, 82-84 AND 87-98
EQ 22MG BASE XELJANZ XR PFIZER N208246 Dec. 12, 2019 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING ULCERATIVE COLITIS, BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 3, 8, 10, 15-20, 22, 27-31, 34-43, 50, 52, 59, 61, 68-71, 73, 75, 82-84 AND 87-98

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 5MG BASE XELJANZ PF PRISM CV N203214 Nov. 6, 2012 RX TABLET ORAL Sept. 25, 2023 NEW PATIENT POPULATION
EQ 1MG/ML BASE XELJANZ PFIZER N213082 Sept. 25, 2020 RX SOLUTION ORAL Sept. 25, 2023 NEW PRODUCT
EQ 10MG BASE XELJANZ PF PRISM CV N203214 May 30, 2018 RX TABLET ORAL Dec. 14, 2024 TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION
EQ 5MG BASE XELJANZ PF PRISM CV N203214 Nov. 6, 2012 RX TABLET ORAL Dec. 14, 2024 TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION
EQ 11MG BASE XELJANZ XR PFIZER N208246 Feb. 23, 2016 RX TABLET, EXTENDED RELEASE ORAL Dec. 14, 2024 TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
JAK1/TYK2 Kinase INHIBITOR IC50 7.46 CHEMBL CHEMBL
JAK2/TYK2 Kinase INHIBITOR IC50 6.64 CHEMBL CHEMBL
JAK2/JAK1 Kinase INHIBITOR IC50 6.39 DRUG LABEL DRUG LABEL
JAK3/JAK1 Kinase INHIBITOR IC50 7.25 DRUG LABEL DRUG LABEL
Proto-oncogene tyrosine-protein kinase receptor Ret Kinase Kd 5.48 CHEMBL
Calcium/calmodulin-dependent protein kinase type 1 Kinase Kd 5.92 CHEMBL
Rho-associated protein kinase 1 Kinase Kd 6.33 CHEMBL
Tyrosine-protein kinase JAK1 Kinase INHIBITOR Ki 9.17 CHEMBL
Protein kinase C delta type Kinase Kd 5.70 CHEMBL
Tyrosine-protein kinase JAK2 Kinase INHIBITOR Kd 9.24 CHEMBL
Rho-associated protein kinase 2 Kinase Kd 6.38 CHEMBL
Protein kinase C alpha type Kinase Kd 4.55 CHEMBL
Calcium/calmodulin-dependent protein kinase type II subunit delta Kinase Kd 5.57 CHEMBL
Serine/threonine-protein kinase MARK2 Kinase Kd 5.18 CHEMBL
Ribosomal protein S6 kinase alpha-2 Kinase Kd 6.22 CHEMBL
Calcium/calmodulin-dependent protein kinase type II subunit alpha Kinase Kd 5.46 CHEMBL
Serine/threonine-protein kinase N1 Kinase Kd 6.77 CHEMBL
BMP-2-inducible protein kinase Kinase Kd 5.15 CHEMBL
Calcium/calmodulin-dependent protein kinase type 1D Kinase Kd 5.80 CHEMBL
Activated CDC42 kinase 1 Kinase Kd 5.97 CHEMBL
MAP kinase-interacting serine/threonine-protein kinase 2 Kinase Kd 5.80 CHEMBL
MAP/microtubule affinity-regulating kinase 3 Kinase Kd 4.97 CHEMBL
Dual specificity mitogen-activated protein kinase kinase 1 Kinase Kd 6.37 CHEMBL
Serine/threonine-protein kinase N2 Kinase Kd 5.92 CHEMBL
Serine/threonine-protein kinase DCLK3 Kinase Kd 8.35 CHEMBL
Serine/threonine-protein kinase 3 Kinase Kd 5.37 CHEMBL
Ribosomal protein S6 kinase alpha-6 Kinase Kd 6.27 CHEMBL
NUAK family SNF1-like kinase 2 Kinase Kd 6.62 CHEMBL
Non-receptor tyrosine-protein kinase TNK1 Kinase Kd 6.92 CHEMBL
Non-receptor tyrosine-protein kinase TYK2 Kinase INHIBITOR Ki 8.36 CHEMBL
Tyrosine-protein kinase JAK3 Kinase INHIBITOR IC50 8.48 WOMBAT-PK
Aurora kinase B Kinase Kd 6.28 CHEMBL
Serine/threonine-protein kinase DCLK1 Kinase Kd 5.17 CHEMBL
Ribosomal protein S6 kinase alpha-1 Kinase Kd 5.85 CHEMBL
Mitogen-activated protein kinase kinase kinase kinase 2 Kinase Kd 5.32 CHEMBL
G protein-coupled receptor kinase 7 Kinase Kd 5.37 CHEMBL
Serine/threonine-protein kinase ULK3 Kinase Kd 5.19 CHEMBL
Leucine-rich repeat serine/threonine-protein kinase 2 Kinase Kd 6.26 CHEMBL
JAK1/JAK2/TYK2 Kinase INHIBITOR IC50 7.12 CHEMBL
Myotonin-protein kinase Kinase Kd 5.92 CHEMBL
Tyrosine-protein kinase ABL1 Kinase Kd 5.66 CHEMBL
Tyrosine-protein kinase Lck Kinase Kd 6.34 CHEMBL
Tyrosine-protein kinase Fyn Kinase Kd 5.96 CHEMBL
Tyrosine-protein kinase JAK3 Kinase IC50 7.32 CHEMBL
Tyrosine-protein kinase JAK2 Kinase IC50 5.69 CHEMBL
Serine/threonine-protein kinase PknB Kinase Kd 5.70 CHEMBL
Tyrosine-protein kinase JAK3 Kinase IC50 5.92 CHEMBL
Tyrosine-protein kinase JAK2 Kinase IC50 5.74 CHEMBL

External reference:

IDSource
D09783 KEGG_DRUG
4031786 VUID
N0000186059 NUI
540737-29-9 SECONDARY_CAS_RN
4031786 VANDF
CHEBI:71200 CHEBI
CHEMBL221959 ChEMBL_ID
CHEMBL459769 ChEMBL_ID
C479163 MESH_SUPPLEMENTAL_RECORD_UI
5677 IUPHAR_LIGAND_ID
9298 INN_ID
DB08895 DRUGBANK_ID
87LA6FU830 UNII
1357536 RXNORM
194456 MMSL
28976 MMSL
31571 MMSL
d07925 MMSL
014743 NDDF
014744 NDDF
704313003 SNOMEDCT_US
704314009 SNOMEDCT_US
704316006 SNOMEDCT_US
C2930696 UMLSCUI
MI1 PDB_CHEM_ID
CHEMBL2103743 ChEMBL_ID
9926791 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
XELJANZ XR HUMAN PRESCRIPTION DRUG LABEL 1 0069-0501 TABLET, FILM COATED, EXTENDED RELEASE 11 mg ORAL NDA 35 sections
XELJANZ XR HUMAN PRESCRIPTION DRUG LABEL 1 0069-0501 TABLET, FILM COATED, EXTENDED RELEASE 11 mg ORAL NDA 35 sections
XELJANZ XR HUMAN PRESCRIPTION DRUG LABEL 1 0069-0501 TABLET, FILM COATED, EXTENDED RELEASE 11 mg ORAL NDA 35 sections
XELJANZ XR HUMAN PRESCRIPTION DRUG LABEL 1 0069-0502 TABLET, FILM COATED, EXTENDED RELEASE 22 mg ORAL NDA 35 sections
XELJANZ XR HUMAN PRESCRIPTION DRUG LABEL 1 0069-0502 TABLET, FILM COATED, EXTENDED RELEASE 22 mg ORAL NDA 35 sections
XELJANZ XR HUMAN PRESCRIPTION DRUG LABEL 1 0069-0502 TABLET, FILM COATED, EXTENDED RELEASE 22 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1001 TABLET, FILM COATED 5 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1001 TABLET, FILM COATED 5 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1001 TABLET, FILM COATED 5 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1002 TABLET, FILM COATED 10 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1002 TABLET, FILM COATED 10 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1002 TABLET, FILM COATED 10 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1029 SOLUTION 1 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1029 SOLUTION 1 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1029 SOLUTION 1 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 63539-012 TABLET, FILM COATED 5 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 63539-012 TABLET, FILM COATED 5 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 63539-016 TABLET, FILM COATED 10 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 63539-016 TABLET, FILM COATED 10 mg ORAL NDA 35 sections
XELJANZ XR HUMAN PRESCRIPTION DRUG LABEL 1 63539-501 TABLET, EXTENDED RELEASE 11 mg ORAL NDA 35 sections
XELJANZ XR HUMAN PRESCRIPTION DRUG LABEL 1 63539-501 TABLET, EXTENDED RELEASE 11 mg ORAL NDA 35 sections
XELJANZ XR HUMAN PRESCRIPTION DRUG LABEL 1 63539-502 TABLET, EXTENDED RELEASE 22 mg ORAL NDA 35 sections
XELJANZ XR HUMAN PRESCRIPTION DRUG LABEL 1 63539-502 TABLET, EXTENDED RELEASE 22 mg ORAL NDA 35 sections