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

Stem definitionDrug idCAS RN
humanized origin 4968 428863-50-7

Description:

MoleculeDescription

Synonyms:

  • certolizumab pegol
  • cimzia
  • certolizumab
A polyethylene-glycolated Fab' fragment of TUMOR NECROSIS FACTOR antibody that binds specifically to TNF-ALPHA and neutralises it in a dose-dependent manner. It also inhibits the production of lipopolysaccharide-induced TNF-ALPHA and IL-1 BETA and is used to treat RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
14 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
April 22, 2008 FDA UCB INC
Oct. 1, 2009 EMA
Dec. 25, 2012 PMDA UCB Japan Co., Ltd.

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 3955.27 18.47 9737 201900 809596 49583891
Pemphigus 2900.81 18.47 3013 208624 117153 50276334
Contraindicated product administered 2708.35 18.47 3220 208417 145738 50247749
Systemic lupus erythematosus 2677.91 18.47 3113 208524 137509 50255978
Glossodynia 2345.24 18.47 2645 208992 112924 50280563
Alopecia 2005.76 18.47 3633 208004 241414 50152073
Hand deformity 1961.98 18.47 2252 209385 97947 50295540
Swelling 1930.37 18.47 3198 208439 197674 50195813
Abdominal discomfort 1883.38 18.47 3425 208212 228216 50165271
Drug intolerance 1859.48 18.47 3301 208336 215803 50177684
Maternal exposure during pregnancy 1853.38 18.47 2774 208863 157004 50236483
Joint swelling 1720.69 18.47 3406 208231 241880 50151607
Arthropathy 1643.54 18.47 2608 209029 155298 50238189
Synovitis 1634.61 18.47 2287 209350 121578 50271909
Therapeutic product effect decreased 1525.47 18.47 2326 209311 133724 50259763
Wound 1483.61 18.47 2012 209625 103782 50289705
Anti-cyclic citrullinated peptide antibody positive 1439.15 18.47 1621 210016 68966 50324521
Pain 1401.28 18.47 5433 206204 573470 49820017
Hypersensitivity 1258.40 18.47 2775 208862 212386 50181101
Pericarditis 1231.59 18.47 1580 210057 77109 50316378
Discomfort 1185.93 18.47 1833 209804 106547 50286940
Treatment failure 1095.24 18.47 2019 209618 135618 50257869
Rash 1064.17 18.47 4117 207520 433354 49960133
Muscle injury 955.19 18.47 965 210672 36146 50357341
Folliculitis 953.45 18.47 989 210648 38236 50355251
Lower respiratory tract infection 952.60 18.47 1546 210091 93655 50299832
Irritable bowel syndrome 882.68 18.47 1082 210555 50359 50343128
Rheumatoid arthritis 865.63 18.47 2316 209321 200234 50193253
Rheumatoid factor positive 864.04 18.47 1054 210583 48805 50344682
Acute kidney injury 749.51 18.47 53 211584 228005 50165482
Ill-defined disorder 746.20 18.47 1027 210610 53627 50339860
Hepatic enzyme increased 743.65 18.47 1720 209917 135660 50257827
Blister 736.01 18.47 1298 210339 84120 50309367
Drug interaction 734.41 18.47 22 211615 199599 50193888
Duodenal ulcer perforation 727.44 18.47 925 210712 44686 50348801
Sleep disorder due to general medical condition, insomnia type 696.87 18.47 755 210882 30692 50362795
Toxicity to various agents 696.48 18.47 50 211587 212449 50181038
Infection 692.91 18.47 1932 209705 171022 50222465
Hypotension 686.14 18.47 88 211549 235381 50158106
Helicobacter infection 683.07 18.47 937 210700 48765 50344722
Anaemia 681.31 18.47 118 211519 252338 50141149
Product use issue 641.73 18.47 1713 209924 147762 50245725
Impaired healing 621.22 18.47 1076 210561 68710 50324777
Death 620.54 18.47 293 211344 325086 50068401
Maternal exposure before pregnancy 620.37 18.47 350 211287 5247 50388240
Infusion related reaction 589.63 18.47 1801 209836 167756 50225731
Sinusitis 561.00 18.47 1777 209860 168781 50224706
Fall 546.06 18.47 366 211271 334566 50058921
Gastrointestinal disorder 493.58 18.47 1167 210470 93289 50300198
Arthralgia 461.72 18.47 3274 208363 435428 49958059
Peripheral swelling 451.32 18.47 1880 209757 204056 50189431
Thrombocytopenia 412.48 18.47 32 211605 127641 50265846
Constipation 406.42 18.47 135 211502 185573 50207914
Dizziness 402 18.47 516 211121 345853 50047634
Hip arthroplasty 397.47 18.47 560 211077 29869 50363618
Blood iron abnormal 382.22 18.47 213 211424 3113 50390374
Stomatitis 371.15 18.47 1097 210540 100247 50293240
Febrile neutropenia 365.50 18.47 9 211628 97658 50295829
Rheumatic fever 359.71 18.47 397 211240 16470 50377017
Knee arthroplasty 356.43 18.47 581 211056 35265 50358222
Neutropenia 355.95 18.47 90 211547 147875 50245612
Maternal exposure during breast feeding 348.53 18.47 199 211438 3055 50390432
Nasopharyngitis 342.55 18.47 1655 209982 191272 50202215
Hyponatraemia 334.83 18.47 16 211621 96123 50297364
Platelet count decreased 328.86 18.47 24 211613 100702 50292785
Haemoglobin decreased 328.80 18.47 66 211571 127150 50266337
Dehydration 321.14 18.47 118 211519 152331 50241156
Seizure 315.61 18.47 56 211581 117818 50275669
White blood cell count decreased 313.51 18.47 55 211582 116667 50276820
Fatigue 310.78 18.47 4403 207234 703198 49690289
Musculoskeletal stiffness 306.58 18.47 1205 210432 127276 50266211
Swollen joint count increased 291.44 18.47 335 211302 14538 50378949
Tremor 285.91 18.47 65 211572 114838 50278649
Renal failure 284.73 18.47 51 211586 106582 50286905
Pregnancy 278.72 18.47 468 211169 29109 50364378
Cardiac arrest 278.69 18.47 18 211619 83633 50309854
Loss of personal independence in daily activities 276.37 18.47 779 210858 69271 50324216
Nausea 271.00 18.47 1786 209851 703612 49689875
Anxiety 266.89 18.47 211 211426 177395 50216092
Pulmonary embolism 266.50 18.47 51 211586 101653 50291834
Tachycardia 265.75 18.47 48 211589 99715 50293772
Respiratory failure 265.43 18.47 34 211603 91147 50302340
Overdose 263.46 18.47 49 211588 99678 50293809
Pancytopenia 263.26 18.47 24 211613 84006 50309481
Oxygen saturation decreased 258.94 18.47 11 211626 73237 50320250
Disease progression 255.63 18.47 46 211591 95820 50297667
Hypokalaemia 253.28 18.47 34 211603 87958 50305529
Intentional overdose 240.84 18.47 4 211633 62500 50330987
Neuropathy peripheral 236.22 18.47 57 211580 96700 50296787
Oedema peripheral 233.12 18.47 191 211446 157770 50235717
Bradycardia 230.01 18.47 9 211628 64417 50329070
Drug abuse 229.88 18.47 4 211633 59842 50333645
Muscle spasticity 228.45 18.47 319 211318 16865 50376622
Cough 227.92 18.47 413 211224 240851 50152636
Somnolence 219.43 18.47 195 211442 154790 50238697
Syncope 214.70 18.47 81 211556 102921 50290566
Renal impairment 213.60 18.47 31 211606 75630 50317857
Night sweats 213.58 18.47 449 211188 33125 50360362
Cardiac failure congestive 213.39 18.47 46 211591 84336 50309151
Cardio-respiratory arrest 209.54 18.47 3 211634 53889 50339598
Gastrointestinal haemorrhage 207.09 18.47 30 211607 73291 50320196
Coma 206.32 18.47 7 211630 56872 50336615
Chest pain 204.27 18.47 264 211373 176618 50216869
Body temperature increased 203.87 18.47 423 211214 30918 50362569
Cerebrovascular accident 203.19 18.47 71 211566 94609 50298878
Psoriatic arthropathy 202.33 18.47 540 211097 46492 50346995
Ear pain 199.76 18.47 395 211242 27888 50365599
Therapeutic product effect incomplete 197.26 18.47 832 210805 90683 50302804
Sepsis 197.01 18.47 160 211477 132765 50260722
Electrocardiogram QT prolonged 193.25 18.47 5 211632 51881 50341606
Dyspnoea 192.30 18.47 1422 210215 546186 49847301
Depressed level of consciousness 189.84 18.47 6 211631 51947 50341540
Cardiac failure 189.15 18.47 43 211594 75997 50317490
Hyperkalaemia 185.59 18.47 3 211634 48086 50345401
Weight decreased 185.48 18.47 406 211231 220839 50172648
Hypoglycaemia 183.10 18.47 10 211627 53571 50339916
No adverse event 181.85 18.47 421 211216 33157 50360330
Myalgia 181.31 18.47 152 211485 124167 50269320
Dysphagia 180.90 18.47 50 211587 77468 50316019
Decreased appetite 179.11 18.47 356 211281 200567 50192920
Deep vein thrombosis 175.38 18.47 45 211592 73259 50320228
Gastrooesophageal reflux disease 175.20 18.47 51 211586 76377 50317110
Balance disorder 173.43 18.47 41 211596 70549 50322938
Agitation 173.40 18.47 13 211624 53371 50340116
Neutrophil count decreased 173.08 18.47 4 211633 46022 50347465
Suicide attempt 169.75 18.47 12 211625 51720 50341767
Pruritus 167.75 18.47 1868 209769 281700 50111787
Breast feeding 166.64 18.47 78 211559 770 50392717
Flushing 166.47 18.47 38 211599 66977 50326510
Hypoxia 164.50 18.47 13 211624 51110 50342377
Multiple organ dysfunction syndrome 164.23 18.47 12 211625 50325 50343162
International normalised ratio increased 161.30 18.47 4 211633 43148 50350339
Depression 158.95 18.47 280 211357 165143 50228344
Hallucination 158.52 18.47 9 211628 46648 50346839
Vomiting 155.14 18.47 1210 210427 459548 49933939
Type 2 diabetes mellitus 154.27 18.47 401 211236 33974 50359513
Blood pressure increased 153.34 18.47 199 211438 132933 50260554
Chest discomfort 152.45 18.47 100 211537 92622 50300865
Pulmonary oedema 150.55 18.47 15 211622 48923 50344564
Pleural effusion 147.83 18.47 78 211559 81376 50312111
Injection site discolouration 146.69 18.47 163 211474 6811 50386676
Diarrhoea 145.38 18.47 1669 209968 586807 49806680
Foot deformity 145.06 18.47 276 211361 18934 50374553
Blood pressure decreased 144.39 18.47 29 211608 55880 50337607
Adverse event 143.47 18.47 456 211181 43307 50350180
Blood creatinine increased 141.09 18.47 71 211566 76089 50317398
Suicidal ideation 140.41 18.47 30 211607 55355 50338132
Cognitive disorder 139.80 18.47 12 211625 44111 50349376
Rheumatoid nodule 139.75 18.47 216 211421 12519 50380968
Off label use 139.20 18.47 2768 208869 471658 49921829
Product availability issue 138.12 18.47 94 211543 1994 50391493
Rhabdomyolysis 137.45 18.47 6 211631 39021 50354466
Chronic kidney disease 137.21 18.47 7 211630 39764 50353723
Epistaxis 137.12 18.47 48 211589 63906 50329581
Feeling abnormal 136.03 18.47 196 211441 125296 50268191
Asthenia 135.72 18.47 781 210856 318261 50075226
Bone erosion 133.56 18.47 202 211435 11485 50382002
Respiratory disorder 133.02 18.47 357 211280 30830 50362657
Dyspnoea exertional 131.42 18.47 27 211610 51206 50342281
Mucosal inflammation 129.73 18.47 10 211627 40132 50353355
Lethargy 129.00 18.47 25 211612 49407 50344080
Blood alkaline phosphatase increased 125.18 18.47 8 211629 37518 50355969
Asthma 124.46 18.47 114 211523 89223 50304264
Colitis microscopic 122.93 18.47 144 211493 6376 50387111
Encephalopathy 122.78 18.47 4 211633 33707 50359780
Metabolic acidosis 121.81 18.47 11 211626 38814 50354673
Pulmonary hypertension 121.58 18.47 4 211633 33413 50360074
Vision blurred 121.12 18.47 91 211546 78556 50314931
Heart rate increased 120.75 18.47 88 211549 77162 50316325
Hyperglycaemia 120.73 18.47 8 211629 36397 50357090
Hyperhidrosis 120.03 18.47 118 211519 89308 50304179
Blood bilirubin increased 119.63 18.47 3 211634 32035 50361452
Chills 117.10 18.47 139 211498 96548 50296939
Hepatic failure 116.98 18.47 4 211633 32279 50361208
C-reactive protein abnormal 116.26 18.47 316 211321 27493 50365994
Psoriasis 115.07 18.47 582 211055 68418 50325069
Mental status changes 114.55 18.47 10 211627 36262 50357225
Drug tolerance decreased 114.29 18.47 165 211472 8995 50384492
Pneumonia 113.95 18.47 1023 210614 377378 50016109
Mobility decreased 113.38 18.47 645 210992 79303 50314184
Plasma cell myeloma 113.08 18.47 4 211633 31318 50362169
Heart rate decreased 112.75 18.47 11 211626 36486 50357001
Injection site reaction 112.54 18.47 461 211176 49571 50343916
Bone pain 111.05 18.47 30 211607 47199 50346288
Blood glucose increased 110.51 18.47 82 211555 71242 50322245
Urticaria 110.29 18.47 922 210715 128639 50264848
Unresponsive to stimuli 110.18 18.47 4 211633 30605 50362882
Glaucoma 109.45 18.47 218 211419 15468 50378019
Disorientation 108.82 18.47 11 211626 35473 50358014
Onychomycosis 108.04 18.47 119 211518 4923 50388564
Respiratory arrest 107.75 18.47 4 211633 30005 50363482
Ascites 107.71 18.47 12 211625 35849 50357638
Muscular weakness 107.35 18.47 144 211493 94869 50298618
Muscle spasms 107.09 18.47 228 211409 125325 50268162
Septic shock 106.34 18.47 53 211584 57122 50336365
Adverse drug reaction 105.95 18.47 485 211152 54737 50338750
Wrong technique in product usage process 105.46 18.47 50 211587 55460 50338027
Condition aggravated 104.60 18.47 1784 209853 295274 50098213
Dyskinesia 102.57 18.47 3 211634 27858 50365629
Pustular psoriasis 101.37 18.47 103 211534 3878 50389609
Red blood cell sedimentation rate increased 100.54 18.47 311 211326 29105 50364382
Leukopenia 100.35 18.47 81 211556 67447 50326040
Palpitations 99.08 18.47 151 211486 94355 50299132
Pain in jaw 99.08 18.47 20 211617 38408 50355079
Fluid retention 97.18 18.47 45 211592 50604 50342883
Pneumonia aspiration 96.69 18.47 9 211628 30995 50362492
Grip strength decreased 96.30 18.47 178 211459 11943 50381544
Lymphocyte count decreased 96.24 18.47 3 211634 26304 50367183
Dysarthria 95.33 18.47 20 211617 37383 50356104
Hypophagia 95.27 18.47 5 211632 27723 50365764
Contusion 93.69 18.47 795 210842 111388 50282099
Liver function test abnormal 92.13 18.47 35 211602 44304 50349183
Productive cough 91.91 18.47 53 211584 52641 50340846
Acute respiratory failure 90.71 18.47 8 211629 28774 50364713
Thrombosis 90.69 18.47 61 211576 55772 50337715
Emotional distress 90.25 18.47 8 211629 28655 50364832
Atrial fibrillation 89.93 18.47 181 211456 101564 50291923
Disturbance in attention 89.83 18.47 12 211625 31174 50362313
Gamma-glutamyltransferase increased 88.75 18.47 10 211627 29613 50363874
Orthostatic hypotension 88.20 18.47 10 211627 29471 50364016
Intentional product use issue 84.92 18.47 582 211055 76336 50317151
Blood creatine phosphokinase increased 84.00 18.47 7 211630 26360 50367127
COVID-19 immunisation 83.61 18.47 47 211590 699 50392788
Urinary retention 83.30 18.47 7 211630 26183 50367304
Intentional self-injury 83.26 18.47 3 211634 23109 50370378
Alanine aminotransferase increased 82.61 18.47 152 211485 88207 50305280
Memory impairment 82.04 18.47 128 211509 79232 50314255
Joint stiffness 81.87 18.47 296 211341 30012 50363475
Jaundice 81.55 18.47 8 211629 26421 50367066
Presyncope 81.18 18.47 5 211632 24193 50369294
Full blood count abnormal 81.05 18.47 4 211633 23384 50370103
Urinary incontinence 80.90 18.47 11 211626 28197 50365290
Haemorrhage 80.78 18.47 63 211574 53378 50340109
Blood cholesterol increased 80.60 18.47 449 211188 54766 50338721
Blood parathyroid hormone decreased 79.93 18.47 122 211515 6992 50386495
Haematemesis 79.07 18.47 11 211626 27714 50365773
Dysgeusia 78.74 18.47 32 211605 38884 50354603
Altered state of consciousness 78.39 18.47 3 211634 21907 50371580
Respiratory distress 78.33 18.47 16 211621 30473 50363014
Coronary artery disease 77.62 18.47 15 211622 29711 50363776
Enthesopathy 77.52 18.47 121 211516 7072 50386415
Haematocrit decreased 77.14 18.47 25 211612 34951 50358536
Melaena 75.81 18.47 11 211626 26853 50366634
Dysphonia 75.47 18.47 34 211603 38858 50354629
Cardiac disorder 75.28 18.47 43 211594 42936 50350551
Aphasia 75.21 18.47 14 211623 28480 50365007
Nephrolithiasis 75.13 18.47 316 211321 34377 50359110
Tenosynovitis 75.12 18.47 148 211489 10417 50383070
Cerebral haemorrhage 74.24 18.47 12 211625 27040 50366447
Speech disorder 73.96 18.47 28 211609 35520 50357967
Femur fracture 73.89 18.47 32 211605 37432 50356055
Full blood count decreased 73.83 18.47 5 211632 22341 50371146
Granuloma skin 72.88 18.47 105 211532 5713 50387774
Cholestasis 72.62 18.47 10 211627 25391 50368096
Hepatocellular injury 72.36 18.47 11 211626 25936 50367551
Myocardial infarction 72.33 18.47 166 211471 88861 50304626
Red blood cell count decreased 71.48 18.47 26 211611 33809 50359678
Systemic lupus erythematosus rash 71.32 18.47 59 211578 1696 50391791
Pericardial effusion 71.01 18.47 11 211626 25578 50367909
Therapy interrupted 70.67 18.47 215 211422 19937 50373550
Haematoma 70.56 18.47 20 211617 30490 50362997
Blood urea increased 70.56 18.47 8 211629 23577 50369910
Panniculitis 70.25 18.47 127 211510 8376 50385111
Nail disorder 70.24 18.47 137 211500 9571 50383916
Agranulocytosis 70.17 18.47 5 211632 21416 50372071
Arthrodesis 70.13 18.47 68 211569 2417 50391070
Angioedema 69.94 18.47 35 211602 37641 50355846
Acute myocardial infarction 69.94 18.47 18 211619 29255 50364232
Sinus tachycardia 69.91 18.47 5 211632 21349 50372138
Transient ischaemic attack 69.33 18.47 24 211613 32186 50361301
Hepatic function abnormal 69.24 18.47 25 211612 32656 50360831
Sleep apnoea syndrome 69.18 18.47 9 211628 23859 50369628
Irritability 68.84 18.47 17 211620 28409 50365078
Accidental exposure to product 68.53 18.47 8 211629 23049 50370438
Tinnitus 67.79 18.47 17 211620 28115 50365372
Drug level increased 67.72 18.47 3 211634 19265 50374222
Bedridden 67.55 18.47 132 211505 9235 50384252
Arrhythmia 67.43 18.47 27 211610 33105 50360382
Generalised tonic-clonic seizure 67.19 18.47 14 211623 26296 50367191
Product label confusion 67.15 18.47 36 211601 485 50393002
Shock 67.13 18.47 5 211632 20645 50372842
Blood sodium decreased 66.31 18.47 6 211631 21141 50372346
Aspartate aminotransferase increased 66.18 18.47 142 211495 77856 50315631
Blood potassium decreased 66.10 18.47 36 211601 36909 50356578
Stevens-Johnson syndrome 66.03 18.47 7 211630 21745 50371742
Coeliac disease 65.83 18.47 125 211512 8560 50384927
Red blood cell sedimentation rate 65.62 18.47 78 211559 3508 50389979
Nerve injury 65.55 18.47 122 211515 8228 50385259
Restlessness 65.11 18.47 13 211624 25160 50368327
Weight increased 63.67 18.47 1192 210445 200699 50192788
Drug dependence 63.62 18.47 5 211632 19754 50373733
Haemoptysis 62.51 18.47 15 211622 25558 50367929
Chronic obstructive pulmonary disease 62.37 18.47 79 211558 53356 50340131
Eosinophilia 62.14 18.47 4 211633 18648 50374839
General physical health deterioration 61.64 18.47 886 210751 141548 50251939
Live birth 61.27 18.47 179 211458 16229 50377258
Cholelithiasis 60.98 18.47 42 211595 37931 50355556
Rash maculo-papular 60.62 18.47 18 211619 26623 50366864
Abnormal behaviour 60.52 18.47 6 211631 19652 50373835
Blood lactate dehydrogenase increased 60.15 18.47 6 211631 19556 50373931
Onychomadesis 59.96 18.47 74 211563 3462 50390025
Leukocytosis 59.80 18.47 11 211626 22568 50370919
Transaminases abnormal 58.42 18.47 34 211603 542 50392945
Dry mouth 57.68 18.47 91 211546 56087 50337400
Visual acuity reduced 57.41 18.47 8 211629 20131 50373356
Hot flush 57.29 18.47 60 211577 44109 50349378
Hemiparesis 57.06 18.47 8 211629 20040 50373447
Psychotic disorder 56.97 18.47 11 211626 21801 50371686
Head injury 56.95 18.47 15 211622 24005 50369482
Metastases to bone 56.71 18.47 5 211632 17990 50375497
Delirium 56.49 18.47 46 211591 38146 50355341
Pancreatitis 56.28 18.47 57 211580 42557 50350930
Ejection fraction decreased 56.12 18.47 6 211631 18514 50374973
Vertigo 56.08 18.47 81 211556 51751 50341736
Epilepsy 56.07 18.47 11 211626 21556 50371931
Withdrawal syndrome 55.13 18.47 5 211632 17585 50375902
Throat irritation 54.78 18.47 29 211608 30210 50363277
Upper gastrointestinal haemorrhage 54.75 18.47 3 211634 16032 50377455
Feeling hot 54.60 18.47 50 211587 39152 50354335
Transaminases increased 54.50 18.47 24 211613 27800 50365687
Heart rate irregular 54.46 18.47 8 211629 19352 50374135
Aggression 54.41 18.47 11 211626 21105 50372382
Pancreatitis acute 54.35 18.47 16 211621 23796 50369691
Cerebral infarction 54.14 18.47 12 211625 21592 50371895
White blood cell count increased 54.09 18.47 58 211579 42182 50351305
Angina pectoris 53.86 18.47 21 211616 26167 50367320
Haematuria 53.57 18.47 20 211617 25593 50367894
Disseminated intravascular coagulation 53.36 18.47 5 211632 17130 50376357
Obstructive airways disorder 53.22 18.47 3 211634 15649 50377838
Lymphopenia 53.10 18.47 3 211634 15618 50377869
Metastases to liver 52.80 18.47 10 211627 20094 50373393
Circulatory collapse 52.42 18.47 10 211627 19990 50373497
Joint dislocation 52.40 18.47 141 211496 12192 50381295
Laboratory test abnormal 52.23 18.47 16 211621 23192 50370295
Pallor 52.20 18.47 16 211621 23183 50370304
Coagulopathy 51.45 18.47 7 211630 17937 50375550
Myelodysplastic syndrome 51.15 18.47 3 211634 15129 50378358
Ventricular tachycardia 50.95 18.47 4 211633 15817 50377670
Pulmonary fibrosis 50.91 18.47 220 211417 24217 50369270
Blood calcium decreased 50.89 18.47 12 211625 20694 50372793
Erythema 50.68 18.47 381 211256 146033 50247454
Rectal haemorrhage 50.43 18.47 52 211585 38506 50354981
Depressed mood 50.30 18.47 41 211596 33982 50359505
Hip fracture 49.80 18.47 23 211614 25908 50367579
Ankle arthroplasty 49.73 18.47 40 211597 1104 50392383
Diplopia 49.70 18.47 10 211627 19250 50374237
Underdose 49.35 18.47 12 211625 20266 50373221
Complication associated with device 49.25 18.47 3 211634 14652 50378835
Amnesia 48.78 18.47 63 211574 42197 50351290
Device malfunction 48.20 18.47 4 211633 15117 50378370
Acute myeloid leukaemia 48.02 18.47 4 211633 15070 50378417
Nervousness 47.95 18.47 28 211609 27623 50365864
Crying 47.93 18.47 13 211624 20403 50373084
Basal cell carcinoma 47.69 18.47 209 211428 23147 50370340
Product administration error 47.28 18.47 12 211625 19687 50373800
Hypoacusis 46.89 18.47 14 211623 20633 50372854
Product substitution issue 46.87 18.47 3 211634 14054 50379433
Oral pain 46.85 18.47 23 211614 25010 50368477
Hypocalcaemia 46.72 18.47 27 211610 26789 50366698
Acute respiratory distress syndrome 46.67 18.47 15 211622 21084 50372403
Device issue 46.36 18.47 13 211624 19959 50373528
Rhinorrhoea 46.22 18.47 91 211546 51492 50341995
Renal disorder 46.09 18.47 29 211608 27476 50366011
Mitral valve incompetence 45.23 18.47 9 211628 17462 50376025
Hypermobility syndrome 45.19 18.47 32 211605 725 50392762
Cytomegalovirus infection 44.96 18.47 10 211627 17952 50375535
Skin necrosis 44.92 18.47 123 211514 10744 50382743
Osteonecrosis 44.77 18.47 19 211618 22498 50370989
Frequent bowel movements 44.66 18.47 144 211493 13774 50379713
Mental disorder 44.62 18.47 18 211619 21973 50371514
Multiple sclerosis 44.57 18.47 15 211622 20478 50373009
SARS-CoV-2 test negative 44.52 18.47 25 211612 371 50393116
Twin pregnancy 44.36 18.47 37 211600 1076 50392411
Pneumonitis 44.33 18.47 35 211602 29475 50364012
Nasal congestion 44.25 18.47 92 211545 51028 50342459
Swollen tongue 44.22 18.47 33 211604 28597 50364890
Anal abscess 43.99 18.47 66 211571 3725 50389762
Restless legs syndrome 43.73 18.47 7 211630 15890 50377597
Eye pain 43.68 18.47 33 211604 28416 50365071
Skin lesion 43.67 18.47 29 211608 26698 50366789
Skin exfoliation 43.21 18.47 46 211591 33566 50359921
Myoclonus 43.06 18.47 5 211632 14465 50379022
Skin reaction 43.00 18.47 126 211511 11442 50382045
Extremity contracture 42.66 18.47 38 211599 1210 50392277
Transfusion 42.31 18.47 3 211634 12902 50380585
Ankylosing spondylitis 42.30 18.47 93 211544 7072 50386415
Abdominal pain 42.25 18.47 714 210923 235514 50157973
Tuberculin test positive 42.12 18.47 59 211578 3127 50390360
Loss of consciousness 41.83 18.47 260 211377 104093 50289394
Blood pressure fluctuation 41.77 18.47 53 211584 35770 50357717
Urinary tract infection 41.74 18.47 672 210965 223348 50170139
Ischaemic stroke 41.74 18.47 8 211629 15940 50377547
Fine motor skill dysfunction 41.43 18.47 67 211570 4036 50389451
Feeling cold 41.27 18.47 15 211622 19516 50373971
Panic attack 40.63 18.47 15 211622 19327 50374160
Dry skin 39.73 18.47 75 211562 43116 50350371
Bunion operation 39.62 18.47 35 211602 1102 50392385
Fear of injection 39.24 18.47 82 211555 6021 50387466
Diabetic ketoacidosis 39.01 18.47 13 211624 17859 50375628
Tachypnoea 38.82 18.47 7 211630 14570 50378917
Vaginal haemorrhage 38.31 18.47 28 211609 24523 50368964
Nightmare 38.22 18.47 10 211627 16076 50377411
Drug tolerance 38.18 18.47 72 211565 4904 50388583
X-ray abnormal 37.91 18.47 51 211586 2601 50390886
Dementia 37.90 18.47 10 211627 15987 50377500
Inability to afford medication 37.89 18.47 39 211598 1491 50391996
Dysuria 37.78 18.47 38 211599 28466 50365021
Liver injury 37.71 18.47 204 211433 24602 50368885
Infusion site pain 37.41 18.47 4 211633 12342 50381145
Hiatus hernia 37.25 18.47 15 211622 18329 50375158
Subdural haematoma 37.24 18.47 5 211632 12942 50380545
Oedema 37.08 18.47 159 211478 70022 50323465
Blood glucose decreased 36.80 18.47 15 211622 18196 50375291
Tricuspid valve incompetence 36.57 18.47 5 211632 12765 50380722
Mental impairment 36.24 18.47 4 211633 12040 50381447
Uveitis 36.15 18.47 103 211534 9207 50384280
Peritonitis 36.09 18.47 10 211627 15476 50378011
Hyperlipidaemia 36.01 18.47 14 211623 17476 50376011
Ileus 36.00 18.47 6 211631 13223 50380264
Tongue disorder 35.82 18.47 102 211535 9114 50384373
Hypercholesterolaemia 35.68 18.47 119 211518 11584 50381903
Rib fracture 35.46 18.47 18 211619 19203 50374284
Foot operation 35.38 18.47 74 211563 5436 50388051
Hypothyroidism 35.29 18.47 55 211582 34070 50359417
Blood pressure diastolic decreased 35.27 18.47 13 211624 16768 50376719
Blindness 35.26 18.47 14 211623 17255 50376232
Gastritis 35.23 18.47 52 211585 32931 50360556
Flatulence 34.95 18.47 43 211594 29415 50364072
Electrolyte imbalance 34.92 18.47 14 211623 17155 50376332
Treatment noncompliance 34.74 18.47 45 211592 30105 50363382
Disease susceptibility 34.64 18.47 17 211620 188 50393299
Ageusia 34.47 18.47 4 211633 11579 50381908
Supraventricular tachycardia 34.41 18.47 6 211631 12795 50380692
Bacteraemia 34.24 18.47 9 211628 14424 50379063
Body temperature decreased 33.96 18.47 13 211624 16382 50377105
Bone disorder 33.94 18.47 18 211619 18734 50374753
Blood triglycerides increased 33.43 18.47 4 211633 11308 50382179
Exostosis 33.34 18.47 116 211521 11537 50381950
Metastases to central nervous system 33.32 18.47 4 211633 11278 50382209
Acute hepatic failure 33.19 18.47 12 211625 15665 50377822
Surgery 32.98 18.47 228 211409 29977 50363510
Left ventricular dysfunction 32.89 18.47 3 211634 10503 50382984
Platelet count increased 32.76 18.47 10 211627 14530 50378957
Intentional dose omission 32.64 18.47 68 211569 4982 50388505
Face oedema 32.47 18.47 17 211620 17822 50375665
Lung infiltration 32.45 18.47 8 211629 13385 50380102
Adverse reaction 32.38 18.47 94 211543 8492 50384995
Muscle twitching 32.35 18.47 12 211625 15419 50378068
Glomerular filtration rate decreased 32.35 18.47 5 211632 11647 50381840
Macular degeneration 32.23 18.47 10 211627 14378 50379109
Abdominal distension 32.22 18.47 176 211461 72727 50320760
Clostridium difficile colitis 32.16 18.47 17 211620 17725 50375762
Hyperthyroidism 32.09 18.47 6 211631 12169 50381318
Tuberculosis 32.06 18.47 104 211533 9979 50383508
Mania 31.92 18.47 4 211633 10912 50382575
Acidosis 31.80 18.47 3 211634 10224 50383263
Swelling face 31.72 18.47 113 211524 52482 50341005
Limb injury 31.72 18.47 23 211614 20227 50373260
Lupus-like syndrome 31.18 18.47 99 211538 9392 50384095
Device related infection 30.63 18.47 25 211612 20710 50372777
Lip swelling 30.53 18.47 35 211602 24701 50368786
Device difficult to use 30.48 18.47 3 211634 9883 50383604
Bronchospasm 30.40 18.47 12 211625 14842 50378645
Ventricular extrasystoles 30.39 18.47 4 211633 10512 50382975
Wheezing 30.13 18.47 145 211492 61902 50331585
Poor quality sleep 30.10 18.47 16 211621 16630 50376857
Urine output decreased 30.03 18.47 4 211633 10417 50383070
Abdominal pain lower 30.00 18.47 28 211609 21728 50371759
Tubulointerstitial nephritis 29.98 18.47 13 211624 15198 50378289
Rash erythematous 29.93 18.47 63 211574 34789 50358698
Polyneuropathy 29.87 18.47 7 211630 12124 50381363
Drug hypersensitivity 29.82 18.47 1309 210328 249701 50143786
Maternal exposure timing unspecified 29.81 18.47 54 211583 3566 50389921
Seasonal allergy 29.80 18.47 12 211625 14664 50378823
Diabetic eye disease 29.75 18.47 14 211623 140 50393347
Product complaint 29.49 18.47 6 211631 11460 50382027
Haemorrhoids 29.38 18.47 22 211615 19031 50374456
Cardiomegaly 29.31 18.47 15 211622 15930 50377557
Pneumothorax 29.28 18.47 11 211626 14023 50379464
Herpes zoster 29.27 18.47 437 211200 70349 50323138
Therapeutic response unexpected 29.21 18.47 15 211622 15900 50377587
Immobile 29.16 18.47 65 211572 4989 50388498
Liver function test increased 28.98 18.47 195 211442 25411 50368076
C-reactive protein increased 28.92 18.47 414 211223 66060 50327427
Latent tuberculosis 28.86 18.47 41 211596 2202 50391285
Sensory disturbance 28.79 18.47 7 211630 11822 50381665
Pain in extremity 28.60 18.47 896 210741 271969 50121518
Cold sweat 28.59 18.47 5 211632 10639 50382848
Pelvic pain 28.56 18.47 6 211631 11207 50382280
Oral discomfort 28.54 18.47 86 211551 7931 50385556
Osteopenia 28.43 18.47 18 211619 17000 50376487
Dry eye 28.42 18.47 57 211580 32038 50361449
Mood altered 28.40 18.47 9 211628 12764 50380723
Lacrimation increased 28.35 18.47 18 211619 16974 50376513
Back pain 28.31 18.47 702 210935 219328 50174159
Delusion 28.31 18.47 5 211632 10564 50382923
Blood albumin decreased 28.25 18.47 10 211627 13226 50380261
Neutrophil count increased 28.19 18.47 12 211625 14183 50379304
Cardiomyopathy 28.15 18.47 15 211622 15571 50377916
Lower limb fracture 27.96 18.47 126 211511 14120 50379367
Product dose omission issue 27.75 18.47 984 210653 182854 50210633
Breast cancer metastatic 27.55 18.47 5 211632 10359 50383128
Ulcer 27.32 18.47 161 211476 20039 50373448
Hepatomegaly 27.03 18.47 6 211631 10787 50382700
Anger 27.01 18.47 7 211630 11326 50382161
Thinking abnormal 26.80 18.47 4 211633 9563 50383924
Toothache 26.71 18.47 19 211618 16875 50376612
Blood magnesium decreased 26.40 18.47 7 211630 11153 50382334
Feeding disorder 26.38 18.47 6 211631 10607 50382880
Pseudomonas infection 26.29 18.47 4 211633 9426 50384061
Decubitus ulcer 26.24 18.47 4 211633 9414 50384073
Gallbladder disorder 26.24 18.47 19 211618 16723 50376764
Dermatitis psoriasiform 26.22 18.47 34 211603 1672 50391815
Inflammation 26.19 18.47 358 211279 56554 50336933
Abnormal dreams 26.09 18.47 4 211633 9373 50384114
Hypoalbuminaemia 25.69 18.47 5 211632 9855 50383632
Faeces discoloured 25.67 18.47 18 211619 16106 50377381
Aspiration 25.66 18.47 4 211633 9260 50384227
Oesophagitis 25.50 18.47 12 211625 13371 50380116
Retching 25.34 18.47 11 211626 12851 50380636
Lymphoedema 25.13 18.47 4 211633 9118 50384369
Chromaturia 24.98 18.47 15 211622 14575 50378912
Splenomegaly 24.96 18.47 5 211632 9655 50383832
Neuralgia 24.81 18.47 33 211604 21830 50371657
Hypophosphataemia 24.81 18.47 3 211634 8411 50385076
Epicondylitis 24.71 18.47 35 211602 1874 50391613
Sneezing 24.66 18.47 14 211623 14030 50379457
Sudden death 24.64 18.47 4 211633 8987 50384500
Sleep disorder 24.61 18.47 356 211281 56927 50336560
Alanine aminotransferase abnormal 24.60 18.47 54 211583 4102 50389385
Musculoskeletal disorder 24.59 18.47 140 211497 17209 50376278
Acute generalised exanthematous pustulosis 24.44 18.47 4 211633 8934 50384553
Myocardial ischaemia 24.40 18.47 9 211628 11604 50381883
Eye pruritus 24.25 18.47 11 211626 12523 50380964
Pollakiuria 24.13 18.47 39 211598 23812 50369675
Incontinence 24.12 18.47 6 211631 9979 50383508
Rales 24.10 18.47 6 211631 9972 50383515
Prothrombin time prolonged 24.07 18.47 4 211633 8834 50384653
Eosinophil count increased 24.04 18.47 4 211633 8826 50384661
Middle insomnia 23.89 18.47 6 211631 9915 50383572
Colitis 23.76 18.47 82 211555 38447 50355040
Product use in unapproved indication 23.74 18.47 341 211296 115478 50278009
Premature delivery 23.74 18.47 175 211462 23488 50369999
Confusional state 23.73 18.47 977 210660 184951 50208536
Paraesthesia 23.61 18.47 357 211280 119886 50273601
Incorrect product administration duration 23.55 18.47 5 211632 9270 50384217
Emotional disorder 23.51 18.47 10 211627 11826 50381661
Injection site pallor 23.33 18.47 9 211628 52 50393435
Cardiac murmur 23.27 18.47 8 211629 10776 50382711
Hypokinesia 23.20 18.47 11 211626 12206 50381281
Spinal compression fracture 23.12 18.47 12 211625 12644 50380843
Throat tightness 23.12 18.47 32 211605 20815 50372672
Rectal abscess 23.03 18.47 25 211612 1017 50392470
Rash macular 23.02 18.47 28 211609 19249 50374238
Musculoskeletal chest pain 22.98 18.47 26 211611 18460 50375027
Choking 22.81 18.47 4 211633 8494 50384993
Petechiae 22.66 18.47 12 211625 12500 50380987
Immune thrombocytopenia 22.61 18.47 5 211632 9012 50384475
Atelectasis 22.39 18.47 26 211611 18244 50375243
Axial spondyloarthritis 22.35 18.47 13 211624 207 50393280
Mycobacterium tuberculosis complex test positive 22.31 18.47 32 211605 1734 50391753
Ileocolectomy 22.26 18.47 7 211630 19 50393468
Hepatitis 22.17 18.47 63 211574 31390 50362097
Taste disorder 22.16 18.47 4 211633 8320 50385167
Cataract 22.12 18.47 112 211525 47188 50346299
Retinitis 22.11 18.47 33 211604 1854 50391633
Respiratory rate increased 22.01 18.47 10 211627 11375 50382112
Injection site swelling 21.83 18.47 269 211368 41504 50351983
Retinal deposits 21.52 18.47 9 211628 66 50393421
Hallucination, auditory 21.41 18.47 9 211628 10719 50382768
Gastric ulcer 21.40 18.47 35 211602 21270 50372217
Sputum discoloured 21.26 18.47 15 211622 13380 50380107
Palmoplantar pustulosis 21.14 18.47 16 211621 403 50393084
Tenderness 21.09 18.47 28 211609 18537 50374950
Hepatic encephalopathy 21.05 18.47 7 211630 9629 50383858
Hemiplegia 20.88 18.47 3 211634 7378 50386109
Skin laceration 20.82 18.47 29 211608 18813 50374674
Metastases to lung 20.81 18.47 10 211627 11010 50382477
Head discomfort 20.81 18.47 10 211627 11009 50382478
Premature labour 20.79 18.47 11 211626 11465 50382022
Myocarditis 20.77 18.47 4 211633 7943 50385544
Adjustment disorder with depressed mood 20.71 18.47 40 211597 2774 50390713
Deafness 20.70 18.47 21 211616 15670 50377817
Diverticulitis 20.63 18.47 221 211416 32961 50360526
Burning sensation 20.47 18.47 109 211528 45337 50348150
Blood pressure systolic increased 20.17 18.47 78 211559 35371 50358116
Paranoia 20.15 18.47 9 211628 10339 50383148
Sensory loss 20.00 18.47 4 211633 7734 50385753
Rheumatoid factor negative 19.98 18.47 18 211619 582 50392905
Eating disorder 19.90 18.47 21 211616 15388 50378099
Eructation 19.90 18.47 3 211634 7118 50386369
Hyperthermia 19.85 18.47 4 211633 7692 50385795
Cholecystitis acute 19.84 18.47 3 211634 7103 50386384
Impaired gastric emptying 19.64 18.47 6 211631 8712 50384775
Spinal osteoarthritis 19.59 18.47 18 211619 14074 50379413
Haematochezia 19.48 18.47 93 211544 39789 50353698
Glycosylated haemoglobin increased 19.46 18.47 10 211627 10596 50382891
Epstein-Barr virus infection 19.43 18.47 3 211634 6994 50386493
Tendonitis 19.38 18.47 128 211509 16577 50376910
Malnutrition 19.36 18.47 16 211621 13173 50380314
Skin discolouration 19.34 18.47 71 211566 32686 50360801
Dislocation of vertebra 19.29 18.47 41 211596 3046 50390441
Perirectal abscess 19.27 18.47 21 211616 858 50392629
Drug resistance 19.26 18.47 31 211606 18958 50374529
Spinal fracture 19.26 18.47 22 211615 15551 50377936
Liver disorder 19.25 18.47 85 211552 37137 50356350
Disseminated large cell lymphoma 19.21 18.47 8 211629 58 50393429
Heavy menstrual bleeding 19.16 18.47 22 211615 15515 50377972
Dysstasia 19.12 18.47 28 211609 17791 50375696
Syringe issue 18.97 18.47 33 211604 2111 50391376
Nodule 18.95 18.47 129 211508 16874 50376613
Lip ulceration 18.94 18.47 30 211607 1775 50391712
Anti-cyclic citrullinated peptide antibody 18.88 18.47 28 211609 1564 50391923
Central nervous system lesion 18.87 18.47 8 211629 9481 50384006
Aspergillus infection 18.77 18.47 3 211634 6818 50386669
Purpura 18.71 18.47 9 211628 9902 50383585
Diabetes mellitus 18.70 18.47 124 211513 48909 50344578
Exposure via breast milk 18.67 18.47 28 211609 1580 50391907
Skin disorder 18.56 18.47 46 211591 23984 50369503
Eye haemorrhage 18.53 18.47 4 211633 7331 50386156
Insurance issue 18.48 18.47 36 211601 2512 50390975

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 1304.86 18.97 1562 23704 361608 29187653
Synovitis 498.82 18.97 224 25042 10666 29538595
Treatment failure 368.41 18.97 282 24984 36657 29512604
No adverse event 331.98 18.97 199 25067 17279 29531982
Loss of personal independence in daily activities 284.23 18.97 208 25058 25232 29524029
Rheumatoid arthritis 270.12 18.97 222 25044 31930 29517331
Joint swelling 262.18 18.97 264 25002 49366 29499895
Therapeutic product effect decreased 227.99 18.97 194 25072 29257 29520004
Maternal exposure before pregnancy 199.85 18.97 52 25214 432 29548829
Contraindicated product administered 196.40 18.97 146 25120 18120 29531141
Product dose omission issue 192.41 18.97 316 24950 96067 29453194
Drug hypersensitivity 188.85 18.97 261 25005 68145 29481116
Tenosynovitis 181.09 18.97 80 25186 3653 29545608
Enthesopathy 180.88 18.97 80 25186 3663 29545598
Pain 180.11 18.97 429 24837 171003 29378258
C-reactive protein abnormal 163.14 18.97 89 25177 6447 29542814
Drug intolerance 160.35 18.97 202 25064 48177 29501084
Musculoskeletal stiffness 158.16 18.97 177 25089 37281 29511980
Ankylosing spondylitis 154.05 18.97 74 25192 4102 29545159
Arthropathy 146.67 18.97 132 25134 21422 29527839
Arthralgia 143.86 18.97 347 24919 139270 29409991
Maternal exposure during pregnancy 139.88 18.97 69 25197 4054 29545207
Acute kidney injury 128.87 18.97 34 25232 265233 29284028
Tongue disorder 123.71 18.97 66 25200 4570 29544691
Red blood cell sedimentation rate abnormal 123.58 18.97 53 25213 2250 29547011
Toxicity to various agents 123.52 18.97 6 25260 173655 29375606
Psoriasis 120.39 18.97 143 25123 32084 29517177
Alanine aminotransferase abnormal 120.11 18.97 56 25210 2901 29546360
Drug interaction 115.41 18.97 16 25250 197369 29351892
Frequent bowel movements 108.67 18.97 78 25188 9161 29540100
Surgery 106.55 18.97 85 25181 11694 29537567
Hypotension 97.98 18.97 23 25243 194331 29354930
Product availability issue 95.99 18.97 36 25230 1071 29548190
Cytology abnormal 95.72 18.97 28 25238 372 29548889
Tendonitis 93.14 18.97 67 25199 7894 29541367
Gastric disorder 92.06 18.97 75 25191 10629 29538632
C-reactive protein increased 89.28 18.97 146 25120 44117 29505144
Physical disability 88.12 18.97 35 25231 1219 29548042
Knee arthroplasty 84.73 18.97 56 25210 5753 29543508
Infection 84.53 18.97 196 25070 76555 29472706
Therapy interrupted 79.02 18.97 62 25204 8324 29540937
Confusional state 77.98 18.97 9 25257 127868 29421393
Joint lock 74.02 18.97 30 25236 1102 29548159
Neutropenia 73.86 18.97 12 25254 131699 29417562
Prerenal failure 73.04 18.97 34 25232 1754 29547507
Polyarthritis 72.45 18.97 44 25222 3901 29545360
Injection site pain 72.25 18.97 112 25154 32334 29516927
Rash 70.81 18.97 335 24931 189484 29359777
Renal failure 70.70 18.97 9 25257 118590 29430671
Mobility decreased 70.44 18.97 98 25168 25682 29523579
Premature baby 70.04 18.97 80 25186 17200 29532061
Nasopharyngitis 68.57 18.97 155 25111 59510 29489751
Fine motor skill dysfunction 68.07 18.97 31 25235 1520 29547741
Abdominal pain 67.53 18.97 261 25005 135096 29414165
Inflammation 66.02 18.97 89 25177 22639 29526622
Seronegative arthritis 65.66 18.97 26 25240 898 29548363
Exposure via breast milk 65.15 18.97 31 25235 1681 29547580
Skin mass 64.77 18.97 39 25227 3404 29545857
Bone erosion 61.79 18.97 35 25231 2725 29546536
Psoriatic arthropathy 61.21 18.97 69 25197 14622 29534639
Low birth weight baby 60.42 18.97 48 25218 6560 29542701
Pancytopenia 58.65 18.97 3 25263 83165 29466096
Thrombocytopenia 58.62 18.97 21 25245 134802 29414459
Abdominal abscess 58.53 18.97 38 25228 3786 29545475
Completed suicide 58.52 18.97 5 25261 90241 29459020
Off label use 57.59 18.97 446 24820 300354 29248907
Prostate cancer 56.66 18.97 88 25178 25439 29523822
Palmoplantar pustulosis 56.15 18.97 14 25252 96 29549165
Pustular psoriasis 56.01 18.97 27 25239 1507 29547754
Hypersensitivity 54.82 18.97 132 25134 52771 29496490
Tuberculosis 54.78 18.97 47 25219 7149 29542112
Foetal exposure during pregnancy 54.30 18.97 101 25165 33766 29515495
Anaemia 53.21 18.97 56 25210 200895 29348366
Latent tuberculosis 52.33 18.97 23 25243 1036 29548225
Therapeutic product effect incomplete 51.86 18.97 108 25158 39197 29510064
Herpes zoster 51.18 18.97 92 25174 29960 29519301
Joint stiffness 51.01 18.97 51 25215 9422 29539839
White blood cell count decreased 50.46 18.97 6 25260 83356 29465905
Blood creatinine increased 49.41 18.97 7 25259 85095 29464166
Disease progression 49.32 18.97 6 25260 81910 29467351
Renal impairment 48.87 18.97 6 25260 81327 29467934
Peripheral swelling 48.71 18.97 142 25124 63597 29485664
Anti-cyclic citrullinated peptide antibody positive 47.65 18.97 20 25246 804 29548457
Nephrolithiasis 46.30 18.97 80 25186 25254 29524007
Neck mass 44.98 18.97 23 25243 1458 29547803
Rheumatoid factor negative 44.19 18.97 19 25247 811 29548450
Sinusitis 43.70 18.97 93 25173 34257 29515004
Injection site reaction 42.32 18.97 50 25216 11138 29538123
Fistula 42.07 18.97 35 25231 5104 29544157
Arthritis 41.84 18.97 76 25190 24943 29524318
Musculoskeletal pain 39.88 18.97 81 25185 28872 29520389
Impaired work ability 39.24 18.97 35 25231 5605 29543656
Crohn's disease 39.08 18.97 27 25239 2982 29546279
Platelet count decreased 38.09 18.97 21 25245 104651 29444610
Seizure 37.98 18.97 16 25250 93107 29456154
Mass 37.76 18.97 38 25228 7073 29542188
Cardiac arrest 37.74 18.97 13 25253 85578 29463683
Hospitalisation 37.59 18.97 105 25161 45883 29503378
Injection site bruising 37.52 18.97 39 25227 7541 29541720
Syncope 36.50 18.97 12 25254 81359 29467902
Rectal abscess 35.46 18.97 17 25249 937 29548324
Overdose 35.40 18.97 12 25254 79807 29469454
Rhabdomyolysis 35.29 18.97 5 25261 60803 29488458
Constipation 34.68 18.97 28 25238 114132 29435129
Dyspnoea 34.46 18.97 153 25113 326579 29222682
Abscess 34.26 18.97 42 25224 9720 29539541
COVID-19 immunisation 34.11 18.97 10 25256 134 29549127
Motor dysfunction 33.92 18.97 33 25233 5897 29543364
Tachycardia 33.69 18.97 10 25256 72400 29476861
Anal fistula 33.16 18.97 28 25238 4167 29545094
Insurance issue 32.60 18.97 16 25250 929 29548332
Swelling 32.29 18.97 84 25182 35199 29514062
Hyponatraemia 32.09 18.97 9 25257 67624 29481637
Disability 31.91 18.97 28 25238 4388 29544873
Basal cell carcinoma 31.68 18.97 54 25212 16856 29532405
Axial spondyloarthritis 31.55 18.97 11 25255 264 29548997
Bradycardia 30.65 18.97 9 25257 65620 29483641
Red blood cell sedimentation rate 30.55 18.97 13 25253 541 29548720
Intentional dose omission 30.32 18.97 20 25246 2046 29547215
Body mass index abnormal 30.14 18.97 9 25257 129 29549132
Limb discomfort 30.13 18.97 39 25227 9529 29539732
Rheumatoid factor 29.98 18.97 8 25258 74 29549187
Product use in unapproved indication 29.39 18.97 19 25247 86856 29462405
Headache 28.82 18.97 250 25016 173757 29375504
Decreased appetite 28.80 18.97 50 25216 145292 29403969
Granuloma skin 28.59 18.97 13 25253 635 29548626
Somnolence 28.59 18.97 23 25243 93932 29455329
Rheumatoid factor positive 28.40 18.97 13 25253 645 29548616
Maternal exposure during breast feeding 28.38 18.97 17 25249 1469 29547792
Mycobacterium tuberculosis complex test positive 28.38 18.97 15 25251 1018 29548243
Cardiac failure congestive 28.38 18.97 15 25251 76566 29472695
Ill-defined disorder 28.37 18.97 42 25224 11636 29537625
Joint range of motion decreased 27.92 18.97 30 25236 6024 29543237
Anal abscess 27.77 18.97 28 25238 5223 29544038
Cardio-respiratory arrest 27.47 18.97 5 25261 50596 29498665
Rheumatoid factor increased 27.31 18.97 12 25254 540 29548721
Drug tolerance decreased 27.28 18.97 16 25250 1330 29547931
Bladder transitional cell carcinoma 27.16 18.97 20 25246 2441 29546820
Sacroiliitis 27.16 18.97 15 25251 1112 29548149
Asthenia 26.97 18.97 94 25172 215156 29334105
Folliculitis 26.73 18.97 24 25242 3876 29545385
Perirectal abscess 26.03 18.97 16 25250 1449 29547812
Ligament calcification 26.01 18.97 9 25257 211 29549050
Respiratory failure 25.73 18.97 27 25239 97104 29452157
Blood parathyroid hormone decreased 25.62 18.97 13 25253 811 29548450
Multiple organ dysfunction syndrome 25.47 18.97 11 25255 63105 29486156
Injection site erythema 25.40 18.97 44 25222 13912 29535349
Hallucination 25.20 18.97 4 25262 44708 29504553
Atrial fibrillation 25.14 18.97 32 25234 105614 29443647
Cellulitis 24.94 18.97 91 25175 45749 29503512
Gastrointestinal haemorrhage 24.78 18.97 19 25247 79514 29469747
Blood creatine phosphokinase increased 24.40 18.97 3 25263 40641 29508620
Dermatitis psoriasiform 24.32 18.97 14 25252 1124 29548137
Oedema 24.27 18.97 3 25263 40480 29508781
Fall 23.82 18.97 75 25191 177103 29372158
Hypoglycaemia 23.75 18.97 6 25260 48340 29500921
Hip arthroplasty 23.56 18.97 22 25244 3736 29545525
Erythema 23.53 18.97 127 25139 75479 29473782
Panniculitis 23.40 18.97 14 25252 1207 29548054
Hypokalaemia 23.23 18.97 7 25259 50196 29499065
Oxygen saturation decreased 23.22 18.97 5 25261 44932 29504329
Fistula discharge 23.08 18.97 10 25256 435 29548826
Pneumonia 22.87 18.97 392 24874 319780 29229481
International normalised ratio increased 22.80 18.97 5 25261 44367 29504894
Loss of consciousness 22.68 18.97 18 25248 74038 29475223
Haematuria 22.63 18.97 5 25261 44134 29505127
Therapeutic response shortened 22.55 18.97 24 25242 4767 29544494
Bronchitis 22.48 18.97 76 25190 36792 29512469
Spinal pain 22.25 18.97 24 25242 4840 29544421
Agitation 22.25 18.97 8 25258 51296 29497965
Septic shock 22.10 18.97 13 25253 62547 29486714
Bradycardia foetal 21.97 18.97 9 25257 340 29548921
Spondyloarthropathy 21.90 18.97 10 25256 493 29548768
Dysphagia 21.49 18.97 10 25256 54916 29494345
Inappropriate schedule of product administration 21.48 18.97 85 25181 44387 29504874
Quarantine 21.23 18.97 5 25261 26 29549235
Delirium 21.16 18.97 4 25262 39393 29509868
Tremor 21.14 18.97 19 25247 73519 29475742
Balance disorder 20.92 18.97 3 25263 36167 29513094
Injection site rash 20.70 18.97 20 25246 3544 29545717
Single functional kidney 20.29 18.97 6 25260 83 29549178
Oral herpes 20.10 18.97 22 25244 4510 29544751
Metabolic acidosis 19.85 18.97 4 25262 37658 29511603
Hyperglycaemia 19.47 18.97 3 25263 34284 29514977
Bronchial dysplasia 19.27 18.97 5 25261 41 29549220
Bladder cancer recurrent 19.24 18.97 8 25258 314 29548947
Therapy non-responder 19.09 18.97 64 25202 30847 29518414
Upper respiratory tract infection 19.04 18.97 59 25207 27290 29521971

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 3233.89 20.64 6357 141293 833890 63517192
Contraindicated product administered 2201.02 20.64 1884 145766 105945 64245137
Synovitis 2176.13 20.64 1806 145844 97284 64253798
Drug intolerance 2015.83 20.64 2311 145339 185681 64165401
Joint swelling 1873.49 20.64 2381 145269 213001 64138081
Pemphigus 1863.44 20.64 1350 146300 59351 64291731
Systemic lupus erythematosus 1754.15 20.64 1439 146211 76173 64274909
Hand deformity 1737.97 20.64 1312 146338 61459 64289623
Glossodynia 1596.37 20.64 1263 146387 63433 64287649
Anti-cyclic citrullinated peptide antibody positive 1591.25 20.64 1133 146517 48429 64302653
Therapeutic product effect decreased 1565.35 20.64 1607 146043 113744 64237338
Swelling 1470.96 20.64 1821 145829 158397 64192685
Arthropathy 1396.80 20.64 1547 146103 119420 64231662
Abdominal discomfort 1279.79 20.64 1817 145833 180505 64170577
Alopecia 1273.26 20.64 1725 145925 163965 64187117
Maternal exposure during pregnancy 1250.20 20.64 1308 146342 94576 64256506
Pericarditis 1230.67 20.64 1071 146579 61445 64289637
Treatment failure 1167.82 20.64 1387 146263 115429 64235653
Hypersensitivity 1152.39 20.64 1800 145850 194652 64156430
Wound 1123.69 20.64 1113 146537 75364 64275718
Pain 953.93 20.64 3102 144548 550409 63800673
Rheumatoid factor positive 936.95 20.64 717 146933 34221 64316861
Discomfort 926.95 20.64 1031 146619 79847 64271235
Hepatic enzyme increased 812.10 20.64 1227 146423 128716 64222366
Acute kidney injury 809.72 20.64 57 147593 449183 63901899
Duodenal ulcer perforation 793.88 20.64 648 147002 33977 64317105
Rash 775.24 20.64 2555 145095 455994 63895088
Rheumatoid arthritis 772.69 20.64 1364 146286 162930 64188152
Helicobacter infection 752.06 20.64 656 146994 37706 64313376
Lower respiratory tract infection 734.65 20.64 991 146659 93623 64257459
Sleep disorder due to general medical condition, insomnia type 730.48 20.64 551 147099 25719 64325363
Drug interaction 729.25 20.64 22 147628 362061 63989021
Folliculitis 719.36 20.64 577 147073 29500 64321582
Irritable bowel syndrome 718.46 20.64 632 147018 36737 64314345
Muscle injury 714.13 20.64 545 147105 25892 64325190
Toxicity to various agents 663.87 20.64 43 147607 363470 63987612
Arthralgia 623.75 20.64 2322 145328 439938 63911144
Sinusitis 620.42 20.64 1160 146490 144768 64206314
Hypotension 615.28 20.64 75 147575 380899 63970183
Infection 608.58 20.64 1321 146329 183559 64167523
Anaemia 542.20 20.64 105 147545 378575 63972507
Maternal exposure before pregnancy 537.98 20.64 226 147424 3257 64347825
Blister 530.34 20.64 782 146868 80185 64270897
Infusion related reaction 516 20.64 1153 146497 163314 64187768
Peripheral swelling 514.19 20.64 1334 146316 207819 64143263
Completed suicide 477.53 20.64 7 147643 224407 64126675
Ill-defined disorder 474.36 20.64 544 147106 43508 64307574
Impaired healing 462.39 20.64 629 147021 59844 64291238
Musculoskeletal stiffness 461.88 20.64 929 146721 122277 64228805
Loss of personal independence in daily activities 441.96 20.64 677 146973 71777 64279305
Thrombocytopenia 425.06 20.64 21 147629 223780 64127302
Febrile neutropenia 390.32 20.64 8 147642 187649 64163433
Pregnancy 379.30 20.64 342 147308 20523 64330559
Gastrointestinal disorder 370.78 20.64 705 146945 89004 64262078
Neutropenia 361.05 20.64 58 147592 239566 64111516
Death 360.37 20.64 345 147305 482360 63868722
Nasopharyngitis 352.67 20.64 1118 146532 194955 64156127
Fall 341.14 20.64 273 147377 416553 63934529
Knee arthroplasty 329.43 20.64 356 147294 26643 64324439
Product use issue 314.93 20.64 910 146740 150805 64200277
Hip arthroplasty 306.23 20.64 307 147343 21044 64330038
Renal failure 294.78 20.64 35 147615 181653 64169429
Maternal exposure during breast feeding 288.74 20.64 124 147526 1892 64349190
Hyponatraemia 287.83 20.64 12 147638 148327 64202755
Rheumatic fever 287.63 20.64 208 147442 9086 64341996
Cardiac arrest 287.58 20.64 16 147634 154048 64197034
Haemoglobin decreased 281.11 20.64 53 147597 195010 64156072
Platelet count decreased 270.36 20.64 33 147617 167678 64183404
Constipation 258.13 20.64 101 147549 229236 64121846
Pancytopenia 255.26 20.64 19 147631 143290 64207792
Seizure 241.18 20.64 45 147605 166847 64184235
Drug hypersensitivity 235.67 20.64 1123 146527 236692 64114390
Stomatitis 235.65 20.64 666 146984 108939 64242143
Disease progression 235.56 20.64 25 147625 141655 64209427
Overdose 234.96 20.64 41 147609 159525 64191557
Respiratory failure 231.77 20.64 44 147606 161139 64189943
Swollen joint count increased 226.43 20.64 167 147483 7522 64343560
White blood cell count decreased 225.02 20.64 44 147606 157793 64193289
Enthesopathy 222.08 20.64 181 147469 9457 64341625
Renal impairment 221.49 20.64 25 147625 134992 64216090
Bradycardia 221.46 20.64 12 147638 118207 64232875
Tachycardia 221.19 20.64 38 147612 149541 64201541
C-reactive protein abnormal 218.68 20.64 300 147350 28747 64322335
Dehydration 218.00 20.64 112 147538 216651 64134431
Hyperkalaemia 215.64 20.64 3 147647 101126 64249956
Therapeutic product effect incomplete 213.91 20.64 620 147030 102862 64248220
Tenosynovitis 211.19 20.64 192 147458 11641 64339441
Gastrointestinal haemorrhage 210.87 20.64 27 147623 132285 64218797
Syncope 208.44 20.64 52 147598 157583 64193499
Oxygen saturation decreased 206.79 20.64 9 147641 107167 64243915
Psoriatic arthropathy 206.37 20.64 362 147288 42919 64308163
Off label use 205.58 20.64 2281 145369 630525 63720557
Foot deformity 205.50 20.64 220 147430 16284 64334798
Cardiac failure congestive 204.87 20.64 28 147622 130552 64220530
Cardio-respiratory arrest 201.37 20.64 5 147645 98388 64252694
Rheumatoid nodule 198.34 20.64 191 147459 12460 64338622
Psoriasis 196.33 20.64 477 147173 71226 64279856
Adverse event 191.80 20.64 333 147317 39156 64311926
Night sweats 186.99 20.64 313 147337 35733 64315349
Somnolence 186.48 20.64 118 147532 203527 64147555
Hypokalaemia 184.61 20.64 29 147621 121874 64229208
Tremor 182.71 20.64 56 147594 148174 64202908
Intentional overdose 182.45 20.64 5 147645 89939 64261143
Dyspnoea 181.87 20.64 938 146712 717736 63633346
Sepsis 181.77 20.64 156 147494 230185 64120897
Coma 181.04 20.64 4 147646 87611 64263471
Mobility decreased 179.01 20.64 516 147134 85324 64265758
Breast feeding 177.57 20.64 65 147585 632 64350450
Rhabdomyolysis 175.98 20.64 8 147642 91718 64259364
Dizziness 175.54 20.64 460 147190 429703 63921379
Pustular psoriasis 175.51 20.64 113 147537 4070 64347012
Hypoglycaemia 175.25 20.64 7 147643 89885 64261197
Pulmonary embolism 170.39 20.64 61 147589 146295 64204787
Muscle spasticity 169.56 20.64 200 147450 16469 64334613
Fatigue 169.08 20.64 2524 145126 746206 63604876
Ear pain 169.06 20.64 246 147404 24890 64326192
Glaucoma 167.71 20.64 197 147453 16151 64334931
Oedema peripheral 167.69 20.64 141 147509 210176 64140906
Depressed level of consciousness 167.17 20.64 4 147646 81432 64269650
Multiple organ dysfunction syndrome 165.75 20.64 19 147631 101394 64249688
Neutrophil count decreased 161.59 20.64 3 147647 77193 64273889
Electrocardiogram QT prolonged 159.01 20.64 5 147645 79443 64271639
Bone erosion 157.64 20.64 162 147488 11433 64339649
Cardiac failure 154.38 20.64 55 147595 132318 64218764
Colitis microscopic 149.39 20.64 129 147521 7303 64343779
Pruritus 147.64 20.64 1220 146430 311180 64039902
Agitation 145.81 20.64 16 147634 88351 64262731
Hypoxia 145.35 20.64 16 147634 88133 64262949
Red blood cell sedimentation rate increased 144.69 20.64 258 147392 30977 64320105
Cerebrovascular accident 141.40 20.64 69 147581 137514 64213568
Blood creatinine increased 141.22 20.64 67 147583 135715 64215367
Dysphagia 139.69 20.64 36 147614 106776 64244306
Urticaria 138.77 20.64 686 146964 146631 64204451
Blood parathyroid hormone decreased 138.32 20.64 123 147527 7243 64343839
Tongue disorder 134.73 20.64 152 147498 11928 64339154
Contusion 132.02 20.64 564 147086 113401 64237681
Anxiety 128.64 20.64 165 147485 202484 64148598
Hallucination 128.58 20.64 10 147640 72778 64278304
Injection site reaction 128.31 20.64 311 147339 46353 64304729
Adverse drug reaction 126.07 20.64 304 147346 45160 64305922
Panniculitis 126.07 20.64 127 147523 8752 64342330
Pulmonary oedema 125.46 20.64 16 147634 78658 64272424
Metabolic acidosis 124.64 20.64 10 147640 70948 64280134
Granuloma skin 123.24 20.64 106 147544 5968 64345114
C-reactive protein increased 121.98 20.64 485 147165 94424 64256658
Joint stiffness 121.86 20.64 236 147414 30168 64320914
Grip strength decreased 121.45 20.64 142 147508 11582 64339500
Ankylosing spondylitis 121.01 20.64 120 147530 8114 64342968
Body temperature increased 120.28 20.64 262 147388 36404 64314678
Alanine aminotransferase abnormal 119.47 20.64 110 147540 6778 64344304
Blood pressure decreased 116.72 20.64 27 147623 86172 64264910
Mental status changes 115.17 20.64 6 147644 61156 64289926
Chronic kidney disease 114.64 20.64 4 147646 57915 64293167
Suicide attempt 114.30 20.64 14 147636 70993 64280089
Blood creatine phosphokinase increased 112.66 20.64 5 147645 58553 64292529
Gastric disorder 112.61 20.64 223 147427 28974 64322108
Deep vein thrombosis 112.31 20.64 50 147600 105132 64245950
Product dose omission issue 112.25 20.64 797 146853 193950 64157132
Pleural effusion 112.17 20.64 76 147574 126483 64224599
Injection site discolouration 111.95 20.64 106 147544 6769 64344313
Hyperglycaemia 111.68 20.64 7 147643 60961 64290121
Septic shock 111.21 20.64 51 147599 105386 64245696
Epistaxis 110.66 20.64 43 147607 98088 64252994
Neuropathy peripheral 110.43 20.64 66 147584 117459 64233623
Drug tolerance decreased 110.35 20.64 106 147544 6892 64344190
Cough 109.22 20.64 342 147308 301806 64049276
Red blood cell sedimentation rate 107.86 20.64 80 147570 3634 64347448
Balance disorder 106.50 20.64 30 147620 83896 64267186
Product availability issue 106.05 20.64 64 147586 2052 64349030
Hepatic failure 105.69 20.64 5 147645 55389 64295693
Tendonitis 105.02 20.64 176 147474 20106 64330976
Lethargy 103.91 20.64 20 147630 72574 64278508
Ascites 102.86 20.64 11 147639 61990 64289092
Chest pain 102.58 20.64 244 147406 235736 64115346
Pneumonia aspiration 102.32 20.64 9 147641 59262 64291820
Myalgia 101.83 20.64 128 147522 158489 64192593
Blood alkaline phosphatase increased 101.50 20.64 7 147643 56272 64294810
Leukopenia 100.67 20.64 53 147597 101189 64249893
Herpes zoster 98.81 20.64 401 147249 78786 64272296
Asthenia 98.39 20.64 576 147074 427468 63923614
Acute myocardial infarction 98.13 20.64 20 147630 69698 64281384
Onychomycosis 98.03 20.64 87 147563 5109 64345973
Unresponsive to stimuli 97.95 20.64 4 147646 50389 64300693
Atrial fibrillation 97.89 20.64 150 147500 170939 64180143
Flushing 96.36 20.64 30 147620 78618 64272464
Dyspnoea exertional 94.22 20.64 26 147624 73704 64277378
Blood glucose increased 93.66 20.64 54 147596 98019 64253063
Decreased appetite 92.99 20.64 331 147319 280958 64070124
Arthrodesis 92.10 20.64 58 147592 2009 64349073
Haemoptysis 91.76 20.64 5 147645 49043 64302039
Type 2 diabetes mellitus 91.67 20.64 225 147425 33795 64317287
Cognitive disorder 90.81 20.64 10 147640 55077 64296005
Condition aggravated 90.50 20.64 1273 146377 371153 63979929
Nail disorder 90.24 20.64 105 147545 8519 64342563
Dysarthria 90.21 20.64 14 147636 59392 64291690
Haematuria 90.15 20.64 15 147635 60456 64290626
Disorientation 89.87 20.64 11 147639 55817 64295265
Fine motor skill dysfunction 89.29 20.64 79 147571 4620 64346462
Blood bilirubin increased 88.69 20.64 13 147637 57540 64293542
Myocardial infarction 88.66 20.64 152 147498 165669 64185413
Plasma cell myeloma 88.42 20.64 4 147646 46071 64305011
COVID-19 immunisation 87.39 20.64 37 147613 544 64350538
Heart rate decreased 85.88 20.64 12 147638 55055 64296027
Respiratory disorder 85.04 20.64 227 147423 35884 64315198
Therapy interrupted 84.57 20.64 159 147491 19877 64331205
Basal cell carcinoma 84.20 20.64 205 147445 30633 64320449
Coeliac disease 83.92 20.64 94 147556 7318 64343764
Inflammation 83.32 20.64 333 147317 64967 64286115
Skin necrosis 83.23 20.64 131 147519 14198 64336884
Gamma-glutamyltransferase increased 82.04 20.64 8 147642 48502 64302580
Blood iron abnormal 82.02 20.64 44 147606 1121 64349961
Chest discomfort 81.74 20.64 87 147563 116019 64235063
Coronary artery disease 81.67 20.64 19 147631 60414 64290668
Orthostatic hypotension 80.94 20.64 7 147643 46731 64304351
Arthritis 80.79 20.64 393 147257 83421 64267661
Respiratory distress 80.23 20.64 12 147638 52319 64298763
Hyperhidrosis 79.97 20.64 101 147549 124819 64226263
Melaena 78.25 20.64 14 147636 53534 64297548
Cerebral haemorrhage 77.67 20.64 12 147638 51078 64300004
Aggression 77.21 20.64 8 147642 46224 64304858
Jaundice 77.01 20.64 10 147640 48502 64302580
Suicidal ideation 76.95 20.64 28 147622 66514 64284568
Haemorrhage 76.76 20.64 43 147607 79308 64271774
Haematocrit decreased 76.25 20.64 16 147634 54639 64296443
Blood urea increased 75.42 20.64 7 147643 44146 64306936
Acute respiratory failure 75.30 20.64 12 147638 49922 64301160
Mucosal inflammation 74.67 20.64 25 147625 62559 64288523
Onychomadesis 74.65 20.64 58 147592 2826 64348256
Hepatic function abnormal 74.48 20.64 27 147623 64286 64286796
Agranulocytosis 74.42 20.64 3 147647 38226 64312856
Vomiting 74.15 20.64 856 146794 550261 63800821
Loss of consciousness 73.94 20.64 142 147508 148223 64202859
Haematemesis 73.87 20.64 10 147640 46989 64304093
Weight decreased 73.00 20.64 371 147279 285368 64065714
Fibromyalgia 72.71 20.64 213 147437 35518 64315564
Latent tuberculosis 72.57 20.64 56 147594 2701 64348381
Hypomagnesaemia 72.53 20.64 3 147647 37373 64313709
Gastrooesophageal reflux disease 72.23 20.64 51 147599 83092 64267990
Blood pressure increased 72.13 20.64 182 147468 172370 64178712
Cholestasis 71.84 20.64 9 147641 44863 64306219
Urinary retention 71.60 20.64 13 147637 49188 64301894
Shock 71.22 20.64 4 147646 38236 64312846
Systemic lupus erythematosus rash 71.16 20.64 43 147607 1382 64349700
Nephrolithiasis 71.06 20.64 241 147409 43442 64307640
Hypophagia 68.36 20.64 6 147644 39581 64311501
Lower limb fracture 68.08 20.64 116 147534 13429 64337653
Altered state of consciousness 67.52 20.64 5 147645 37897 64313185
Premature delivery 66.94 20.64 138 147512 18451 64332631
Exposure during pregnancy 66.30 20.64 352 147298 77323 64273759
Aphasia 65.99 20.64 8 147642 40898 64310184
Liver function test abnormal 65.37 20.64 27 147623 59374 64291708
Heart rate increased 65.02 20.64 78 147572 98597 64252485
Fear of injection 63.57 20.64 73 147577 5839 64345243
Ulcer 62.94 20.64 153 147497 22837 64328245
Maternal exposure timing unspecified 62.70 20.64 51 147599 2656 64348426
Depression 62.32 20.64 213 147437 183078 64168004
Seronegative arthritis 62.11 20.64 51 147599 2692 64348390
Vision blurred 62.09 20.64 69 147581 90247 64260835
Chills 61.96 20.64 139 147511 137125 64213957
Presyncope 61.46 20.64 5 147645 35084 64315998
Blood cholesterol increased 61.22 20.64 252 147398 49814 64301268
Hypercholesterolaemia 61.20 20.64 119 147531 15254 64335828
Abnormal behaviour 61.16 20.64 4 147646 33618 64317464
Emotional distress 60.79 20.64 6 147644 36032 64315050
Tuberculosis 60.76 20.64 108 147542 12930 64338152
Muscular weakness 60.75 20.64 125 147525 127213 64223869
Transaminases abnormal 60.18 20.64 31 147619 725 64350357
Blood lactate dehydrogenase increased 59.98 20.64 4 147646 33074 64318008
Cerebral infarction 59.39 20.64 11 147639 41033 64310049
Generalised tonic-clonic seizure 59.15 20.64 10 147640 39847 64311235
Abortion spontaneous 59.14 20.64 158 147492 24985 64326097
Live birth 59.04 20.64 98 147552 11106 64339976
Restlessness 59.01 20.64 10 147640 39775 64311307
Pain in jaw 58.80 20.64 11 147639 40744 64310338
Nerve injury 58.77 20.64 80 147570 7605 64343477
Red blood cell sedimentation rate abnormal 58.65 20.64 121 147529 16185 64334897
Skin reaction 58.44 20.64 103 147547 12249 64338833
Angioedema 57.66 20.64 35 147615 61786 64289296
Rash maculo-papular 57.49 20.64 18 147632 47008 64304074
Rheumatoid factor negative 57.22 20.64 34 147616 1059 64350023
Tuberculin test positive 57.14 20.64 51 147599 3017 64348065
Ventricular tachycardia 57.03 20.64 6 147644 34259 64316823
Drug tolerance 56.95 20.64 70 147580 6015 64345067
Delirium 56.81 20.64 45 147605 69149 64281933
Upper gastrointestinal haemorrhage 56.54 20.64 7 147643 35213 64315869
Haematoma 56.01 20.64 18 147632 46232 64304850
Pericardial effusion 55.78 20.64 11 147639 39243 64311839
Disturbance in attention 55.33 20.64 13 147637 41061 64310021
Blood sodium decreased 55.16 20.64 3 147647 29479 64321603
Red blood cell count decreased 54.87 20.64 21 147629 48365 64302717
Leukocytosis 54.85 20.64 10 147640 37730 64313352
Intentional self-injury 54.21 20.64 3 147647 29041 64322041
White blood cell count increased 54.11 20.64 43 147607 65971 64285111
Twin pregnancy 54.11 20.64 30 147620 817 64350265
Hepatocellular injury 54.08 20.64 18 147632 45217 64305865
Fluid retention 53.86 20.64 35 147615 59571 64291511
Angina pectoris 53.79 20.64 18 147632 45063 64306019
Productive cough 53.61 20.64 53 147597 73150 64277932
Palmoplantar pustulosis 53.39 20.64 25 147625 472 64350610
Weight increased 53.21 20.64 733 146917 212615 64138467
Disseminated intravascular coagulation 52.99 20.64 6 147644 32342 64318740
Transaminases increased 52.87 20.64 18 147632 44576 64306506
Psychotic disorder 52.84 20.64 8 147642 34570 64316512
Bedridden 52.70 20.64 88 147562 10021 64341061
Sinus tachycardia 52.65 20.64 6 147644 32182 64318900
Nausea 52.60 20.64 1384 146266 784416 63566666
Drug dependence 52.56 20.64 7 147643 33305 64317777
Joint dislocation 52.19 20.64 94 147556 11371 64339711
Stevens-Johnson syndrome 52.16 20.64 8 147642 34241 64316841
Coagulopathy 52.09 20.64 6 147644 31914 64319168
Blood potassium decreased 52.07 20.64 14 147636 40385 64310697
Cytology abnormal 51.99 20.64 22 147628 323 64350759
Speech disorder 51.74 20.64 23 147627 48418 64302664
Extremity contracture 51.72 20.64 37 147613 1588 64349494
Cytomegalovirus infection 51.66 20.64 11 147639 37188 64313894
Urinary incontinence 51.64 20.64 10 147640 36141 64314941
Pallor 50.82 20.64 13 147637 38768 64312314
Arrhythmia 50.75 20.64 29 147621 52915 64298167
Feeling abnormal 49.78 20.64 149 147501 133453 64217629
Intentional product use issue 49.02 20.64 380 147270 94984 64256098
Wrong technique in product usage process 48.79 20.64 46 147604 64928 64286154
Irritability 48.77 20.64 12 147638 36734 64314348
Foot operation 48.44 20.64 54 147596 4181 64346901
Axial spondyloarthritis 48.44 20.64 22 147628 386 64350696
Pancreatitis acute 47.93 20.64 19 147631 42836 64308246
Eosinophilia 47.58 20.64 14 147636 38062 64313020
Full blood count abnormal 47.56 20.64 6 147644 29751 64321331
Lymphopenia 46.82 20.64 3 147647 25654 64325428
Circulatory collapse 46.79 20.64 10 147640 33722 64317360
Subdural haematoma 46.47 20.64 5 147645 28049 64323033
Epilepsy 46.39 20.64 10 147640 33521 64317561
Pulmonary fibrosis 46.12 20.64 162 147488 29716 64321366
Acute myeloid leukaemia 45.22 20.64 5 147645 27458 64323624
Bunion operation 45.03 20.64 26 147624 767 64350315
Dysgeusia 44.77 20.64 26 147624 47021 64304061
Transient ischaemic attack 44.10 20.64 23 147627 44159 64306923
Mitral valve incompetence 43.74 20.64 4 147646 25534 64325548
Cardiac disorder 43.72 20.64 38 147612 55778 64295304
Hemiparesis 43.14 20.64 8 147642 29819 64321263
Ejection fraction decreased 43.05 20.64 7 147643 28700 64322382
Diverticulitis 43.05 20.64 189 147461 38429 64312653
Myelodysplastic syndrome 43.02 20.64 6 147644 27573 64323509
Bone pain 42.89 20.64 28 147622 47544 64303538
Thrombosis 42.26 20.64 60 147590 70582 64280500
Caesarean section 42.14 20.64 85 147565 11189 64339893
Withdrawal syndrome 42.13 20.64 3 147647 23489 64327593
Foot fracture 41.60 20.64 113 147537 18044 64333038
Musculoskeletal disorder 41.59 20.64 112 147538 17794 64333288
Adverse reaction 41.53 20.64 68 147582 7619 64343463
Exostosis 41.28 20.64 85 147565 11353 64339729
Diabetic ketoacidosis 41.09 20.64 9 147641 29836 64321246
Epicondylitis 41.04 20.64 34 147616 1817 64349265
Pneumonitis 41.04 20.64 33 147617 50332 64300750
Rectal haemorrhage 40.57 20.64 49 147601 61768 64289314
Myelosuppression 40.11 20.64 4 147646 23826 64327256
Asthma 40.11 20.64 100 147550 95125 64255957
Tinnitus 40.08 20.64 14 147636 34119 64316963
Hypocalcaemia 39.84 20.64 23 147627 41730 64309352
Bacteraemia 39.39 20.64 7 147643 26904 64324178
Cyanosis 39.24 20.64 3 147647 22152 64328930
Blood calcium decreased 38.84 20.64 6 147644 25548 64325534
Product administration error 38.75 20.64 8 147642 27635 64323447
Depressed mood 38.55 20.64 23 147627 40989 64310093
Surgery 38.51 20.64 147 147503 28066 64323016
Accidental exposure to product 38.28 20.64 7 147643 26357 64324725
Product use in unapproved indication 38.20 20.64 242 147408 176376 64174706
Status epilepticus 38.18 20.64 3 147647 21660 64329422
Bronchitis 37.78 20.64 398 147252 108345 64242737
Head injury 37.66 20.64 14 147636 32828 64318254
Hypermobility syndrome 37.62 20.64 20 147630 500 64350582
Disease susceptibility 37.50 20.64 16 147634 240 64350842
General physical health deterioration 37.48 20.64 667 146983 203758 64147324
Muscle spasms 37.17 20.64 181 147469 140842 64210240
Diarrhoea 36.95 20.64 1319 146331 721385 63629697
Inability to afford medication 36.42 20.64 32 147618 1854 64349228
Intentional dose omission 36.10 20.64 54 147596 5598 64345484
Kidney infection 35.96 20.64 106 147544 17732 64333350
Uveitis 35.24 20.64 85 147565 12623 64338459
Impaired work ability 35.15 20.64 95 147555 15124 64335958
Full blood count decreased 35.02 20.64 5 147645 22577 64328505
Acute respiratory distress syndrome 34.99 20.64 23 147627 38912 64312170
Treatment noncompliance 34.79 20.64 29 147621 43453 64307629
Tachypnoea 34.64 20.64 9 147641 26562 64324520
Injection site bruising 34.63 20.64 170 147480 36203 64314879
Adjustment disorder with depressed mood 34.62 20.64 35 147615 2422 64348660
Joint range of motion decreased 34.39 20.64 110 147540 19233 64331849
Tubulointerstitial nephritis 34.09 20.64 14 147636 30895 64320187
Neck mass 33.85 20.64 44 147606 4000 64347082
Lupus-like syndrome 33.72 20.64 67 147583 8724 64342358
Dysuria 33.71 20.64 28 147622 42029 64309053
Glomerular filtration rate decreased 33.70 20.64 3 147647 19569 64331513
Nodule 33.69 20.64 104 147546 17843 64333239
Retinitis 33.66 20.64 32 147618 2053 64349029
Anal abscess 33.46 20.64 61 147589 7447 64343635
Pneumonia 33.37 20.64 1001 146649 558575 63792507
Bronchopulmonary aspergillosis 32.66 20.64 3 147647 19082 64332000
Dislocation of vertebra 32.63 20.64 38 147612 3086 64347996
Heart rate irregular 32.61 20.64 11 147639 27402 64323680
Ischaemic stroke 32.26 20.64 13 147637 29022 64322060
Pneumothorax 32.12 20.64 8 147642 24290 64326792
Visual acuity reduced 32.10 20.64 11 147639 27130 64323952
Myocardial ischaemia 32.03 20.64 7 147643 23244 64327838
Anti-cyclic citrullinated peptide antibody 31.93 20.64 26 147624 1356 64349726
Acute hepatic failure 31.90 20.64 10 147640 26102 64324980
Respiratory tract congestion 31.59 20.64 95 147555 16070 64335012
Therapeutic response decreased 31.42 20.64 216 147434 51972 64299110
Underdose 31.37 20.64 10 147640 25819 64325263
Gastric ulcer 31.29 20.64 15 147635 30219 64320863
Pulmonary tuberculosis 31.21 20.64 58 147592 7186 64343896
Skin ulcer 30.75 20.64 189 147461 43785 64307297
Rash pruritic 30.75 20.64 231 147419 57173 64293909
Haematochezia 30.11 20.64 67 147583 66306 64284776
Pseudomonas infection 30.10 20.64 3 147647 17880 64333202
Product substitution issue 30.06 20.64 3 147647 17858 64333224
Acidosis 29.92 20.64 3 147647 17792 64333290
Sudden death 29.91 20.64 5 147645 20091 64330991
Diabetic eye disease 29.88 20.64 12 147638 153 64350929
Supraventricular tachycardia 29.76 20.64 4 147646 18903 64332179
Diplopia 29.71 20.64 12 147638 26753 64324329
Ankle arthroplasty 29.69 20.64 21 147629 885 64350197
Myopathy 29.67 20.64 3 147647 17677 64333405
Pharyngitis streptococcal 29.63 20.64 63 147587 8605 64342477
Perirectal abscess 29.61 20.64 28 147622 1785 64349297
Polyneuropathy 29.50 20.64 5 147645 19889 64331193
Physical disability 29.40 20.64 31 147619 2254 64348828
Injection site urticaria 29.11 20.64 73 147577 11108 64339974
Cardiomegaly 29.06 20.64 9 147641 23675 64327407
Feeling cold 29.05 20.64 9 147641 23669 64327413
Pancreatitis 28.85 20.64 58 147592 59549 64291533
Joint lock 28.84 20.64 34 147616 2797 64348285
Palpitations 28.76 20.64 132 147518 104356 64246726
Cardiomyopathy 28.76 20.64 11 147639 25345 64325737
Drug resistance 28.59 20.64 23 147627 35079 64316003
Respiratory rate increased 28.57 20.64 4 147646 18327 64332755
Electrolyte imbalance 28.55 20.64 11 147639 25232 64325850
Metastases to bone 28.46 20.64 6 147644 20429 64330653
Neutrophil count increased 28.42 20.64 11 147639 25163 64325919
Abdominal pain 28.29 20.64 524 147126 311851 64039231
Osteoporosis 28.26 20.64 179 147471 41901 64309181
Disability 28.13 20.64 76 147574 12096 64338986
Polyarthritis 28.04 20.64 66 147584 9649 64341433
Limb discomfort 28.04 20.64 130 147520 27045 64324037
Cutaneous lymphoma 27.93 20.64 13 147637 242 64350840
Delusion 27.91 20.64 4 147646 18010 64333072
Cholelithiasis 27.87 20.64 38 147612 45468 64305614
Hepatic encephalopathy 27.72 20.64 7 147643 21059 64330023
Ileus 27.70 20.64 9 147641 22957 64328125
Clostridium difficile colitis 27.42 20.64 14 147636 27209 64323873
Dermatitis psoriasiform 27.40 20.64 29 147621 2117 64348965
Lung infiltration 27.37 20.64 7 147643 20882 64330200
Chronic obstructive pulmonary disease 27.35 20.64 78 147572 70970 64280112
Headache 27.09 20.64 1476 146174 527991 63823091
Femur fracture 27.02 20.64 23 147627 34112 64316970
Aspergillus infection 26.92 20.64 3 147647 16376 64334706
Ventricular extrasystoles 26.91 20.64 4 147646 17525 64333557
Disseminated large cell lymphoma 26.81 20.64 9 147641 66 64351016
Therapy non-responder 26.67 20.64 249 147401 65650 64285432
SARS-CoV-2 test negative 26.59 20.64 16 147634 510 64350572
Abdominal abscess 26.57 20.64 50 147600 6254 64344828
Hunger 26.06 20.64 40 147610 4241 64346841
Hyperthyroidism 26.03 20.64 5 147645 18174 64332908
Gait disturbance 26.02 20.64 260 147390 171895 64179187
Throat irritation 25.94 20.64 22 147628 32689 64318393
Myocarditis 25.91 20.64 4 147646 17039 64334043
Arteriosclerosis 25.87 20.64 3 147647 15874 64335208
Nightmare 25.72 20.64 8 147642 20985 64330097
Ear infection 25.67 20.64 114 147536 23290 64327792
Rectal abscess 25.34 20.64 24 147626 1533 64349549
Bronchospasm 25.27 20.64 9 147641 21673 64329409
Hypoacusis 25.03 20.64 14 147636 25853 64325229
Device related infection 25.03 20.64 20 147630 30606 64320476
Tooth infection 25.02 20.64 82 147568 14519 64336563
Mycobacterium tuberculosis complex test positive 24.97 20.64 27 147623 2020 64349062
Device malfunction 24.93 20.64 5 147645 17628 64333454
Vertigo 24.82 20.64 62 147588 58949 64292133
Blood pressure fluctuation 24.66 20.64 51 147599 51820 64299262
Mental disorder 24.62 20.64 15 147635 26430 64324652
Memory impairment 24.33 20.64 107 147543 85575 64265507
Blindness 24.24 20.64 10 147640 22009 64329073
Amnesia 24.20 20.64 46 147604 48223 64302859
Thyroid disorder 24.07 20.64 70 147580 11622 64339460
Peritonitis 23.56 20.64 14 147636 25009 64326073
Blood triglycerides increased 23.46 20.64 7 147643 18859 64332223
Feeling hot 23.35 20.64 43 147607 45620 64305462
Platelet count increased 23.13 20.64 7 147643 18689 64332393
Hypoalbuminaemia 23.01 20.64 6 147644 17668 64333414
Petechiae 23.00 20.64 7 147643 18619 64332463
Quarantine 22.95 20.64 7 147643 36 64351046
Hyperlipidaemia 22.87 20.64 12 147638 22964 64328118
Arteriosclerosis coronary artery 22.81 20.64 4 147646 15525 64335557
Atrial flutter 22.67 20.64 8 147642 19372 64331710
Mental impairment 22.35 20.64 5 147645 16338 64334744
Crying 22.31 20.64 9 147641 20081 64331001
Mania 22.24 20.64 5 147645 16281 64334801
Rales 22.21 20.64 4 147646 15225 64335857
Eosinophil count increased 22.18 20.64 3 147647 14109 64336973
Spinal fusion surgery 22.07 20.64 34 147616 3617 64347465
Acute generalised exanthematous pustulosis 22.07 20.64 3 147647 14055 64337027
Faeces discoloured 22.05 20.64 16 147634 25713 64325369
Abdominal pain lower 21.99 20.64 17 147633 26452 64324630
Dementia 21.95 20.64 10 147640 20756 64330326
Abortion 21.94 20.64 20 147630 1216 64349866
Hypothyroidism 21.68 20.64 37 147613 40420 64310662
Flatulence 21.62 20.64 30 147620 35636 64315446
Hallucination, auditory 21.58 20.64 6 147644 16933 64334149
Injection site swelling 21.36 20.64 165 147485 41188 64309894
Hepatitis 20.68 20.64 46 147604 45536 64305546
Decubitus ulcer 20.66 20.64 3 147647 13376 64337706
Deformity 20.65 20.64 45 147605 6252 64344830

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AB05 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Tumor necrosis factor alpha (TNF-alpha) inhibitors
FDA MoA N0000175451 Tumor Necrosis Factor Receptor Blocking Activity
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D018501 Antirheumatic Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D000079424 Tumor Necrosis Factor Inhibitors
FDA EPC N0000175610 Tumor Necrosis Factor Blocker

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Ankylosing spondylitis indication 9631008 DOID:7147
Psoriasis with arthropathy indication 33339001
Crohn's disease indication 34000006
Rheumatoid arthritis indication 69896004 DOID:7148
Psoriatic arthritis indication 156370009 DOID:9008
Plaque psoriasis indication 200965009
Pustular psoriasis indication 200973000
Erythrodermic psoriasis indication 200977004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Tumor necrosis factor Cytokine ANTIBODY BINDING Kd 10.05 DRUG LABEL DRUG LABEL

External reference:

IDSource
D03441 KEGG_DRUG
4028807 VUID
N0000178499 NUI
4027433 VANDF
4028807 VANDF
CHEMBL1201831 ChEMBL_ID
6774 IUPHAR_LIGAND_ID
8448 INN_ID
DB08904 DRUGBANK_ID
UMD07X179E UNII
709271 RXNORM
136438 MMSL
25282 MMSL
d07134 MMSL
430306004 SNOMEDCT_US
430307008 SNOMEDCT_US
D000068582 MESH_DESCRIPTOR_UI
C1872109 UMLSCUI
CHEMBL4297565 ChEMBL_ID
012650 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cimzia HUMAN PRESCRIPTION DRUG LABEL 1 50474-710 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 33 sections