tocilizumab Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
humanized origin 4933 375823-41-9

Description:

MoleculeDescription

Synonyms:

  • tocilizumab
  • MRA
  • RoActemra
  • actemra
  • R-1569
a humanised anti-interleukin-6 receptor monoclonal antibody
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
20 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 16, 2009 EMA
Jan. 8, 2010 FDA GENENTECH
March 6, 2008 PMDA

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
Rheumatoid arthritis 7122.58 14.21 8702 286678 305829 52747857
Drug ineffective 6027.69 14.21 13594 281786 803651 52250035
Contraindicated product administered 4090.79 14.21 4365 291015 131264 52922422
Joint swelling 3288.44 14.21 5165 290215 229473 52824213
Treatment failure 3129.33 14.21 3700 291680 124703 52928983
Drug intolerance 3126.36 14.21 4700 290680 200793 52852893
Synovitis 3025.84 14.21 3344 292036 104549 52949137
Arthropathy 2230.25 14.21 3293 292087 138160 52915526
Therapeutic product effect decreased 2064.09 14.21 2983 292397 122672 52931014
Pemphigus 1996.22 14.21 2662 292718 101369 52952317
Systemic lupus erythematosus 1820.13 14.21 2810 292570 122604 52931082
Swelling 1603.48 14.21 3372 292008 187733 52865953
Glossodynia 1532.03 14.21 2302 293078 97989 52955697
Pain 1478.79 14.21 6794 288586 581604 52472082
Arthralgia 1435.85 14.21 5504 289876 434279 52619407
Hand deformity 1433.99 14.21 2043 293337 82806 52970880
Abdominal discomfort 1269.91 14.21 3365 292015 217697 52835989
Rheumatoid factor positive 1116.49 14.21 1256 294124 39942 53013744
Hepatic enzyme increased 1102.92 14.21 2266 293114 123929 52929757
Alopecia 1062.19 14.21 3278 292102 231305 52822381
Hypersensitivity 1036.80 14.21 3032 292348 207633 52846053
Infusion related reaction 1029.98 14.21 2504 292876 153453 52900233
Wound 940.27 14.21 1760 293620 89797 52963889
Death 919.03 14.21 415 294965 356817 52696869
C-reactive protein abnormal 914.93 14.21 909 294471 24961 53028725
Anti-cyclic citrullinated peptide antibody positive 891.71 14.21 1326 294054 55846 52997840
Acute kidney injury 843.92 14.21 187 295193 253681 52800005
Musculoskeletal stiffness 835.73 14.21 2001 293379 121367 52932319
Rash 814.23 14.21 4719 290661 441472 52612214
Toxicity to various agents 806.24 14.21 126 295254 219472 52834214
Drug interaction 778.22 14.21 138 295242 219191 52834495
Red blood cell sedimentation rate abnormal 769.88 14.21 662 294718 15027 53038659
Peripheral swelling 747.29 14.21 2673 292707 203435 52850251
Lower respiratory tract infection 731.84 14.21 1580 293800 89401 52964285
Infection 725.75 14.21 2349 293031 169856 52883830
Pericarditis 712.61 14.21 1279 294101 63127 52990559
Loss of personal independence in daily activities 706.47 14.21 1334 294046 68481 52985205
Anaemia 657.43 14.21 357 295023 276361 52777325
Discomfort 580.10 14.21 1486 293894 93986 52959700
Ill-defined disorder 571.46 14.21 1001 294379 48443 53005243
Product use issue 566.16 14.21 1880 293500 137704 52915982
Dehydration 545.43 14.21 131 295249 168279 52885407
Muscle injury 506.95 14.21 720 294660 29046 53024640
Folliculitis 505.03 14.21 743 294637 30966 53022720
Red blood cell sedimentation rate increased 503.64 14.21 696 294684 27361 53026325
Hyponatraemia 494.22 14.21 26 295354 108581 52945105
Decreased appetite 492.14 14.21 290 295090 214684 52839002
Impaired healing 484.32 14.21 1087 294293 63118 52990568
Drug hypersensitivity 478.51 14.21 2800 292580 262442 52791244
Therapeutic product effect incomplete 456.02 14.21 1327 294053 90457 52963229
Febrile neutropenia 451.01 14.21 34 295346 104902 52948784
Dizziness 444.01 14.21 869 294511 371390 52682296
Maternal exposure during pregnancy 439.91 14.21 1867 293513 153772 52899914
Product dose omission issue 432.21 14.21 263 295117 191357 52862329
Nausea 429.46 14.21 2449 292931 753642 52300044
Intentional product use issue 416.24 14.21 1105 294275 71389 52982297
Anxiety 403.36 14.21 300 295080 196404 52857282
Seizure 397.73 14.21 112 295268 129397 52924289
C-reactive protein increased 390.99 14.21 1036 294344 66850 52986836
Constipation 389.86 14.21 316 295064 198096 52855590
Bone erosion 385.23 14.21 387 294993 10765 53042921
Tremor 381.95 14.21 111 295269 125625 52928061
Helicobacter infection 380.78 14.21 735 294645 38334 53015352
Nasopharyngitis 374.02 14.21 2072 293308 190223 52863463
Irritable bowel syndrome 372.79 14.21 777 294603 42855 53010831
Duodenal ulcer perforation 365.28 14.21 680 294700 34503 53019183
Overdose 360.28 14.21 78 295302 107658 52946028
Off label use 360.19 14.21 4094 291286 468118 52585568
Dyspnoea 359.68 14.21 1849 293531 584383 52469303
Diarrhoea 359.00 14.21 2018 293362 623528 52430158
Intentional overdose 354.87 14.21 3 295377 67202 52986484
Condition aggravated 354.30 14.21 2833 292547 294301 52759385
Knee arthroplasty 343.76 14.21 645 294735 32924 53020762
Rheumatoid nodule 338.89 14.21 372 295008 11492 53042194
Sleep disorder due to general medical condition, insomnia type 334.76 14.21 533 294847 23816 53029870
Injection site pain 331.95 14.21 107 295273 113284 52940402
Blood iron abnormal 326.87 14.21 213 295167 3114 53050572
Depression 324.26 14.21 321 295059 182731 52870955
Cardiac arrest 316.90 14.21 66 295314 93601 52960085
Renal failure 314.30 14.21 131 295249 118321 52935365
Sinusitis 313.56 14.21 1795 293585 166769 52886917
Somnolence 310.11 14.21 283 295097 167451 52886235
Asthenia 308.40 14.21 930 294450 342660 52711026
Hypotension 306.10 14.21 589 294791 253487 52800199
Cardiac failure congestive 300.44 14.21 72 295308 92685 52961001
Blister 298.94 14.21 1038 294342 77715 52975971
Joint stiffness 289.32 14.21 565 294815 29718 53023968
Thrombocytopenia 287.60 14.21 209 295171 138518 52915168
Hypokalaemia 286.19 14.21 89 295291 96428 52957258
Hip arthroplasty 284.84 14.21 535 294845 27327 53026359
Bradycardia 283.87 14.21 31 295349 71025 52982661
Electrocardiogram QT prolonged 278.86 14.21 7 295373 56396 52997290
Muscle spasms 278.23 14.21 204 295176 134591 52919095
Vomiting 273.84 14.21 1624 293756 495515 52558171
Oedema peripheral 266.74 14.21 332 295048 170455 52883231
Tachycardia 266.33 14.21 133 295247 108079 52945607
Neuropathy peripheral 265.98 14.21 119 295261 103068 52950618
Suicide attempt 264.32 14.21 14 295366 58154 52995532
Mobility decreased 263.63 14.21 975 294405 75296 52978390
Haemoglobin decreased 261.78 14.21 225 295155 137082 52916604
Skin ulcer 260.58 14.21 601 294779 35518 53018168
Hyperkalaemia 256.52 14.21 10 295370 54246 52999440
Inflammation 256.18 14.21 797 294583 56339 52997347
Hypoglycaemia 251.03 14.21 20 295360 58993 52994693
Feeling abnormal 242.13 14.21 235 295145 135066 52918620
Cardio-respiratory arrest 241.55 14.21 23 295357 58735 52994951
Malignant neoplasm progression 238.72 14.21 52 295328 71489 52982197
Osteoporosis 237.59 14.21 679 294701 45781 53007905
Abdominal pain 234.93 14.21 685 294695 255218 52798468
Respiratory failure 232.02 14.21 134 295246 100378 52953308
Atrial fibrillation 231.66 14.21 168 295212 111484 52942202
Arthritis 231.62 14.21 1028 294352 86270 52967416
Rheumatic fever 229.64 14.21 315 295065 12289 53041397
Plasma cell myeloma 229.17 14.21 8 295372 47866 53005820
Balance disorder 225.25 14.21 63 295317 73144 52980542
Panniculitis 224.88 14.21 246 295134 7568 53046118
Coma 222.94 14.21 37 295343 61746 52991940
Wrong technique in product usage process 221.02 14.21 34 295346 59998 52993688
Juvenile idiopathic arthritis 220.08 14.21 190 295190 4334 53049352
Depressed level of consciousness 219.31 14.21 23 295357 54405 52999281
Vision blurred 218.61 14.21 100 295280 85504 52968182
Granuloma skin 216.07 14.21 199 295181 4955 53048731
Rhabdomyolysis 215.07 14.21 6 295374 43917 53009769
Blood parathyroid hormone decreased 210.44 14.21 215 295165 6103 53047583
Pulmonary embolism 209.16 14.21 195 295185 114247 52939439
Sleep disorder 207.98 14.21 758 294622 58112 52995574
Gastrointestinal haemorrhage 206.44 14.21 93 295287 80237 52973449
Deformity 205.97 14.21 237 295143 7717 53045969
Blood cholesterol increased 205.88 14.21 704 294676 52285 53001401
Coeliac disease 205.83 14.21 248 295132 8487 53045199
Agitation 205.23 14.21 38 295342 58588 52995098
Cerebrovascular accident 200.85 14.21 172 295208 105002 52948684
Gastrooesophageal reflux disease 199.79 14.21 104 295276 82559 52971127
Gastrointestinal disorder 198.75 14.21 1005 294375 88999 52964687
Paraesthesia 192.70 14.21 254 295126 127261 52926425
Hallucination 192.58 14.21 33 295347 53805 52999881
Metabolic acidosis 192.45 14.21 10 295370 42232 53011454
Pancytopenia 190.99 14.21 135 295245 90793 52962893
Chest pain 189.46 14.21 489 294891 189696 52863990
Fall 189.09 14.21 1186 294194 357254 52696432
International normalised ratio increased 187.84 14.21 22 295358 47739 53005947
Chest discomfort 185.58 14.21 167 295213 99528 52954158
Urinary tract infection 183.14 14.21 696 294684 239207 52814479
Syncope 181.91 14.21 211 295169 111782 52941904
Swollen joint count increased 181.79 14.21 266 295114 11024 53042662
Cardiac failure 179.58 14.21 128 295252 85716 52967970
Inappropriate schedule of product administration 178.31 14.21 96 295284 74782 52978904
Dysphagia 177.66 14.21 125 295255 84272 52969414
Memory impairment 173.89 14.21 129 295251 84628 52969058
Cognitive disorder 172.73 14.21 22 295358 44756 53008930
Joint destruction 172.33 14.21 148 295232 3351 53050335
Disability assessment scale score increased 171.62 14.21 127 295253 2302 53051384
Weight increased 168.62 14.21 1803 293577 202764 52850922
Lactic acidosis 166.06 14.21 10 295370 37243 53016443
Chronic obstructive pulmonary disease 164.44 14.21 66 295314 61007 52992679
Lethargy 164.01 14.21 47 295333 53713 52999973
Hyperglycaemia 161.33 14.21 17 295363 40067 53013619
Musculoskeletal pain 161.32 14.21 833 294547 74367 52979319
Therapeutic response decreased 160.89 14.21 604 294776 46965 53006721
Hospitalisation 156.41 14.21 100 295280 70912 52982774
Unresponsive to stimuli 155.20 14.21 7 295373 33419 53020267
Disorientation 155.10 14.21 18 295362 39341 53014345
Ear pain 154.93 14.21 437 294943 29236 53024450
Hypoxia 153.50 14.21 58 295322 55622 52998064
Platelet count decreased 151.67 14.21 227 295153 107872 52945814
Dysarthria 151.57 14.21 22 295358 40546 53013140
Disturbance in attention 150.96 14.21 10 295370 34373 53019313
Diverticulitis 148.22 14.21 486 294894 35315 53018371
Pleural effusion 148.07 14.21 163 295217 88416 52965270
Suicidal ideation 147.89 14.21 75 295305 60436 52993250
Blood alkaline phosphatase increased 146.51 14.21 26 295354 41336 53012350
Deep vein thrombosis 145.98 14.21 146 295234 82767 52970919
Limb deformity 145.83 14.21 141 295239 3738 53049948
Respiratory arrest 143.67 14.21 11 295369 33529 53020157
Product quality issue 143.26 14.21 18 295362 37005 53016681
Neoplasm progression 143.20 14.21 5 295375 29914 53023772
Epistaxis 142.98 14.21 103 295277 68607 52985079
Stomatitis 142.17 14.21 981 294399 97177 52956509
Musculoskeletal deformity 142.16 14.21 80 295300 881 53052805
Blood glucose increased 139.93 14.21 133 295247 77228 52976458
Pulmonary fibrosis 139.53 14.21 369 295011 23766 53029920
Skin necrosis 137.89 14.21 226 295154 10346 53043340
Mental status changes 137.74 14.21 26 295354 39545 53014141
Myalgia 137.71 14.21 337 295043 133154 52920532
Pyrexia 135.69 14.21 1503 293877 401690 52651996
Palpitations 134.97 14.21 224 295156 102124 52951562
Sciatica 133.98 14.21 340 295040 21353 53032333
Hypophagia 133.58 14.21 10 295370 31052 53022634
Bronchitis chronic 131.33 14.21 139 295241 4115 53049571
Muscle spasticity 131.04 14.21 299 295081 17539 53036147
Incorrect dose administered 129.72 14.21 60 295320 50985 53002701
Dyskinesia 129.41 14.21 13 295367 31820 53021866
Drug tolerance decreased 128.21 14.21 180 295200 7178 53046508
No adverse event 128.18 14.21 493 294887 38772 53014914
Muscular weakness 127.71 14.21 227 295153 100765 52952921
Immobile 127.59 14.21 151 295229 5069 53048617
Coronary artery disease 127.59 14.21 17 295363 33420 53020266
Foot deformity 127.38 14.21 303 295077 18265 53035421
Disease progression 127.17 14.21 231 295149 101689 52951997
Injection site erythema 127.08 14.21 144 295236 77105 52976581
Blood potassium decreased 125.98 14.21 34 295346 40426 53013260
Emotional distress 124.35 14.21 16 295364 32301 53021385
Blood pressure systolic increased 123.41 14.21 452 294928 34725 53018961
Liver function test increased 122.60 14.21 375 295005 26253 53027433
Tenosynovitis 122.31 14.21 207 295173 9732 53043954
Pulmonary oedema 121.99 14.21 73 295307 53650 53000036
Osteonecrosis of jaw 121.12 14.21 26 295354 36120 53017566
Pneumonia aspiration 120.54 14.21 22 295358 34279 53019407
Generalised tonic-clonic seizure 118.87 14.21 11 295369 28747 53024939
Orthostatic hypotension 118.76 14.21 13 295367 29740 53023946
Neutropenia 118.68 14.21 466 294914 158719 52894967
Intentional self-injury 118.36 14.21 5 295375 25279 53028407
Ascites 117.10 14.21 37 295343 39698 53013988
Skin exfoliation 116.81 14.21 28 295352 36055 53017631
Body height below normal 116.30 14.21 92 295288 1849 53051837
Foetal exposure during pregnancy 116.26 14.21 25 295355 34690 53018996
Sedation 115.86 14.21 14 295366 29661 53024025
Oral mucosal exfoliation 115.04 14.21 85 295295 1537 53052149
Pneumonia 113.91 14.21 1579 293801 405590 52648096
Joint laxity 113.41 14.21 98 295282 2238 53051448
Dysgeusia 112.97 14.21 48 295332 42883 53010803
Irritability 112.86 14.21 18 295362 30935 53022751
Toxic epidermal necrolysis 112.48 14.21 4 295376 23546 53030140
Osteoarthritis 112.01 14.21 721 294659 69765 52983921
Blood pressure diastolic decreased 111.83 14.21 271 295109 16532 53037154
Aggression 111.69 14.21 4 295376 23399 53030287
Investigation abnormal 111.06 14.21 77 295303 1254 53052432
Mucosal inflammation 110.73 14.21 49 295331 42735 53010951
Blood pressure systolic abnormal 110.33 14.21 165 295215 6974 53046712
Depressed mood 109.68 14.21 34 295346 36930 53016756
Blood bilirubin increased 109.42 14.21 31 295349 35699 53017987
Fatigue 108.39 14.21 5009 290371 725497 52328189
Intentional product misuse 108.15 14.21 70 295310 49322 53004364
Delirium 107.93 14.21 47 295333 41382 53012304
Blood pressure diastolic abnormal 107.44 14.21 182 295198 8563 53045123
Psychotic disorder 107.33 14.21 7 295373 24378 53029308
Abnormal behaviour 107.00 14.21 3 295377 21863 53031823
Temperature regulation disorder 106.65 14.21 124 295256 4083 53049603
Blood pressure decreased 106.56 14.21 111 295269 61758 52991928
Fluid overload 106.55 14.21 14 295366 27817 53025869
Sepsis 105.15 14.21 435 294945 145994 52907692
Immunodeficiency 104.58 14.21 246 295134 14721 53038965
Treatment noncompliance 104.29 14.21 27 295353 33008 53020678
Restlessness 103.16 14.21 16 295364 28071 53025615
Stevens-Johnson syndrome 102.69 14.21 9 295371 24573 53029113
Pneumonia viral 102.32 14.21 159 295221 6953 53046733
Abdominal distension 102.09 14.21 178 295202 79612 52974074
Human antichimeric antibody positive 101.80 14.21 76 295304 1397 53052289
Pulmonary hypertension 100.77 14.21 40 295340 37230 53016456
Body temperature increased 100.73 14.21 404 294976 32395 53021291
Sinus tachycardia 100.20 14.21 8 295372 23564 53030122
Wheezing 99.61 14.21 129 295251 65146 52988540
Basal cell carcinoma 99.30 14.21 321 295059 23148 53030538
Dyspnoea exertional 98.93 14.21 95 295285 54905 52998781
Encephalopathy 98.71 14.21 40 295340 36768 53016918
Psoriatic arthropathy 98.63 14.21 527 294853 47663 53006023
Pulmonary toxicity 98.60 14.21 135 295245 5256 53048430
Urinary retention 98.44 14.21 19 295361 28447 53025239
Drug eruption 97.96 14.21 334 295046 24760 53028926
Bone density decreased 96.75 14.21 199 295181 10865 53042821
Bone pain 96.73 14.21 83 295297 50639 53003047
Dysuria 95.93 14.21 25 295355 30428 53023258
Drug reaction with eosinophilia and systemic symptoms 95.84 14.21 31 295349 32769 53020917
Cough 95.50 14.21 935 294445 255958 52797728
Blood sodium decreased 95.12 14.21 9 295371 23107 53030579
Bone marrow failure 94.33 14.21 25 295355 30090 53023596
Aphasia 93.70 14.21 27 295353 30751 53022935
Jaundice 93.38 14.21 26 295354 30287 53023399
Chills 92.91 14.21 285 295095 104563 52949123
Accidental exposure to product 92.84 14.21 11 295369 23663 53030023
Rheumatoid factor negative 92.42 14.21 51 295329 539 53053147
Fibromyalgia 92.25 14.21 485 294895 43590 53010096
Speech disorder 92.15 14.21 51 295329 39130 53014556
Accidental overdose 92.12 14.21 7 295373 21472 53032214
Red blood cell sedimentation rate 91.90 14.21 97 295283 2862 53050824
Physical disability 91.46 14.21 80 295300 1858 53051828
Joint range of motion decreased 90.38 14.21 261 295119 17695 53035991
Haemophagocytic lymphohistiocytosis 90.33 14.21 173 295207 8964 53044722
Grip strength decreased 89.71 14.21 200 295180 11549 53042137
Blood urea increased 89.68 14.21 18 295362 26213 53027473
Product prescribing error 89.59 14.21 11 295369 23020 53030666
Flushing 88.06 14.21 160 295220 70440 52983246
Type 2 diabetes mellitus 87.77 14.21 378 295002 31292 53022394
Chronic kidney disease 87.66 14.21 67 295313 43303 53010383
Hallucination, visual 87.24 14.21 4 295376 18828 53034858
Respiratory distress 87.13 14.21 39 295341 33788 53019898
Arrhythmia 86.31 14.21 48 295332 36731 53016955
Haematuria 86.25 14.21 25 295355 28364 53025322
Blood calcium decreased 86.18 14.21 6 295374 19788 53033898
Pulmonary arterial hypertension 85.94 14.21 22 295358 27100 53026586
Blood pressure fluctuation 85.32 14.21 406 294974 35064 53018622
Hepatic failure 85.09 14.21 46 295334 35760 53017926
Altered state of consciousness 85.00 14.21 17 295363 24819 53028867
Surgical failure 84.97 14.21 57 295323 877 53052809
Dry mouth 83.55 14.21 125 295255 59425 52994261
Presyncope 83.48 14.21 21 295359 26173 53027513
Pollakiuria 81.80 14.21 21 295359 25818 53027868
Exposure during pregnancy 81.70 14.21 384 294996 124476 52929210
Onychomycosis 81.23 14.21 120 295260 5016 53048670
Circulatory collapse 81.05 14.21 14 295366 22700 53030986
Dry skin 80.04 14.21 81 295299 45679 53008007
Acute myocardial infarction 80.00 14.21 42 295338 33193 53020493
Spinal column injury 78.78 14.21 73 295307 1832 53051854
Diabetic ketoacidosis 78.73 14.21 9 295371 19906 53033780
Ventricular tachycardia 78.46 14.21 5 295375 17757 53035929
Withdrawal syndrome 78.14 14.21 8 295372 19293 53034393
Device issue 78.05 14.21 13 295367 21645 53032041
Malaise 77.52 14.21 1454 293926 356163 52697523
Asthma 77.41 14.21 325 295055 108647 52945039
Full blood count decreased 77.09 14.21 19 295361 24010 53029676
Mental disorder 76.80 14.21 20 295360 24356 53029330
Toothache 76.67 14.21 246 295134 17668 53036018
Rectal haemorrhage 76.54 14.21 70 295310 41411 53012275
Renal disorder 75.99 14.21 33 295347 29106 53024580
Ejection fraction decreased 75.94 14.21 10 295370 19838 53033848
Cardiomegaly 75.78 14.21 6 295374 17794 53035892
White blood cell count decreased 75.59 14.21 393 294987 124082 52929604
Blood creatine phosphokinase increased 75.32 14.21 33 295347 28952 53024734
Angioedema 75.30 14.21 73 295307 42003 53011683
Haematochezia 75.21 14.21 74 295306 42284 53011402
Blood creatinine increased 75.16 14.21 222 295158 82440 52971246
Hemiparesis 74.97 14.21 14 295366 21461 53032225
Myocardial infarction 73.91 14.21 291 295089 99063 52954623
Haematocrit decreased 73.76 14.21 59 295321 37272 53016414
Haemorrhage 73.59 14.21 130 295250 57857 52995829
Electrolyte imbalance 73.50 14.21 9 295371 18875 53034811
Abortion spontaneous 73.40 14.21 90 295290 46545 53007141
Ulcer 73.20 14.21 266 295114 20353 53033333
Red cell distribution width decreased 73.01 14.21 54 295326 978 53052708
Thrombosis 72.97 14.21 141 295239 60652 52993034
Pericardial effusion 72.57 14.21 30 295350 27248 53026438
Cholestasis 72.48 14.21 34 295346 28661 53025025
Unevaluable event 72.29 14.21 101 295279 49397 53004289
Vaginal haemorrhage 72.25 14.21 29 295351 26812 53026874
Colitis microscopic 72.21 14.21 136 295244 6958 53046728
Food allergy 72.08 14.21 148 295232 8070 53045616
Gamma-glutamyltransferase increased 71.51 14.21 49 295331 33506 53020180
Melaena 71.32 14.21 36 295344 29093 53024593
Obstructive airways disorder 71.15 14.21 7 295373 17422 53036264
Impaired work ability 71.10 14.21 205 295175 13885 53039801
Metastases to bone 71.00 14.21 11 295369 19317 53034369
Vascular access complication 70.43 14.21 55 295325 1084 53052602
Therapeutic response unexpected 70.33 14.21 7 295373 17263 53036423
Nightmare 70.23 14.21 8 295372 17743 53035943
Joint injury 70.09 14.21 275 295105 21825 53031861
Atelectasis 69.54 14.21 13 295367 19913 53033773
Mean platelet volume decreased 69.33 14.21 64 295316 1598 53052088
Tubulointerstitial nephritis 69.05 14.21 6 295374 16498 53037188
Acute respiratory failure 68.84 14.21 44 295336 31214 53022472
Haematemesis 68.55 14.21 43 295337 30814 53022872
Nervousness 68.51 14.21 41 295339 30137 53023549
Herpes zoster 68.30 14.21 668 294712 73351 52980335
Hypersomnia 68.28 14.21 6 295374 16349 53037337
Blood pressure diastolic increased 68.12 14.21 133 295247 6991 53046695
Rash macular 67.83 14.21 16 295364 20831 53032855
Device dislocation 67.72 14.21 23 295357 23574 53030112
Oral herpes 67.54 14.21 264 295116 20915 53032771
Transient ischaemic attack 67.46 14.21 59 295321 35666 53018020
Multiple sclerosis 67.32 14.21 33 295347 27120 53026566
Blood count abnormal 67.27 14.21 15 295365 20300 53033386
Arthrodesis 67.17 14.21 75 295305 2361 53051325
Blood lactate dehydrogenase increased 66.50 14.21 19 295361 21762 53031924
Cardiac disorder 66.45 14.21 98 295282 46868 53006818
Heart rate decreased 66.27 14.21 390 294990 36557 53017129
Rheumatoid lung 66.25 14.21 73 295307 2264 53051422
Loose body in joint 66.03 14.21 54 295326 1140 53052546
Musculoskeletal disorder 65.76 14.21 230 295150 17269 53036417
Staphylococcal infection 65.43 14.21 70 295310 38478 53015208
Migraine 65.40 14.21 227 295153 80190 52973496
Cerebral haemorrhage 65.00 14.21 43 295337 29953 53023733
Visual acuity reduced 64.38 14.21 22 295358 22463 53031223
Demyelination 64.15 14.21 120 295260 6107 53047579
Blood glucose decreased 63.87 14.21 16 295364 20000 53033686
Product administration error 63.53 14.21 20 295360 21511 53032175
Colitis 63.51 14.21 82 295298 41470 53012216
Antibody test positive 63.09 14.21 71 295309 2255 53051431
Epilepsy 62.85 14.21 32 295348 25735 53027951
Bedridden 62.64 14.21 156 295224 9681 53044005
Injection site pruritus 62.61 14.21 83 295297 41506 53012180
Cutaneous vasculitis 62.49 14.21 99 295281 4402 53049284
Vertigo 62.28 14.21 136 295244 55945 52997741
Premature delivery 61.35 14.21 34 295346 26070 53027616
Injection site swelling 61.24 14.21 88 295292 42540 53011146
Pharyngitis 60.86 14.21 237 295143 18743 53034943
Clostridium difficile colitis 60.79 14.21 17 295363 19748 53033938
Pancreatitis 60.79 14.21 101 295279 46041 53007645
Respiratory disorder 60.57 14.21 359 295021 33738 53019948
Lip swelling 60.30 14.21 38 295342 27163 53026523
Small intestinal obstruction 60.24 14.21 11 295369 17136 53036550
Eating disorder 60.00 14.21 9 295371 16188 53037498
Ataxia 59.95 14.21 6 295374 14731 53038955
Retinal toxicity 59.70 14.21 51 295329 1146 53052540
Hyperhidrosis 59.66 14.21 304 295076 96489 52957197
Infusion site reaction 58.95 14.21 66 295314 2084 53051602
Red blood cell count decreased 58.95 14.21 67 295313 35836 53017850
Muscle twitching 58.88 14.21 10 295370 16416 53037270
Intestinal obstruction 58.59 14.21 44 295336 28697 53024989
Osteoporotic fracture 58.45 14.21 81 295299 3190 53050496
Lymphocyte count decreased 58.41 14.21 42 295338 28010 53025676
Tricuspid valve incompetence 58.20 14.21 6 295374 14390 53039296
Urinary incontinence 58.08 14.21 51 295329 30770 53022916
Mitral valve incompetence 57.97 14.21 18 295362 19533 53034153
Upper gastrointestinal haemorrhage 57.46 14.21 13 295367 17417 53036269
Neutropenic sepsis 56.97 14.21 7 295373 14642 53039044
Hypothermia 56.72 14.21 4 295376 13052 53040634
Feeling hot 56.55 14.21 89 295291 41455 53012231
Eye swelling 55.89 14.21 25 295355 21669 53032017
Fear 55.69 14.21 12 295368 16629 53037057
Influenza like illness 55.64 14.21 163 295217 60696 52992990
Myelosuppression 55.53 14.21 4 295376 12824 53040862
Multiple organ dysfunction syndrome 55.47 14.21 143 295237 55534 52998152
Diplopia 54.97 14.21 23 295357 20742 53032944
Anal incontinence 54.58 14.21 4 295376 12643 53041043
Haemoptysis 54.54 14.21 45 295335 27994 53025692
Sinus bradycardia 54.35 14.21 8 295372 14593 53039093
Limb mass 54.30 14.21 73 295307 2792 53050894
Finger deformity 54.30 14.21 106 295274 5571 53048115
Premature baby 53.94 14.21 21 295359 19780 53033906
Dystonia 53.76 14.21 5 295375 13016 53040670
Infusion site pain 53.27 14.21 3 295377 11830 53041856
Oedema 53.24 14.21 221 295159 74125 52979561
Clostridium difficile infection 52.74 14.21 46 295334 27847 53025839
Diverticular perforation 52.70 14.21 79 295301 3346 53050340
Confusional state 52.44 14.21 758 294622 193463 52860223
Acute hepatic failure 52.14 14.21 14 295366 16706 53036980
Neutrophil count decreased 52.13 14.21 122 295258 48976 53004710
Disability 52.02 14.21 170 295210 12328 53041358
Joint arthroplasty 51.90 14.21 62 295318 2102 53051584
Myelodysplastic syndrome 51.86 14.21 14 295366 16646 53037040
Gastritis 51.85 14.21 75 295305 36159 53017527
Presbyacusis 51.84 14.21 73 295307 2919 53050767
Blood albumin decreased 51.80 14.21 9 295371 14533 53039153
Fine motor skill dysfunction 51.68 14.21 87 295293 4072 53049614
Bursitis 51.60 14.21 254 295126 22238 53031448
Hypocalcaemia 51.22 14.21 52 295328 29285 53024401
Renal tubular necrosis 51.09 14.21 3 295377 11416 53042270
Soft tissue disorder 51.01 14.21 88 295292 4202 53049484
Night sweats 50.98 14.21 350 295030 34597 53019089
Mood altered 50.86 14.21 8 295372 13893 53039793
Anuria 50.77 14.21 5 295375 12435 53041251
X-ray abnormal 50.63 14.21 64 295316 2302 53051384
Nodule 50.59 14.21 211 295169 17218 53036468
Transaminases abnormal 50.53 14.21 35 295345 569 53053117
Flatulence 50.47 14.21 60 295320 31457 53022229
Dementia 50.42 14.21 15 295365 16735 53036951
Oesophagitis 50.32 14.21 10 295370 14667 53039019
Device malfunction 50.22 14.21 13 295367 15895 53037791
Osteonecrosis 50.04 14.21 44 295336 26531 53027155
Tachypnoea 49.96 14.21 13 295367 15841 53037845
Cyanosis 49.91 14.21 15 295365 16624 53037062
Injection site mass 49.77 14.21 14 295366 16200 53037486
Faeces discoloured 49.45 14.21 18 295362 17668 53036018
Ageusia 49.12 14.21 6 295374 12608 53041078
Polyarthritis 49.05 14.21 123 295257 7666 53046020
Frequent bowel movements 49.04 14.21 10 295370 14402 53039284
Sinus disorder 48.84 14.21 21 295359 18633 53035053
Gastrointestinal perforation 48.57 14.21 76 295304 3343 53050343
Cardiogenic shock 48.52 14.21 18 295362 17464 53036222
Peptic ulcer haemorrhage 48.26 14.21 43 295337 1024 53052662
Pallor 48.26 14.21 41 295339 25141 53028545
Hyperlipidaemia 47.95 14.21 24 295356 19491 53034195
Mean cell volume decreased 47.75 14.21 67 295313 2670 53051016
Blood magnesium decreased 47.56 14.21 5 295375 11809 53041877
Pleural thickening 47.50 14.21 66 295314 2606 53051080
Right ventricular failure 47.33 14.21 17 295363 16826 53036860
Metastases to liver 46.33 14.21 31 295349 21465 53032221
Swelling face 46.06 14.21 162 295218 57006 52996680
Acute myeloid leukaemia 46.05 14.21 18 295362 16914 53036772
Malignant melanoma 45.92 14.21 148 295232 10654 53043032
Neurotoxicity 45.74 14.21 14 295366 15335 53038351
Injection site warmth 45.65 14.21 11 295369 14117 53039569
Breast cancer metastatic 45.65 14.21 14 295366 15314 53038372
Abortion induced 45.12 14.21 4 295376 10822 53042864
Schizophrenia 45.09 14.21 3 295377 10276 53043410
Aspiration 44.73 14.21 3 295377 10207 53043479
Retching 44.73 14.21 11 295369 13922 53039764
Localised infection 44.72 14.21 277 295103 26439 53027247
Joint effusion 44.68 14.21 169 295211 13183 53040503
Pleural fibrosis 44.20 14.21 75 295305 3533 53050153
Body temperature decreased 44.19 14.21 196 295184 16431 53037255
Drug specific antibody 44.00 14.21 49 295331 1538 53052148
Agranulocytosis 43.90 14.21 40 295340 23709 53029977
Face oedema 43.87 14.21 29 295351 20211 53033475
Interstitial lung disease 43.75 14.21 507 294873 58115 52995571
Delusion 43.74 14.21 7 295373 12002 53041684
Multiple fractures 43.64 14.21 106 295274 6475 53047211
Ventricular fibrillation 43.32 14.21 7 295373 11918 53041768
Premature labour 43.28 14.21 8 295372 12354 53041332
Systemic lupus erythematosus rash 43.28 14.21 50 295330 1635 53052051
Ankle arthroplasty 43.25 14.21 37 295343 833 53052853
Hypercholesterolaemia 43.23 14.21 161 295219 12465 53041221
Status epilepticus 43.22 14.21 15 295365 15169 53038517
Renal injury 43.12 14.21 3 295377 9901 53043785
Eosinophilia 43.06 14.21 33 295347 21302 53032384
Leukocytosis 43.00 14.21 44 295336 24690 53028996
Coagulopathy 43.00 14.21 28 295352 19670 53034016
Brain oedema 42.95 14.21 11 295369 13547 53040139
Hypovolaemia 42.93 14.21 4 295376 10398 53043288
Prothrombin time prolonged 42.69 14.21 3 295377 9819 53043867
Glaucoma 42.63 14.21 197 295183 16806 53036880
Dermatitis allergic 42.35 14.21 168 295212 13400 53040286
Nail disorder 42.28 14.21 135 295245 9670 53044016
Growth failure 42.23 14.21 25 295355 305 53053381
Progressive multifocal leukoencephalopathy 42.14 14.21 8 295372 12121 53041565
Cardiomyopathy 42.01 14.21 21 295359 17067 53036619
Haematoma 41.93 14.21 77 295303 33767 53019919
Urine output decreased 41.83 14.21 7 295373 11616 53042070
Myocardial ischaemia 41.50 14.21 10 295370 12834 53040852
Wheelchair user 41.25 14.21 86 295294 4740 53048946
Cholecystitis chronic 40.97 14.21 5 295375 10513 53043173
Mean cell haemoglobin decreased 40.81 14.21 70 295310 3327 53050359
Hepatitis 40.63 14.21 324 295056 33570 53020116
Arthritis bacterial 40.52 14.21 98 295282 5970 53047716
Subdural haematoma 40.45 14.21 13 295367 13800 53039886
Hypokinesia 40.45 14.21 11 295369 13016 53040670
Shock 40.41 14.21 41 295339 23098 53030588
Exostosis 40.23 14.21 147 295233 11277 53042409
Sleep apnoea syndrome 40.06 14.21 51 295329 25951 53027735
Iron deficiency anaemia 39.77 14.21 27 295353 18553 53035133
Acute generalised exanthematous pustulosis 39.77 14.21 5 295375 10276 53043410
Escherichia infection 39.69 14.21 9 295371 12041 53041645
Vasculitic rash 39.66 14.21 43 295337 1309 53052377
Pancreatitis acute 39.41 14.21 52 295328 26057 53027629
Lung infiltration 39.40 14.21 16 295364 14691 53038995
Supraventricular tachycardia 39.34 14.21 15 295365 14310 53039376
Weight decreased 39.05 14.21 996 294384 233952 52819734
Eczema 38.76 14.21 46 295334 24136 53029550
White blood cell count abnormal 38.45 14.21 89 295291 5269 53048417
Pulmonary mass 38.39 14.21 215 295165 19789 53033897
Hepatocellular injury 38.24 14.21 67 295313 29919 53023767
Complication associated with device 38.07 14.21 21 295359 16144 53037542
Cold sweat 37.84 14.21 9 295371 11653 53042033
Left ventricular dysfunction 37.81 14.21 8 295372 11229 53042457
Intercepted product storage error 37.71 14.21 12 295368 23 53053663
Glomerular filtration rate decreased 37.41 14.21 12 295368 12755 53040931
Toxic skin eruption 37.37 14.21 13 295367 13126 53040560
Infiltration anaesthesia 37.20 14.21 18 295362 141 53053545
Concomitant disease aggravated 37.04 14.21 3 295377 8735 53044951
Oliguria 36.96 14.21 4 295376 9234 53044452
Incorrect product administration duration 36.93 14.21 7 295373 10617 53043069
Pruritus allergic 36.92 14.21 38 295342 1088 53052598
Paranoia 36.71 14.21 9 295371 11415 53042271
Oral candidiasis 36.67 14.21 30 295350 18743 53034943
Blood magnesium increased 36.28 14.21 63 295317 3024 53050662
Viral upper respiratory tract infection 35.99 14.21 105 295275 7159 53046527
Head injury 35.48 14.21 55 295325 25778 53027908
Hypotonia 35.44 14.21 4 295376 8937 53044749
Renal impairment 35.37 14.21 293 295087 83025 52970661
Mesenteritis 35.05 14.21 17 295363 134 53053552
Aplastic anaemia 34.88 14.21 3 295377 8318 53045368
Device related infection 34.78 14.21 45 295335 22741 53030945
Adverse event 34.71 14.21 364 295016 40697 53012989
Blood calcium increased 34.44 14.21 3 295377 8233 53045453
Ileus 34.39 14.21 20 295360 14935 53038751
Ventricular extrasystoles 34.39 14.21 11 295369 11713 53041973
Malnutrition 34.04 14.21 20 295360 14851 53038835
Atrial flutter 34.02 14.21 6 295374 9585 53044101
Anger 33.98 14.21 13 295367 12377 53041309
Psoriasis 33.98 14.21 313 295067 86776 52966910
Torus fracture 33.88 14.21 16 295364 118 53053568
Extremity contracture 33.79 14.21 39 295341 1274 53052412
Nonalcoholic fatty liver disease 33.79 14.21 35 295345 1010 53052676
Peritonitis bacterial 33.60 14.21 6 295374 9499 53044187
Device difficult to use 33.60 14.21 8 295372 10351 53043335
Hysterectomy 33.51 14.21 4 295376 8557 53045129
Femur fracture 33.50 14.21 351 295029 39234 53014452
Injection site urticaria 33.32 14.21 14 295366 12593 53041093
Joint dislocation 33.17 14.21 146 295234 12199 53041487
Hypoaesthesia 33.14 14.21 527 294853 132468 52921218
Skin papilloma 33.12 14.21 75 295305 4376 53049310
Sensory loss 32.73 14.21 3 295377 7902 53045784
Device breakage 32.66 14.21 9 295371 10558 53043128
Feeling jittery 32.61 14.21 13 295367 12070 53041616
Posterior reversible encephalopathy syndrome 32.60 14.21 25 295355 16135 53037551
Blood pressure abnormal 32.50 14.21 17 295363 13466 53040220
Infusion site erythema 32.45 14.21 5 295375 8817 53044869
Ischaemic stroke 32.44 14.21 31 295349 17962 53035724
Myopathy 32.41 14.21 7 295373 9685 53044001
Ocular hyperaemia 32.28 14.21 44 295336 21747 53031939
Macular degeneration 32.23 14.21 14 295366 12347 53041339
Haemolytic anaemia 32.07 14.21 9 295371 10430 53043256
Panic attack 31.98 14.21 43 295337 21375 53032311
Contusion 31.90 14.21 821 294559 109911 52943775
Pelvic pain 31.84 14.21 14 295366 12259 53041427
Flank pain 31.79 14.21 19 295361 13977 53039709
Deafness neurosensory 31.72 14.21 77 295303 4701 53048985
Hypercalcaemia 31.54 14.21 237 295143 24111 53029575
Injection site hypersensitivity 31.09 14.21 43 295337 1690 53051996
Paralysis 30.93 14.21 7 295373 9377 53044309
Central nervous system lesion 30.77 14.21 9 295371 10153 53043533
Deafness 30.50 14.21 30 295350 17146 53036540
Onychomadesis 30.13 14.21 64 295316 3574 53050112
Anti-cyclic citrullinated peptide antibody 30.13 14.21 32 295348 951 53052735
Hypoaesthesia oral 30.09 14.21 13 295367 11503 53042183
Autoimmune hepatitis 29.96 14.21 5 295375 8313 53045373
Apathy 29.93 14.21 5 295375 8307 53045379
Haemorrhoids 29.72 14.21 42 295338 20447 53033239
Hemiplegia 29.67 14.21 4 295376 7796 53045890
Skin discolouration 29.51 14.21 98 295282 35094 53018592
Adverse drug reaction 29.24 14.21 438 294942 53187 53000499
Intestinal sepsis 29.10 14.21 18 295362 239 53053447
Nephropathy toxic 29.06 14.21 6 295374 8566 53045120
Peripheral sensory neuropathy 28.84 14.21 3 295377 7145 53046541
Rash papular 28.80 14.21 20 295360 13582 53040104
Arteriosclerosis 28.76 14.21 10 295370 10101 53043585
Hip fracture 28.59 14.21 72 295308 28185 53025501
Major depression 28.58 14.21 4 295376 7578 53046108
Chromaturia 28.16 14.21 28 295352 15922 53037764
Bundle branch block left 28.15 14.21 3 295377 7010 53046676
Loss of consciousness 27.98 14.21 454 294926 113758 52939928
Polyuria 27.95 14.21 5 295375 7906 53045780
Heavy menstrual bleeding 27.90 14.21 33 295347 17343 53036343
Therapy non-responder 27.87 14.21 404 294976 48716 53004970
Tumour lysis syndrome 27.77 14.21 5 295375 7869 53045817
Pulmonary haemorrhage 27.74 14.21 3 295377 6930 53046756
Eructation 27.68 14.21 5 295375 7850 53045836
Glycosylated haemoglobin increased 27.65 14.21 15 295365 11640 53042046
Liver disorder 27.64 14.21 342 295038 39813 53013873
Cardiac failure acute 27.63 14.21 8 295372 9084 53044602
Hypoalbuminaemia 27.55 14.21 13 295367 10923 53042763
Accident 27.54 14.21 80 295300 5441 53048245
Underdose 27.53 14.21 48 295332 21474 53032212
Hypoacusis 27.47 14.21 52 295328 22547 53031139
Pre-eclampsia 27.42 14.21 7 295373 8640 53045046
Intestinal perforation 27.17 14.21 130 295250 11250 53042436
Productive cough 27.13 14.21 193 295187 56536 52997150
Rales 27.10 14.21 13 295367 10819 53042867
Foetal death 27.01 14.21 9 295371 9338 53044348
Drug resistance 26.94 14.21 43 295337 19919 53033767
Drug level decreased 26.93 14.21 3 295377 6771 53046915
Hot flush 26.89 14.21 152 295228 47008 53006678
Device occlusion 26.88 14.21 3 295377 6762 53046924
Bipolar disorder 26.85 14.21 5 295375 7681 53046005
Crohn's disease 26.81 14.21 3 295377 6747 53046939
Gallbladder disorder 26.58 14.21 37 295343 18128 53035558
Amyotrophic lateral sclerosis 26.58 14.21 32 295348 1094 53052592
Prosthesis user 26.30 14.21 12 295368 81 53053605
Graft versus host disease 26.28 14.21 4 295376 7118 53046568
Mood swings 26.21 14.21 35 295345 17451 53036235
Skin burning sensation 26.04 14.21 16 295364 11594 53042092
Injection site reaction 26.01 14.21 413 294967 50753 53002933
Eyelid oedema 25.90 14.21 13 295367 10541 53043145
Motor dysfunction 25.87 14.21 7 295373 8311 53045375
Troponin increased 25.83 14.21 8 295372 8697 53044989
Intermenstrual bleeding 25.80 14.21 8 295372 8690 53044996
Hepatic encephalopathy 25.72 14.21 14 295366 10845 53042841
Ankylosing spondylitis 25.68 14.21 101 295279 8024 53045662
Brachiocephalic artery stenosis 25.49 14.21 9 295371 27 53053659
Toe amputation 25.46 14.21 43 295337 2018 53051668
Bone cyst 25.37 14.21 44 295336 2110 53051576
Thrombotic microangiopathy 25.27 14.21 10 295370 9327 53044359
Pain of skin 25.13 14.21 8 295372 8544 53045142
Erythema 25.11 14.21 669 294711 156300 52897386
Electrocardiogram abnormal 25.10 14.21 7 295373 8146 53045540
Injection site rash 25.04 14.21 33 295347 16546 53037140
Cholelithiasis 25.03 14.21 129 295251 40835 53012851
Feeding disorder 24.97 14.21 16 295364 11338 53042348
Dysstasia 24.97 14.21 42 295338 19057 53034629
Abdominal pain lower 24.74 14.21 59 295321 23534 53030152
Vitamin D deficiency 24.64 14.21 19 295361 12229 53041457
Cytomegalovirus infection 24.61 14.21 44 295336 19495 53034191
Lymphadenopathy 24.58 14.21 110 295270 36145 53017541
Wrist surgery 24.56 14.21 27 295353 835 53052851
Thirst 24.50 14.21 17 295363 11549 53042137
Taste disorder 24.23 14.21 7 295373 7961 53045725
Tinnitus 24.23 14.21 87 295293 30432 53023254
Rash maculo-papular 24.16 14.21 84 295296 29665 53024021
Paraesthesia oral 24.00 14.21 22 295358 13003 53040683
Diabetic eye disease 23.99 14.21 14 295366 166 53053520
Activated partial thromboplastin time prolonged 23.80 14.21 5 295375 7054 53046632
Acute pulmonary oedema 23.77 14.21 8 295372 8247 53045439
Metastases to lung 23.75 14.21 18 295362 11686 53042000
Genital haemorrhage 23.73 14.21 5 295375 7039 53046647
Skin reaction 23.73 14.21 131 295249 11992 53041694
Congestive cardiomyopathy 23.70 14.21 3 295377 6135 53047551
Metastases to lymph nodes 23.64 14.21 6 295374 7434 53046252
Erythema multiforme 23.57 14.21 14 295366 10335 53043351
Dermatitis contact 23.56 14.21 10 295370 8942 53044744
Orthopnoea 23.53 14.21 3 295377 6101 53047585
Illness 23.49 14.21 56 295324 22340 53031346
Hyperthermia 23.49 14.21 9 295371 8560 53045126
Eye pain 23.47 14.21 89 295291 30636 53023050
Personality change 23.40 14.21 3 295377 6074 53047612
Skin plaque 23.22 14.21 4 295376 6500 53047186
Nystagmus 23.19 14.21 3 295377 6033 53047653
Adverse reaction 23.18 14.21 105 295275 8882 53044804
Oral discomfort 23.17 14.21 103 295277 8643 53045043
Atrial septal defect 23.11 14.21 5 295375 6909 53046777
Epigastric discomfort 23.07 14.21 81 295299 6092 53047594
Shock haemorrhagic 23.01 14.21 11 295369 9172 53044514
Amylase increased 22.98 14.21 3 295377 5991 53047695
Arteriosclerosis coronary artery 22.97 14.21 9 295371 8445 53045241
Throat tightness 22.95 14.21 56 295324 22160 53031526
Dislocation of vertebra 22.87 14.21 48 295332 2658 53051028
Thinking abnormal 22.85 14.21 15 295365 10493 53043193
Back pain 22.79 14.21 1062 294318 233185 52820501
White blood cell count increased 22.77 14.21 156 295224 46089 53007597
Aortic arteriosclerosis 22.58 14.21 3 295377 5911 53047775
Pseudomonas infection 22.52 14.21 15 295365 10413 53043273
Polyneuropathy 22.49 14.21 24 295356 13209 53040477
Immune reconstitution inflammatory syndrome 22.45 14.21 4 295376 6342 53047344
Expired product administered 22.38 14.21 3 295377 5873 53047813
Pharyngeal abscess 22.35 14.21 15 295365 231 53053455
Enthesopathy 22.27 14.21 83 295297 6428 53047258
Amenorrhoea 22.22 14.21 12 295368 9337 53044349
Atrioventricular block 22.22 14.21 6 295374 7134 53046552
Dizziness postural 22.20 14.21 5 295375 6720 53046966
Injection site bruising 22.19 14.21 120 295260 37526 53016160
Impaired gastric emptying 22.10 14.21 104 295276 8939 53044747
Hepatitis cholestatic 22.03 14.21 6 295374 7093 53046593
Product label confusion 21.98 14.21 20 295360 490 53053196
Angina unstable 21.92 14.21 7 295373 7461 53046225
Pulseless electrical activity 21.85 14.21 7 295373 7447 53046239
Poor quality sleep 21.82 14.21 39 295341 17284 53036402
Hepatomegaly 21.78 14.21 20 295360 11811 53041875
Wrist deformity 21.64 14.21 37 295343 1754 53051932
Monocyte count increased 21.60 14.21 75 295305 5610 53048076
Rheumatic disorder 21.54 14.21 34 295346 1507 53052179
Hiatus hernia 21.43 14.21 48 295332 19572 53034114
Device failure 21.41 14.21 4 295376 6131 53047555
Acidosis 21.28 14.21 19 295361 11373 53042313
Neck surgery 21.28 14.21 34 295346 1523 53052163
Splenomegaly 21.25 14.21 16 295364 10423 53043263
Rheumatoid vasculitis 21.23 14.21 17 295363 348 53053338
Mouth ulceration 21.15 14.21 252 295128 29074 53024612
Gestational diabetes 21.13 14.21 9 295371 8030 53045656
Eyelid ptosis 21.11 14.21 5 295375 6492 53047194
Product complaint 21.09 14.21 22 295358 12235 53041451
Angina pectoris 20.80 14.21 85 295295 28640 53025046
Therapy change 20.76 14.21 3 295377 5549 53048137
Refusal of treatment by patient 20.70 14.21 3 295377 5537 53048149
Jaundice cholestatic 20.67 14.21 3 295377 5531 53048155
Coronary artery occlusion 20.65 14.21 10 295370 8277 53045409
Normal newborn 20.59 14.21 7 295373 7172 53046514
Lower limb fracture 20.55 14.21 142 295238 14063 53039623
Hepatic function abnormal 20.46 14.21 120 295260 36779 53016907
Laboratory test abnormal 20.45 14.21 68 295312 24341 53029345
Tooth infection 20.44 14.21 143 295237 14220 53039466
Photosensitivity reaction 20.40 14.21 28 295352 13800 53039886
Second primary malignancy 20.38 14.21 7 295373 7125 53046561
Obesity 20.36 14.21 160 295220 16502 53037184
Abscess rupture 20.36 14.21 15 295365 270 53053416
Stress cardiomyopathy 20.34 14.21 11 295369 8551 53045135
Body height decreased 20.29 14.21 15 295365 9864 53043822
Eye irritation 20.26 14.21 45 295335 18404 53035282
Secretion discharge 20.21 14.21 113 295267 10393 53043293
Injection site haemorrhage 20.19 14.21 59 295321 21992 53031694
Sensory disturbance 20.13 14.21 25 295355 12861 53040825
Product temperature excursion issue 20.00 14.21 8 295372 37 53053649
Drug dependence 19.99 14.21 57 295323 21415 53032271
Partial seizures 19.90 14.21 3 295377 5377 53048309
Increased appetite 19.87 14.21 13 295367 9109 53044577
Extra dose administered 19.85 14.21 3 295377 5367 53048319
Middle insomnia 19.83 14.21 18 295362 10690 53042996
Hyperventilation 19.72 14.21 5 295375 6199 53047487
Lipase increased 19.58 14.21 14 295366 9364 53044322
Infected skin ulcer 19.57 14.21 41 295339 2268 53051418
Swollen tongue 19.49 14.21 97 295283 30983 53022703
Intervertebral disc compression 19.45 14.21 26 295354 989 53052697
Tendon disorder 19.41 14.21 72 295308 5563 53048123
Pleurisy 19.36 14.21 92 295288 7939 53045747
Pancreatic toxicity 19.35 14.21 7 295373 23 53053663
Injection site induration 19.32 14.21 12 295368 8646 53045040
Sputum discoloured 19.24 14.21 31 295349 14308 53039378
Purpura 19.22 14.21 19 295361 10834 53042852
Eye pruritus 19.15 14.21 28 295352 13441 53040245
Androgenetic alopecia 19.10 14.21 12 295368 164 53053522
Micturition urgency 19.09 14.21 12 295368 8590 53045096
Drug-induced liver injury 19.04 14.21 90 295290 29143 53024543
Blood thyroid stimulating hormone increased 19.02 14.21 6 295374 6446 53047240
Generalised oedema 19.02 14.21 34 295346 15065 53038621
Intervertebral disc space narrowing 18.98 14.21 25 295355 937 53052749
Faecaloma 18.98 14.21 11 295369 8230 53045456
Hyperbilirubinaemia 18.89 14.21 20 295360 11049 53042637
Amnesia 18.88 14.21 160 295220 45128 53008558
Blood pressure increased 18.86 14.21 955 294425 139524 52914162
Hypovolaemic shock 18.80 14.21 4 295376 5593 53048093
Initial insomnia 18.79 14.21 3 295377 5152 53048534
Embolism 18.78 14.21 9 295371 7494 53046192
Vaginal haematoma 18.74 14.21 11 295369 132 53053554
Bacteraemia 18.71 14.21 36 295344 15513 53038173
Aphthous ulcer 18.58 14.21 114 295266 10844 53042842
Infected bite 18.40 14.21 30 295350 1367 53052319
Asphyxia 18.29 14.21 5 295375 5896 53047790
Cerebral ischaemia 18.27 14.21 7 295373 6658 53047028
Protein total decreased 18.20 14.21 5 295375 5878 53047808
Oesophageal candidiasis 18.14 14.21 4 295376 5456 53048230
Restless legs syndrome 18.12 14.21 43 295337 17180 53036506
Hereditary angioedema 18.11 14.21 6 295374 6247 53047439
Metabolic disorder 17.98 14.21 4 295376 5423 53048263
Multiple system atrophy 17.98 14.21 13 295367 227 53053459
Jaw disorder 17.94 14.21 4 295376 5414 53048272
Thyroid disorder 17.94 14.21 132 295248 13341 53040345
Effusion 17.93 14.21 32 295348 1570 53052116
Ear discomfort 17.91 14.21 9 295371 7292 53046394
Injury 17.86 14.21 188 295192 50783 53002903
Hyperthyroidism 17.79 14.21 28 295352 13045 53040641
Synovial cyst 17.76 14.21 93 295287 8343 53045343
Klebsiella infection 17.67 14.21 11 295369 7915 53045771
Gastropleural fistula 17.66 14.21 8 295372 53 53053633
Wound infection 17.64 14.21 125 295255 12482 53041204
Lower respiratory tract congestion 17.63 14.21 37 295343 2049 53051637
Vaginal discharge 17.60 14.21 5 295375 5748 53047938
Cholecystectomy 17.59 14.21 17 295363 9798 53043888
Neck pain 17.57 14.21 446 294934 59570 52994116
Lower gastrointestinal haemorrhage 17.57 14.21 10 295370 7556 53046130
Gait inability 17.54 14.21 304 295076 38007 53015679
Hepatitis C 17.53 14.21 7 295373 6494 53047192
Haemolysis 17.51 14.21 7 295373 6489 53047197
Gastric disorder 17.47 14.21 249 295131 29916 53023770
Respiratory tract infection 17.40 14.21 110 295270 33114 53020572
Proctalgia 17.36 14.21 4 295376 5292 53048394
Exercise tolerance decreased 17.35 14.21 4 295376 5291 53048395
Urine abnormality 17.35 14.21 7 295373 6453 53047233
Rib fracture 17.33 14.21 56 295324 20222 53033464
Spinal cord infection 17.30 14.21 19 295361 587 53053099
Nasal congestion 17.30 14.21 200 295180 53087 53000599
Cerebral infarction 17.28 14.21 73 295307 24371 53029315
Pulmonary congestion 17.26 14.21 40 295340 16116 53037570
Pain in jaw 17.26 14.21 143 295237 40526 53013160
Odynophagia 17.13 14.21 9 295371 7110 53046576
Sleep disorder due to a general medical condition 17.11 14.21 10 295370 7447 53046239
Blood disorder 17.09 14.21 6 295374 6024 53047662
Disseminated large cell lymphoma 17.06 14.21 8 295372 58 53053628
Poor venous access 17.06 14.21 104 295276 9871 53043815
Rhinitis allergic 17.03 14.21 11 295369 7762 53045924
Large intestine polyp 17.02 14.21 12 295368 8085 53045601
Heart rate irregular 16.93 14.21 57 295323 20327 53033359
Head discomfort 16.90 14.21 24 295356 11660 53042026
Herpes simplex 16.85 14.21 11 295369 7718 53045968
Anti-neutrophil cytoplasmic antibody positive vasculitis 16.81 14.21 39 295341 2312 53051374
Adenoiditis 16.75 14.21 7 295373 37 53053649
Emotional disorder 16.72 14.21 29 295351 13001 53040685
Metastasis 16.69 14.21 3 295377 4728 53048958
Epstein-Barr viraemia 16.68 14.21 22 295358 826 53052860
Dermatitis exfoliative 16.66 14.21 6 295374 5930 53047756
Iron deficiency 16.64 14.21 7 295373 6293 53047393
Onychoclasis 16.57 14.21 5 295375 5528 53048158
Hypofibrinogenaemia 16.53 14.21 26 295354 1149 53052537
Acute coronary syndrome 16.52 14.21 20 295360 10404 53043282
Post procedural haemorrhage 16.50 14.21 12 295368 7956 53045730
Movement disorder 16.38 14.21 51 295329 18630 53035056
Candida infection 16.35 14.21 78 295302 25195 53028491
Pneumonia fungal 16.33 14.21 3 295377 4653 53049033
Juvenile psoriatic arthritis 16.30 14.21 6 295374 21 53053665
Neutrophil count increased 16.28 14.21 38 295342 15272 53038414
Sexual abuse 16.22 14.21 10 295370 132 53053554
Lymphopenia 16.21 14.21 44 295336 16799 53036887
Decreased activity 16.19 14.21 5 295375 5446 53048240
Blood loss anaemia 16.14 14.21 15 295365 8808 53044878
Synovial rupture 16.08 14.21 11 295369 175 53053511
Dermatitis bullous 16.00 14.21 13 295367 8150 53045536
Squamous cell carcinoma of skin 15.99 14.21 5 295375 5402 53048284
Mental fatigue 15.97 14.21 15 295365 383 53053303
Fracture delayed union 15.92 14.21 38 295342 2295 53051391
Sudden death 15.89 14.21 20 295360 10228 53043458
Spinal osteoarthritis 15.82 14.21 38 295342 15119 53038567
Heparin-induced thrombocytopenia 15.80 14.21 3 295377 4546 53049140
Tuberculin test positive 15.78 14.21 46 295334 3134 53050552
Abnormal faeces 15.73 14.21 3 295377 4531 53049155
Thermal burn 15.70 14.21 64 295316 5169 53048517
Post procedural complication 15.69 14.21 44 295336 16622 53037064
Skin irritation 15.64 14.21 14 295366 8370 53045316
Azotaemia 15.63 14.21 3 295377 4510 53049176
Lacrimation increased 15.61 14.21 49 295331 17854 53035832
Gout 15.54 14.21 28 295352 12371 53041315
Rhinorrhoea 15.54 14.21 206 295174 53372 53000314
Localised oedema 15.54 14.21 5 295375 5304 53048382
Tooth loss 15.52 14.21 9 295371 6730 53046956
Gastric infection 15.45 14.21 45 295335 3065 53050621
Dermatitis acneiform 15.42 14.21 3 295377 4467 53049219
Upper-airway cough syndrome 15.38 14.21 17 295363 9210 53044476
Pulmonary alveolar haemorrhage 15.32 14.21 3 295377 4447 53049239
Coronary artery stenosis 15.28 14.21 4 295376 4855 53048831
Procedural pain 15.28 14.21 37 295343 14680 53039006
Pustular psoriasis 15.27 14.21 55 295325 4189 53049497
Low birth weight baby 15.26 14.21 8 295372 6329 53047357
Intercepted medication error 15.22 14.21 16 295364 470 53053216
Peroneal nerve palsy 15.19 14.21 3 295377 4420 53049266
Blood glucose abnormal 15.18 14.21 11 295369 7308 53046378
Tongue disorder 15.15 14.21 93 295287 8848 53044838
Escherichia urinary tract infection 15.14 14.21 24 295356 11149 53042537
Serum amyloid A protein increased 15.12 14.21 9 295371 111 53053575
Fluid retention 15.12 14.21 211 295169 54190 52999496
Petechiae 15.09 14.21 33 295347 13572 53040114
Neuralgia 14.98 14.21 73 295307 23448 53030238
Anosmia 14.96 14.21 3 295377 4372 53049314
Affective disorder 14.88 14.21 6 295374 5533 53048153
Vascular rupture 14.84 14.21 27 295353 1345 53052341
Breath sounds abnormal 14.83 14.21 15 295365 8462 53045224
Hyperammonaemia 14.81 14.21 5 295375 5144 53048542
Post-traumatic stress disorder 14.81 14.21 4 295376 4754 53048932
Hypertonia 14.71 14.21 4 295376 4733 53048953
Gastric haemorrhage 14.64 14.21 8 295372 6183 53047503
Ligament sprain 14.64 14.21 109 295271 11057 53042629
Cardiac valve disease 14.60 14.21 3 295377 4299 53049387
Thiopurine methyltransferase decreased 14.47 14.21 13 295367 313 53053373
Retinal haemorrhage 14.42 14.21 5 295375 5060 53048626
Headache 14.39 14.21 2686 292694 534135 52519551
Liver injury 14.25 14.21 186 295194 21917 53031769

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
Rheumatoid arthritis 2020.60 14.70 1123 52631 43421 32416351
Drug ineffective 1703.92 14.70 2575 51179 380902 32078870
Off label use 1542.60 14.70 2185 51569 304135 32155637
Joint swelling 1072.14 14.70 797 52957 50938 32408834
Intentional product use issue 939.10 14.70 679 53075 41532 32418240
Contraindicated product administered 792.65 14.70 455 53299 18621 32441151
Synovitis 771.05 14.70 371 53383 10507 32449265
Apparent death 583.29 14.70 221 53533 3394 32456378
Treatment failure 535.91 14.70 474 53280 38689 32421083
Diverticulitis 518.41 14.70 347 53407 18681 32441091
Bone erosion 517.35 14.70 188 53566 2551 32457221
Drug intolerance 441.32 14.70 477 53277 49758 32410014
Arthropathy 411.06 14.70 322 53432 22167 32437605
Therapeutic product effect decreased 397.65 14.70 362 53392 30655 32429117
C-reactive protein abnormal 397.13 14.70 199 53555 6157 32453615
No adverse event 349.01 14.70 279 53475 19774 32439998
Arthralgia 344.68 14.70 758 52996 147690 32312082
Red blood cell sedimentation rate abnormal 333.43 14.70 129 53625 2101 32457671
Drug eruption 311.01 14.70 256 53498 18910 32440862
Pain 297.84 14.70 828 52926 186728 32273044
Stomatitis 281.95 14.70 340 53414 39889 32419883
Urticaria 263.96 14.70 403 53351 59211 32400561
Toxicity to various agents 235.43 14.70 15 53739 178026 32281746
Red blood cell sedimentation rate increased 232.97 14.70 151 53603 7684 32452088
Hypersensitivity 211.23 14.70 358 53396 57400 32402372
Pain in extremity 203.36 14.70 540 53214 118361 32341411
Hepatic function abnormal 191.19 14.70 298 53456 44542 32415230
Drug hypersensitivity 178.04 14.70 382 53372 73018 32386754
Musculoskeletal stiffness 173.05 14.70 265 53489 38999 32420773
Diarrhoea 173.02 14.70 210 53544 364592 32095180
Peripheral swelling 171.89 14.70 361 53393 67984 32391788
Pulmonary thrombosis 171.49 14.70 119 53635 6785 32452987
Rheumatoid factor negative 171.42 14.70 60 53694 724 32459048
Loss of personal independence in daily activities 170.54 14.70 216 53538 26617 32433155
Ill-defined disorder 160.58 14.70 143 53611 11746 32448026
Knee arthroplasty 158.51 14.70 107 53647 5830 32453942
C-reactive protein increased 151.08 14.70 279 53475 47823 32411949
Anaemia 147.70 14.70 94 53660 223530 32236242
Bone cyst 145.89 14.70 50 53704 564 32459208
Mobility decreased 136.96 14.70 200 53554 28209 32431563
Acute kidney injury 136.78 14.70 171 53583 293297 32166475
Impaired work ability 131.23 14.70 95 53659 5793 32453979
Completed suicide 131.06 14.70 5 53749 92512 32367260
Overdose 125.81 14.70 4 53750 87073 32372699
Anti-cyclic citrullinated peptide antibody positive 125.56 14.70 48 53706 755 32459017
Haemophagocytic lymphohistiocytosis 125.39 14.70 122 53632 11213 32448559
Drug specific antibody present 124.49 14.70 67 53687 2406 32457366
Arthritis bacterial 124.49 14.70 84 53670 4573 32455199
Terminal state 123.61 14.70 78 53676 3786 32455986
Confusional state 122.36 14.70 42 53712 143073 32316699
Fatigue 120.52 14.70 250 53504 350451 32109321
Swelling 120.37 14.70 222 53532 38000 32421772
Epistaxis 118.85 14.70 276 53478 55579 32404193
Drug interaction 118.30 14.70 112 53642 218073 32241699
Mass 110.84 14.70 96 53658 7596 32452176
Infusion related reaction 107.81 14.70 235 53519 45364 32414408
Febrile neutropenia 107.66 14.70 32 53722 119534 32340238
Deep vein thrombosis 107.32 14.70 288 53466 63425 32396347
Vomiting 106.79 14.70 140 53614 235417 32224355
Dehydration 106.55 14.70 40 53714 128918 32330854
Pulmonary embolism 105.40 14.70 341 53413 83318 32376454
Interstitial lung disease 101.71 14.70 286 53468 64715 32395057
Skin ulcer 99.83 14.70 146 53608 20613 32439159
Joint ankylosis 99.48 14.70 34 53720 380 32459392
Limb discomfort 98.90 14.70 102 53652 10052 32449720
Death 97.41 14.70 317 53437 382200 32077572
Herpes zoster 97.02 14.70 184 53570 32157 32427615
Bladder transitional cell carcinoma 95.41 14.70 57 53697 2506 32457266
Hypofibrinogenaemia 93.46 14.70 49 53705 1667 32458105
COVID-19 93.40 14.70 180 53574 31835 32427937
Juvenile idiopathic arthritis 93.24 14.70 47 53707 1471 32458301
Intestinal polyp 90.68 14.70 40 53714 920 32458852
Gastric disorder 88.74 14.70 102 53652 11354 32448418
Nodule 86.91 14.70 71 53683 5181 32454591
Malignant neoplasm progression 84.73 14.70 14 53740 78482 32381290
Joint lock 82.89 14.70 40 53714 1137 32458635
COVID-19 pneumonia 78.51 14.70 84 53670 8636 32451136
Nasopharyngitis 77.60 14.70 257 53497 63530 32396242
X-ray abnormal 77.55 14.70 30 53724 488 32459284
Cytology abnormal 77.55 14.70 28 53726 372 32459400
Cytokine release syndrome 76.69 14.70 103 53651 13432 32446340
Dizziness 74.73 14.70 146 53608 209472 32250300
Pyrexia 74.69 14.70 275 53479 319693 32140079
Hyponatraemia 74.64 14.70 16 53738 74497 32385275
Polyarthritis 73.81 14.70 58 53696 4002 32455770
Sleep disorder due to general medical condition, insomnia type 73.76 14.70 38 53716 1246 32458526
Physical disability 73.56 14.70 38 53716 1253 32458519
Asthenia 72.85 14.70 178 53576 235766 32224006
Dyspnoea 72.75 14.70 330 53424 361715 32098057
Joint arthroplasty 72.65 14.70 31 53723 656 32459116
Drug use disorder 70.78 14.70 54 53700 3567 32456205
Arthritis 70.53 14.70 144 53610 26548 32433224
Plasma cell myeloma 70.05 14.70 7 53747 57607 32402165
Constipation 69.41 14.70 64 53690 126309 32333463
Decreased appetite 68.34 14.70 100 53654 160713 32299059
Rheumatoid factor positive 67.35 14.70 29 53725 628 32459144
Cardiac failure congestive 64.12 14.70 30 53724 84822 32374950
Hepatitis B virus test positive 63.57 14.70 22 53732 256 32459516
Muscle spasms 63.12 14.70 257 53497 70161 32389611
Loss of consciousness 62.87 14.70 29 53725 82678 32377094
Blood pressure diastolic abnormal 62.87 14.70 42 53712 2248 32457524
Seizure 62.66 14.70 48 53706 103806 32355966
Rhabdomyolysis 62.36 14.70 17 53737 67248 32392524
Rheumatoid nodule 61.13 14.70 40 53714 2067 32457705
Intestinal sepsis 60.59 14.70 24 53730 417 32459355
Syncope 60.58 14.70 37 53717 90087 32369685
Hepatitis 60.45 14.70 126 53628 23567 32436205
Somnolence 60.09 14.70 50 53704 103747 32356025
Hyperkalaemia 58.63 14.70 21 53733 69729 32390043
Joint stiffness 58.24 14.70 77 53677 9888 32449884
Disability 58.09 14.70 54 53700 4686 32455086
Dysphagia 58.01 14.70 15 53739 61461 32398311
Depression 57.12 14.70 46 53708 97014 32362758
Photosensitivity reaction 57.05 14.70 77 53677 10086 32449686
Hypokalaemia 56.89 14.70 11 53743 55083 32404689
General physical health deterioration 56.88 14.70 64 53690 115195 32344577
Alanine aminotransferase abnormal 56.50 14.70 44 53710 2996 32456776
Drug effective for unapproved indication 56.17 14.70 33 53721 1406 32458366
Blood pressure diastolic decreased 55.60 14.70 64 53690 7133 32452639
Malaise 53.55 14.70 135 53619 177003 32282769
Localised infection 52.62 14.70 92 53662 15095 32444677
Gait inability 51.60 14.70 107 53647 19940 32439832
Lymphoedema 50.83 14.70 45 53709 3665 32456107
Skin laceration 50.20 14.70 79 53675 11887 32447885
Pulmonary fibrosis 50.18 14.70 96 53658 16878 32442894
Seronegative arthritis 50.15 14.70 27 53727 970 32458802
Fall 50.14 14.70 162 53592 196039 32263733
Hospitalisation 50.10 14.70 10 53744 48961 32410811
Prerenal failure 50.04 14.70 35 53719 2020 32457752
Disability assessment scale score increased 49.71 14.70 16 53738 146 32459626
Vision blurred 49.68 14.70 7 53747 44179 32415593
Anxiety 48.80 14.70 52 53702 95953 32363819
Liver function test increased 48.70 14.70 80 53674 12480 32447292
International normalised ratio increased 48.14 14.70 11 53743 49024 32410748
Coma 47.32 14.70 7 53747 42605 32417167
Osteolysis 47.17 14.70 32 53722 1757 32458015
Therapeutic product effect incomplete 47.10 14.70 163 53591 41178 32418594
Skin mass 47.09 14.70 43 53711 3646 32456126
Agitation 46.81 14.70 18 53736 57218 32402554
Oxygen saturation decreased 46.66 14.70 180 53574 47919 32411853
Immobile 46.66 14.70 36 53718 2418 32457354
Blood pressure diastolic increased 46.13 14.70 42 53712 3548 32456224
Wrong technique in product usage process 46.11 14.70 3 53751 35056 32424716
Immune effector cell-associated neurotoxicity syndrome 46.06 14.70 30 53724 1538 32458234
Mental status changes 45.72 14.70 5 53749 38332 32421440
Hallucination 45.68 14.70 15 53739 52604 32407168
Musculoskeletal pain 45.64 14.70 136 53618 31761 32428011
Gastrointestinal haemorrhage 45.35 14.70 46 53708 86836 32372936
Suicidal ideation 45.33 14.70 5 53749 38078 32421694
Hip arthroplasty 45.15 14.70 44 53710 4050 32455722
Infection 44.83 14.70 266 53488 84449 32375323
Oral surgery 44.50 14.70 21 53733 567 32459205
Blood pressure systolic abnormal 44.45 14.70 33 53721 2091 32457681
Abscess 44.25 14.70 70 53684 10580 32449192
Incorrect dose administered 43.25 14.70 4 53750 35024 32424748
Hypoglycaemia 43.01 14.70 18 53736 54364 32405408
Atrial fibrillation 42.63 14.70 80 53674 116624 32343148
Medical device implantation 41.95 14.70 20 53734 553 32459219
Hypotension 41.48 14.70 200 53554 215910 32243862
Blood glucose increased 40.83 14.70 29 53725 65212 32394560
Blood creatinine increased 40.58 14.70 60 53694 96072 32363700
Depressed level of consciousness 40.43 14.70 9 53745 40838 32418934
Drug tolerance decreased 39.62 14.70 26 53728 1350 32458422
Suicide attempt 38.72 14.70 8 53746 38236 32421536
Product dose omission issue 38.63 14.70 69 53685 102506 32357266
Hand deformity 38.09 14.70 30 53724 2077 32457695
Blood fibrinogen decreased 37.89 14.70 23 53731 1041 32458731
Poor venous access 37.71 14.70 35 53719 3031 32456741
Soft tissue swelling 37.70 14.70 16 53738 334 32459438
Fine motor skill dysfunction 37.51 14.70 27 53727 1631 32458141
Abdominal distension 37.42 14.70 19 53735 51276 32408496
Osteoarthritis 37.12 14.70 93 53661 19626 32440146
Haematuria 36.67 14.70 17 53737 48344 32411428
Dysarthria 35.63 14.70 6 53748 33195 32426577
Bronchopulmonary aspergillosis 35.15 14.70 73 53681 13614 32446158
Aggression 34.59 14.70 11 53743 39378 32420394
Lactic acidosis 33.98 14.70 7 53747 33529 32426243
Myalgia 32.08 14.70 53 53701 81177 32378595
Interleukin level increased 31.97 14.70 9 53745 49 32459723
Metabolic acidosis 31.34 14.70 14 53740 40685 32419087
Abscess limb 31.05 14.70 33 53721 3365 32456407
Abdominal pain 30.66 14.70 135 53619 149394 32310378
Amnesia 30.53 14.70 3 53751 25033 32434739
Bursitis 30.43 14.70 40 53714 5106 32454666
Renal impairment 30.21 14.70 67 53687 91905 32367867
Abnormal behaviour 30.20 14.70 4 53750 26462 32433310
Pulmonary toxicity 30.07 14.70 39 53715 4914 32454858
Haematemesis 29.64 14.70 5 53749 27630 32432142
Blood pressure systolic increased 29.61 14.70 79 53675 17317 32442455
Coronary artery disease 28.67 14.70 24 53730 49682 32410090
Thrombocytopenia 27.97 14.70 138 53616 148161 32311611
Unresponsive to stimuli 27.49 14.70 6 53748 27603 32432169
Pneumatosis intestinalis 27.41 14.70 31 53723 3389 32456383
Hepatic steatosis 27.19 14.70 73 53681 16060 32443712
Cardio-respiratory arrest 26.61 14.70 32 53722 55957 32403815
Disorientation 26.52 14.70 11 53743 33414 32426358
Pancytopenia 26.40 14.70 71 53683 91164 32368608
Urinary retention 26.37 14.70 13 53741 35684 32424088
Chronic kidney disease 26.03 14.70 17 53737 39958 32419814
Skin exfoliation 26.01 14.70 5 53749 25152 32434620
Thrombosis 25.70 14.70 146 53608 45608 32414164
Rheumatoid factor increased 25.58 14.70 14 53740 520 32459252
Cytokine storm 25.47 14.70 15 53739 642 32459130
Infectious pleural effusion 25.29 14.70 24 53730 2137 32457635
Irritability 25.28 14.70 5 53749 24649 32435123
Joint injury 25.20 14.70 45 53709 7505 32452267
Heart rate decreased 25.00 14.70 95 53659 25105 32434667
Lethargy 24.91 14.70 19 53735 41209 32418563
Rheumatoid factor 24.76 14.70 8 53746 74 32459698
Muscle strain 24.48 14.70 31 53723 3814 32455958
Ulcerative keratitis 23.82 14.70 20 53734 1516 32458256
Nephrolithiasis 23.82 14.70 99 53655 27255 32432517
Mucosal inflammation 23.48 14.70 13 53741 33421 32426351
Stent placement 23.18 14.70 33 53721 4542 32455230
Intercepted product storage error 23.12 14.70 9 53745 149 32459623
Haematocrit decreased 22.69 14.70 12 53742 31650 32428122
Gastrointestinal perforation 22.64 14.70 30 53724 3860 32455912
Hepatic enzyme abnormal 22.48 14.70 24 53730 2460 32457312
Tubulointerstitial nephritis 22.24 14.70 3 53751 19574 32440198
Inappropriate schedule of product administration 21.98 14.70 26 53728 45799 32413973
Infective chondritis 21.56 14.70 5 53749 10 32459762
Drug ineffective for unapproved indication 21.51 14.70 61 53693 13851 32445921
Toxic epidermal necrolysis 21.49 14.70 4 53750 20589 32439183
Neuropathy peripheral 21.45 14.70 61 53693 76921 32382851
Joint effusion 21.44 14.70 31 53723 4328 32455444
Long QT syndrome 21.34 14.70 24 53730 2607 32457165
Therapy partial responder 21.30 14.70 33 53721 4897 32454875
Excessive cerumen production 20.99 14.70 10 53744 276 32459496
Pharyngitis 20.68 14.70 42 53712 7708 32452064
Respiratory arrest 20.65 14.70 11 53743 28897 32430875
Disease progression 20.59 14.70 74 53680 86788 32372984
Septic arthritis staphylococcal 20.54 14.70 12 53742 506 32459266
Large intestine perforation 20.45 14.70 43 53711 8087 32451685
Blood cholesterol abnormal 20.18 14.70 18 53736 1480 32458292
Oral disorder 20.16 14.70 30 53724 4298 32455474
Septic shock 20.06 14.70 188 53566 68801 32390971
Infective spondylitis 19.97 14.70 9 53745 218 32459554
Treatment noncompliance 19.95 14.70 10 53744 27192 32432580
Ankle operation 19.53 14.70 9 53745 230 32459542
Cardiac arrest 19.44 14.70 88 53666 96688 32363084
Osteonecrosis of jaw 19.42 14.70 4 53750 19162 32440610
Lower respiratory tract congestion 19.39 14.70 16 53738 1184 32458588
Hepatic enzyme increased 19.37 14.70 116 53638 36921 32422851
Oedema 19.21 14.70 28 53726 45119 32414653
Alveolar proteinosis 19.10 14.70 10 53744 339 32459433
Liver disorder 19.10 14.70 103 53651 31551 32428221
Panniculitis 19.09 14.70 16 53738 1210 32458562
Jaundice 19.08 14.70 17 53737 34141 32425631
Condition aggravated 18.97 14.70 362 53392 155299 32304473
Drug withdrawal syndrome 18.95 14.70 5 53749 20226 32439546
Hypomagnesaemia 18.89 14.70 4 53750 18801 32440971
Chills 18.85 14.70 66 53688 78018 32381754
Joint destruction 18.84 14.70 9 53745 250 32459522
Haemorrhage 18.84 14.70 33 53721 49415 32410357
Nausea 18.57 14.70 397 53357 320452 32139320
Disturbance in attention 18.55 14.70 8 53746 23745 32436027
Diverticular perforation 18.53 14.70 25 53729 3273 32456499
Diabetes mellitus 18.47 14.70 133 53621 45040 32414732
White blood cell count increased 18.29 14.70 25 53729 41377 32418395
Polyarteritis nodosa 18.26 14.70 9 53745 268 32459504
Respiratory tract infection bacterial 18.15 14.70 12 53742 631 32459141
Delirium 18.08 14.70 28 53726 44018 32415754
Red blood cell sedimentation rate 18.08 14.70 11 53743 500 32459272
Angioedema 18.04 14.70 20 53734 36269 32423503
Hepatic cirrhosis 18.03 14.70 65 53689 16744 32443028
Intestinal perforation 17.91 14.70 43 53711 8832 32450940
JC virus CSF test positive 17.87 14.70 7 53747 118 32459654
Body temperature decreased 17.72 14.70 49 53705 10965 32448807
Fluid retention 17.68 14.70 11 53743 26539 32433233
Suture rupture 17.64 14.70 10 53744 398 32459374
Visual impairment 17.62 14.70 17 53737 32871 32426901
Pulmonary hypertension 17.50 14.70 6 53748 20488 32439284
Therapeutic response decreased 17.48 14.70 87 53667 25833 32433939
Myocardial ischaemia 17.39 14.70 4 53750 17755 32442017
Giant cell arteritis 17.30 14.70 13 53741 839 32458933
Hyperglycaemia 17.14 14.70 23 53731 38368 32421404
Neutrophil count increased 17.10 14.70 3 53751 16111 32443661
Inflammation 17.08 14.70 83 53671 24410 32435362
Paraesthesia 16.94 14.70 46 53708 58898 32400874
Oesophageal rupture 16.94 14.70 10 53744 430 32459342
Cholestasis 16.92 14.70 12 53742 27021 32432751
Squamous cell carcinoma of lung 16.91 14.70 18 53736 1839 32457933
Therapy non-responder 16.91 14.70 102 53652 32552 32427220
Gastrointestinal disorder 16.90 14.70 98 53656 30833 32428939
Weight increased 16.90 14.70 212 53542 83451 32376321
Blood pressure increased 16.86 14.70 203 53551 79151 32380621
Hypophagia 16.85 14.70 9 53745 23614 32436158
Human herpesvirus 6 encephalitis 16.85 14.70 8 53746 219 32459553
Stevens-Johnson syndrome 16.83 14.70 5 53749 18704 32441068
Dyspnoea exertional 16.73 14.70 24 53730 38937 32420835
Nasal crusting 16.71 14.70 10 53744 441 32459331
Chest pain 16.39 14.70 129 53625 124008 32335764
Solar urticaria 16.36 14.70 4 53750 11 32459761
Oropharyngeal pain 16.27 14.70 98 53656 31254 32428518
Local reaction 16.27 14.70 6 53748 85 32459687
Enterobacter pneumonia 16.22 14.70 5 53749 39 32459733
Anorectal agenesis 16.22 14.70 3 53751 0 32459772
Gait disturbance 16.21 14.70 73 53681 80335 32379437
Bradycardia foetal 16.04 14.70 9 53745 351 32459421
Blood potassium increased 16.04 14.70 4 53750 16800 32442972
Disseminated strongyloidiasis 16.02 14.70 6 53748 89 32459683
Bursitis infective staphylococcal 15.86 14.70 4 53750 13 32459759
Intentional product misuse 15.69 14.70 22 53732 36029 32423743
Oral herpes 15.68 14.70 29 53725 4968 32454804
Blood alkaline phosphatase increased 15.65 14.70 18 53736 32114 32427658
Rheumatoid lung 15.52 14.70 9 53745 374 32459398
Listeria encephalitis 15.50 14.70 5 53749 46 32459726
Medication error 15.48 14.70 9 53745 22526 32437246
Head injury 15.38 14.70 5 53749 17658 32442114
Post procedural infection 15.31 14.70 28 53726 4757 32455015
Polychondritis 15.29 14.70 7 53747 176 32459596
Faeces discoloured 15.29 14.70 3 53751 14874 32444898
Scalloped tongue 15.22 14.70 4 53750 16 32459756
Ventricular tachycardia 15.16 14.70 12 53742 25544 32434228
Ascites 15.15 14.70 27 53727 40164 32419608
Pollakiuria 15.14 14.70 6 53748 18738 32441034
Circulatory collapse 15.14 14.70 8 53746 21117 32438655
Injury 15.12 14.70 9 53745 22236 32437536
Epstein-Barr viraemia 15.04 14.70 13 53741 1025 32458747
Vertigo 14.91 14.70 11 53743 24272 32435500
Presyncope 14.89 14.70 5 53749 17296 32442476
Cellulitis gangrenous 14.87 14.70 7 53747 188 32459584
Product prescribing error 14.84 14.70 7 53747 19710 32440062
Erysipelas 14.77 14.70 28 53726 4888 32454884
Hypocalcaemia 14.74 14.70 10 53744 23044 32436728
Speech disorder 14.74 14.70 13 53741 26240 32433532
Dry mouth 14.72 14.70 11 53743 24108 32435664

Pharmacologic Action:

SourceCodeDescription
ATC L04AC07 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Interleukin inhibitors
FDA MoA N0000190478 Interleukin 6 Receptor Antagonists
FDA EPC N0000190480 Interleukin-6 Receptor Antagonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Rheumatoid arthritis indication 69896004 DOID:7148
Castleman's disease indication 207036003 DOID:0111157
Still's disease indication 410794002
Juvenile rheumatoid arthritis indication 410795001
Giant cell arteritis indication 414341000 DOID:13375
Cytokine release syndrome induced by tumor-specific T-cell infusion therapy indication 710027002
Coronavirus infection off-label use 186747009

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
Interleukin-6 receptor Membrane receptor ANTIBODY BINDING DRUG LABEL DRUG LABEL

External reference:

IDSource
D02596 KEGG_DRUG
4029705 VUID
N0000180629 NUI
4029705 VANDF
CHEMBL1237022 ChEMBL_ID
C502936 MESH_SUPPLEMENTAL_RECORD_UI
6881 IUPHAR_LIGAND_ID
8394 INN_ID
DB06273 DRUGBANK_ID
I031V2H011 UNII
10150081 PUBCHEM_CID
612865 RXNORM
169600 MMSL
26778 MMSL
d07496 MMSL
013198 NDDF
444648007 SNOMEDCT_US
444649004 SNOMEDCT_US
C1609165 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ACTEMRA HUMAN PRESCRIPTION DRUG LABEL 1 50242-135 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS BLA 33 sections
ACTEMRA HUMAN PRESCRIPTION DRUG LABEL 1 50242-136 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS BLA 33 sections
ACTEMRA HUMAN PRESCRIPTION DRUG LABEL 1 50242-137 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS BLA 33 sections
Actemra HUMAN PRESCRIPTION DRUG LABEL 1 50242-138 INJECTION, SOLUTION 180 mg SUBCUTANEOUS BLA 33 sections
Actemra ACTPen HUMAN PRESCRIPTION DRUG LABEL 1 50242-143 INJECTION, SOLUTION 180 mg SUBCUTANEOUS BLA 33 sections