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

Stem definitionDrug idCAS RN
cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) receptors 5089 332348-12-6

Description:

MoleculeDescription

Synonyms:

  • abatacept
  • orencia
  • BMS-188667
  • BMS 188667
A fusion protein immunoconjugate of the extracellular domain of CTLA4 and the Fc domain of human IgG1. It functions as a T-cell co-stimulation blocker that inhibits TNF-ALPHA and prevents the activation of T-LYMPHOCYTES. It is used in the treatment of RHEUMATOID ARTHRITIS.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
27 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 23, 2005 FDA BRISTOL MYERS SQUIBB
Feb. 21, 2020 PMDA Bristol-Myers Squibb K.K.

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 8887.22 17.26 12277 181020 665561 45827204
Rheumatoid arthritis 7661.67 17.26 6956 186341 233259 46259506
Contraindicated product administered 6426.81 17.26 4037 189260 75910 46416855
Treatment failure 3708.97 17.26 3072 190225 90015 46402750
Drug intolerance 3514.45 17.26 3647 189650 143402 46349363
Synovitis 3166.58 17.26 2356 190941 58719 46434046
Arthropathy 2392.01 17.26 2303 190994 82397 46410368
Joint swelling 2344.48 17.26 3148 190149 162925 46329840
Therapeutic product effect decreased 1786.25 17.26 1946 191351 80655 46412110
Pemphigus 1367.63 17.26 1279 192018 43995 46448770
Systemic lupus erythematosus 1254.75 17.26 1446 191851 63734 46429031
C-reactive protein abnormal 1207.72 17.26 868 192429 20402 46472363
Red blood cell sedimentation rate abnormal 1064.14 17.26 678 192619 12971 46479794
Hand deformity 1029.01 17.26 969 192328 33605 46459160
Pain 1026.42 17.26 4289 189008 472659 46020106
Glossodynia 890.00 17.26 1006 192291 43367 46449398
Rheumatoid factor positive 878.78 17.26 707 192590 19754 46473011
Alopecia 843.85 17.26 1988 191309 160426 46332339
Loss of personal independence in daily activities 831.40 17.26 1102 192195 56081 46436684
Abdominal discomfort 818.84 17.26 1881 191416 149284 46343481
Infection 805.19 17.26 1735 191562 131857 46360908
Hepatic enzyme increased 769.65 17.26 1285 192012 80502 46412263
Therapeutic product effect incomplete 752.95 17.26 1241 192056 76912 46415853
Arthralgia 728.88 17.26 3210 190087 361393 46131372
Swelling 718.23 17.26 1589 191708 122922 46369843
Musculoskeletal stiffness 678.57 17.26 1348 191949 96645 46396120
Drug hypersensitivity 654.93 17.26 2356 190941 241469 46251296
Acute kidney injury 630.48 17.26 109 193188 235746 46257019
Hypersensitivity 566.29 17.26 1632 191665 148689 46344076
Rash 552.84 17.26 2919 190378 353593 46139172
Drug interaction 535.82 17.26 97 193200 202997 46289768
Hypotension 533.94 17.26 151 193146 232438 46260327
Red blood cell sedimentation rate increased 521.30 17.26 555 192742 22334 46470431
Dyspnoea 508.99 17.26 847 192450 514701 45978064
Condition aggravated 490.14 17.26 2160 191137 242892 46249873
Death 477.76 17.26 413 192884 335135 46157630
Mobility decreased 452.56 17.26 861 192436 59733 46433032
Anti-cyclic citrullinated peptide antibody positive 448.00 17.26 471 192826 18674 46474091
Anaemia 444.05 17.26 254 193043 255525 46237240
Knee arthroplasty 443.01 17.26 518 192779 23147 46469618
Device malfunction 396.04 17.26 374 192923 13000 46479765
Toxicity to various agents 395.93 17.26 191 193106 211575 46281190
C-reactive protein increased 392.04 17.26 795 192502 57795 46434970
Wound 389.60 17.26 663 192634 42139 46450626
Adverse event 381.53 17.26 581 192716 33603 46459162
Dehydration 368.82 17.26 102 193195 159438 46333327
Febrile neutropenia 353.04 17.26 8 193289 94619 46398146
Off label use 330.37 17.26 2691 190606 377150 46115615
Decreased appetite 329.80 17.26 197 193100 193639 46299126
Anxiety 328.19 17.26 172 193125 181785 46310980
Seizure 323.82 17.26 59 193238 122995 46369770
Bone erosion 320.39 17.26 285 193012 9158 46483607
Tremor 318.57 17.26 49 193248 115590 46377175
Dizziness 317.13 17.26 579 192718 339835 46152930
Product use issue 313.84 17.26 983 192314 93661 46399104
Hyponatraemia 313.46 17.26 29 193268 101303 46391462
Sleep disorder 310.66 17.26 633 192664 46162 46446603
Peripheral swelling 309.85 17.26 1386 191911 156685 46336080
Abdominal pain 300.06 17.26 306 192991 229725 46263040
Overdose 286.00 17.26 41 193256 101938 46390827
Rheumatoid nodule 285.88 17.26 262 193035 8758 46484007
Pericarditis 284.56 17.26 419 192878 23508 46469257
Fracture 284.32 17.26 346 192951 16125 46476640
Confusional state 284.10 17.26 154 193143 159738 46333027
Pyrexia 278.51 17.26 648 192649 348154 46144611
Disability 275.88 17.26 271 193026 9896 46482869
Arthritis 273.96 17.26 822 192475 76494 46416271
Cardiac arrest 271.42 17.26 29 193268 90370 46402395
Deformity 270.32 17.26 231 193066 7026 46485739
Inflammation 269.99 17.26 613 192684 48168 46444597
Haemoglobin decreased 266.88 17.26 100 193197 128849 46363916
Lower respiratory tract infection 261.36 17.26 652 192645 54437 46438328
Hip arthroplasty 261.31 17.26 348 192949 17764 46475001
Oedema peripheral 254.22 17.26 175 193122 159531 46333234
Product storage error 245.86 17.26 273 193024 11519 46481246
Constipation 245.18 17.26 216 193081 173881 46318884
Asthenia 244.95 17.26 582 192715 310493 46182272
Tachycardia 242.99 17.26 57 193240 99565 46393200
Osteoporosis 232.19 17.26 517 192780 40091 46452674
Drug abuse 230.33 17.26 7 193290 63401 46429364
Gastrointestinal haemorrhage 224.33 17.26 28 193269 77345 46415420
Thrombocytopenia 221.77 17.26 124 193173 126457 46366308
Coeliac disease 221.11 17.26 205 193092 6956 46485809
Bradycardia 219.01 17.26 14 193283 66284 46426481
Musculoskeletal pain 218.36 17.26 713 192584 69415 46423350
Respiratory failure 218.28 17.26 61 193236 94755 46398010
Panniculitis 217.43 17.26 184 193113 5520 46487245
Foot deformity 217.36 17.26 293 193004 15132 46477633
Platelet count decreased 216.47 17.26 72 193225 99952 46392813
Somnolence 213.44 17.26 200 193097 156321 46336444
Finger deformity 212.30 17.26 174 193123 4988 46487777
Renal failure 209.73 17.26 104 193193 113490 46379275
Blood parathyroid hormone decreased 202.19 17.26 158 193139 4223 46488542
Pancytopenia 199.03 17.26 53 193244 85005 46407760
Suicide attempt 196.62 17.26 7 193290 55029 46437736
Hyperkalaemia 194.32 17.26 3 193294 50706 46442059
Pulmonary embolism 192.18 17.26 105 193192 108480 46384285
Granuloma skin 186.35 17.26 137 193160 3333 46489432
Joint stiffness 186.17 17.26 372 192925 26736 46466029
Liver function test increased 184.85 17.26 336 192961 22490 46470275
Hypokalaemia 184.20 17.26 67 193230 87957 46404808
Coma 179.60 17.26 17 193280 58332 46434433
Cardiac failure congestive 178.63 17.26 78 193219 91672 46401093
Hallucination 176.22 17.26 7 193290 49944 46442821
Drug tolerance decreased 173.88 17.26 125 193172 2934 46489831
Epistaxis 173.10 17.26 29 193268 64276 46428489
Skin ulcer 173.05 17.26 402 192895 32056 46460709
Chest pain 170.97 17.26 292 193005 176032 46316733
White blood cell count decreased 170.65 17.26 129 193168 112102 46380663
Dysphagia 170.18 17.26 54 193243 77258 46415507
Fine motor skill dysfunction 169.80 17.26 133 193164 3567 46489198
Maternal exposure during pregnancy 169.26 17.26 856 192441 101693 46391072
Chest discomfort 169.11 17.26 81 193216 90188 46402577
International normalised ratio increased 167.34 17.26 6 193291 46877 46445888
Hypoglycaemia 166.84 17.26 16 193281 54333 46438432
Hypoxia 165.28 17.26 13 193284 51825 46440940
Vomiting 164.59 17.26 1149 192148 451645 46041120
Depressed level of consciousness 163.42 17.26 8 193289 47561 46445204
Limb deformity 162.94 17.26 128 193169 3448 46489317
Agitation 160.75 17.26 20 193277 55395 46437370
Blood glucose increased 159.04 17.26 50 193247 71963 46420802
Fibromyalgia 156.81 17.26 416 192881 36047 46456718
Arthrodesis 155.67 17.26 104 193193 2160 46490605
Multiple sclerosis relapse 155.39 17.26 4 193293 42121 46450644
Osteoarthritis 155.36 17.26 587 192710 61438 46431327
Oxygen saturation decreased 154.58 17.26 47 193250 69117 46423648
Rhabdomyolysis 154.51 17.26 4 193293 41905 46450860
Neutropenia 154.17 17.26 221 193076 142983 46349782
Diarrhoea 154.06 17.26 1529 191768 558073 45934692
Basal cell carcinoma 153.90 17.26 292 193005 20195 46472570
Balance disorder 151.32 17.26 40 193257 64481 46428284
Malignant neoplasm progression 150.85 17.26 41 193256 64885 46427880
Tenosynovitis 149.84 17.26 170 193127 7345 46485420
Sciatica 148.99 17.26 276 193021 18744 46474021
Helicobacter infection 148.97 17.26 212 193085 11524 46481241
Sinusitis 147.40 17.26 981 192316 128787 46363978
Musculoskeletal deformity 146.97 17.26 70 193227 729 46492036
Nausea 146.76 17.26 1988 191309 685466 45807299
Elbow deformity 145.85 17.26 83 193214 1279 46491486
Neuropathy peripheral 144.00 17.26 100 193197 90793 46401972
Breast cancer stage III 142.78 17.26 82 193215 1287 46491478
Musculoskeletal disorder 141.63 17.26 241 193056 15304 46477461
Discomfort 139.41 17.26 468 192829 46202 46446563
Glaucoma 138.72 17.26 242 193055 15679 46477086
Suicidal ideation 137.96 17.26 32 193265 56350 46436415
Multiple organ dysfunction syndrome 137.67 17.26 24 193273 51686 46441079
Joint range of motion decreased 135.85 17.26 233 193064 14891 46477874
Vision blurred 135.40 17.26 81 193216 79627 46413138
Blood alkaline phosphatase increased 134.98 17.26 7 193290 39602 46453163
Juvenile idiopathic arthritis 134.80 17.26 122 193175 4010 46488755
Myalgia 132.43 17.26 190 193107 122898 46369867
Oral mucosal exfoliation 130.66 17.26 81 193216 1472 46491293
Muscle spasms 129.55 17.26 193 193104 122920 46369845
Joint laxity 129.21 17.26 90 193207 2006 46490759
Injection site pain 129.05 17.26 152 193145 107000 46385765
Joint destruction 127.51 17.26 104 193193 2960 46489805
Ascites 126.15 17.26 6 193291 36578 46456187
Dyspnoea exertional 126.15 17.26 27 193270 50262 46442503
Pleural effusion 125.24 17.26 96 193201 82856 46409909
Duodenal ulcer perforation 125.15 17.26 165 193132 8337 46484428
Deep vein thrombosis 124.73 17.26 89 193208 79684 46413081
Dysarthria 123.59 17.26 8 193289 37490 46455275
Psoriatic arthropathy 123.34 17.26 381 192916 35998 46456767
Feeling abnormal 122.18 17.26 206 193091 124854 46367911
Disorientation 121.31 17.26 8 193289 36910 46455855
Body height below normal 120.52 17.26 82 193215 1757 46491008
Metabolic acidosis 120.13 17.26 11 193286 38769 46453996
Plasma cell myeloma 119.82 17.26 20 193277 44458 46448307
Infusion related reaction 119.07 17.26 772 192525 100436 46392329
Skin necrosis 119.03 17.26 162 193135 8442 46484323
Lethargy 117.59 17.26 33 193264 51138 46441627
Syncope 117.51 17.26 157 193140 104646 46388119
Exposure during pregnancy 115.45 17.26 168 193129 108044 46384721
Human antichimeric antibody positive 115.40 17.26 72 193225 1324 46491441
Ill-defined disorder 115.27 17.26 306 192991 26521 46466244
Rheumatic fever 115.17 17.26 95 193202 2748 46490017
Temperature regulation disorder 115.14 17.26 102 193195 3258 46489507
Intentional product use issue 113.27 17.26 476 192821 52304 46440461
Grip strength decreased 112.99 17.26 158 193139 8448 46484317
Wrong technique in product usage process 112.86 17.26 42 193255 54380 46438385
SLE arthritis 112.49 17.26 54 193243 573 46492192
Bronchitis chronic 111.05 17.26 110 193187 4057 46488708
Mental status changes 109.85 17.26 14 193283 38074 46454691
Gastrooesophageal reflux disease 109.75 17.26 88 193209 74256 46418509
Neutrophil count decreased 109.57 17.26 23 193274 43403 46449362
Therapeutic response decreased 108.58 17.26 409 192888 42736 46450029
Palpitations 108.54 17.26 141 193156 95118 46397647
Drug reaction with eosinophilia and systemic symptoms 108.25 17.26 3 193294 29545 46463220
Device defective 107.73 17.26 62 193235 977 46491788
Cerebrovascular accident 107.65 17.26 157 193140 100882 46391883
Blood pressure decreased 105.95 17.26 52 193245 57107 46435658
Encephalopathy 105.47 17.26 9 193288 33580 46459185
Jaundice 105.41 17.26 3 193294 28842 46463923
Sepsis 104.78 17.26 257 193040 135757 46357008
Onychomycosis 104.23 17.26 106 193191 4037 46488728
Rectal haemorrhage 103.50 17.26 17 193280 38238 46454527
Weight increased 103.05 17.26 343 192954 164130 46328635
Adverse drug reaction 103.03 17.26 410 192887 43952 46448813
Chills 102.52 17.26 149 193148 95883 46396882
Weight decreased 102.14 17.26 487 192810 210362 46282403
Spinal stenosis 102.00 17.26 185 193112 12358 46480407
Surgery 101.81 17.26 306 192991 28479 46464286
Pulmonary oedema 101.75 17.26 42 193255 51063 46441702
Hepatocellular injury 101.29 17.26 5 193292 29517 46463248
Flushing 101.12 17.26 72 193225 64542 46428223
Dysgeusia 101.02 17.26 22 193275 40469 46452296
Drug eruption 100.62 17.26 252 193045 21077 46471688
Swelling face 100.29 17.26 47 193250 53012 46439753
Rheumatoid factor negative 100.02 17.26 48 193249 509 46492256
Physical disability 98.90 17.26 73 193224 1787 46490978
Hyperglycaemia 98.50 17.26 14 193283 35057 46457708
Intentional product misuse 98.35 17.26 36 193261 47092 46445673
Bone density decreased 97.98 17.26 158 193139 9594 46483171
Hypophagia 97.33 17.26 6 193291 29300 46463465
Foetal exposure during pregnancy 97.20 17.26 8 193289 30739 46462026
Respiratory arrest 96.15 17.26 13 193284 33803 46458962
Colitis microscopic 96.13 17.26 127 193170 6429 46486336
Fluid overload 95.24 17.26 4 193293 27181 46465584
Pulmonary fibrosis 94.38 17.26 237 193060 19855 46472910
Injection site erythema 93.49 17.26 102 193195 74325 46418440
Depression 93.22 17.26 375 192922 169729 46323036
Surgical failure 92.96 17.26 55 193242 915 46491850
Disturbance in attention 92.48 17.26 11 193286 31549 46461216
Cardiac failure 92.45 17.26 117 193180 79831 46412934
Hepatic failure 92.32 17.26 14 193283 33402 46459363
Cognitive disorder 92.10 17.26 20 193277 36863 46455902
Emotional distress 91.75 17.26 10 193287 30697 46462068
Spinal column injury 91.58 17.26 69 193228 1744 46491021
Immunodeficiency 91.35 17.26 181 193116 12925 46479840
Blood urea increased 91.33 17.26 3 193294 25349 46467416
Gamma-glutamyltransferase increased 90.73 17.26 12 193285 31728 46461037
Dermatitis allergic 90.20 17.26 176 193121 12427 46480338
Dyskinesia 90.14 17.26 8 193289 28917 46463848
Haematemesis 89.68 17.26 8 193289 28798 46463967
Heart rate increased 89.06 17.26 107 193190 74684 46418081
Paraesthesia 88.03 17.26 225 193072 117212 46375553
Thrombosis 87.05 17.26 63 193234 56006 46436759
Respiratory distress 86.75 17.26 14 193283 31902 46460863
Intentional self-injury 86.56 17.26 3 193294 24163 46468602
Mouth ulceration 86.33 17.26 276 193021 26556 46466209
Hepatic function abnormal 85.27 17.26 19 193278 34402 46458363
Irritability 85.04 17.26 10 193287 28936 46463829
Wrist deformity 83.71 17.26 61 193236 1463 46491302
Aphasia 83.60 17.26 10 193287 28557 46464208
Bone pain 83.41 17.26 45 193252 46845 46445920
Wheelchair user 82.18 17.26 92 193205 3916 46488849
Incorrect dose administered 82.08 17.26 43 193254 45507 46447258
Red blood cell sedimentation rate 81.94 17.26 64 193233 1709 46491056
Pulmonary toxicity 81.65 17.26 99 193198 4594 46488171
Tuberculin test positive 81.35 17.26 80 193217 2924 46489841
Blood potassium decreased 81.26 17.26 28 193269 38035 46454730
Haematuria 79.60 17.26 9 193288 26849 46465916
Pulmonary hypertension 79.43 17.26 25 193272 35968 46456797
Ankle operation 79.28 17.26 54 193243 1159 46491606
Red cell distribution width decreased 78.95 17.26 48 193249 841 46491924
Disease progression 78.87 17.26 162 193135 91138 46401627
Hypomagnesaemia 78.71 17.26 3 193294 22207 46470558
Pulmonary arterial hypertension 78.60 17.26 8 193289 25920 46466845
Bone marrow failure 78.47 17.26 14 193283 29655 46463110
Adverse reaction 78.46 17.26 129 193168 7961 46484804
Blood creatine phosphokinase increased 78.02 17.26 11 193286 27713 46465052
Vascular access complication 77.78 17.26 49 193248 917 46491848
Osteonecrosis of jaw 77.54 17.26 23 193274 34379 46458386
Muscle injury 77.19 17.26 98 193199 4768 46487997
Device dislocation 77.08 17.26 3 193294 21799 46470966
Speech disorder 76.53 17.26 27 193270 36140 46456625
Impaired work ability 75.73 17.26 164 193133 12472 46480293
Abnormal behaviour 74.10 17.26 3 193294 21055 46471710
Loose body in joint 73.79 17.26 49 193248 1007 46491758
Haemorrhage 73.66 17.26 71 193226 54798 46437967
Coronary artery disease 73.50 17.26 24 193273 33728 46459037
Folliculitis 72.82 17.26 108 193189 6095 46486670
Demyelination 72.66 17.26 103 193194 5577 46487188
Haemoptysis 72.29 17.26 11 193286 26178 46466587
Joint effusion 72.25 17.26 156 193141 11839 46480926
Urinary incontinence 72.20 17.26 15 193282 28515 46464250
Premature delivery 71.87 17.26 5 193292 22064 46470701
Shock 70.99 17.26 5 193292 21840 46470925
Limb operation 70.81 17.26 78 193219 3260 46489505
Presbyacusis 70.62 17.26 72 193225 2750 46490015
Depressed mood 70.29 17.26 25 193272 33294 46459471
Diverticulitis 70.11 17.26 297 193000 32742 46460023
Wheezing 69.46 17.26 71 193226 53315 46439450
Therapy interrupted 69.23 17.26 144 193153 10647 46482118
Generalised tonic-clonic seizure 69.17 17.26 14 193283 27108 46465657
Cutaneous vasculitis 69.12 17.26 84 193213 3907 46488858
Aggression 68.99 17.26 7 193290 22737 46470028
Dislocation of vertebra 68.62 17.26 51 193246 1262 46491503
Wrist surgery 68.58 17.26 42 193255 746 46492019
Atrial fibrillation 68.35 17.26 211 193086 103379 46389386
Haematochezia 68.14 17.26 35 193262 37458 46455307
Restlessness 67.60 17.26 12 193285 25512 46467253
Urinary retention 67.41 17.26 13 193284 26048 46466717
Circulatory collapse 67.33 17.26 6 193291 21618 46471147
Infusion site reaction 67.29 17.26 57 193240 1712 46491053
Altered state of consciousness 66.32 17.26 9 193288 23339 46469426
Herpes zoster 65.81 17.26 494 192803 67378 46425387
Blood lactate dehydrogenase increased 65.74 17.26 5 193292 20495 46472270
Ulcer 65.42 17.26 189 193108 17203 46475562
Abortion spontaneous 65.24 17.26 51 193246 43595 46449170
Food allergy 65.16 17.26 109 193188 6824 46485941
Mean platelet volume decreased 65.14 17.26 53 193244 1503 46491262
Pneumonia aspiration 64.50 17.26 25 193272 31580 46461185
Bedridden 64.44 17.26 127 193170 9032 46483733
Soft tissue disorder 64.35 17.26 83 193214 4103 46488662
Accidental overdose 64.04 17.26 5 193292 20061 46472704
Vertigo 63.53 17.26 73 193224 51975 46440790
Osteoporotic fracture 63.37 17.26 70 193227 2935 46489830
Swollen joint count increased 63.30 17.26 63 193234 2337 46490428
Interstitial lung disease 63.08 17.26 411 192886 53538 46439227
Acute respiratory failure 62.95 17.26 21 193276 29117 46463648
Crying 62.87 17.26 7 193290 21134 46471631
Joint arthroplasty 62.52 17.26 58 193239 1969 46490796
Acute myocardial infarction 62.32 17.26 27 193270 31897 46460868
Full blood count decreased 62.06 17.26 9 193288 22202 46470563
Neck pain 62.04 17.26 417 192880 54889 46437876
Sensitivity to weather change 61.85 17.26 94 193203 5422 46487343
Presyncope 61.58 17.26 13 193284 24441 46468324
Swollen tongue 61.55 17.26 22 193275 29210 46463555
Pancreatitis acute 61.06 17.26 14 193283 24858 46467907
Skin exfoliation 60.98 17.26 30 193267 32908 46459857
Pleural thickening 60.96 17.26 64 193233 2531 46490234
Lip swelling 60.96 17.26 15 193282 25380 46467385
Coagulopathy 60.80 17.26 4 193293 18495 46474270
Cholestasis 60.57 17.26 18 193279 26875 46465890
Cerebral haemorrhage 60.34 17.26 21 193276 28350 46464415
Blood iron abnormal 60.31 17.26 70 193227 3100 46489665
Blood sodium decreased 60.25 17.26 9 193288 21717 46471048
Blood pressure increased 59.85 17.26 295 193002 126371 46366394
Shoulder arthroplasty 59.75 17.26 69 193228 3039 46489726
Needle issue 59.63 17.26 95 193202 5709 46487056
Rheumatoid lung 59.04 17.26 52 193245 1648 46491117
Acute respiratory distress syndrome 58.73 17.26 10 193287 21912 46470853
Dry skin 58.72 17.26 50 193247 40966 46451799
Pleural fibrosis 58.40 17.26 73 193224 3496 46489269
Blood count abnormal 58.36 17.26 4 193293 17874 46474891
Poor venous access 58.21 17.26 115 193182 8193 46484572
Bone swelling 58.21 17.26 45 193252 1183 46491582
Vaginal haemorrhage 57.92 17.26 17 193280 25587 46467178
Lymphocyte count decreased 57.86 17.26 17 193280 25572 46467193
Face oedema 57.83 17.26 6 193291 19147 46473618
Blood cholesterol increased 57.72 17.26 322 192975 39691 46453074
Seronegative arthritis 57.61 17.26 37 193260 717 46492048
Impaired healing 57.27 17.26 302 192995 36441 46456324
Visual acuity reduced 57.26 17.26 11 193286 22102 46470663
Accident 57.26 17.26 87 193210 5017 46487748
Drug specific antibody 57.19 17.26 45 193252 1215 46491550
Oedema 57.08 17.26 120 193177 66951 46425814
Flatulence 57.05 17.26 24 193273 28854 46463911
Panic attack 57.03 17.26 8 193289 20234 46472531
Muscle spasticity 56.96 17.26 138 193159 11302 46481463
Pallor 56.95 17.26 13 193284 23153 46469612
Peptic ulcer haemorrhage 56.67 17.26 41 193256 972 46491793
Premature baby 56.46 17.26 5 193292 18107 46474658
Inappropriate schedule of product administration 56.44 17.26 115 193182 64898 46427867
Leukocytosis 55.81 17.26 14 193283 23384 46469381
Anaphylactic reaction 55.75 17.26 394 192903 52718 46440047
Cardiogenic shock 55.49 17.26 3 193294 16381 46476384
Nodule 55.28 17.26 166 193131 15439 46477326
Muscular weakness 55.12 17.26 195 193102 91649 46401116
Pollakiuria 55.08 17.26 16 193281 24245 46468520
Psychotic disorder 55.01 17.26 13 193284 22608 46470157
Cataract 54.94 17.26 349 192948 45066 46447699
Ventricular tachycardia 54.80 17.26 4 193293 16963 46475802
Nervousness 54.15 17.26 25 193272 28450 46464315
Ankle arthroplasty 54.09 17.26 33 193264 582 46492183
Abdominal distension 53.82 17.26 142 193155 73209 46419556
Electrolyte imbalance 53.04 17.26 5 193292 17221 46475544
Nail disorder 52.58 17.26 107 193190 7789 46484976
Pericardial effusion 52.47 17.26 20 193277 25523 46467242
Disseminated intravascular coagulation 52.41 17.26 8 193289 18997 46473768
Transaminases abnormal 52.38 17.26 31 193266 516 46492249
Mental disorder 52.38 17.26 14 193283 22411 46470354
Osteonecrosis 51.50 17.26 21 193276 25723 46467042
Epilepsy 51.47 17.26 17 193280 23721 46469044
Sleep disorder due to general medical condition, insomnia type 51.31 17.26 84 193213 5165 46487600
Polyarthritis 51.31 17.26 95 193202 6447 46486318
Blood magnesium increased 51.27 17.26 63 193234 2964 46489801
Orthostatic hypotension 51.16 17.26 19 193278 24639 46468126
Cyanosis 50.92 17.26 4 193293 15967 46476798
Memory impairment 50.67 17.26 158 193139 77179 46415586
Product label confusion 50.66 17.26 26 193271 322 46492443
Nightmare 50.63 17.26 5 193292 16593 46476172
Dry mouth 50.41 17.26 94 193203 54832 46437933
Gastritis 50.33 17.26 41 193256 34337 46458428
Chronic kidney disease 50.23 17.26 57 193240 40814 46451951
Adjustment disorder with depressed mood 50.21 17.26 40 193257 1100 46491665
Heart rate decreased 50.08 17.26 35 193262 31688 46461077
Hemiparesis 49.86 17.26 11 193286 20058 46472707
Blood calcium decreased 49.76 17.26 4 193293 15669 46477096
Alanine aminotransferase increased 48.40 17.26 195 193102 88256 46404509
Agranulocytosis 47.91 17.26 16 193281 22169 46470596
Chronic obstructive pulmonary disease 47.47 17.26 105 193192 57528 46435237
Pruritus 47.36 17.26 712 192585 241640 46251125
Irritable bowel syndrome 47.00 17.26 163 193134 16352 46476413
Eosinophilia 46.81 17.26 11 193286 19206 46473559
Deafness neurosensory 46.78 17.26 74 193223 4420 46488345
Mean cell volume decreased 46.62 17.26 54 193243 2386 46490379
Nasopharyngitis 46.62 17.26 896 192401 153102 46339663
Gastrointestinal disorder 46.60 17.26 413 192884 59163 46433602
Pain in extremity 46.57 17.26 1401 191896 257279 46235486
Inappropriate antidiuretic hormone secretion 46.49 17.26 3 193294 14099 46478666
Clostridium difficile colitis 46.44 17.26 10 193287 18543 46474222
Cholelithiasis 46.40 17.26 55 193242 38626 46454139
Tubulointerstitial nephritis 46.32 17.26 4 193293 14784 46477981
Abdominal pain lower 46.22 17.26 15 193282 21166 46471599
Sinus tachycardia 46.08 17.26 16 193281 21633 46471132
Nephrolithiasis 45.71 17.26 263 193034 32788 46459977
Arrhythmia 45.70 17.26 46 193251 34795 46457970
Atelectasis 45.29 17.26 11 193286 18779 46473986
Multiple sclerosis 45.26 17.26 23 193274 24768 46467997
Sinus bradycardia 45.23 17.26 3 193294 13779 46478986
Back injury 45.15 17.26 93 193204 6828 46485937
Multiple fractures 45.12 17.26 82 193215 5485 46487280
Migraine 44.51 17.26 145 193152 69881 46422884
Therapeutic response unexpected 44.40 17.26 6 193291 15610 46477155
Small intestinal obstruction 44.16 17.26 7 193290 16165 46476600
Joint injury 44.16 17.26 177 193120 19032 46473733
Upper gastrointestinal haemorrhage 44.04 17.26 8 193289 16730 46476035
Exostosis 44.01 17.26 117 193180 10146 46482619
Colitis 43.85 17.26 54 193243 37293 46455472
Hypersomnia 43.74 17.26 6 193291 15433 46477332
Mitral valve incompetence 43.60 17.26 12 193285 18840 46473925
Myocardial infarction 43.31 17.26 232 193065 97296 46395469
Malnutrition 43.29 17.26 4 193293 13999 46478766
Sebaceous gland infection 43.28 17.26 17 193280 105 46492660
Muscle twitching 43.27 17.26 5 193292 14667 46478098
Transfusion 43.07 17.26 3 193294 13228 46479537
Anti-cyclic citrullinated peptide antibody 43.04 17.26 22 193275 270 46492495
Cytomegalovirus infection 43 17.26 11 193286 18133 46474632
Fall 42.43 17.26 1038 192259 328059 46164706
Skin papilloma 42.41 17.26 68 193229 4108 46488657
Device related infection 42.35 17.26 17 193280 21024 46471741
Pruritus allergic 42.32 17.26 35 193262 1016 46491749
Blood albumin decreased 42.30 17.26 4 193293 13741 46479024
White blood cell count abnormal 42.12 17.26 76 193221 5056 46487709
Viral upper respiratory tract infection 41.95 17.26 91 193206 6927 46485838
Skin discolouration 41.90 17.26 44 193253 32636 46460129
Staphylococcal infection 41.70 17.26 52 193245 35719 46457046
Delirium 41.46 17.26 56 193241 37172 46455593
Ovarian neoplasm 41.23 17.26 31 193266 781 46491984
Cough 40.78 17.26 689 192608 229560 46263205
Cerebral infarction 40.72 17.26 23 193274 23343 46469422
Product prescribing error 40.67 17.26 16 193281 20031 46472734
Mean cell haemoglobin decreased 40.54 17.26 55 193242 2857 46489908
Bone cyst 40.21 17.26 46 193251 2005 46490760
Blood creatinine increased 40.20 17.26 171 193126 76232 46416533
Diplopia 40.18 17.26 15 193282 19390 46473375
Mesenteritis 40.10 17.26 17 193280 131 46492634
Foot operation 39.96 17.26 71 193226 4666 46488099
Infiltration anaesthesia 39.88 17.26 17 193280 133 46492632
Tricuspid valve incompetence 39.65 17.26 5 193292 13712 46479053
Right ventricular failure 39.62 17.26 9 193288 16084 46476681
Caesarean section 39.47 17.26 10 193287 16593 46476172
Mucosal inflammation 39.14 17.26 63 193234 38913 46453852
Angioedema 39.13 17.26 64 193233 39278 46453487
Acute hepatic failure 38.81 17.26 7 193290 14714 46478051
Haematocrit decreased 38.78 17.26 53 193244 35004 46457761
Bursitis 38.76 17.26 174 193123 19668 46473097
Joint dislocation 38.69 17.26 118 193179 11068 46481697
Bone disorder 38.63 17.26 175 193122 19858 46472907
Blood glucose decreased 38.46 17.26 15 193282 18877 46473888
Breast cancer 38.46 17.26 321 192976 45197 46447568
X-ray abnormal 38.43 17.26 35 193262 1160 46491605
Malignant melanoma 38.28 17.26 111 193186 10123 46482642
Onychomadesis 38.23 17.26 53 193244 2810 46489955
Peritonitis 38.14 17.26 19 193278 20695 46472070
Diabetic ketoacidosis 37.83 17.26 14 193283 18196 46474569
Vasculitic rash 37.56 17.26 36 193261 1274 46491491
Ear pain 37.51 17.26 186 193111 21906 46470859
Injection site pruritus 37.37 17.26 67 193230 39676 46453089
Mental impairment 37.35 17.26 4 193293 12452 46480313
Upper respiratory tract infection 37.27 17.26 415 192882 63141 46429624
Glomerular filtration rate decreased 37.08 17.26 3 193294 11691 46481074
Lymphopenia 36.77 17.26 9 193288 15284 46477481
Erythema 36.65 17.26 396 192901 142424 46350341
Sensory disturbance 36.63 17.26 4 193293 12263 46480502
Feeling cold 36.44 17.26 16 193281 18755 46474010
Thyroid neoplasm 36.25 17.26 59 193238 3610 46489155
Eye swelling 36.18 17.26 19 193278 20084 46472681
Product dose omission issue 36.10 17.26 486 192811 168034 46324731
Premature labour 35.55 17.26 3 193294 11296 46481469
Secretion discharge 35.46 17.26 101 193196 9118 46483647
Eye pain 35.39 17.26 38 193259 27902 46464863
Pneumonia viral 35.24 17.26 82 193215 6542 46486223
Skin neoplasm excision 35.21 17.26 25 193272 575 46492190
Fatigue 35.21 17.26 2950 190347 605747 45887018
Diabetes mellitus 35.09 17.26 339 192958 49726 46443039
Blood triglycerides increased 34.79 17.26 4 193293 11779 46480986
Extremity contracture 34.71 17.26 33 193264 1156 46491609
Impaired gastric emptying 34.59 17.26 92 193205 7980 46484785
Femur fracture 34.57 17.26 267 193030 36730 46456035
Skin cancer 34.27 17.26 97 193200 8726 46484039
Nerve injury 34.22 17.26 89 193208 7616 46485149
Hypercalcaemia 34.18 17.26 175 193122 20871 46471894
Intestinal sepsis 34.11 17.26 18 193279 237 46492528
Hypothermia 33.89 17.26 5 193292 12178 46480587
Ageusia 33.61 17.26 4 193293 11468 46481297
Frequent bowel movements 33.32 17.26 6 193291 12626 46480139
Metastases to liver 33.10 17.26 20 193277 19565 46473200
Acute myeloid leukaemia 33 17.26 12 193285 15766 46476999
Medication error 32.93 17.26 48 193249 30863 46461902
Heart rate irregular 32.83 17.26 18 193279 18573 46474192
Retching 32.76 17.26 7 193290 13050 46479715
Hypoaesthesia oral 32.69 17.26 3 193294 10556 46482209
Obstructive airways disorder 32.04 17.26 8 193289 13404 46479361
Skin reaction 31.99 17.26 109 193188 10837 46481928
Aspartate aminotransferase increased 31.81 17.26 193 193104 78507 46414258
Eye disorder 31.70 17.26 154 193143 17987 46474778
Abnormal dreams 31.61 17.26 3 193294 10276 46482489
Left ventricular dysfunction 31.51 17.26 3 193294 10252 46482513
Tinnitus 31.46 17.26 41 193256 27632 46465133
Immobile 31.36 17.26 63 193234 4543 46488222
Hepatic encephalopathy 31.14 17.26 3 193294 10154 46482611
Myelodysplastic syndrome 31.12 17.26 13 193284 15698 46477067
Bacteraemia 31.01 17.26 10 193287 14169 46478596
Cardiomegaly 30.76 17.26 17 193280 17465 46475300
Sleep apnoea syndrome 30.65 17.26 28 193269 22173 46470592
Hyperhidrosis 30.62 17.26 230 193067 89078 46403687
Subdural haematoma 30.57 17.26 8 193289 12989 46479776
Extrapyramidal disorder 30.49 17.26 5 193292 11263 46481502
Cartilage atrophy 30.46 17.26 15 193282 169 46492596
Overlap syndrome 30.44 17.26 23 193274 584 46492181
Obesity 30.36 17.26 128 193169 14078 46478687
Hypoaesthesia 30.32 17.26 330 192967 118539 46374226
Dysphonia 30.01 17.26 72 193225 38342 46454423
Thyroid disorder 29.97 17.26 114 193183 11962 46480803
Hyperlipidaemia 29.87 17.26 20 193277 18519 46474246
Urine output decreased 29.86 17.26 5 193292 11092 46481673
Injection site reaction 29.69 17.26 316 192981 47533 46445232
Bone density abnormal 29.67 17.26 49 193248 3035 46489730
Injection site warmth 29.62 17.26 10 193287 13762 46479003
Posterior reversible encephalopathy syndrome 29.24 17.26 13 193284 15128 46477637
Transient ischaemic attack 29.22 17.26 63 193234 34840 46457925
Pregnancy 29.04 17.26 42 193255 27095 46465670
Red blood cell count decreased 28.91 17.26 57 193240 32566 46460199
Mood altered 28.76 17.26 9 193288 12998 46479767
Hepatitis 28.73 17.26 230 193067 31985 46460780
Hypoalbuminaemia 28.53 17.26 4 193293 10123 46482642
Investigation abnormal 28.50 17.26 28 193269 1022 46491743
Rash papular 28.38 17.26 9 193288 12889 46479876
Ankle deformity 28.38 17.26 19 193278 396 46492369
Disease recurrence 28.34 17.26 21 193276 18450 46474315
Metastases to central nervous system 28.18 17.26 6 193291 11215 46481550
Hypocalcaemia 28.13 17.26 42 193255 26743 46466022
Dysuria 27.94 17.26 45 193252 27788 46464977
Myocardial ischaemia 27.87 17.26 9 193288 12740 46480025
Hypovolaemia 27.64 17.26 4 193293 9884 46482881
Lower limb fracture 27.51 17.26 113 193184 12285 46480480
Injection site swelling 27.40 17.26 81 193216 40246 46452519
Thinking abnormal 27.36 17.26 4 193293 9810 46482955
Night sweats 27.34 17.26 200 193097 27050 46465715
Antibody test positive 27.31 17.26 39 193258 2126 46490639
Eyelid oedema 27.14 17.26 5 193292 10352 46482413
White blood cell count increased 27.11 17.26 93 193204 44126 46448639
Enthesopathy 27.11 17.26 60 193237 4630 46488135
Ischaemic stroke 26.99 17.26 18 193279 16704 46476061
Gait disturbance 26.97 17.26 790 192507 144473 46348292
Product quality issue 26.91 17.26 68 193229 35580 46457185
Device breakage 26.91 17.26 4 193293 9688 46483077
Cardiac murmur 26.86 17.26 7 193290 11397 46481368
Mania 26.83 17.26 6 193291 10840 46481925
Lymphadenopathy 26.77 17.26 62 193235 33426 46459339
Eye irritation 26.66 17.26 18 193279 16596 46476169
Feeling hot 26.63 17.26 75 193222 37853 46454912
Emotional disorder 26.41 17.26 9 193288 12315 46480450
Supraventricular tachycardia 26.26 17.26 11 193286 13259 46479506
Angina pectoris 26.21 17.26 44 193253 26731 46466034
Hyperthyroidism 26.08 17.26 8 193289 11703 46481062
Petechiae 25.89 17.26 10 193287 12660 46480105
Hypothyroidism 25.88 17.26 57 193240 31281 46461484
Oliguria 25.79 17.26 3 193294 8756 46484009
Unevaluable event 25.75 17.26 101 193196 46074 46446691
Clostridium difficile infection 25.75 17.26 40 193257 25063 46467702
Neck surgery 25.61 17.26 31 193266 1436 46491329
Epigastric discomfort 25.60 17.26 66 193231 5618 46487147
Osteopenia 25.46 17.26 138 193159 16823 46475942
Therapy cessation 25.33 17.26 193 193104 26436 46466329
Atrial flutter 24.89 17.26 4 193293 9144 46483621
Arteriosclerosis 24.87 17.26 5 193292 9728 46483037
Acute coronary syndrome 24.54 17.26 6 193291 10198 46482567
Breast cancer metastatic 24.51 17.26 13 193284 13665 46479100
Central nervous system lesion 24.44 17.26 5 193292 9610 46483155
Oesophagitis 24.42 17.26 13 193284 13638 46479127
Hot flush 24.39 17.26 95 193202 43422 46449343
Transplant rejection 24.37 17.26 5 193292 9591 46483174
Ileus 24.28 17.26 14 193283 14050 46478715
Dialysis 24.23 17.26 6 193291 10110 46482655
Accidental exposure to product 24.20 17.26 31 193266 21050 46471715
Fracture treatment 24.20 17.26 11 193286 102 46492663
Subarachnoid haemorrhage 24.16 17.26 8 193289 11145 46481620
Alanine aminotransferase abnormal 24.11 17.26 40 193257 2487 46490278
Systemic lupus erythematosus rash 24.05 17.26 28 193269 1244 46491521
Pancreatitis 23.97 17.26 96 193201 43531 46449234
Myopathy 23.90 17.26 4 193293 8877 46483888
Hypotonia 23.78 17.26 3 193294 8226 46484539
Tendon disorder 23.54 17.26 59 193238 4936 46487829
Throat irritation 23.51 17.26 53 193244 28848 46463917
Ankylosing spondylitis 23.23 17.26 71 193226 6666 46486099
Cardiac failure acute 23.21 17.26 3 193294 8075 46484690
Lacrimation increased 23.11 17.26 19 193278 15842 46476923
Dry eye 23.09 17.26 209 193088 30113 46462652
Muscle tightness 23.02 17.26 7 193290 10298 46482467
Fistula 22.96 17.26 3 193294 8007 46484758
Lung infiltration 22.83 17.26 15 193282 14028 46478737
Hepatomegaly 22.80 17.26 9 193288 11244 46481521
Erythema multiforme 22.77 17.26 6 193291 9698 46483067
Blood loss anaemia 22.71 17.26 4 193293 8553 46484212
Ocular hyperaemia 22.61 17.26 29 193268 19681 46473084
Increased appetite 22.60 17.26 4 193293 8523 46484242
Cardiomyopathy 22.51 17.26 20 193277 16053 46476712
Eosinophil count increased 22.42 17.26 3 193294 7863 46484902
Hyperaesthesia 22.38 17.26 3 193294 7853 46484912
Bronchitis 22.38 17.26 586 192711 105393 46387372
Pelvic pain 22.35 17.26 10 193287 11592 46481173
Incorrect product administration duration 22.33 17.26 6 193291 9571 46483194
Cancer surgery 22.28 17.26 17 193280 438 46492327
Micturition urgency 22.23 17.26 3 193294 7814 46484951
Juvenile psoriatic arthritis 22.07 17.26 7 193290 20 46492745
Feeling jittery 21.98 17.26 9 193288 10999 46481766
Rash maculo-papular 21.96 17.26 52 193245 27822 46464943
Therapy non-responder 21.57 17.26 263 193034 40889 46451876
Glycosylated haemoglobin increased 21.54 17.26 9 193288 10867 46481898
Oral discomfort 21.54 17.26 77 193220 7841 46484924
Pulmonary nocardiosis 21.52 17.26 10 193287 98 46492667
Incontinence 21.49 17.26 7 193290 9855 46482910
Peripheral coldness 21.47 17.26 7 193290 9848 46482917
Rheumatic disorder 21.46 17.26 28 193269 1400 46491365
Head discomfort 21.43 17.26 8 193289 10343 46482422
Paraesthesia oral 21.37 17.26 11 193286 11762 46481003
Blood calcium increased 21.37 17.26 3 193294 7584 46485181
Arteriosclerosis coronary artery 21.24 17.26 4 193293 8152 46484613
Multiple allergies 21.19 17.26 73 193224 7298 46485467
Bronchopulmonary aspergillosis 21.03 17.26 3 193294 7493 46485272
Head injury 21.02 17.26 44 193253 24592 46468173
Metastases to lung 20.95 17.26 9 193288 10687 46482078
Haematoma 20.95 17.26 65 193232 31807 46460958
Hip surgery 20.92 17.26 37 193260 2423 46490342
Shock haemorrhagic 20.88 17.26 5 193292 8619 46484146
Body temperature increased 20.82 17.26 175 193122 24686 46468079
Product leakage 20.79 17.26 15 193282 354 46492411
Pneumothorax 20.73 17.26 18 193279 14611 46478154
Schizophrenia 20.68 17.26 5 193292 8563 46484202
Eye pruritus 20.32 17.26 12 193285 11886 46480879
Diabetes mellitus inadequate control 20.31 17.26 15 193282 13199 46479566
Sudden death 20.27 17.26 7 193290 9497 46483268
Precancerous cells present 20.25 17.26 25 193272 1182 46491583
Lip ulceration 20.23 17.26 30 193267 1693 46491072
Cold sweat 20.21 17.26 10 193287 10935 46481830
Purpura 20.12 17.26 8 193289 9950 46482815
Upper-airway cough syndrome 20.11 17.26 4 193293 7843 46484922
Fracture delayed union 20.10 17.26 34 193263 2148 46490617
Faeces discoloured 19.99 17.26 24 193273 16763 46476002
Injury 19.94 17.26 104 193193 43923 46448842
Cyst 19.92 17.26 101 193196 11999 46480766
Polyuria 19.91 17.26 3 193294 7192 46485573
Carpal tunnel syndrome 19.87 17.26 123 193174 15736 46477029
Tendon operation 19.83 17.26 14 193283 319 46492446
Pain of skin 19.73 17.26 4 193293 7738 46485027
Synovial cyst 19.61 17.26 71 193226 7275 46485490
Product administration error 19.58 17.26 32 193265 19649 46473116
Fungal infection 19.54 17.26 60 193237 29460 46463305
Eczema 19.53 17.26 34 193263 20366 46472399
Rash macular 19.46 17.26 31 193266 19229 46473536
Type 2 diabetes mellitus 19.44 17.26 145 193152 19730 46473035
Amyotrophic lateral sclerosis 19.44 17.26 23 193274 1040 46491725
Nasal congestion 19.43 17.26 118 193179 47995 46444770
Dermatitis bullous 19.37 17.26 4 193293 7639 46485126
Disseminated large cell lymphoma 19.29 17.26 8 193289 58 46492707
Splenomegaly 19.22 17.26 8 193289 9680 46483085
Breast pain 19.20 17.26 4 193293 7590 46485175
Haemorrhoids 19.18 17.26 30 193267 18747 46474018
Dermatitis contact 19.10 17.26 5 193292 8118 46484647
Monocyte count increased 19.01 17.26 55 193242 5009 46487756
Drug ineffective for unapproved indication 18.98 17.26 24 193273 16389 46476376
Anti-neutrophil cytoplasmic antibody positive vasculitis 18.96 17.26 31 193266 1904 46490861
Hemiplegia 18.95 17.26 3 193294 6935 46485830
Respiratory rate increased 18.87 17.26 12 193285 11421 46481344
Wound infection 18.87 17.26 89 193208 10270 46482495
Sinus congestion 18.74 17.26 16 193281 13093 46479672
Post procedural haemorrhage 18.59 17.26 4 193293 7422 46485343
Uterine disorder 18.58 17.26 37 193260 2651 46490114
Neck deformity 18.57 17.26 30 193267 1824 46490941
Adrenal insufficiency 18.51 17.26 105 193192 13019 46479746
Amnesia 18.49 17.26 99 193198 41532 46451233
Atrioventricular block 18.48 17.26 3 193294 6808 46485957
Sinusitis bacterial 18.44 17.26 19 193278 735 46492030
Escherichia infection 18.35 17.26 11 193286 10806 46481959
Vitamin D decreased 18.30 17.26 5 193292 7888 46484877
Enteritis 18.27 17.26 3 193294 6752 46486013
Product complaint 18.26 17.26 14 193283 12087 46480678
Photophobia 18.18 17.26 20 193277 14524 46478241
Major depression 18.03 17.26 3 193294 6687 46486078
Troponin increased 18.03 17.26 5 193292 7811 46484954
Cardiac disorder 18.01 17.26 107 193190 43751 46449014
Device leakage 18.00 17.26 56 193241 5309 46487456
Abdominal pain upper 17.94 17.26 461 192836 144844 46347921
Failure to thrive 17.94 17.26 3 193294 6661 46486104
Respiratory tract congestion 17.93 17.26 102 193195 12662 46480103
Loss of employment 17.91 17.26 24 193273 1232 46491533
Pseudomonas infection 17.89 17.26 9 193288 9749 46483016
Duodenal ulcer 17.84 17.26 4 193293 7214 46485551
Metastases to lymph nodes 17.81 17.26 3 193294 6628 46486137
Myocarditis 17.76 17.26 5 193292 7734 46485031
Colitis ischaemic 17.61 17.26 10 193287 10122 46482643
Multiple system atrophy 17.55 17.26 11 193286 204 46492561
Neutrophil count increased 17.38 17.26 20 193277 14233 46478532
Dysstasia 17.33 17.26 29 193268 17639 46475126

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 2160.61 26.03 2169 29159 338218 29582932
Rheumatoid arthritis 1844.28 26.03 885 30443 40312 29880838
Contraindicated product administered 1636.71 26.03 631 30697 16600 29904550
Joint swelling 1167.98 26.03 682 30646 46264 29874886
Drug intolerance 973.08 26.03 599 30729 44692 29876458
Synovitis 933.99 26.03 360 30968 9423 29911727
Treatment failure 750.20 26.03 461 30867 34218 29886932
Apparent death 666.61 26.03 216 31112 3326 29917824
Arthropathy 521.73 26.03 304 31024 20423 29900727
C-reactive protein abnormal 512.83 26.03 200 31128 5393 29915757
Diverticulitis 487.61 26.03 274 31054 17171 29903979
Drug hypersensitivity 454.42 26.03 452 30876 68067 29853083
Bone erosion 411.80 26.03 135 31193 2158 29918992
Loss of personal independence in daily activities 392.07 26.03 257 31071 21278 29899872
Therapeutic product effect decreased 361.91 26.03 275 31053 28801 29892349
Pain 356.36 26.03 642 30686 171999 29749151
Arthralgia 273.39 26.03 500 30828 135291 29785859
Musculoskeletal stiffness 254.76 26.03 246 31082 35635 29885515
Red blood cell sedimentation rate abnormal 234.37 26.03 83 31245 1692 29919458
Knee arthroplasty 229.88 26.03 114 31214 5516 29915634
Mobility decreased 226.74 26.03 200 31128 25799 29895351
Acute kidney injury 206.53 26.03 23 31305 273819 29647331
Pulmonary thrombosis 205.71 26.03 110 31218 6233 29914917
Red blood cell sedimentation rate increased 199.38 26.03 113 31215 7182 29913968
Osteoarthritis 192.47 26.03 157 31171 18192 29902958
Chondropathy 180.18 26.03 57 31271 807 29920343
Onychoclasis 179.59 26.03 67 31261 1592 29919558
Impaired work ability 177.78 26.03 96 31232 5547 29915603
Disability 176.05 26.03 88 31240 4330 29916820
Tenosynovitis 160.99 26.03 77 31251 3438 29917712
Toxicity to various agents 159.25 26.03 6 31322 177177 29743973
Herpes zoster 156.03 26.03 174 31154 29769 29891381
Rheumatoid factor negative 155.91 26.03 46 31282 507 29920643
Lymphoma 155.91 26.03 109 31219 10012 29911138
Drug specific antibody present 155.65 26.03 64 31264 1983 29919167
Peripheral swelling 148.75 26.03 245 31083 60829 29860321
Atlantoaxial instability 145.50 26.03 39 31289 293 29920857
Terminal state 144.22 26.03 72 31256 3532 29917618
Spinal instability 143.91 26.03 39 31289 307 29920843
C-reactive protein increased 143.60 26.03 201 31127 43272 29877878
Mineral metabolism disorder 143.46 26.03 39 31289 311 29920839
Enthesopathy 143.34 26.03 67 31261 2839 29918311
Dislocation of vertebra 143.25 26.03 40 31288 356 29920794
Hypotension 138.73 26.03 22 31306 200543 29720607
Drug tolerance decreased 138.21 26.03 50 31278 1086 29920064
Deep vein thrombosis 135.76 26.03 234 31094 60267 29860883
Acne cystic 134.91 26.03 40 31288 449 29920701
Sarcoidosis 134.85 26.03 63 31265 2666 29918484
Device malfunction 133.51 26.03 91 31237 8020 29913130
Tooth loss 129.16 26.03 69 31259 3900 29917250
Intervertebral disc space narrowing 119.28 26.03 39 31289 617 29920533
Pulmonary embolism 118.52 26.03 256 31072 77879 29843271
Rheumatoid factor positive 115.56 26.03 36 31292 483 29920667
Hand deformity 110.74 26.03 49 31279 1824 29919326
Tongue disorder 110.19 26.03 64 31264 4258 29916892
Diarrhoea 109.77 26.03 113 31215 333990 29587160
Musculoskeletal pain 106.54 26.03 146 31182 30794 29890356
Off label use 105.01 26.03 526 30802 248764 29672386
Tooth fracture 101.36 26.03 55 31273 3207 29917943
Pyrexia 100.82 26.03 96 31232 294393 29626757
Osteosclerosis 100.14 26.03 40 31288 1148 29920002
Gastric disorder 99.71 26.03 85 31243 10458 29910692
Intestinal polyp 96.11 26.03 36 31292 865 29920285
Intentional product use issue 95.20 26.03 151 31177 36289 29884861
Anaemia 94.48 26.03 50 31278 207942 29713208
Drug use disorder 93.31 26.03 52 31276 3196 29917954
Arthritis 92.98 26.03 121 31207 24280 29896870
Alopecia 91.88 26.03 107 31221 19168 29901982
Alanine aminotransferase abnormal 89.37 26.03 47 31281 2572 29918578
Vomiting 87.11 26.03 62 31266 219756 29701394
X-ray abnormal 86.82 26.03 29 31299 492 29920658
Limb discomfort 83.62 26.03 72 31256 8978 29912172
Photosensitivity reaction 81.31 26.03 73 31255 9621 29911529
Decreased appetite 80.82 26.03 28 31300 149882 29771268
Dehydration 80.00 26.03 16 31312 123523 29797627
Thrombocytopenia 78.49 26.03 23 31305 137021 29784129
Joint arthroplasty 77.78 26.03 28 31300 599 29920551
Gastrointestinal disorder 76.82 26.03 119 31209 28018 29893132
Sleep disorder due to general medical condition, insomnia type 76.00 26.03 33 31295 1173 29919977
Intestinal sepsis 75.40 26.03 25 31303 414 29920736
Overdose 75.18 26.03 3 31325 84334 29836816
Abdominal pain 73.70 26.03 25 31303 135629 29785521
Confusional state 72.99 26.03 25 31303 134809 29786341
Swelling 72.70 26.03 133 31195 35842 29885308
Physical disability 71.29 26.03 31 31297 1106 29920044
C-reactive protein decreased 67.52 26.03 33 31295 1545 29919605
Polyarthritis 66.79 26.03 42 31286 3227 29917923
Fracture 66.35 26.03 53 31275 5953 29915197
Adverse event 66.25 26.03 81 31247 15260 29905890
Neoplasm malignant 65.78 26.03 87 31241 17727 29903423
Hepatitis B virus test positive 64.34 26.03 19 31309 210 29920940
Gait inability 63.46 26.03 88 31240 18753 29902397
Seizure 63.22 26.03 13 31315 98462 29822688
Joint lock 63.16 26.03 28 31300 1047 29920103
Malignant neoplasm progression 63.01 26.03 3 31325 72284 29848866
Surgery 61.62 26.03 68 31260 11483 29909667
Thrombosis 61.25 26.03 136 31192 42095 29879055
Nephrolithiasis 60.94 26.03 100 31228 24710 29896440
Gastrointestinal haemorrhage 60.26 26.03 8 31320 83438 29837712
Infection 60.14 26.03 199 31129 77875 29843275
Joint stiffness 56.80 26.03 59 31269 9302 29911848
Tendonitis 56.76 26.03 55 31273 7981 29913169
Hyperkalaemia 56.70 26.03 3 31325 66007 29855143
Therapeutic product effect incomplete 56.02 26.03 115 31213 33719 29887431
Fine motor skill dysfunction 54.89 26.03 26 31302 1135 29920015
Ill-defined disorder 54.69 26.03 61 31267 10423 29910727
Oral surgery 54.33 26.03 21 31307 551 29920599
Rhabdomyolysis 54.27 26.03 3 31325 63577 29857573
Renal impairment 54.27 26.03 11 31317 84173 29836977
Dyspnoea 54.18 26.03 174 31154 333121 29588029
Product storage error 53.34 26.03 48 31280 6343 29914807
Prostate cancer 52.79 26.03 92 31236 23865 29897285
Disease progression 52.40 26.03 10 31318 79864 29841286
Cardiac arrest 52.37 26.03 16 31312 92834 29828316
Hyponatraemia 52.14 26.03 5 31323 67197 29853953
Skin cancer 51.61 26.03 52 31276 7909 29913241
Skin laceration 51.18 26.03 61 31267 11190 29909960
Psoriatic arthropathy 50.68 26.03 72 31256 15689 29905461
Skin ulcer 50.43 26.03 79 31249 18770 29902380
Immobile 50.30 26.03 30 31298 2096 29919054
Headache 50.04 26.03 344 30984 181962 29739188
Joint range of motion decreased 48.98 26.03 44 31284 5801 29915349
Somnolence 48.88 26.03 20 31308 96743 29824407
Pain in extremity 48.60 26.03 236 31092 109985 29811165
Cardio-respiratory arrest 48.01 26.03 3 31325 57303 29863847
Interstitial lung disease 47.74 26.03 155 31173 60042 29861108
Constipation 47.11 26.03 30 31298 112876 29808274
Death 46.67 26.03 204 31124 357079 29564071
Blood glucose increased 46.64 26.03 5 31323 61525 29859625
Device defective 46.53 26.03 17 31311 380 29920770
Anxiety 46.34 26.03 18 31310 89853 29831297
Vitamin D deficiency 45.47 26.03 40 31288 5130 29916020
Tachycardia 44.77 26.03 11 31317 73728 29847422
Urticaria 44.56 26.03 142 31186 54464 29866686
Platelet count decreased 44.55 26.03 28 31300 106101 29815049
Renal failure 44.45 26.03 258 31070 128708 29792442
Plasma cell myeloma 44.19 26.03 3 31325 53459 29867691
Bradycardia 43.41 26.03 8 31320 65518 29855632
Skin mass 43.39 26.03 33 31295 3449 29917701
Tooth disorder 42.22 26.03 50 31278 9111 29912039
Soft tissue swelling 41.51 26.03 14 31314 245 29920905
Seronegative arthritis 40.88 26.03 19 31309 794 29920356
Fatigue 40.10 26.03 186 31142 320487 29600663
Agitation 39.47 26.03 5 31323 54068 29867082
Pancytopenia 39.19 26.03 20 31308 85032 29836118
Hypoglycaemia 39.00 26.03 4 31324 50977 29870173
Oral disorder 38.91 26.03 33 31295 4029 29917121
Liver function test increased 38.69 26.03 53 31275 11163 29909987
International normalised ratio increased 38.53 26.03 3 31325 47736 29873414
Malignant melanoma 36.74 26.03 42 31286 7369 29913781
Rheumatoid factor increased 36.13 26.03 15 31313 476 29920674
Loss of consciousness 36.07 26.03 19 31309 79356 29841794
Tooth extraction 36.00 26.03 34 31294 4777 29916373
Dizziness 35.75 26.03 96 31232 194813 29726337
Therapy partial responder 35.38 26.03 30 31298 3661 29917489
Respiratory failure 34.07 26.03 33 31295 100609 29820541
Atrial fibrillation 33.74 26.03 38 31290 108086 29813064
Stent placement 33.48 26.03 32 31296 4564 29916586
Dysphagia 33.37 26.03 9 31319 56689 29864461
Neuropathy peripheral 33.32 26.03 16 31312 70459 29850691
Hip arthroplasty 33.02 26.03 29 31299 3711 29917439
Lymphoedema 32.64 26.03 28 31300 3471 29917679
Multiple organ dysfunction syndrome 32.25 26.03 13 31315 63474 29857676
Myalgia 31.11 26.03 21 31307 76646 29844504
Lower respiratory tract infection 31.09 26.03 79 31249 26635 29894515
Syncope 30.93 26.03 26 31302 84877 29836273
Localised infection 30.57 26.03 53 31275 13684 29907466
Nodule 30.53 26.03 31 31297 4757 29916393
Hepatic function abnormal 30.32 26.03 4 31324 41941 29879209
Hepatic cirrhosis 29.62 26.03 57 31271 15942 29905208
Muscle spasms 28.75 26.03 16 31312 64822 29856328
Stomatitis 28.64 26.03 95 31233 37184 29883966
Blood pressure decreased 28.61 26.03 7 31321 47068 29874082
Rheumatoid factor 28.37 26.03 8 31320 74 29921076
Pulmonary toxicity 28.36 26.03 29 31299 4487 29916663
Back disorder 28.09 26.03 33 31295 5961 29915189
Colitis 27.78 26.03 83 31245 30737 29890413
Lesion excision 27.47 26.03 7 31321 42 29921108
Rheumatoid lung 27.11 26.03 11 31317 329 29920821
Delirium 26.82 26.03 5 31323 40626 29880524
Epistaxis 26.66 26.03 11 31317 52970 29868180
Mass 26.55 26.03 35 31293 7105 29914045
Chronic kidney disease 26.43 26.03 4 31324 37834 29883316
Pneumonia aspiration 26.37 26.03 4 31324 37776 29883374

Pharmacologic Action:

SourceCodeDescription
ATC L04AA24 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
FDA CS M0018640 Recombinant Fusion Proteins
FDA PE N0000008571 Decreased Cytokine Activity
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018501 Antirheumatic Agents
MeSH PA D000082082 Immune Checkpoint Inhibitors
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
FDA EPC N0000182159 Selective T Cell Costimulation Modulator

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Rheumatoid arthritis indication 69896004 DOID:7148
Juvenile idiopathic arthritis indication 410502007

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
T-lymphocyte activation antigen CD80 Surface antigen INHIBITOR Kd 7.92 IUPHAR DRUG LABEL
T-lymphocyte activation antigen CD86 Surface antigen INHIBITOR Kd 7.92 IUPHAR DRUG LABEL

External reference:

IDSource
7D0YB67S97 UNII
D03203 KEGG_DRUG
4025085 VANDF
C1619966 UMLSCUI
CHEMBL1201823 ChEMBL_ID
DB01281 DRUGBANK_ID
D000069594 MESH_DESCRIPTOR_UI
8495 INN_ID
6891 IUPHAR_LIGAND_ID
614391 RXNORM
20795 MMSL
73627 MMSL
d05694 MMSL
011175 NDDF
421412005 SNOMEDCT_US
421777009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ORENCIA HUMAN PRESCRIPTION DRUG LABEL 1 0003-2187 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 250 mg INTRAVENOUS BLA 30 sections
ORENCIA HUMAN PRESCRIPTION DRUG LABEL 1 0003-2188 INJECTION, SOLUTION 125 mg SUBCUTANEOUS BLA 30 sections
ORENCIA HUMAN PRESCRIPTION DRUG LABEL 1 0003-2814 INJECTION, SOLUTION 50 mg SUBCUTANEOUS BLA 30 sections
ORENCIA HUMAN PRESCRIPTION DRUG LABEL 1 0003-2818 INJECTION, SOLUTION 87.50 mg SUBCUTANEOUS BLA 30 sections