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

Stem definitionDrug idCAS RN
human origin 4966 815610-63-0

Description:

MoleculeDescription

Synonyms:

  • ustekinumab
  • stelara
  • CNTO 1275
  • CNTO-1275
A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.54 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 1, 2009 EMA
Sept. 25, 2009 FDA CENTOCOR ORTHO BIOTECH INC
March 25, 2020 PMDA Janssen Pharmaceutical 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
Product dose omission issue 1506.01 17.84 2260 145711 232053 63108998
Product use issue 1388.32 17.84 2107 145864 218413 63122638
Rheumatoid factor positive 1188.28 17.84 1210 146761 83196 63257855
Anti-cyclic citrullinated peptide antibody positive 1093.30 17.84 1350 146621 114862 63226189
Synovitis 1066.71 17.84 1708 146263 185210 63155841
Pericarditis 986.62 17.84 1367 146604 130212 63210839
Syringe issue 897.83 17.84 313 147658 2556 63338495
Wound 856.79 17.84 1437 146534 161826 63179225
Infusion related reaction 833.26 17.84 1794 146177 243727 63097324
Hepatic enzyme increased 822.05 17.84 1593 146378 200735 63140316
Hand deformity 814.78 17.84 1387 146584 158070 63182981
Off label use 781.45 17.84 3368 144603 671094 62669957
Discomfort 762.08 17.84 1384 146587 165990 63175061
Glossodynia 735.70 17.84 1416 146555 177460 63163591
Drug ineffective 731.01 17.84 4528 143443 1040237 62300814
Treatment failure 709.07 17.84 1484 146487 197559 63143492
Pemphigus 693.47 17.84 1403 146568 182323 63158728
Systemic lupus erythematosus 672.45 17.84 1495 146476 207423 63133628
Rheumatic fever 648.30 17.84 641 147330 42470 63298581
Drug intolerance 611.65 17.84 1840 146131 306821 63034230
Arthropathy 580.21 17.84 1517 146454 233275 63107776
Helicobacter infection 568.59 17.84 877 147094 91908 63249143
Therapeutic product effect decreased 566.71 17.84 1333 146638 191854 63149197
Duodenal ulcer perforation 556.54 17.84 840 147131 86369 63254682
Swollen joint count increased 554.95 17.84 543 147428 35511 63305540
Toxicity to various agents 530.91 17.84 9 147962 247241 63093810
General physical health deterioration 512.50 17.84 1316 146655 200086 63140965
Psoriatic arthropathy 474.65 17.84 802 147169 90718 63250333
Type 2 diabetes mellitus 472.66 17.84 660 147311 63208 63277843
Alopecia 464.32 17.84 1781 146190 335755 63005296
Blood cholesterol increased 456.16 17.84 800 147171 93232 63247819
Hypotension 437.25 17.84 59 147912 272545 63068506
Acute kidney injury 434.63 17.84 52 147919 263363 63077688
Rheumatoid arthritis 425.27 17.84 1429 146542 252390 63088661
Drug interaction 412.81 17.84 32 147939 229099 63111952
Hypersensitivity 400.30 17.84 1542 146429 291143 63049908
Death 399.11 17.84 187 147784 374194 62966857
Joint swelling 389.82 17.84 1653 146318 326013 63015038
Contraindicated product administered 388.29 17.84 1252 146719 216396 63124655
Abdominal discomfort 384.20 17.84 1622 146349 319263 63021788
Anaemia 368.54 17.84 113 147858 293317 63047734
Exposure during pregnancy 361.39 17.84 983 146988 154564 63186487
Neutropenia 361.33 17.84 10 147961 174995 63166056
Swelling 357.13 17.84 1427 146544 273951 63067100
Dyspnoea 343.33 17.84 638 147333 660675 62680376
Psoriasis 339.34 17.84 674 147297 86283 63254768
Completed suicide 322.71 17.84 3 147968 145670 63195381
Blister 320.27 17.84 839 147132 128975 63212076
Fall 320.14 17.84 267 147704 392067 62948984
Musculoskeletal stiffness 317.40 17.84 1049 146922 183569 63157482
Hip arthroplasty 310.96 17.84 464 147507 47182 63293869
Needle issue 290.07 17.84 220 147751 10156 63330895
Inappropriate schedule of product administration 284.57 17.84 699 147272 103266 63237785
Intestinal resection 269.38 17.84 132 147839 2716 63338335
Somnolence 267.38 17.84 47 147924 178638 63162413
Knee arthroplasty 261.16 17.84 460 147511 53746 63287305
Mobility decreased 253.11 17.84 737 147234 120422 63220629
Adverse drug reaction 253.04 17.84 568 147403 79146 63261905
Injury 247.28 17.84 535 147436 72712 63268339
Condition aggravated 246.54 17.84 1692 146279 400525 62940526
Product storage error 244.64 17.84 233 147738 14723 63326328
Hyponatraemia 240.31 17.84 4 147967 111896 63229155
Thrombocytopenia 236.82 17.84 35 147936 151122 63189929
Constipation 230.85 17.84 118 147853 224825 63116226
Maternal exposure during pregnancy 227.09 17.84 1065 146906 218997 63122054
Disease progression 218.56 17.84 18 147953 122740 63218311
Adverse event 218.44 17.84 485 147486 67074 63273977
White blood cell count decreased 209.36 17.84 36 147935 139068 63201983
Drug tolerance decreased 207.31 17.84 229 147742 17244 63323807
Pancytopenia 202.03 17.84 5 147966 96928 63244123
Liver injury 201.92 17.84 440 147531 60080 63280971
Platelet count decreased 198.75 17.84 20 147951 116102 63224949
Hypokalaemia 197.11 17.84 11 147960 103793 63237258
Therapy non-responder 193.65 17.84 497 147474 75404 63265647
Haemoglobin decreased 193.65 17.84 50 147921 145435 63195616
Cough 193.24 17.84 239 147732 292504 63048547
Lower respiratory tract infection 190.21 17.84 709 147262 131598 63209453
Fibromyalgia 184.30 17.84 506 147465 79914 63261137
Cardiac arrest 181.48 17.84 8 147963 92537 63248514
Oxygen saturation decreased 179.37 17.84 6 147965 88579 63252472
Dehydration 176.23 17.84 92 147879 173262 63167789
Prescribed overdose 175.15 17.84 298 147673 33855 63307196
Tremor 173.05 17.84 47 147924 132192 63208859
Bone erosion 172.94 17.84 210 147761 17507 63323544
Neuropathy peripheral 171.96 17.84 29 147942 113638 63227413
Exostosis 165.13 17.84 206 147765 17656 63323395
Retinitis 163.60 17.84 127 147844 6069 63334982
C-reactive protein abnormal 162.80 17.84 343 147628 45753 63295298
Renal failure 161.30 17.84 38 147933 117614 63223437
Hepatic cirrhosis 160.07 17.84 240 147731 24494 63316557
Joint dislocation 158.32 17.84 207 147764 18593 63322458
Rash 157.22 17.84 1995 145976 558876 62782175
Back pain 149.09 17.84 241 147730 263904 63077147
Bradycardia 148.11 17.84 5 147966 73222 63267829
Atrial fibrillation 147.89 17.84 44 147927 116592 63224459
Intentional product use issue 145.22 17.84 637 147334 127255 63213796
Folliculitis 145.07 17.84 426 147545 69891 63271160
Balance disorder 143.26 17.84 15 147956 84407 63256644
Asthenia 142.08 17.84 441 147530 383163 62957888
Deep vein thrombosis postoperative 141.82 17.84 153 147818 11216 63329835
Pleural effusion 140.50 17.84 24 147947 93186 63247865
Chills 139.75 17.84 45 147926 113333 63227718
Lip dry 139.16 17.84 176 147795 15294 63325757
Enthesopathy 132.96 17.84 130 147841 8484 63332567
Colectomy 132.34 17.84 80 147891 2526 63338525
Facet joint syndrome 131.91 17.84 152 147819 11986 63329065
Respiratory failure 131.76 17.84 37 147934 101821 63239230
Depressed level of consciousness 130.12 17.84 3 147968 62075 63278976
Pyrexia 127.84 17.84 613 147358 469865 62871186
Gastrointestinal haemorrhage 126.62 17.84 19 147952 81157 63259894
Irritable bowel syndrome 124.56 17.84 449 147522 81963 63259088
Live birth 124.04 17.84 218 147753 25412 63315639
Leukopenia 123.10 17.84 17 147954 77273 63263778
X-ray abnormal 122.58 17.84 121 147850 7989 63333062
Coma 121.63 17.84 7 147964 64357 63276694
Hypoxia 121.21 17.84 4 147967 59788 63281263
Blood pressure increased 118.06 17.84 122 147849 161940 63179111
Agitation 114.47 17.84 6 147965 59751 63281300
Cardio-respiratory arrest 111.85 17.84 7 147964 59952 63281099
Lupus-like syndrome 111.46 17.84 157 147814 15138 63325913
Adjustment disorder with depressed mood 111.26 17.84 128 147843 10076 63330975
Overdose 111.22 17.84 65 147906 115013 63226038
Feeling abnormal 110.03 17.84 110 147861 148282 63192769
Peripheral venous disease 110.03 17.84 157 147814 15320 63325731
Nausea 109.95 17.84 1371 146600 853100 62487951
Syncope 109.68 17.84 69 147902 117316 63223735
Loss of consciousness 109.59 17.84 70 147901 118051 63223000
Seizure 109.47 17.84 89 147882 132545 63208506
Cardiac failure 108.76 17.84 36 147935 89106 63251945
Tachycardia 108.28 17.84 71 147900 118085 63222966
Muscle injury 108.24 17.84 367 147604 64978 63276073
Cardiac failure congestive 108.18 17.84 40 147931 92393 63248658
Anal abscess 107.46 17.84 88 147883 4544 63336507
Hypoglycaemia 106.35 17.84 9 147962 60056 63280995
Pulmonary embolism 105.74 17.84 71 147900 116613 63224438
Basal cell carcinoma 105.53 17.84 214 147757 27777 63313274
Blood pressure decreased 104.26 17.84 14 147957 65008 63276043
Hallucination 103.46 17.84 6 147965 54811 63286240
Pustular psoriasis 101.31 17.84 85 147886 4541 63336510
Sepsis 100.92 17.84 125 147846 152998 63188053
Renal impairment 100.47 17.84 40 147931 88315 63252736
Autoimmune disorder 100.37 17.84 159 147812 17018 63324033
Cognitive disorder 99.83 17.84 8 147963 55807 63285244
Therapeutic response decreased 99.67 17.84 343 147628 61182 63279869
Joint range of motion decreased 97.21 17.84 226 147745 32202 63308849
Hyperhidrosis 95.87 17.84 67 147904 107769 63233282
Mucosal inflammation 95.62 17.84 3 147968 46925 63294126
Suicide attempt 95.60 17.84 14 147957 60904 63280147
Diarrhoea 95.22 17.84 1139 146832 714227 62626824
Dyspnoea exertional 94.31 17.84 14 147957 60288 63280763
Foot deformity 93.42 17.84 203 147768 27650 63313401
Epistaxis 92.97 17.84 27 147944 72698 63268353
Red blood cell sedimentation rate increased 92.16 17.84 268 147703 43714 63297337
Weight decreased 90.92 17.84 335 147636 276463 63064588
Red blood cell sedimentation rate 89.78 17.84 81 147890 4773 63336278
Multiple organ dysfunction syndrome 89.16 17.84 13 147958 56739 63284312
Pulmonary fibrosis 88.69 17.84 248 147723 39561 63301490
Dislocation of vertebra 88.61 17.84 105 147866 8530 63332521
Anti-cyclic citrullinated peptide antibody 86.14 17.84 92 147879 6666 63334385
Deep vein thrombosis 85.81 17.84 44 147927 83756 63257295
Tongue disorder 85.23 17.84 114 147857 10466 63330585
Pulmonary oedema 85.21 17.84 13 147958 54860 63286191
Arthralgia 85.07 17.84 1828 146143 567882 62773169
Blood pressure fluctuation 84.65 17.84 6 147965 46311 63294740
Osteoarthritis 84.33 17.84 442 147529 94901 63246150
Heart rate increased 81.87 17.84 60 147911 94178 63246873
Vomiting 81.83 17.84 872 147099 558745 62782306
Productive cough 81.66 17.84 23 147948 63185 63277866
Gastrooesophageal reflux disease 81.65 17.84 62 147909 95577 63245474
Blood parathyroid hormone decreased 81.18 17.84 107 147864 9684 63331367
Heart rate decreased 80.18 17.84 7 147964 45553 63295498
Palpitations 79.75 17.84 87 147884 112683 63228368
Myalgia 79.52 17.84 137 147834 146392 63194659
Rhabdomyolysis 79.44 17.84 6 147965 43945 63297106
Drug level decreased 79.13 17.84 95 147876 7824 63333227
Hypercholesterolaemia 79.11 17.84 162 147809 21172 63319879
Haematocrit decreased 78.46 17.84 3 147968 39337 63301714
Wound infection 76.37 17.84 160 147811 21250 63319801
Interstitial lung disease 75.51 17.84 25 147946 61883 63279168
Inflammation 75.24 17.84 385 147586 81888 63259163
Fluid retention 74.76 17.84 23 147948 59663 63281388
Sleep disorder due to general medical condition, insomnia type 74.26 17.84 279 147692 51938 63289113
Pain in jaw 73.09 17.84 8 147963 43488 63297563
Panniculitis 72.98 17.84 110 147861 11275 63329776
Product use in unapproved indication 71.49 17.84 684 147287 178396 63162655
Granuloma skin 71.19 17.84 93 147878 8344 63332707
Skin haemorrhage 71.17 17.84 102 147869 9992 63331059
Accidental exposure to product 70.41 17.84 180 147791 27225 63313826
Arthritis 70.27 17.84 487 147484 115434 63225617
Grip strength decreased 69.75 17.84 158 147813 22129 63318922
Hyperglycaemia 69.60 17.84 8 147963 41859 63299192
Red blood cell count decreased 69.52 17.84 7 147964 40638 63300413
Blood glucose increased 69.34 17.84 56 147915 83700 63257351
Osteonecrosis of jaw 68.96 17.84 3 147968 35120 63305931
Tenosynovitis 68.91 17.84 119 147852 13676 63327375
Lupus vulgaris 68.41 17.84 77 147894 5917 63335134
Prescribed underdose 68.15 17.84 187 147784 29502 63311549
Encephalopathy 67.79 17.84 6 147965 38614 63302437
Breast cancer stage III 67.51 17.84 101 147870 10285 63330766
Blood bilirubin increased 67.33 17.84 5 147966 37135 63303916
Mental status changes 67.26 17.84 7 147964 39592 63301459
Suicidal ideation 66.60 17.84 31 147940 62390 63278661
Cutaneous T-cell lymphoma 66.58 17.84 41 147930 1339 63339712
Drug reaction with eosinophilia and systemic symptoms 66.07 17.84 3 147968 33833 63307218
Unresponsive to stimuli 66.03 17.84 3 147968 33813 63307238
Neurologic neglect syndrome 65.88 17.84 53 147918 2668 63338383
Chronic kidney disease 65.58 17.84 13 147958 45385 63295666
Injection site pain 65.39 17.84 127 147844 129673 63211378
Disorientation 64.44 17.84 8 147963 39444 63301607
Rectal abscess 64.16 17.84 39 147932 1244 63339807
Carotid artery thrombosis 62.56 17.84 52 147919 2742 63338309
Urinary tract infection 62.15 17.84 362 147609 264322 63076729
Liquid product physical issue 61.87 17.84 37 147934 1145 63339906
Anxiety 61.54 17.84 279 147692 217262 63123789
Dizziness 61.51 17.84 673 147298 429252 62911799
Gastric disorder 61.09 17.84 209 147762 37160 63303891
Laryngitis 60.75 17.84 127 147844 16840 63324211
Drug delivery system malfunction 60.49 17.84 36 147935 1104 63339947
Injection site erythema 60.10 17.84 63 147908 83111 63257940
No adverse event 59.51 17.84 12 147959 41393 63299658
Cardiac disorder 59.43 17.84 22 147949 50794 63290257
Product leakage 59.33 17.84 32 147939 809 63340242
Skin necrosis 59.06 17.84 112 147859 13838 63327213
Joint stiffness 58.94 17.84 223 147748 41646 63299405
Septic shock 58.41 17.84 42 147929 66587 63274464
Disturbance in attention 57.17 17.84 10 147961 38179 63302872
Skin plaque 57.09 17.84 83 147888 8237 63332814
Impaired healing 57.05 17.84 422 147549 102120 63238931
Ileostomy 56.58 17.84 38 147933 1444 63339607
Pneumonia aspiration 56.42 17.84 7 147964 34533 63306518
Restlessness 56.27 17.84 3 147968 29450 63311601
Cholestasis 56.23 17.84 3 147968 29431 63311620
C-reactive protein 56.21 17.84 63 147908 4819 63336232
Femur fracture 56.20 17.84 14 147957 41742 63299309
Urinary incontinence 56.12 17.84 5 147966 32009 63309042
Therapeutic product effect incomplete 55.63 17.84 489 147482 124567 63216484
Orthostatic hypotension 55.16 17.84 9 147962 36151 63304900
Intestinal stenosis 55.07 17.84 49 147922 2835 63338216
Serotonin syndrome 54.55 17.84 3 147968 28679 63312372
Coronary artery disease 54.29 17.84 6 147965 32371 63308680
Tinnitus 54.06 17.84 9 147962 35619 63305432
Acute respiratory failure 53.93 17.84 8 147963 34477 63306574
Anal fistula 53.70 17.84 53 147918 3498 63337553
Lethargy 53.58 17.84 32 147939 55975 63285076
Rash maculo-papular 53.25 17.84 6 147965 31890 63309161
Pulmonary hypertension 52.85 17.84 11 147960 37112 63303939
Respiratory distress 52.81 17.84 8 147963 33943 63307108
Tendonitis 52.65 17.84 131 147840 19484 63321567
Eye pain 52.61 17.84 8 147963 33846 63307205
Melaena 52.54 17.84 5 147966 30360 63310691
Urinary retention 52.40 17.84 5 147966 30296 63310755
Haematoma 52.38 17.84 9 147962 34811 63306240
Lymphocyte count decreased 52.30 17.84 5 147966 30252 63310799
Pneumonitis 51.06 17.84 10 147961 35212 63305839
Ascites 50.46 17.84 16 147955 40712 63300339
Bone pain 49.82 17.84 33 147938 54608 63286443
Blood potassium decreased 49.48 17.84 18 147953 42008 63299043
Hypophagia 49.47 17.84 7 147964 31252 63309799
Apoptotic colonopathy 49.42 17.84 12 147959 19 63341032
Body temperature increased 49.04 17.84 13 147958 37179 63303872
Intentional product misuse 48.86 17.84 42 147929 60875 63280176
Dyskinesia 48.74 17.84 8 147963 31994 63309057
Neck pain 48.42 17.84 54 147917 69264 63271787
Hypervolaemia 48.32 17.84 5 147966 28408 63312643
Oedema peripheral 47.83 17.84 253 147718 189258 63151793
Arrhythmia 47.22 17.84 15 147956 38125 63302926
Fistula 47.20 17.84 86 147885 10307 63330744
Vision blurred 47.11 17.84 89 147882 91835 63249216
Dysgeusia 47.11 17.84 25 147946 46685 63294366
Acute myocardial infarction 46.82 17.84 9 147962 32115 63308936
Plasma cell myeloma 46.49 17.84 13 147958 35892 63305159
Haemoptysis 46.49 17.84 6 147965 28720 63312331
Blood alkaline phosphatase increased 46.36 17.84 21 147950 42946 63298105
Hepatic failure 46.00 17.84 13 147958 35643 63305408
Tooth disorder 45.28 17.84 6 147965 28151 63312900
Frequent bowel movements 45.10 17.84 137 147834 22885 63318166
Device dislocation 45.09 17.84 4 147967 25701 63315350
Alanine aminotransferase abnormal 44.95 17.84 54 147917 4450 63336601
Sinus tachycardia 44.76 17.84 3 147968 24265 63316786
Blood calcium decreased 44.10 17.84 5 147966 26446 63314605
Adjustment disorder 43.60 17.84 45 147926 3133 63337918
Obesity 43.38 17.84 161 147810 29791 63311260
Abscess 43.36 17.84 110 147861 16558 63324493
Blood creatine phosphokinase increased 43.36 17.84 9 147962 30421 63310630
Haematemesis 43.32 17.84 9 147962 30403 63310648
Chest discomfort 43.06 17.84 123 147848 109846 63231205
Injection site swelling 43.01 17.84 29 147942 47543 63293508
Nasal congestion 42.82 17.84 54 147917 65606 63275445
Lower limb fracture 42.73 17.84 139 147832 24082 63316969
Thrombosis 42.49 17.84 53 147918 64702 63276349
Angioedema 42.35 17.84 30 147941 47935 63293116
Hepatic function abnormal 41.91 17.84 17 147954 37125 63303926
Ill-defined disorder 41.85 17.84 330 147641 81425 63259626
Pallor 41.62 17.84 10 147961 30558 63310493
Hypothyroidism 41.28 17.84 24 147947 42608 63298443
Sciatica 41.24 17.84 174 147797 34150 63306901
Latent tuberculosis 41.20 17.84 40 147931 2587 63338464
Erythrodermic psoriasis 41.04 17.84 27 147944 991 63340060
Jaundice 40.96 17.84 9 147962 29242 63311809
Flushing 40.90 17.84 70 147901 75017 63266034
Breast cancer 40.51 17.84 221 147750 48162 63292889
Ejection fraction decreased 40.50 17.84 3 147968 22329 63318722
Myocardial infarction 40.39 17.84 110 147861 99783 63241268
Rheumatoid nodule 40.32 17.84 109 147862 17046 63324005
Abscess intestinal 40.27 17.84 32 147939 1582 63339469
Hot flush 40.15 17.84 36 147935 51123 63289928
Dysphagia 40.14 17.84 92 147879 88493 63252558
Bursitis 40.10 17.84 182 147789 36859 63304192
Squamous cell carcinoma 39.93 17.84 72 147899 8560 63332491
Limb discomfort 39.92 17.84 10 147961 29706 63311345
Accidental overdose 39.90 17.84 4 147967 23305 63317746
Intestinal obstruction 39.77 17.84 160 147811 30739 63310312
Macular degeneration 39.67 17.84 5 147966 24371 63316680
Blood sodium decreased 39.41 17.84 5 147966 24247 63316804
Dry eye 39.40 17.84 23 147948 40738 63300313
Product packaging issue 39.18 17.84 28 147943 1178 63339873
Nervousness 38.68 17.84 12 147959 30967 63310084
Drug level increased 38.66 17.84 4 147967 22732 63318319
Atelectasis 38.63 17.84 3 147968 21480 63319571
Abnormal behaviour 38.51 17.84 3 147968 21423 63319628
Aggression 37.81 17.84 5 147966 23493 63317558
Metastases to bone 37.62 17.84 3 147968 21016 63320035
Fear of injection 37.36 17.84 63 147908 7101 63333950
Hepatocellular injury 37.20 17.84 9 147962 27372 63313679
Dysuria 37.17 17.84 16 147955 33722 63307329
Pyoderma gangrenosum 37.06 17.84 44 147927 3581 63337470
Rash erythematous 36.99 17.84 27 147944 42483 63298568
Hypoaesthesia 36.80 17.84 574 147397 167819 63173232
Generalised tonic-clonic seizure 36.66 17.84 11 147960 29005 63312046
Coagulopathy 36.58 17.84 3 147968 20541 63320510
Pain 36.55 17.84 2091 145880 738537 62602514
Eye disorder 36.09 17.84 5 147966 22680 63318371
Ulcer 35.88 17.84 138 147833 25969 63315082
Pulmonary arterial hypertension 35.86 17.84 5 147966 22572 63318479
Ear infection 35.74 17.84 180 147791 38033 63303018
Withdrawal syndrome 35.38 17.84 3 147968 19994 63321057
Ventricular tachycardia 35.34 17.84 3 147968 19976 63321075
Vertigo 35.28 17.84 53 147918 59834 63281217
Device malfunction 34.73 17.84 106 147865 17751 63323300
Hypoacusis 34.70 17.84 7 147964 24144 63316907
Walking aid user 34.68 17.84 77 147894 10640 63330411
Hypertension 34.64 17.84 874 147097 278429 63062622
Blood creatinine increased 34.57 17.84 98 147873 87746 63253305
Leukocytosis 34.31 17.84 9 147962 25926 63315125
Visual acuity reduced 34.28 17.84 5 147966 21821 63319230
Lichen myxoedematosus 34.21 17.84 9 147962 23 63341028
Feeling cold 34.17 17.84 7 147964 23881 63317170
Injection related reaction 33.94 17.84 22 147949 787 63340264
Unevaluable event 33.77 17.84 42 147929 51344 63289707
Chronic recurrent multifocal osteomyelitis 33.70 17.84 10 147961 45 63341006
Metastases to liver 33.66 17.84 7 147964 23632 63317419
Infection 33.59 17.84 734 147237 228439 63112612
Cholangitis sclerosing 33.58 17.84 29 147942 1612 63339439
Gait inability 33.56 17.84 225 147746 52734 63288317
Depression 33.31 17.84 295 147676 196197 63144854
Swelling face 32.92 17.84 61 147910 63414 63277637
Hepatotoxicity 32.92 17.84 23 147948 37018 63304033
Small intestinal resection 32.81 17.84 18 147953 471 63340580
Ileectomy 32.70 17.84 13 147958 158 63340893
Poor quality sleep 32.66 17.84 4 147967 19931 63321120
Speech disorder 32.59 17.84 28 147943 40601 63300450
Red blood cell sedimentation rate abnormal 32.33 17.84 4 147967 19778 63321273
Drug resistance 32.23 17.84 7 147964 22926 63318125
Gastritis 32.06 17.84 24 147947 37279 63303772
Pericardial effusion 31.95 17.84 15 147956 30043 63311008
Night sweats 31.91 17.84 209 147762 48605 63292446
Eosinophilia 31.87 17.84 7 147964 22749 63318302
Oropharyngeal pain 31.86 17.84 113 147858 94374 63246677
Swollen tongue 31.74 17.84 21 147950 34779 63306272
Blood potassium increased 31.71 17.84 3 147968 18306 63322745
Cerebral haemorrhage 31.65 17.84 16 147955 30713 63310338
Rib fracture 31.55 17.84 7 147964 22590 63318461
Transient ischaemic attack 31.54 17.84 25 147946 37728 63303323
Personality disorder 31.51 17.84 52 147919 5759 63335292
Sinus congestion 31.07 17.84 103 147868 18020 63323031
Disseminated intravascular coagulation 30.78 17.84 4 147967 19047 63322004
Glaucoma 30.47 17.84 4 147967 18901 63322150
Haemorrhage 30.46 17.84 60 147911 60962 63280089
Upper gastrointestinal haemorrhage 30.36 17.84 4 147967 18848 63322203
Mitral valve incompetence 29.61 17.84 5 147966 19589 63321462
Hiatus hernia 29.53 17.84 7 147964 21587 63319464
Lip swelling 29.36 17.84 18 147953 31045 63310006
Dysphonia 29.16 17.84 41 147930 47573 63293478
Spinal fracture 29.13 17.84 4 147967 18267 63322784
Road traffic accident 29.11 17.84 165 147806 36467 63304584
C-reactive protein increased 28.97 17.84 343 147628 94364 63246687
Nightmare 28.78 17.84 5 147966 19189 63321862
White blood cell count increased 28.58 17.84 43 147928 48518 63292533
Injection site pruritus 28.49 17.84 38 147933 45078 63295973
Chronic obstructive pulmonary disease 28.48 17.84 65 147906 62621 63278430
Electrolyte imbalance 28.47 17.84 6 147965 20070 63320981
Insomnia 28.35 17.84 343 147628 214909 63126142
Blood glucose decreased 28.24 17.84 7 147964 20945 63320106
Diplopia 28.21 17.84 10 147961 23718 63317333
Chest pain 28.11 17.84 345 147626 215614 63125437
Abdominal abscess 27.98 17.84 43 147928 4483 63336568
Hip fracture 27.96 17.84 17 147954 29457 63311594
Dementia 27.96 17.84 5 147966 18789 63322262
Sleep disorder 27.93 17.84 302 147669 81264 63259787
Acute respiratory distress syndrome 27.84 17.84 10 147961 23524 63317527
Dyspepsia 27.77 17.84 362 147609 101834 63239217
Neutropenic sepsis 27.67 17.84 3 147968 16435 63324616
Flank pain 27.61 17.84 3 147968 16407 63324644
Restless legs syndrome 27.41 17.84 5 147966 18526 63322525
Lymphopenia 26.99 17.84 5 147966 18322 63322729
Foot fracture 26.89 17.84 11 147960 23903 63317148
Product substitution issue 26.73 17.84 3 147968 15993 63325058
Ileal stenosis 26.71 17.84 26 147945 1687 63339364
Kidney infection 26.69 17.84 116 147855 23060 63317991
Pollakiuria 26.66 17.84 16 147955 27921 63313130
Faecal calprotectin increased 26.55 17.84 35 147936 3168 63337883
Intervertebral disc protrusion 26.51 17.84 11 147960 23698 63317353
Pneumocystis jirovecii pneumonia 26.27 17.84 4 147967 16910 63324141
Blood pressure diastolic decreased 26.26 17.84 10 147961 22696 63318355
Tubulointerstitial nephritis 26.16 17.84 7 147964 19896 63321155
Underdose 26.15 17.84 130 147841 27326 63313725
Haematuria 26.05 17.84 18 147953 29139 63311912
Vaginal haemorrhage 25.87 17.84 16 147955 27471 63313580
Head injury 25.72 17.84 16 147955 27380 63313671
Gastric ulcer 25.54 17.84 12 147959 24025 63317026
Infected dermal cyst 25.44 17.84 15 147956 452 63340599
Cerebral infarction 25.28 17.84 12 147959 23881 63317170
Transfusion 25.06 17.84 3 147968 15214 63325837
Osteonecrosis 24.92 17.84 13 147958 24517 63316534
Osteoporosis 24.85 17.84 223 147748 57115 63283936
Migraine 24.79 17.84 358 147613 102988 63238063
Bronchiectasis 24.66 17.84 4 147967 16138 63324913
Nasopharyngitis 24.62 17.84 771 147200 253486 63087565
Neuralgia 24.53 17.84 15 147956 25911 63315140
Musculoskeletal discomfort 24.22 17.84 6 147965 17961 63323090
Loss of personal independence in daily activities 24.12 17.84 339 147632 96951 63244100
Myoclonus 24.09 17.84 4 147967 15864 63325187
Product administration error 24.08 17.84 11 147960 22386 63318665
Lacrimation increased 24.01 17.84 9 147962 20622 63320429
Bone density decreased 23.77 17.84 3 147968 14609 63326442
Mastitis 23.76 17.84 30 147941 2602 63338449
Fracture 23.72 17.84 8 147963 19576 63321475
Cardiac murmur 23.64 17.84 3 147968 14549 63326502
Eye irritation 23.30 17.84 11 147960 21960 63319091
Plasmablastic lymphoma 23.19 17.84 11 147960 210 63340841
Sacroiliitis 23.09 17.84 33 147938 3224 63337827
Surgery 23.01 17.84 153 147818 35759 63305292
Bacteraemia 22.99 17.84 6 147965 17342 63323709
Small intestine operation 22.99 17.84 7 147964 35 63341016
Toothache 22.98 17.84 8 147963 19191 63321860
Premature delivery 22.94 17.84 22 147949 30259 63310792
Mental impairment 22.79 17.84 3 147968 14148 63326903
Mouth ulceration 22.70 17.84 26 147945 32958 63308093
Heart rate irregular 22.61 17.84 12 147959 22409 63318642
Oedema 22.56 17.84 336 147635 97286 63243765
Oesophagitis 22.31 17.84 4 147967 15004 63326047
Petechiae 22.25 17.84 3 147968 13894 63327157
Feeling hot 22.24 17.84 53 147918 50301 63290750
Malignant melanoma in situ 22.24 17.84 18 147953 914 63340137
Therapy cessation 22.14 17.84 134 147837 30323 63310728
Cervical dysplasia 21.96 17.84 32 147939 3182 63337869
Injection site mass 21.94 17.84 8 147963 18648 63322403
Anaphylactic shock 21.91 17.84 14 147957 23619 63317432
Body temperature decreased 21.81 17.84 10 147961 20309 63320742
Chromaturia 21.74 17.84 6 147965 16711 63324340
Immunodeficiency 21.69 17.84 10 147961 20244 63320807
Renal disorder 21.62 17.84 27 147944 32947 63308104
Nodule 21.58 17.84 11 147960 21015 63320036
Seasonal allergy 21.44 17.84 11 147960 20939 63320112
Postoperative wound infection 21.39 17.84 65 147906 10860 63330191
Disability 21.26 17.84 92 147879 18255 63322796
Pain in extremity 21.25 17.84 599 147372 330887 63010164
Intestinal operation 21.23 17.84 14 147957 516 63340535
Mood swings 21.17 17.84 8 147963 18240 63322811
Flatulence 21.14 17.84 30 147941 34672 63306379
Pelvic fracture 21.10 17.84 3 147968 13345 63327706
Premature baby 21.05 17.84 11 147960 20724 63320327
Bronchospasm 21.03 17.84 7 147964 17273 63323778
Genital cyst 21.01 17.84 7 147964 49 63341002
Skin discolouration 20.84 17.84 35 147936 37793 63303258
Supraventricular tachycardia 20.79 17.84 4 147967 14267 63326784
Ear injury 20.75 17.84 10 147961 198 63340853
Mental disorder 20.62 17.84 18 147953 25901 63315150
Adrenal insufficiency 20.54 17.84 8 147963 17907 63323144
Drug level below therapeutic 20.51 17.84 39 147932 4827 63336224
Device defective 20.37 17.84 24 147947 1938 63339113
Progressive multifocal leukoencephalopathy 20.30 17.84 3 147968 12968 63328083
Pancreatitis acute 20.27 17.84 20 147951 27146 63313905
Abdominal pain lower 20.23 17.84 18 147953 25660 63315391
Presyncope 20.12 17.84 21 147950 27764 63313287
Infected fistula 20.01 17.84 10 147961 215 63340836
Diabetes mellitus 20.00 17.84 65 147906 55745 63285306
Generalised oedema 19.98 17.84 6 147965 15812 63325239
Cardiomegaly 19.97 17.84 8 147963 17606 63323445
Anaplastic large-cell lymphoma 19.92 17.84 8 147963 100 63340951
Blindness 19.92 17.84 13 147958 21686 63319365
Fear 19.88 17.84 6 147965 15760 63325291
Drug-induced liver injury 19.83 17.84 161 147810 40061 63300990
Muscle spasms 19.73 17.84 251 147720 155899 63185152
Hemiplegia 19.71 17.84 57 147914 9266 63331785
Urticaria 19.69 17.84 516 147455 165286 63175765
Proteinuria 19.67 17.84 10 147961 19135 63321916
Tooth abscess 19.65 17.84 78 147893 14891 63326160
Enteropathic spondylitis 19.54 17.84 6 147965 31 63341020
Retching 19.53 17.84 5 147966 14640 63326411
Inflammatory bowel disease 19.49 17.84 34 147937 3939 63337112
Tonsillitis 19.46 17.84 42 147929 5693 63335358
Polyneuropathy 19.42 17.84 5 147966 14584 63326467
Dactylitis 19.31 17.84 27 147944 2585 63338466
Dysstasia 19.00 17.84 13 147958 21153 63319898
Joint effusion 18.94 17.84 8 147963 17052 63323999
Spinal osteoarthritis 18.94 17.84 7 147964 16179 63324872
Loss of therapeutic response 18.86 17.84 14 147957 625 63340426
Musculoskeletal chest pain 18.86 17.84 13 147958 21070 63319981
Throat irritation 18.80 17.84 37 147934 37610 63303441
Proctectomy 18.79 17.84 8 147963 117 63340934
Laboratory test abnormal 18.75 17.84 21 147950 26891 63314160
Insurance issue 18.71 17.84 43 147928 6078 63334973
Sleep disorder due to a general medical condition 18.66 17.84 3 147968 12185 63328866
Panic attack 18.39 17.84 15 147956 22316 63318735
Procedural pain 18.38 17.84 14 147957 21555 63319496
Hyperadrenocorticism 18.35 17.84 11 147960 342 63340709
Seronegative arthritis 18.28 17.84 33 147938 3926 63337125
Sensory loss 18.28 17.84 59 147912 10179 63330872
Stoma site ulcer 18.25 17.84 10 147961 261 63340790
Ocular hyperaemia 18.21 17.84 19 147952 25125 63315926
Bacterial vulvovaginitis 18.21 17.84 15 147956 781 63340270
Guttate psoriasis 18.08 17.84 12 147959 447 63340604
Product dispensing error 18.05 17.84 59 147912 10246 63330805
Depressed mood 17.99 17.84 42 147929 40149 63300902
Intestinal anastomosis 17.99 17.84 12 147959 451 63340600
Bone disorder 17.97 17.84 14 147957 21312 63319739
Wheezing 17.97 17.84 318 147653 95277 63245774
Blood albumin decreased 17.94 17.84 6 147965 14760 63326291
Sleep apnoea syndrome 17.93 17.84 25 147946 29108 63311943
Alanine aminotransferase increased 17.92 17.84 155 147816 103615 63237436
Myocardial ischaemia 17.92 17.84 4 147967 12855 63328196
Drug level abnormal 17.87 17.84 8 147963 133 63340918
Hypoalbuminaemia 17.87 17.84 3 147968 11802 63329249
Multiple allergies 17.86 17.84 5 147966 13797 63327254

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
Product dose omission issue 2847.33 15.30 1839 44741 117872 34792479
Drug ineffective 1316.72 15.30 2240 44340 454511 34455840
Off label use 832.18 15.30 1759 44821 417765 34492586
Product use issue 811.47 15.30 672 45908 62544 34847807
Inappropriate schedule of product administration 637.15 15.30 582 45998 61714 34848637
Syringe issue 577.69 15.30 234 46346 5430 34904921
Psoriasis 557.53 15.30 441 46139 38371 34871980
Psoriatic arthropathy 463.86 15.30 303 46277 19495 34890856
Drug eruption 411.93 15.30 282 46298 19616 34890735
Therapeutic product effect decreased 371.23 15.30 333 46247 34410 34875941
Product storage error 365.59 15.30 190 46390 7932 34902419
Needle issue 285.44 15.30 147 46433 6018 34904333
Hypersensitivity 266.71 15.30 366 46214 60669 34849682
Hepatic function abnormal 243.78 15.30 298 46282 44065 34866286
Intestinal resection 233.96 15.30 88 46492 1661 34908690
Treatment failure 233.17 15.30 299 46281 46398 34863953
Acute kidney injury 225.36 15.30 64 46516 304924 34605427
Drug interaction 225.00 15.30 21 46559 225925 34684426
Basal cell carcinoma 216.95 15.30 192 46388 19466 34890885
Synovitis 212.87 15.30 165 46415 13901 34896450
Toxicity to various agents 209.48 15.30 15 46565 200347 34710004
Latent tuberculosis 202.21 15.30 74 46506 1289 34909062
Urticaria 201.91 15.30 325 46255 62052 34848299
Hypotension 199.81 15.30 29 46551 221620 34688731
Therapeutic response decreased 189.38 15.30 214 46366 29099 34881252
Anal abscess 181.33 15.30 111 46469 6362 34903989
Lower respiratory tract infection 171.27 15.30 211 46369 31426 34878925
Tenosynovitis 163.97 15.30 92 46488 4478 34905873
Stomatitis 163.51 15.30 240 46340 42274 34868077
Arthritis 163.18 15.30 205 46375 31141 34879210
Alanine aminotransferase abnormal 151.10 15.30 88 46492 4600 34905751
Enthesopathy 147.12 15.30 86 46494 4527 34905824
Febrile neutropenia 143.64 15.30 10 46570 136839 34773512
Therapeutic product effect incomplete 142.99 15.30 248 46332 50293 34860058
Squamous cell carcinoma 136.49 15.30 117 46463 11358 34898993
C-reactive protein abnormal 135.76 15.30 104 46476 8606 34901745
Mycobacterium tuberculosis complex test positive 135.65 15.30 55 46525 1277 34909074
Muscle spasms 130.14 15.30 300 46280 74701 34835650
Vein rupture 129.60 15.30 48 46532 866 34909485
Pyrexia 125.56 15.30 156 46424 332857 34577494
Pain in extremity 125.39 15.30 412 46168 126101 34784250
Epistaxis 122.71 15.30 252 46328 57999 34852352
Neutropenia 117.21 15.30 32 46548 156746 34753605
Dyspnoea 112.60 15.30 207 46373 376575 34533776
Anaemia 112.38 15.30 88 46492 233247 34677104
Tongue disorder 111.18 15.30 76 46504 5263 34905088
Drug level decreased 109.98 15.30 88 46492 7758 34902593
Abscess 108.16 15.30 104 46476 11713 34898638
Drug abuse 107.67 15.30 6 46574 99090 34811261
Product leakage 104.31 15.30 36 46544 524 34909827
Death 100.20 15.30 241 46339 397808 34512543
Device deployment issue 100.05 15.30 27 46553 158 34910193
Completed suicide 95.25 15.30 10 46570 98158 34812193
Arthralgia 93.62 15.30 461 46119 169580 34740771
Liquid product physical issue 92.45 15.30 32 46548 470 34909881
Accidental exposure to product 92.22 15.30 99 46481 12703 34897648
Cellulitis 88.72 15.30 209 46371 52742 34857609
Fistula 88.04 15.30 73 46507 6767 34903584
Hyponatraemia 86.84 15.30 6 46574 82685 34827666
Thrombocytopenia 85.73 15.30 51 46529 156196 34754155
Asthenia 85.04 15.30 122 46458 245129 34665222
Tuberculin test positive 81.84 15.30 37 46543 1130 34909221
Therapy non-responder 80.80 15.30 168 46412 38978 34871373
Infusion related reaction 79.90 15.30 201 46379 52856 34857495
Hepatic steatosis 79.89 15.30 110 46470 18252 34892099
Device malfunction 79.34 15.30 83 46497 10338 34900013
Somnolence 78.76 15.30 25 46555 111091 34799260
Surgery 77.51 15.30 95 46485 14062 34896289
Prostate cancer 77.02 15.30 166 46414 39483 34870868
Vomiting 76.53 15.30 133 46447 247488 34662863
Hyperkalaemia 75.98 15.30 4 46576 69385 34840966
Pancytopenia 75.77 15.30 17 46563 95140 34815211
Hepatic cirrhosis 75.75 15.30 104 46476 17210 34893141
Platelet count decreased 74.70 15.30 33 46547 119684 34790667
Disease progression 73.66 15.30 26 46554 108051 34802300
Drug delivery system malfunction 68.69 15.30 24 46556 363 34909988
Tendonitis 68.16 15.30 72 46508 9068 34901283
Respiratory failure 67.62 15.30 30 46550 108542 34801809
Skin plaque 67.34 15.30 53 46527 4561 34905790
Device issue 65.87 15.30 73 46507 9704 34900647
Venous injury 65.60 15.30 22 46558 292 34910059
Headache 65.25 15.30 474 46106 200161 34710190
Bradycardia 65.25 15.30 11 46569 75407 34834944
Infection 64.58 15.30 266 46314 90649 34819702
Erythrodermic psoriasis 64.38 15.30 29 46551 878 34909473
Haemoglobin decreased 64.02 15.30 41 46539 120731 34789620
Frequent bowel movements 63.93 15.30 82 46498 12705 34897646
Rhabdomyolysis 63.47 15.30 8 46572 68155 34842196
Colectomy 62.93 15.30 36 46544 1818 34908533
Tachycardia 62.00 15.30 18 46562 84754 34825597
Confusional state 61.30 15.30 61 46519 144099 34766252
Gastrointestinal infection 60.70 15.30 55 46525 5743 34904608
Pneumonia 60.62 15.30 743 45837 361884 34548467
Skin injury 60.07 15.30 38 46542 2307 34908044
Oedema peripheral 59.09 15.30 44 46536 119768 34790583
Overdose 58.55 15.30 24 46556 91035 34819316
Tooth abscess 58.31 15.30 54 46526 5799 34904552
Renal failure 58.13 15.30 53 46527 130504 34779847
Anal fistula 58.07 15.30 52 46528 5347 34905004
Decreased appetite 57.37 15.30 83 46497 166309 34744042
Hepatic enzyme increased 56.69 15.30 146 46434 38934 34871417
Malignant melanoma 55.53 15.30 61 46519 8029 34902322
Incorrect dose administered 55.34 15.30 148 46432 40367 34869984
Clostridium difficile infection 55.05 15.30 94 46486 18804 34891547
Intestinal stenosis 54.94 15.30 35 46545 2151 34908200
Postoperative wound infection 54.94 15.30 48 46532 4778 34905573
Pneumonia lipoid 54.40 15.30 14 46566 66 34910285
Intestinal obstruction 54.35 15.30 104 46476 22718 34887633
Therapy cessation 54.22 15.30 88 46492 16885 34893466
Constipation 53.74 15.30 62 46518 136920 34773431
Pustular psoriasis 53.33 15.30 31 46549 1614 34908737
Product packaging issue 53.16 15.30 23 46557 631 34909720
Neutrophil count decreased 52.80 15.30 4 46576 51100 34859251
Agitation 52.80 15.30 7 46573 57392 34852959
White blood cell count decreased 52.52 15.30 31 46549 95414 34814937
Localised infection 51.91 15.30 88 46492 17499 34892852
Oxygen saturation decreased 50.87 15.30 6 46574 53812 34856539
Hepatic fibrosis 50.80 15.30 45 46535 4562 34905789
Dehydration 50.79 15.30 59 46521 129910 34780441
Cardiac arrest 50.46 15.30 33 46547 96126 34814225
Rectal abscess 49.94 15.30 28 46552 1360 34908991
Underdose 48.94 15.30 75 46505 13705 34896646
Injection site papule 48.68 15.30 18 46562 323 34910028
Abdominal abscess 48.48 15.30 42 46538 4133 34906218
Red blood cell sedimentation rate 48.36 15.30 26 46554 1162 34909189
Gastrointestinal haemorrhage 48.31 15.30 29 46551 88448 34821903
Hypoxia 47.73 15.30 8 46572 55087 34855264
Insurance issue 47.19 15.30 31 46549 2008 34908343
Chikungunya virus infection 47.15 15.30 11 46569 31 34910320
Granuloma skin 46.56 15.30 26 46554 1253 34909098
Neuropathy peripheral 45.87 15.30 27 46553 83236 34827115
Drug level below therapeutic 45.04 15.30 46 46534 5569 34904782
Pleural effusion 44.14 15.30 27 46553 81519 34828832
Delirium 43.91 15.30 4 46576 43987 34866364
Tremor 43.80 15.30 28 46552 82559 34827792
Arthropathy 41.60 15.30 103 46477 26804 34883547
Intentional overdose 40.95 15.30 5 46575 43669 34866682
International normalised ratio increased 40.71 15.30 7 46573 47320 34863031
Blood parathyroid hormone decreased 40.47 15.30 25 46555 1455 34908896
Anti-cyclic citrullinated peptide antibody positive 40.19 15.30 27 46553 1816 34908535
Depressed level of consciousness 39.94 15.30 5 46575 42836 34867515
Ileostomy 39.44 15.30 19 46561 672 34909679
Muscle swelling 39.36 15.30 16 46564 374 34909977
Inflammation 39.27 15.30 104 46476 28191 34882160
Hypoglycaemia 39.21 15.30 12 46568 54628 34855723
Multiple organ dysfunction syndrome 39.19 15.30 27 46553 76539 34833812
Adenocarcinoma of colon 39.15 15.30 34 46546 3357 34906994
Joint ankylosis 39.09 15.30 25 46555 1547 34908804
Bone cyst 38.68 15.30 25 46555 1575 34908776
Panniculitis 38.27 15.30 27 46553 1967 34908384
Dyspnoea exertional 38.12 15.30 6 46574 43273 34867078
Hypokalaemia 37.97 15.30 15 46565 58199 34852152
Musculoskeletal stiffness 37.48 15.30 142 46438 46538 34863813
Subcutaneous abscess 37.40 15.30 35 46545 3808 34906543
Coma 36.66 15.30 8 46572 45670 34864681
Faecal calprotectin increased 36.65 15.30 29 46551 2515 34907836
Pityriasis rubra pilaris 36.55 15.30 11 46569 100 34910251
Sporotrichosis 36.43 15.30 10 46570 63 34910288
Injection site haemorrhage 35.87 15.30 54 46526 9714 34900637
Abscess intestinal 35.62 15.30 24 46556 1622 34908729
Intestinal operation 35.49 15.30 13 46567 227 34910124
Infected fistula 35.00 15.30 12 46568 171 34910180
Pulmonary oedema 34.91 15.30 10 46570 47519 34862832
Device defective 34.68 15.30 18 46562 748 34909603
Hepatocellular carcinoma 34.19 15.30 46 46534 7463 34902888
Hallucination 34.03 15.30 13 46567 51485 34858866
Guttate psoriasis 34.00 15.30 13 46567 257 34910094
Drug intolerance 33.74 15.30 163 46417 59407 34850944
Cardio-respiratory arrest 33.26 15.30 16 46564 55257 34855094
Dizziness 33.21 15.30 164 46416 218357 34691994
Disability 32.83 15.30 36 46544 4729 34905622
Alcoholic liver disease 32.54 15.30 16 46564 592 34909759
Tuberculosis 32.33 15.30 48 46532 8529 34901822
Post procedural infection 32.27 15.30 36 46544 4820 34905531
Wheezing 31.74 15.30 8 46572 41394 34868957
Atrial fibrillation 31.50 15.30 73 46507 122320 34788031
Hidradenitis 31.44 15.30 19 46561 1063 34909288
Inflammatory bowel disease 31.16 15.30 28 46552 2892 34907459
Aggression 30.92 15.30 7 46573 38957 34871394
Dermatitis exfoliative generalised 30.89 15.30 31 46549 3676 34906675
Haematuria 30.88 15.30 14 46566 50052 34860299
Cutaneous sporotrichosis 30.53 15.30 8 46572 41 34910310
Blood creatinine increased 30.19 15.30 50 46530 94926 34815425
Loss of personal independence in daily activities 30.07 15.30 105 46475 33074 34877277
Mental status changes 29.90 15.30 7 46573 38076 34872275
Abdominal pain 29.71 15.30 341 46239 163277 34747074
Herpes zoster 29.59 15.30 107 46473 34292 34876059
Ileal stenosis 29.56 15.30 20 46560 1361 34908990
Oedema 29.47 15.30 12 46568 45729 34864622
Chills 29.32 15.30 39 46541 81004 34829347
Hand deformity 28.94 15.30 30 46550 3695 34906656
Erysipelas 28.85 15.30 34 46546 4829 34905522
Ankle fracture 28.13 15.30 31 46549 4094 34906257
Prostate infection 28.03 15.30 17 46563 957 34909394
Injection site swelling 28.02 15.30 53 46527 11474 34898877
Cutaneous T-cell lymphoma 27.62 15.30 20 46560 1518 34908833
Infected cyst 27.56 15.30 14 46566 556 34909795
Wrong schedule 27.33 15.30 10 46570 174 34910177
Rheumatoid nodule 27.08 15.30 26 46554 2921 34907430
Pneumonitis 27.05 15.30 6 46574 33872 34876479
Cardiac failure congestive 26.31 15.30 44 46536 83226 34827125
Nasopharyngitis 26.02 15.30 171 46409 69797 34840554
Acne 25.81 15.30 50 46530 11016 34899335
Nephrolithiasis 25.79 15.30 94 46486 30239 34880112
Pneumoretroperitoneum 25.64 15.30 9 46571 138 34910213
Blood pressure increased 25.63 15.30 49 46531 88053 34822298
Suicide attempt 25.63 15.30 10 46570 39106 34871245
Osteolysis 25.63 15.30 26 46554 3122 34907229
Malignant melanoma in situ 25.54 15.30 20 46560 1708 34908643
Blood creatine phosphokinase increased 25.47 15.30 14 46566 44843 34865508
Interferon gamma release assay positive 25.44 15.30 6 46574 18 34910333
Respiratory distress 25.29 15.30 8 46572 35657 34874694
Cognitive disorder 25.22 15.30 4 46576 28689 34881662
Leukopenia 25.11 15.30 28 46552 62828 34847523
Intestinal fistula 25.03 15.30 16 46564 989 34909362
Gastrointestinal inflammation 25.01 15.30 27 46553 3484 34906867
Fall 25.00 15.30 163 46417 202722 34707629
SARS-CoV-2 test positive 24.99 15.30 35 46545 5898 34904453
Dysphagia 24.69 15.30 28 46552 62353 34847998
Cholelithiasis 24.69 15.30 73 46507 21075 34889276
Intentional product use issue 24.61 15.30 26 46554 59790 34850561
Diverticulitis 24.26 15.30 70 46510 19934 34890417
Colitis ulcerative 24.23 15.30 62 46518 16458 34893893
Colon cancer 23.95 15.30 42 46538 8579 34901772
Periumbilical abscess 23.83 15.30 7 46573 58 34910293
Poor quality product administered 23.81 15.30 20 46560 1887 34908464
Loss of therapeutic response 23.77 15.30 13 46567 601 34909750
Laryngeal cancer 23.73 15.30 14 46566 749 34909602
Sacroiliitis 23.58 15.30 18 46562 1480 34908871
Energy increased 23.56 15.30 17 46563 1283 34909068
Neoplasm malignant 23.51 15.30 69 46511 19836 34890515
Coronary artery disease 23.45 15.30 18 46562 48287 34862064
Carbon dioxide abnormal 23.39 15.30 9 46571 181 34910170
Melaena 23.26 15.30 9 46571 35371 34874980
Abscess limb 23.24 15.30 26 46554 3491 34906860
Tonsil cancer 23.22 15.30 16 46564 1122 34909229
Lung neoplasm malignant 23.19 15.30 63 46517 17332 34893019
Small intestinal resection 23.05 15.30 12 46568 502 34909849
Large intestinal stenosis 22.87 15.30 18 46562 1549 34908802
Red blood cell sedimentation rate abnormal 22.81 15.30 26 46554 3563 34906788
Dry mouth 22.80 15.30 6 46574 30159 34880192
Rash maculo-papular 22.79 15.30 5 46575 28446 34881905
Cardiogenic shock 22.75 15.30 4 46576 26614 34883737
Urinary retention 22.61 15.30 10 46570 36278 34874073
Botryomycosis 22.40 15.30 6 46574 34 34910317
Renal impairment 22.25 15.30 59 46521 94454 34815897
Joint swelling 22.04 15.30 146 46434 59744 34850607
Postoperative abscess 22.04 15.30 10 46570 308 34910043
Haematemesis 21.94 15.30 5 46575 27706 34882645
Chronic kidney disease 21.80 15.30 14 46566 41196 34869155
Unresponsive to stimuli 21.78 15.30 5 46575 27564 34882787
Agranulocytosis 21.67 15.30 3 46577 23818 34886533
Kidney infection 21.51 15.30 31 46549 5363 34904988
Renal neoplasm 21.34 15.30 16 46564 1281 34909070
Dysuria 21.30 15.30 5 46575 27147 34883204
Pneumonia aspiration 21.14 15.30 15 46565 41888 34868463
Skin cancer 21.00 15.30 44 46536 10253 34900098
Polydipsia 20.98 15.30 26 46554 3889 34906462
Oral pustule 20.97 15.30 9 46571 242 34910109
Mucous stools 20.87 15.30 18 46562 1760 34908591
Abnormal behaviour 20.81 15.30 4 46576 24965 34885386
Anal fissure 20.64 15.30 27 46553 4263 34906088
Ventricular tachycardia 20.64 15.30 5 46575 26574 34883777
Blood glucose increased 20.39 15.30 36 46544 66682 34843669
Heart rate increased 20.38 15.30 19 46561 46324 34864027
Lymphocyte count decreased 20.23 15.30 3 46577 22619 34887732
Encephalopathy 20.09 15.30 11 46569 35308 34875043
Hypocalcaemia 20.01 15.30 4 46576 24285 34886066
Protein S deficiency 19.79 15.30 7 46573 110 34910241
Thyroid cancer 19.71 15.30 17 46563 1663 34908688
Intentional product misuse 19.70 15.30 19 46561 45592 34864759
Large intestine anastomosis 19.61 15.30 6 46574 58 34910293
Myocardial infarction 19.61 15.30 247 46333 120838 34789513
Skin necrosis 19.58 15.30 31 46549 5822 34904529
Fistula discharge 19.57 15.30 13 46567 858 34909493
Ulcer 19.49 15.30 39 46541 8796 34901555
Restlessness 19.39 15.30 5 46575 25477 34884874
Seizure 19.38 15.30 73 46507 104784 34805567
Contraindication to vaccination 19.35 15.30 5 46575 24 34910327
Cholestasis 19.18 15.30 6 46574 26942 34883409
Bone erosion 18.90 15.30 25 46555 3990 34906361
Guillain-Barre syndrome 18.68 15.30 31 46549 6056 34904295
Cholecystectomy 18.59 15.30 21 46559 2849 34907502
Cardiac failure 18.55 15.30 61 46519 91187 34819164
Onycholysis 18.51 15.30 12 46568 760 34909591
Condition aggravated 18.47 15.30 359 46221 191837 34718514
Circulatory collapse 18.34 15.30 3 46577 21035 34889316
Tubulointerstitial nephritis 18.32 15.30 3 46577 21021 34889330
Alopecia areata 18.14 15.30 8 46572 230 34910121
Haematochezia 18.07 15.30 115 46465 46419 34863932
Carbuncle 18.01 15.30 5 46575 33 34910318
Stoma creation 17.89 15.30 5 46575 34 34910317
Hypophagia 17.73 15.30 5 46575 24017 34886334
Meningitis listeria 17.72 15.30 10 46570 492 34909859
Chest pain 17.61 15.30 98 46482 126664 34783687
Enterocutaneous fistula 17.55 15.30 13 46567 1022 34909329
Therapy change 17.41 15.30 21 46559 3056 34907295
Medical device site fistula 17.29 15.30 5 46575 39 34910312
Accidental overdose 17.27 15.30 3 46577 20137 34890214
COVID-19 17.03 15.30 168 46412 77382 34832969
Upper respiratory tract infection 16.97 15.30 88 46492 32971 34877380
Adrenal cortex necrosis 16.96 15.30 4 46576 12 34910339
Dysarthria 16.83 15.30 13 46567 34769 34875582
Eosinophilia 16.70 15.30 7 46573 26215 34884136
Red blood cell count decreased 16.63 15.30 9 46571 29081 34881270
Cholangiocarcinoma 16.54 15.30 14 46566 1335 34909016
Blood bilirubin increased 16.49 15.30 16 46564 38280 34872071
Gastrointestinal bacterial infection 16.38 15.30 9 46571 420 34909931
Colostomy closure 16.37 15.30 5 46575 48 34910303
Gastrooesophageal reflux disease 16.15 15.30 16 46564 37908 34872443
Ejection fraction decreased 16.11 15.30 3 46577 19151 34891200
Septic shock 16.04 15.30 46 46534 71788 34838563
Anaplastic astrocytoma 15.91 15.30 6 46574 114 34910237
External ear cellulitis 15.88 15.30 4 46576 17 34910334
Proctocolectomy 15.86 15.30 6 46574 115 34910236
Skin ulcer 15.74 15.30 65 46515 22151 34888200
Pertussis 15.72 15.30 7 46573 206 34910145
Transaminases increased 15.61 15.30 74 46506 26749 34883602
Stevens-Johnson syndrome 15.50 15.30 3 46577 18636 34891715
Disorientation 15.32 15.30 13 46567 33175 34877176

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Product dose omission issue 2915.43 14.98 2865 141700 244672 79355151
Product use issue 1949.53 14.98 2141 142424 207681 79392142
Off label use 1230.12 14.98 4012 140553 903203 78696620
Syringe issue 988.42 14.98 387 144178 5911 79593912
Synovitis 971.80 14.98 1279 143286 149455 79450368
Drug ineffective 920.02 14.98 4123 140442 1076790 78523033
Psoriatic arthropathy 812.34 14.98 847 143718 77152 79522671
Rheumatoid factor positive 804.23 14.98 747 143818 59092 79540731
Anti-cyclic citrullinated peptide antibody positive 767.53 14.98 847 143718 82296 79517527
Pericarditis 738.15 14.98 927 143638 103309 79496514
Psoriasis 727.55 14.98 854 143711 88733 79511090
Treatment failure 724.71 14.98 1189 143376 169297 79430526
Inappropriate schedule of product administration 703.72 14.98 1029 143536 132599 79467224
Hand deformity 692.94 14.98 897 143668 103022 79496801
Wound 692.11 14.98 949 143616 115230 79484593
Pemphigus 691.42 14.98 877 143688 98705 79501118
Toxicity to various agents 669.63 14.98 21 144544 421519 79178304
Systemic lupus erythematosus 668.67 14.98 954 143611 120195 79479628
Glossodynia 662.64 14.98 875 143690 102462 79497361
Infusion related reaction 651.57 14.98 1347 143218 228890 79370933
Acute kidney injury 626.61 14.98 97 144468 519307 79080516
Therapeutic product effect decreased 600.32 14.98 1070 143495 162793 79437030
Drug interaction 582.64 14.98 45 144520 415138 79184685
Arthropathy 567.84 14.98 1092 143473 176019 79423804
Hepatic enzyme increased 557.61 14.98 1103 143462 181507 79418316
Discomfort 552.39 14.98 890 143675 124727 79475096
Hypotension 545.32 14.98 76 144489 440241 79159582
Hypersensitivity 530.77 14.98 1344 143221 260895 79338928
Drug intolerance 474.60 14.98 1295 143270 262824 79336999
Duodenal ulcer perforation 465.52 14.98 587 143978 65624 79534199
Rheumatic fever 458.20 14.98 394 144171 28131 79571692
Helicobacter infection 447.82 14.98 591 143974 69113 79530710
Intestinal resection 442.69 14.98 188 144377 3569 79596254
Alopecia 441.41 14.98 1160 143405 230195 79369628
Neutropenia 412.53 14.98 28 144537 287682 79312141
Completed suicide 398.23 14.98 10 144555 245757 79354066
Needle issue 384.35 14.98 259 144306 12809 79587014
Anaemia 378.14 14.98 167 144398 444848 79154975
Death 376.01 14.98 287 144278 566227 79033596
Febrile neutropenia 364.71 14.98 12 144553 230987 79368836
Swollen joint count increased 360.76 14.98 313 144252 22614 79577209
Contraindicated product administered 355.05 14.98 842 143723 156696 79443127
Rheumatoid arthritis 353.31 14.98 1001 143564 207469 79392354
Abdominal discomfort 347.01 14.98 1121 143444 249606 79350217
Dyspnoea 343.63 14.98 646 143919 856379 78743444
Product storage error 342.74 14.98 263 144302 15963 79583860
Thrombocytopenia 327.57 14.98 46 144519 265213 79334610
Joint swelling 324.18 14.98 1204 143361 287442 79312381
Blister 319.91 14.98 684 143881 118792 79481031
Exposure during pregnancy 313.31 14.98 615 143950 100517 79499306
Type 2 diabetes mellitus 301.94 14.98 441 144124 56681 79543142
Musculoskeletal stiffness 295.12 14.98 839 143726 174169 79425654
Hyponatraemia 288.95 14.98 7 144558 177841 79421982
Drug eruption 287.50 14.98 376 144189 43559 79556264
C-reactive protein abnormal 284.54 14.98 393 144172 47974 79551849
Hip arthroplasty 281.96 14.98 336 144229 35420 79564403
Basal cell carcinoma 281.30 14.98 343 144222 37032 79562791
Swelling 276.61 14.98 943 143622 215768 79384055
Blood cholesterol increased 276.31 14.98 523 144042 83197 79516626
Drug abuse 269.84 14.98 5 144560 162686 79437137
Enthesopathy 262.53 14.98 196 144369 11412 79588411
Lower respiratory tract infection 261.65 14.98 663 143902 128557 79471266
Somnolence 253.13 14.98 61 144504 238920 79360903
General physical health deterioration 244.08 14.98 1067 143498 274171 79325652
Mobility decreased 237.15 14.98 617 143948 121558 79478265
Maternal exposure during pregnancy 236.38 14.98 661 143904 135877 79463946
Platelet count decreased 232.80 14.98 37 144528 194627 79405196
Pancytopenia 232.08 14.98 18 144547 165727 79434096
Anal abscess 229.71 14.98 166 144399 9189 79590634
Knee arthroplasty 225.79 14.98 332 144233 42916 79556907
Disease progression 222.83 14.98 34 144531 184328 79415495
Fibromyalgia 218.57 14.98 407 144158 63933 79535890
White blood cell count decreased 207.50 14.98 44 144521 188244 79411579
Therapy non-responder 206.31 14.98 492 144073 91813 79508010
Haemoglobin decreased 205.39 14.98 73 144492 222046 79377777
Tenosynovitis 200.77 14.98 190 144375 15364 79584459
Cardiac arrest 200.69 14.98 35 144530 172061 79427762
Injury 196.30 14.98 434 144131 77062 79522761
Adverse event 194.73 14.98 373 144192 59841 79539982
Bradycardia 194.72 14.98 13 144552 135544 79464279
Adverse drug reaction 193.85 14.98 394 144171 65998 79533825
Oxygen saturation decreased 192.59 14.98 10 144555 129037 79470786
Liver injury 192.14 14.98 358 144207 56256 79543567
Arthritis 191.81 14.98 549 144016 114331 79485492
Hepatic cirrhosis 189.53 14.98 273 144292 34633 79565190
Fall 189.19 14.98 374 144191 487255 79112568
Constipation 189.18 14.98 142 144423 282908 79316915
Hypokalaemia 184.90 14.98 22 144543 144018 79455805
Irritable bowel syndrome 184.85 14.98 372 144193 61869 79537954
Hyperkalaemia 183.90 14.98 5 144560 114393 79485430
Tongue disorder 182.84 14.98 172 144393 13803 79586020
Folliculitis 182.72 14.98 346 144219 55034 79544789
Renal failure 180.82 14.98 69 144496 200899 79398924
Urticaria 179.55 14.98 738 143827 184463 79415360
Alanine aminotransferase abnormal 176.98 14.98 139 144426 8728 79591095
Deep vein thrombosis postoperative 169.55 14.98 147 144418 10605 79589218
Respiratory failure 166.30 14.98 60 144505 180851 79418972
Dehydration 163.92 14.98 126 144439 248061 79351762
Lip dry 163.13 14.98 169 144396 15249 79584574
Intentional overdose 162.02 14.98 7 144558 105953 79493870
Neuropathy peripheral 159.87 14.98 31 144534 141274 79458549
Gastrointestinal haemorrhage 159.74 14.98 36 144529 147683 79452140
Colectomy 158.13 14.98 90 144475 3284 79596539
Pyrexia 157.96 14.98 664 143901 678045 78921778
Facet joint syndrome 157.33 14.98 144 144421 11158 79588665
Hypoxia 157.27 14.98 7 144558 103236 79496587
Retinitis 156.80 14.98 108 144457 5535 79594288
Tremor 155.33 14.98 57 144508 170026 79429797
Overdose 154.81 14.98 70 144495 184136 79415687
Prescribed overdose 152.28 14.98 258 144307 37625 79562198
Pleural effusion 148.13 14.98 40 144525 145222 79454601
Rhabdomyolysis 147.79 14.98 10 144555 103121 79496702
Neutrophil count decreased 147.79 14.98 5 144560 93954 79505869
Agitation 144.87 14.98 9 144556 99706 79500117
Stomatitis 144.72 14.98 588 143977 146169 79453654
Atrial fibrillation 143.16 14.98 91 144474 197795 79402028
Bone erosion 142.80 14.98 169 144396 17678 79582145
Muscle injury 142.71 14.98 289 144276 48272 79551551
Depressed level of consciousness 142.62 14.98 8 144557 96644 79503179
Coma 140.67 14.98 11 144554 100638 79499185
Arthralgia 140.64 14.98 1619 142946 570184 79029639
Exostosis 138.82 14.98 162 144403 16696 79583127
Tachycardia 138.14 14.98 75 144490 177693 79422130
Therapeutic product effect incomplete 136.88 14.98 564 144001 141081 79458742
Latent tuberculosis 134.86 14.98 81 144484 3272 79596551
Cardio-respiratory arrest 133.41 14.98 19 144546 108491 79491332
Therapeutic response decreased 133.12 14.98 341 144224 66512 79533311
International normalised ratio increased 131.54 14.98 5 144560 84716 79515107
Inflammation 130.15 14.98 420 144145 93333 79506490
Red blood cell sedimentation rate 128.15 14.98 95 144470 5470 79594353
Hypoglycaemia 126.77 14.98 17 144548 101577 79498246
Leukopenia 126.76 14.98 28 144537 116485 79483338
Accidental exposure to product 125.47 14.98 213 144352 31109 79568714
Chills 125.38 14.98 67 144498 160167 79439656
Squamous cell carcinoma 125.11 14.98 148 144417 15474 79584349
Vomiting 123.28 14.98 706 143859 665122 78934701
Drug delivery system malfunction 122.94 14.98 47 144518 670 79599153
Autoimmune disorder 122.62 14.98 151 144414 16461 79583362
Multiple organ dysfunction syndrome 120.93 14.98 34 144531 120212 79479611
Lupus-like syndrome 120.56 14.98 137 144428 13720 79586103
Asthenia 120.49 14.98 498 144067 511191 79088632
Live birth 120.39 14.98 159 144406 18585 79581238
Tendonitis 120.15 14.98 180 144385 23650 79576173
Peripheral venous disease 119.67 14.98 146 144419 15763 79584060
Infection 119.61 14.98 799 143766 240913 79358910
Blood parathyroid hormone decreased 117.84 14.98 119 144446 10417 79589406
Joint dislocation 115.51 14.98 148 144417 16791 79583032
Adjustment disorder with depressed mood 115.38 14.98 110 144455 8976 79590847
Sepsis 113.77 14.98 196 144369 269232 79330591
Joint range of motion decreased 113.57 14.98 211 144354 33071 79566752
Osteoarthritis 113.02 14.98 382 144183 86927 79512896
Renal impairment 112.14 14.98 74 144491 157709 79442114
Panniculitis 110.51 14.98 124 144441 12247 79587576
Dyspnoea exertional 110.01 14.98 14 144551 87059 79512764
Cough 109.85 14.98 322 144243 366467 79233356
Sleep disorder due to general medical condition, insomnia type 108.09 14.98 242 144323 43314 79556509
Granuloma skin 106.99 14.98 106 144459 9068 79590755
Hallucination 105.44 14.98 15 144550 85730 79514093
Cardiac failure congestive 105.03 14.98 64 144501 142338 79457485
Cardiac failure 104.25 14.98 77 144488 154765 79445058
Pustular psoriasis 103.90 14.98 79 144486 4727 79595096
Liquid product physical issue 103.70 14.98 48 144517 1126 79598697
Blood pressure increased 103.43 14.98 139 144426 211221 79388602
Hyperglycaemia 103.22 14.98 6 144559 70329 79529494
Frequent bowel movements 102.97 14.98 189 144376 29350 79570473
Drug reaction with eosinophilia and systemic symptoms 102.53 14.98 3 144562 64241 79535582
Cognitive disorder 102.51 14.98 6 144559 69920 79529903
Drug level decreased 101.63 14.98 128 144437 14274 79585549
Product leakage 99.43 14.98 44 144521 926 79598897
Balance disorder 99.31 14.98 28 144537 98829 79500994
Grip strength decreased 98.77 14.98 157 144408 21712 79578111
Pulmonary oedema 98.47 14.98 20 144545 88234 79511589
Pulmonary embolism 95.56 14.98 102 144463 171552 79428271
Ileostomy 94.65 14.98 51 144514 1669 79598154
Anti-cyclic citrullinated peptide antibody 94.28 14.98 81 144484 5771 79594052
Foot deformity 94.16 14.98 162 144403 23912 79575911
Wound infection 93.26 14.98 161 144404 23830 79575993
Respiratory arrest 90.72 14.98 3 144562 57547 79542276
Abscess 90.50 14.98 155 144410 22796 79577027
Gastric disorder 89.56 14.98 205 144360 37228 79562595
Dislocation of vertebra 88.12 14.98 89 144476 7791 79592032
Suicide attempt 88.07 14.98 21 144544 82911 79516912
Red blood cell sedimentation rate increased 88.01 14.98 231 144334 45711 79554112
Loss of consciousness 87.82 14.98 105 144460 167838 79431985
Seizure 87.59 14.98 129 144436 188705 79411118
Fistula 86.57 14.98 112 144453 12828 79586995
Cutaneous T-cell lymphoma 85.33 14.98 56 144509 2647 79597176
Nasopharyngitis 85.30 14.98 767 143798 253114 79346709
Rash 84.22 14.98 1494 143071 576864 79022959
Rectal abscess 84.16 14.98 51 144514 2094 79597729
Mental status changes 84.02 14.98 11 144554 66948 79532875
Hyperhidrosis 81.04 14.98 93 144472 151399 79448424
X-ray abnormal 80.78 14.98 74 144491 5739 79594084
Encephalopathy 80.10 14.98 13 144552 67384 79532439
Impaired healing 79.93 14.98 343 144222 87312 79512511
Skin plaque 79.83 14.98 98 144467 10647 79589176
Blood pressure fluctuation 79.69 14.98 13 144552 67132 79532691
Skin necrosis 79.15 14.98 128 144437 17959 79581864
Vein rupture 78.83 14.98 48 144517 1988 79597835
Drug tolerance decreased 78.62 14.98 107 144458 12871 79586952
Blood bilirubin increased 78.21 14.98 13 144552 66219 79533604
Syncope 78.06 14.98 128 144437 179321 79420502
Breast cancer stage III 76.88 14.98 92 144473 9734 79590089
Back pain 76.60 14.98 288 144277 303892 79295931
Intentional product misuse 75.59 14.98 39 144526 95126 79504697
Unresponsive to stimuli 75.47 14.98 7 144558 55781 79544042
Hepatic function abnormal 75.28 14.98 297 144268 72810 79527013
Intestinal stenosis 75.24 14.98 59 144506 3695 79596128
Heart rate increased 75.03 14.98 65 144500 120659 79479164
Erythrodermic psoriasis 74.70 14.98 44 144521 1714 79598109
Interstitial lung disease 74.49 14.98 57 144508 112543 79487280
Blood pressure decreased 74.32 14.98 44 144521 99422 79500401
Hypocalcaemia 74.05 14.98 4 144561 49920 79549903
Melaena 74.05 14.98 11 144554 60879 79538944
Red blood cell count decreased 73.25 14.98 9 144556 57504 79542319
Rheumatoid nodule 73.05 14.98 121 144444 17317 79582506
Aggression 72.82 14.98 5 144560 50953 79548870
Neurologic neglect syndrome 72.32 14.98 52 144513 2855 79596968
Blood creatine phosphokinase increased 71.64 14.98 16 144549 66074 79533749
Disorientation 70.50 14.98 14 144551 62762 79537061
Heart rate decreased 70.47 14.98 20 144545 70296 79529527
Carotid artery thrombosis 70.03 14.98 52 144513 3001 79596822
Skin haemorrhage 69.90 14.98 97 144468 11884 79587939
Fluid retention 69.69 14.98 20 144545 69789 79530034
Anal fistula 69.68 14.98 74 144491 6870 79592953
Laryngitis 69.49 14.98 113 144452 15926 79583897
Deep vein thrombosis 69.38 14.98 70 144495 120849 79478974
Orthostatic hypotension 68.64 14.98 10 144555 56154 79543669
Rash maculo-papular 68.50 14.98 10 144555 56068 79543755
Abscess intestinal 67.96 14.98 49 144516 2702 79597121
Chronic kidney disease 67.83 14.98 18 144547 66136 79533687
Sciatica 67.72 14.98 171 144394 33051 79566772
Pneumonitis 67.46 14.98 14 144551 60846 79538977
Urinary retention 67.12 14.98 11 144554 56619 79543204
Condition aggravated 67.12 14.98 1278 143287 499846 79099977
Cholestasis 66.74 14.98 8 144557 52101 79547722
Lymphocyte count decreased 66.54 14.98 5 144560 47284 79552539
C-reactive protein 66.51 14.98 62 144503 4917 79594906
Shock 66.16 14.98 3 144562 43545 79556278
Lower limb fracture 65.64 14.98 136 144429 23079 79576744
Osteonecrosis of jaw 65.59 14.98 3 144562 43223 79556600
Agranulocytosis 65.59 14.98 4 144561 45026 79554797
Respiratory distress 65.54 14.98 13 144552 58326 79541497
Intestinal obstruction 65.45 14.98 199 144366 42821 79557002
Dyskinesia 65.15 14.98 4 144561 44769 79555054
Coronary artery disease 64.92 14.98 19 144546 65455 79534368
Blood glucose increased 64.33 14.98 68 144497 114907 79484916
Altered state of consciousness 63.51 14.98 4 144561 43818 79556005
Restlessness 62.45 14.98 6 144559 46486 79553337
Device malfunction 62.23 14.98 127 144438 21321 79578502
Pneumonia aspiration 61.86 14.98 22 144543 66945 79532878
Septic shock 61.85 14.98 79 144486 122722 79477101
Ear infection 61.79 14.98 169 144396 34263 79565560
Postoperative wound infection 61.23 14.98 95 144470 12866 79586957
Therapy cessation 61.17 14.98 178 144387 37384 79562439
Myelosuppression 60.49 14.98 3 144562 40293 79559530
Intentional product use issue 60.29 14.98 477 144088 151635 79448188
Hepatic failure 60.26 14.98 18 144547 61194 79538629
Cardiogenic shock 60.23 14.98 4 144561 41910 79557913
Mucosal inflammation 59.99 14.98 31 144534 75549 79524274
Haematuria 59.63 14.98 25 144540 68811 79531012
Abdominal abscess 59.53 14.98 69 144496 7058 79592765
Hepatocellular injury 59.28 14.98 8 144557 47585 79552238
Hypoaesthesia 59.25 14.98 540 144025 178812 79421011
Ulcer 58.73 14.98 152 144413 29820 79570003
Product packaging issue 58.08 14.98 33 144532 1200 79598623
Productive cough 58.06 14.98 45 144520 88286 79511537
Disturbance in attention 57.74 14.98 11 144554 50790 79549033
Oedema peripheral 57.73 14.98 248 144317 252040 79347783
Bursitis 57.55 14.98 169 144396 35675 79564148
Ill-defined disorder 57.17 14.98 254 144311 65621 79534202
Ascites 57.05 14.98 33 144532 75529 79524294
Pain in jaw 56.91 14.98 8 144557 46143 79553680
Irritability 56.09 14.98 5 144560 41139 79558684
Hypervolaemia 56.07 14.98 6 144559 42684 79557139
Haemoptysis 55.98 14.98 16 144549 55983 79543840
Haematemesis 55.95 14.98 13 144552 52251 79547572
Gastrooesophageal reflux disease 55.74 14.98 64 144501 104182 79495641
Incorrect dose administered 55.24 14.98 280 144285 76350 79523473
Pain 55.15 14.98 1667 142898 702135 78897688
Full blood count abnormal 54.96 14.98 5 144560 40469 79559354
Hypercholesterolaemia 54.72 14.98 126 144439 22969 79576854
Blood urea increased 54.54 14.98 11 144554 48779 79551044
Night sweats 53.92 14.98 212 144353 51883 79547940
Intestinal operation 53.89 14.98 24 144541 513 79599310
Hypophagia 53.35 14.98 9 144556 45358 79554465
Stevens-Johnson syndrome 52.75 14.98 5 144560 39161 79560662
Weight decreased 52.73 14.98 402 144163 354796 79245027
Blood creatinine increased 52.48 14.98 128 144437 154929 79444894
Ventricular tachycardia 52.34 14.98 7 144558 41928 79557895
Blood alkaline phosphatase increased 52.20 14.98 25 144540 63639 79536184
Insurance issue 52.12 14.98 58 144507 5675 79594148
Fear of injection 52.06 14.98 66 144499 7408 79592415
Jaundice 51.95 14.98 16 144549 53333 79546490
Mycobacterium tuberculosis complex test positive 51.94 14.98 42 144523 2750 79597073
Disability 51.61 14.98 103 144462 17017 79582806
Headache 51.60 14.98 1550 143015 652222 78947601
Joint stiffness 51.37 14.98 177 144388 40653 79559170
Lupus vulgaris 51.25 14.98 45 144520 3301 79596522
Eosinophilia 51.16 14.98 10 144555 45335 79554488
Acute respiratory failure 50.97 14.98 22 144543 59519 79540304
Sleep disorder 50.92 14.98 297 144268 85380 79514443
Angioedema 50.91 14.98 38 144527 75997 79523826
Accidental overdose 50.88 14.98 6 144559 39575 79560248
Device deployment issue 50.81 14.98 44 144521 3168 79596655
Cellulitis 50.58 14.98 355 144210 108705 79491118
Circulatory collapse 50.23 14.98 5 144560 37663 79562160
Diabetic ketoacidosis 49.79 14.98 3 144562 34119 79565704
Sinus tachycardia 48.95 14.98 5 144560 36903 79562920
Suicidal ideation 48.78 14.98 40 144525 76300 79523523
Haematoma 48.46 14.98 17 144548 52178 79547645
Urinary incontinence 48.36 14.98 8 144557 40901 79558922
Dysuria 48.34 14.98 16 144549 50935 79548888
Kidney infection 48.27 14.98 116 144449 21735 79578088
Palpitations 48.18 14.98 98 144467 126512 79473311
Abnormal behaviour 48.14 14.98 5 144560 36416 79563407
Feeling abnormal 48.13 14.98 139 144426 159060 79440763
Ejection fraction decreased 47.69 14.98 4 144561 34573 79565250
Coagulopathy 47.44 14.98 5 144560 36001 79563822
Hypothyroidism 47.06 14.98 18 144547 52374 79547449
Obesity 46.60 14.98 155 144410 34970 79564853
Tubulointerstitial nephritis 46.28 14.98 7 144558 38228 79561595
Leukocytosis 46.14 14.98 11 144554 43444 79556379
Acute myocardial infarction 46.03 14.98 43 144522 76993 79522830
Muscle spasms 46.03 14.98 502 144063 174228 79425595
Toxic epidermal necrolysis 45.95 14.98 12 144553 44569 79555254
Pulmonary hypertension 45.78 14.98 15 144550 48065 79551758
Breast cancer 45.64 14.98 150 144415 33631 79566192
Drug withdrawal syndrome 45.29 14.98 5 144560 34713 79565110
Dizziness 45.17 14.98 677 143888 525764 79074059
Upper gastrointestinal haemorrhage 44.88 14.98 10 144555 41370 79558453
Tooth abscess 44.70 14.98 94 144471 16116 79583707
Sinusitis 44.50 14.98 546 144019 194955 79404868
Drug level increased 44.20 14.98 9 144556 39642 79560181
Road traffic accident 43.82 14.98 176 144389 43488 79556335
Tinnitus 43.70 14.98 13 144552 44320 79555503
Ventricular fibrillation 43.20 14.98 4 144561 31922 79567901
Arrhythmia 43.16 14.98 29 144536 61243 79538580
Eye pain 43.00 14.98 8 144557 37570 79562253
Oral pain 42.98 14.98 4 144561 31794 79568029
Adjustment disorder 42.59 14.98 44 144521 3956 79595867
Cerebral haemorrhage 42.39 14.98 26 144539 57647 79542176
No adverse event 42.38 14.98 8 144557 37184 79562639
Drug resistance 42.31 14.98 12 144553 42201 79557622
Gastrointestinal infection 42.06 14.98 75 144490 11386 79588437
Surgery 42.06 14.98 143 144422 32623 79567200
White blood cell count increased 41.90 14.98 44 144521 74589 79525234
Small intestinal resection 41.40 14.98 24 144541 907 79598916
Generalised tonic-clonic seizure 41.29 14.98 14 144551 43896 79555927
Diarrhoea 41.26 14.98 1249 143316 879240 78720583
Sacroiliitis 41.25 14.98 42 144523 3712 79596111
Sinus congestion 41.16 14.98 103 144462 19793 79580030
Inflammatory bowel disease 41.11 14.98 51 144514 5600 79594223
Blood calcium decreased 40.47 14.98 5 144560 31814 79568009
Blood sodium decreased 40.45 14.98 6 144559 33249 79566574
Acute hepatic failure 40.15 14.98 4 144561 30109 79569714
Malignant melanoma 40.09 14.98 85 144480 14656 79585167
Venous injury 39.23 14.98 22 144543 780 79599043
Intentional self-injury 39.09 14.98 6 144559 32413 79567410
Tuberculin test positive 39.04 14.98 39 144526 3369 79596454
Pallor 39.04 14.98 21 144544 50041 79549782
Dysgeusia 39.03 14.98 28 144537 57149 79542674
C-reactive protein increased 38.86 14.98 381 144184 128646 79471177
Body temperature increased 38.69 14.98 16 144549 44404 79555419
Blood potassium decreased 38.54 14.98 18 144547 46494 79553329
Ileal stenosis 38.24 14.98 33 144532 2365 79597458
Lethargy 38.19 14.98 55 144510 81237 79518586
Personality disorder 37.72 14.98 51 144514 6095 79593728
Clostridium difficile infection 37.35 14.98 165 144400 42520 79557303
Drug level below therapeutic 37.23 14.98 65 144500 9705 79590118
Ileectomy 36.72 14.98 14 144551 198 79599625
Cardiac disorder 36.66 14.98 39 144526 65718 79534105
Drug dependence 36.63 14.98 14 144551 40755 79559068
Atelectasis 36.63 14.98 7 144558 32250 79567573
Visual acuity reduced 36.59 14.98 5 144560 29464 79570359
Infected fistula 36.56 14.98 17 144548 403 79599420
Underdose 36.01 14.98 137 144428 33014 79566809
Haemorrhage 35.98 14.98 69 144496 91049 79508774
Pneumonia lipoid 35.96 14.98 13 144552 157 79599666
Plasmablastic lymphoma 35.81 14.98 18 144547 509 79599314
Nausea 35.75 14.98 1397 143168 955799 78644024
Malignant melanoma in situ 35.61 14.98 32 144533 2420 79597403
Faecal calprotectin increased 35.57 14.98 47 144518 5494 79594329
Loss of personal independence in daily activities 35.46 14.98 312 144253 102268 79497555
Lip swelling 35.20 14.98 15 144550 40896 79558927
Myalgia 35.20 14.98 195 144370 185446 79414377
Pericardial effusion 35.18 14.98 20 144545 46217 79553606
Apoptotic colonopathy 35.13 14.98 12 144553 121 79599702
Mucous stools 35.03 14.98 45 144520 5117 79594706
Postoperative abscess 34.79 14.98 20 144545 744 79599079
Injection site erythema 34.71 14.98 55 144510 78142 79521681
Diplopia 34.50 14.98 9 144556 33457 79566366
Electrolyte imbalance 34.44 14.98 7 144558 30874 79568949
Intestinal fistula 34.13 14.98 25 144540 1413 79598410
Adenocarcinoma of colon 34.04 14.98 46 144519 5495 79594328
Manufacturing product shipping issue 34.02 14.98 11 144554 92 79599731
Thrombosis 33.81 14.98 63 144502 84037 79515786
Dysphagia 33.12 14.98 112 144453 122024 79477799
Neurotoxicity 33.04 14.98 9 144556 32509 79567314
Gait inability 32.93 14.98 201 144364 58716 79541107
Mitral valve incompetence 32.86 14.98 6 144559 28559 79571264
Disseminated intravascular coagulation 32.72 14.98 12 144553 35830 79563993
Dermatitis exfoliative generalised 32.71 14.98 52 144513 7189 79592634
Neutropenic sepsis 32.65 14.98 5 144560 27059 79572764
Tumour lysis syndrome 32.39 14.98 3 144562 23936 79575887
Bone pain 32.27 14.98 32 144533 55710 79544113
Acute respiratory distress syndrome 32.20 14.98 20 144545 44047 79555776
Chikungunya virus infection 32.13 14.98 13 144552 217 79599606
Product dispensing error 32.12 14.98 73 144492 13190 79586633
Loss of therapeutic response 32.09 14.98 20 144545 864 79598959
Poisoning 32.07 14.98 4 144561 25268 79574555
Rheumatoid lung 31.99 14.98 39 144526 4206 79595617
Guttate psoriasis 31.87 14.98 16 144549 451 79599372
Subcutaneous abscess 31.75 14.98 54 144511 7895 79591928
Walking aid user 31.73 14.98 62 144503 10086 79589737
Spondylitis 31.73 14.98 41 144524 4690 79595133
Hepatotoxicity 31.47 14.98 28 144537 51324 79548499
Myoclonus 31.41 14.98 6 144559 27654 79572169
Subdural haematoma 31.38 14.98 9 144556 31425 79568398
Haemorrhage intracranial 31.24 14.98 5 144560 26188 79573635
Feeling cold 31.04 14.98 7 144558 28722 79571101
Pyoderma gangrenosum 31.01 14.98 38 144527 4120 79595703
Cervical dysplasia 30.99 14.98 28 144537 2133 79597690
Product container seal issue 30.89 14.98 10 144555 84 79599739
Nightmare 30.70 14.98 5 144560 25856 79573967
Speech disorder 30.67 14.98 32 144533 54413 79545410
Metastases to bone 30.67 14.98 4 144561 24423 79575400
Adrenal insufficiency 30.66 14.98 7 144558 28480 79571343
Femur fracture 30.45 14.98 16 144549 38636 79561187
Muscle swelling 30.37 14.98 19 144546 826 79598997
Swollen tongue 30.18 14.98 20 144545 42550 79557273
Pregnancy 30.02 14.98 112 144453 26739 79573084
Blood potassium increased 29.94 14.98 8 144557 29267 79570556
Cholangitis sclerosing 29.88 14.98 30 144535 2607 79597216
Incorrect route of product administration 29.79 14.98 134 144431 34795 79565028
Anaphylactic shock 29.72 14.98 14 144551 35982 79563841
Sinus bradycardia 29.70 14.98 5 144560 25242 79574581
Pneumocystis jirovecii pneumonia 29.48 14.98 11 144554 32497 79567326
Injection related reaction 29.19 14.98 20 144545 1016 79598807
Nervousness 29.16 14.98 12 144553 33403 79566420
Product packaging quantity issue 28.78 14.98 22 144543 1327 79598496
Periumbilical abscess 28.75 14.98 9 144556 67 79599756
Device dislocation 28.73 14.98 6 144559 25964 79573859
Pityriasis rubra pilaris 28.50 14.98 10 144555 110 79599713
Chronic recurrent multifocal osteomyelitis 28.41 14.98 9 144556 70 79599753
Lymphopenia 28.28 14.98 10 144555 30547 79569276
Blood albumin decreased 28.09 14.98 5 144560 24238 79575585
Hypoalbuminaemia 27.95 14.98 3 144562 21294 79578529
Lichen myxoedematosus 27.78 14.98 8 144557 43 79599780
Drug hypersensitivity 27.77 14.98 724 143841 298192 79301631
Flushing 27.46 14.98 76 144489 88192 79511631
Hepatic steatosis 27.26 14.98 138 144427 37600 79562223
Cutaneous sporotrichosis 27.18 14.98 8 144557 47 79599776
Bronchopulmonary aspergillosis 27.17 14.98 4 144561 22290 79577533
Skin exfoliation 27.10 14.98 182 144383 54918 79544905
Product use in unapproved indication 27.04 14.98 619 143946 249740 79350083
Hot flush 26.91 14.98 36 144529 54841 79544982
Interferon gamma release assay positive 26.76 14.98 8 144557 50 79599773
Pulmonary arterial hypertension 26.74 14.98 9 144556 28357 79571466
Myopathy 26.72 14.98 3 144562 20560 79579263
Delusion 26.49 14.98 3 144562 20420 79579403
Hyperbilirubinaemia 26.44 14.98 6 144559 24512 79575311
Cytopenia 26.42 14.98 3 144562 20380 79579443
Wrong schedule 26.24 14.98 13 144552 356 79599467
Full blood count decreased 26.19 14.98 8 144557 26811 79573012
Product distribution issue 26.18 14.98 21 144544 1359 79598464
Injection site papule 26.17 14.98 18 144547 920 79598903
Oesophagitis 26.08 14.98 6 144559 24283 79575540
Hypoacusis 26.03 14.98 11 144554 30139 79569684
Gastrointestinal bacterial infection 25.88 14.98 18 144547 937 79598886
Chest pain 25.57 14.98 359 144206 281945 79317878
Device issue 25.41 14.98 107 144458 27001 79572822
Injection site pain 25.36 14.98 135 144430 129703 79470120
Blood glucose decreased 25.30 14.98 8 144557 26226 79573597
Bronchiectasis 25.12 14.98 5 144560 22381 79577442
Granuloma 25.11 14.98 50 144515 8247 79591576
Joint ankylosis 25.07 14.98 25 144540 2155 79597668
Skin ulcer 24.94 14.98 176 144389 53974 79545849
Glioblastoma 24.78 14.98 22 144543 1638 79598185
SARS-CoV-2 test positive 24.60 14.98 61 144504 11655 79588168
Sporotrichosis 24.58 14.98 9 144556 113 79599710
Chromaturia 24.57 14.98 8 144557 25738 79574085
Pollakiuria 24.53 14.98 19 144546 37298 79562525
Presyncope 24.43 14.98 23 144542 41031 79558792
Dermatologic examination abnormal 24.40 14.98 6 144559 15 79599808
Vision blurred 24.25 14.98 104 144461 105794 79494029
Nephropathy toxic 24.12 14.98 4 144561 20415 79579408
Restless legs syndrome 23.59 14.98 4 144561 20088 79579735
Tooth disorder 23.58 14.98 9 144556 26224 79573599
Rales 23.45 14.98 4 144561 19997 79579826
Transfusion 23.44 14.98 5 144560 21325 79578498
Proteinuria 23.41 14.98 15 144550 32487 79567336
Hyperlipidaemia 23.37 14.98 9 144556 26084 79573739
Hypophosphataemia 23.30 14.98 4 144561 19909 79579914
Mastitis 23.14 14.98 24 144541 2167 79597656
Plasma cell myeloma 23.13 14.98 38 144527 53221 79546602
Glaucoma 23.06 14.98 4 144561 19757 79580066
Hidradenitis 23.00 14.98 28 144537 3016 79596807
Unevaluable event 22.91 14.98 41 144524 55544 79544279
Anal stenosis 22.85 14.98 13 144552 474 79599349
Sneezing 22.76 14.98 83 144482 19600 79580223
Bacterial vulvovaginitis 22.75 14.98 14 144551 591 79599232
Purpura 22.68 14.98 4 144561 19523 79580300
Post procedural infection 22.58 14.98 58 144507 11326 79588497
Product administration error 22.52 14.98 15 144550 31831 79567992
Fear 22.50 14.98 6 144559 21980 79577843
Lung neoplasm malignant 22.50 14.98 105 144460 27687 79572136
Small intestine operation 22.26 14.98 7 144558 53 79599770
Hepatocellular carcinoma 22.24 14.98 50 144515 8971 79590852
Anxiety 22.16 14.98 317 144248 248195 79351628
Skin discolouration 22.14 14.98 25 144540 41009 79558814
Aspergillus infection 22.09 14.98 4 144561 19157 79580666
Gastritis 22.02 14.98 33 144532 47960 79551863
Neutrophil count increased 21.96 14.98 13 144552 29383 79570440
Neck pain 21.95 14.98 67 144498 75350 79524473
Anaplastic large-cell lymphoma 21.94 14.98 10 144555 226 79599597
Genital cyst 21.92 14.98 7 144558 56 79599767
Dactylitis 21.88 14.98 26 144539 2731 79597092
Status epilepticus 21.84 14.98 9 144556 25032 79574791
Product substitution issue 21.76 14.98 5 144560 20251 79579572
Blood pressure diastolic decreased 21.68 14.98 14 144551 30202 79569621
Dry eye 21.61 14.98 21 144544 36910 79562913
Generalised oedema 21.54 14.98 8 144557 23701 79576122
Infected dermal cyst 21.47 14.98 18 144547 1240 79598583
Drug tolerance 21.29 14.98 48 144517 8627 79591196
Product label confusion 21.24 14.98 20 144545 1606 79598217
Stoma site abscess 21.24 14.98 10 144555 244 79599579
Device ineffective 21.23 14.98 9 144556 170 79599653
Erysipelas 21.23 14.98 55 144510 10795 79589028
Pneumoretroperitoneum 21.18 14.98 9 144556 171 79599652
Infected cyst 21.07 14.98 18 144547 1272 79598551
Osteoporosis 21.04 14.98 169 144396 53943 79545880
Myocardial ischaemia 20.95 14.98 10 144555 25509 79574314
Alcoholic liver disease 20.66 14.98 13 144552 571 79599252
Mania 20.65 14.98 4 144561 18256 79581567
Cardiomegaly 20.62 14.98 11 144554 26341 79573482
Brain oedema 20.59 14.98 10 144555 25253 79574570
Psychomotor hyperactivity 20.59 14.98 3 144562 16846 79582977
Blindness 20.58 14.98 13 144552 28370 79571453
Body temperature decreased 20.34 14.98 17 144548 32128 79567695
Renal disorder 20.26 14.98 28 144537 42077 79557746
Faeces discoloured 20.22 14.98 14 144551 29113 79570710
Mouth ulceration 20.06 14.98 24 144541 38370 79561453
Bronchospasm 20.02 14.98 10 144555 24849 79574974
Mood altered 20.00 14.98 4 144561 17843 79581980
Haemolytic anaemia 19.95 14.98 4 144561 17816 79582007
Gastrointestinal inflammation 19.94 14.98 43 144522 7501 79592322
Tonsillitis 19.77 14.98 40 144525 6674 79593149
Stoma creation 19.71 14.98 7 144558 80 79599743
Toxic skin eruption 19.46 14.98 8 144557 22285 79577538
Pneumonia 19.26 14.98 1417 143148 658829 78940994
Flank pain 19.23 14.98 6 144559 19838 79579985
Chest discomfort 19.17 14.98 159 144406 137885 79461938
Hepatic encephalopathy 19.04 14.98 10 144555 24156 79575667
Adverse reaction 19.04 14.98 48 144517 9266 79590557
Skin injury 19.01 14.98 27 144538 3379 79596444
Affect lability 18.95 14.98 54 144511 11205 79588618
Seronegative arthritis 18.91 14.98 32 144533 4660 79595163
Nodule 18.89 14.98 9 144556 22985 79576838
Maternal exposure timing unspecified 18.86 14.98 36 144529 5756 79594067
Onychomadesis 18.85 14.98 34 144531 5208 79594615
Swelling face 18.83 14.98 66 144499 71146 79528677
Haemophagocytic lymphohistiocytosis 18.80 14.98 8 144557 21829 79577994
Drug delivery system issue 18.76 14.98 7 144558 93 79599730
Urinary tract infection 18.64 14.98 368 144197 274144 79325679
Large intestine anastomosis 18.49 14.98 7 144558 97 79599726
Cardiomyopathy 18.47 14.98 15 144550 28759 79571064
Device defective 18.45 14.98 20 144545 1900 79597923
Muscle twitching 18.43 14.98 11 144554 24753 79575070
Dysphonia 18.42 14.98 48 144517 56824 79542999
Dermatitis psoriasiform 18.40 14.98 24 144541 2770 79597053
Respiratory tract congestion 18.11 14.98 78 144487 19876 79579947
IgA nephropathy 18.02 14.98 19 144546 1749 79598074
Injection site mass 18.02 14.98 7 144558 20177 79579646
Mental impairment 18.02 14.98 6 144559 19030 79580793
Thrombotic microangiopathy 18.00 14.98 7 144558 20162 79579661
Inflammatory pain 17.98 14.98 15 144550 1026 79598797
Secretion discharge 17.92 14.98 64 144501 14958 79584865
Metastases to liver 17.88 14.98 15 144550 28299 79571524
Cardiac failure acute 17.86 14.98 6 144559 18923 79580900
Shock haemorrhagic 17.84 14.98 7 144558 20053 79579770
Sensory loss 17.83 14.98 58 144507 12933 79586890
Stoma site ulcer 17.73 14.98 9 144556 260 79599563
Metastases to central nervous system 17.67 14.98 4 144561 16371 79583452
Face oedema 17.65 14.98 15 144550 28121 79571702
Pulmonary congestion 17.56 14.98 14 144551 27086 79572737
Defaecation urgency 17.51 14.98 35 144530 5789 79594034
Retching 17.44 14.98 5 144560 17462 79582361
Bone cyst 17.40 14.98 26 144539 3407 79596416
Ventricular extrasystoles 17.32 14.98 7 144558 19697 79580126
Impaired work ability 17.28 14.98 7 144558 19674 79580149
Dysstasia 17.16 14.98 15 144550 27731 79572092
Colostomy 17.13 14.98 15 144550 1096 79598727
Nail psoriasis 17.11 14.98 12 144553 633 79599190
Prostate infection 16.96 14.98 12 144553 642 79599181
Benign laryngeal neoplasm 16.90 14.98 5 144560 30 79599793
Eosinophil count increased 16.89 14.98 5 144560 17100 79582723
Intervertebral disc degeneration 16.75 14.98 4 144561 15781 79584042
Proctectomy 16.74 14.98 8 144557 202 79599621
Pulmonary fibrosis 16.73 14.98 137 144428 43975 79555848
Psychotic disorder 16.65 14.98 31 144534 41371 79558452
Klebsiella infection 16.65 14.98 4 144561 15716 79584107
Platelet count increased 16.61 14.98 10 144555 22396 79577427
Eye disorder 16.59 14.98 11 144554 23401 79576422
Flavivirus infection 16.56 14.98 4 144561 9 79599814
Urine output decreased 16.51 14.98 6 144559 18016 79581807
Heart rate irregular 16.47 14.98 21 144544 32658 79567165
Hemiplegia 16.44 14.98 62 144503 14877 79584946
Sleep disorder due to a general medical condition 16.42 14.98 3 144562 14274 79585549
Neuralgia 16.26 14.98 22 144543 33362 79566461
Poor quality product administered 16.23 14.98 26 144539 3619 79596204
Cytomegalovirus infection 16.22 14.98 33 144532 42611 79557212
Invasive ductal breast carcinoma 16.05 14.98 34 144531 5858 79593965
Blood test abnormal 16.04 14.98 6 144559 17704 79582119
Notalgia paraesthetica 15.94 14.98 3 144562 0 79599823
Lung infiltration 15.92 14.98 11 144554 22901 79576922
Fracture 15.78 14.98 10 144555 21791 79578032
Medical device site fistula 15.77 14.98 5 144560 39 79599784
Myelodysplastic syndrome 15.77 14.98 19 144546 30282 79569541
Hepatitis cholestatic 15.74 14.98 3 144562 13849 79585974
Pleomorphic adenoma 15.74 14.98 4 144561 12 79599811
Diverticulitis 15.50 14.98 139 144426 45797 79554026
Eyelid oedema 15.48 14.98 3 144562 13684 79586139
Hypercalcaemia 15.48 14.98 121 144444 38309 79561514
Abdominal pain lower 15.43 14.98 21 144544 31761 79568062
Sudden death 15.39 14.98 11 144554 22500 79577323
Premature delivery 15.36 14.98 12 144553 23455 79576368
Depression 15.21 14.98 289 144276 216501 79383322
Breath sounds abnormal 15.19 14.98 5 144560 15979 79583844
Proctocolectomy 15.09 14.98 7 144558 165 79599658
Large intestinal stenosis 15.01 14.98 22 144543 2834 79596989
Myositis 15.00 14.98 8 144557 19160 79580663
Polyneuropathy 15 14.98 13 144552 24138 79575685

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AC05 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Interleukin inhibitors
MeSH PA D003879 Dermatologic Agents
FDA MoA N0000192796 Interleukin-12 Antagonists
FDA EPC N0000192797 Interleukin-12 Antagonist
FDA MoA N0000192798 Interleukin-23 Antagonists
FDA EPC N0000192799 Interleukin-23 Antagonist

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

DiseaseRelationSNOMED_IDDOID
Psoriasis indication 9014002 DOID:8893
Psoriasis with arthropathy indication 33339001
Crohn's disease indication 34000006
Ulcerative colitis indication 64766004 DOID:8577
Plaque psoriasis indication 200965009




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Interleukin-12 Cytokine ANTIBODY BINDING DRUG LABEL DRUG LABEL
Interleukin-23 Cytokine ANTIBODY BINDING DRUG LABEL DRUG LABEL

External reference:

IDSource
D09214 KEGG_DRUG
4029348 VUID
N0000180304 NUI
4029348 VANDF
CHEMBL1201835 ChEMBL_ID
6885 IUPHAR_LIGAND_ID
DB05679 DRUGBANK_ID
847083 RXNORM
160966 MMSL
26198 MMSL
d07396 MMSL
013009 NDDF
443465002 SNOMEDCT_US
443644001 SNOMEDCT_US
C1608841 UMLSCUI
D000069549 MESH_DESCRIPTOR_UI
8954 INN_ID
FU77B4U5Z0 UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Stelara HUMAN PRESCRIPTION DRUG LABEL 1 57894-054 SOLUTION 130 mg INTRAVENOUS BLA 34 sections
Stelara HUMAN PRESCRIPTION DRUG LABEL 1 57894-054 SOLUTION 130 mg INTRAVENOUS BLA 34 sections
STELARA HUMAN PRESCRIPTION DRUG LABEL 1 57894-060 INJECTION, SOLUTION 45 mg SUBCUTANEOUS BLA 34 sections
STELARA HUMAN PRESCRIPTION DRUG LABEL 1 57894-060 INJECTION, SOLUTION 45 mg SUBCUTANEOUS BLA 34 sections
STELARA HUMAN PRESCRIPTION DRUG LABEL 1 57894-061 INJECTION, SOLUTION 90 mg SUBCUTANEOUS BLA 34 sections
STELARA HUMAN PRESCRIPTION DRUG LABEL 1 57894-061 INJECTION, SOLUTION 90 mg SUBCUTANEOUS BLA 34 sections