vedolizumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
humanized origin 4982 943609-66-3

Description:

MoleculeDescription

Synonyms:

  • vedolizumab
  • entyvio
  • MLN0002
  • MLN02
  • LDP02
a humanized monoclonal antibody that targets the 4beta7 integrin exclusively, and modulates inflammation in the gastrointestinal tract
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
5.40 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
July 2, 2018 PMDA Takeda Pharmaceutical Company Limited
May 20, 2014 FDA TAKEDA PHARMS USA
May 22, 2014 EMA

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
Off label use 3420.87 13.07 5709 119759 1096543 89406436
Therapeutic reaction time decreased 2826.43 13.07 714 124754 2944 90500035
Haematochezia 2548.92 13.07 1446 124022 69467 90433512
Frequent bowel movements 2456.76 13.07 1310 124158 55625 90447354
Pregnancy 1255.96 13.07 880 124588 61167 90441812
Abdominal pain 1253.62 13.07 2081 123387 393640 90109339
Mucous stools 969.99 13.07 339 125129 4932 90498047
Loss of therapeutic response 930.11 13.07 254 125214 1498 90501481
Defaecation urgency 917.68 13.07 340 125128 5902 90497077
Poor venous access 751.56 13.07 417 125051 19110 90483869
No adverse event 748.37 13.07 674 124794 67308 90435671
Rectal haemorrhage 697.52 13.07 708 124760 82036 90420943
Faecal calprotectin increased 477.41 13.07 187 125281 3800 90499179
Drug level decreased 470.68 13.07 242 125226 9488 90493491
Intestinal obstruction 432.00 13.07 380 125088 36751 90466228
Inappropriate schedule of product administration 417.05 13.07 746 124722 149187 90353792
Clostridium difficile infection 384.25 13.07 352 125116 35893 90467086
Toxicity to various agents 376.72 13.07 4 125464 287842 90215137
Faeces soft 355.20 13.07 184 125284 7327 90495652
Anal fistula 340.01 13.07 150 125318 4151 90498828
Colitis ulcerative 333.02 13.07 414 125054 59852 90443127
Diarrhoea 330.71 13.07 2325 123143 936865 89566114
Colectomy 307.39 13.07 130 125338 3237 90499742
Drug interaction 304.22 13.07 20 125448 276433 90226546
Intestinal stenosis 300.87 13.07 127 125341 3147 90499832
Anal abscess 290.70 13.07 147 125321 5561 90497418
Fistula 262.04 13.07 179 125289 11910 90491069
Gastrointestinal inflammation 246.71 13.07 139 125329 6557 90496422
Proctitis 242.02 13.07 187 125281 15072 90487907
Colitis 240.81 13.07 383 125085 69559 90433420
Ileostomy 235.19 13.07 92 125376 1862 90501117
Acute kidney injury 230.51 13.07 78 125390 320309 90182670
Ileal stenosis 220.66 13.07 94 125374 2384 90500595
Hypotension 219.31 13.07 88 125380 325309 90177670
Neutropenia 216.24 13.07 28 125440 224876 90278103
Anal fissure 212.64 13.07 117 125351 5268 90497711
Female genital tract fistula 200.09 13.07 179 125289 17689 90485290
Febrile neutropenia 199.39 13.07 4 125464 158345 90344634
Adjustment disorder with depressed mood 197.04 13.07 312 125156 56441 90446538
Diarrhoea haemorrhagic 192.02 13.07 141 125327 10522 90492457
Flatulence 189.28 13.07 259 125209 41108 90461871
Dislocation of vertebra 189.25 13.07 304 125164 55664 90447315
General symptom 184.49 13.07 157 125311 14511 90488468
Stress 184.04 13.07 371 125097 81024 90421955
Completed suicide 181.31 13.07 4 125464 145054 90357925
Large intestinal stenosis 165.44 13.07 77 125391 2420 90500559
Overdose 163.33 13.07 15 125453 157694 90345285
Product dose omission issue 163.22 13.07 817 124651 290870 90212109
Dyschezia 158.34 13.07 78 125390 2787 90500192
Subcutaneous drug absorption impaired 158.25 13.07 139 125329 13406 90489573
Vaginal flatulence 152.30 13.07 132 125336 12506 90490473
Contraindicated product administered 148.10 13.07 135 125333 320004 90182975
Abdominal pain lower 147.30 13.07 195 125273 29982 90472997
Back disorder 143.01 13.07 177 125291 25454 90477525
Blood pressure increased 139.60 13.07 592 124876 196625 90306354
Maternal exposure during breast feeding 139.32 13.07 94 125374 6126 90496853
Disease progression 137.96 13.07 25 125443 156590 90346389
Drug specific antibody present 137.25 13.07 89 125379 5425 90497554
Pustular psoriasis 135.17 13.07 147 125321 18409 90484570
Abdominal distension 135.07 13.07 443 125025 130158 90372821
Ileal ulcer 134.71 13.07 52 125416 1014 90501965
Vaginal discharge 134.53 13.07 150 125318 19314 90483665
White blood cell count decreased 132.31 13.07 34 125434 167075 90335904
Rash vesicular 132.28 13.07 144 125324 18053 90484926
Pancytopenia 131.33 13.07 9 125459 120254 90382725
Haemorrhoids 131.03 13.07 173 125295 26529 90476450
Intestinal anastomosis 131.03 13.07 49 125419 873 90502106
Drug effect less than expected 130.93 13.07 90 125378 6048 90496931
Weight decreased 130.72 13.07 937 124531 378973 90124006
Hyponatraemia 129.83 13.07 16 125452 133522 90369457
Anal incontinence 127.80 13.07 134 125334 16096 90486883
Malignant neoplasm progression 126.10 13.07 5 125463 106865 90396114
Rectal discharge 125.64 13.07 47 125421 838 90502141
Platelet count decreased 124.75 13.07 20 125448 136949 90366030
Fall 121.54 13.07 308 125160 481502 90021477
Disability 121.23 13.07 209 125259 40536 90462443
X-ray abnormal 121.01 13.07 222 125246 45202 90457777
Walking aid user 117.48 13.07 191 125277 35315 90467664
Abnormal faeces 117.26 13.07 87 125381 6595 90496384
Intestinal resection 116.68 13.07 64 125404 2863 90500116
Terminal ileitis 116.57 13.07 49 125419 1201 90501778
Rectal tenesmus 116.22 13.07 48 125420 1124 90501855
Maternal exposure during pregnancy 113.46 13.07 203 125265 359860 90143119
Social problem 112.90 13.07 48 125420 1211 90501768
Ileocaecal resection 111.22 13.07 38 125430 514 90502465
Radiculopathy 110.08 13.07 132 125336 18373 90484606
Death 107.45 13.07 302 125166 456249 90046730
Thrombocytopenia 106.40 13.07 80 125388 208645 90294334
Wound infection 105.62 13.07 356 125112 106046 90396933
Large intestinal ulcer 104.37 13.07 66 125402 3851 90499128
Myositis 104.28 13.07 147 125321 23981 90478998
Gastrointestinal wall thickening 102.91 13.07 53 125415 2084 90500895
Dyspnoea 102.44 13.07 757 124711 880198 89622781
Cholangitis sclerosing 100.98 13.07 53 125415 2168 90500811
Constipation 100.11 13.07 698 124770 279697 90223282
Small intestinal resection 99.89 13.07 37 125431 641 90502338
Proctalgia 99.54 13.07 86 125382 8112 90494867
Neuropathy peripheral 95.58 13.07 35 125433 136935 90366044
Malaise 95.13 13.07 1233 124235 584753 89918226
Amnesia 94.74 13.07 348 125120 108157 90394822
Inflammatory bowel disease 92.25 13.07 68 125400 5103 90497876
Small intestinal obstruction 89.74 13.07 128 125340 21106 90481873
Blood creatinine increased 89.68 13.07 16 125452 101370 90401609
Large intestine polyp 89.54 13.07 86 125382 9300 90493679
Lupus-like syndrome 88.95 13.07 204 125264 48642 90454337
Respiratory failure 88.32 13.07 27 125441 118391 90384588
Electrocardiogram QT prolonged 86.82 13.07 3 125465 72453 90430526
Rectal abscess 86.37 13.07 42 125426 1458 90501521
Erythema nodosum 86.11 13.07 68 125400 5656 90497323
Cardiac arrest 85.68 13.07 20 125448 104915 90398064
Delirium 84.72 13.07 327 125141 104032 90398947
Oral candidiasis 84.18 13.07 165 125303 35290 90467689
Abortion spontaneous 82.62 13.07 211 125257 53845 90449134
Bile acid malabsorption 82.40 13.07 26 125442 269 90502710
Intestinal anastomosis complication 82.34 13.07 27 125441 319 90502660
Atrial fibrillation 82.28 13.07 41 125427 133570 90369409
Breast cancer stage II 82.16 13.07 163 125305 35171 90467808
Abscess intestinal 81.98 13.07 44 125424 1884 90501095
Arthritis enteropathic 81.66 13.07 28 125440 383 90502596
Dyspepsia 81.41 13.07 511 124957 197649 90305330
Ileectomy 81.22 13.07 26 125442 283 90502696
Abdominal mass 80.75 13.07 54 125414 3467 90499512
Anti-cyclic citrullinated peptide antibody 80.15 13.07 139 125329 27082 90475897
Aspartate aminotransferase increased 79.46 13.07 22 125446 102915 90400064
Rash 78.78 13.07 714 124754 795386 89707593
Steroid dependence 77.94 13.07 45 125423 2224 90500755
Depressed level of consciousness 77.87 13.07 6 125462 72778 90430201
Product temperature excursion issue 76.27 13.07 33 125435 870 90502109
Drug ineffective 76.00 13.07 2476 122992 1381822 89121157
Pyoderma gangrenosum 75.83 13.07 57 125411 4407 90498572
Leukopenia 75.03 13.07 23 125445 100687 90402292
Neutrophil count decreased 73.52 13.07 7 125461 71525 90431454
Hypercholesterolaemia 72.20 13.07 304 125164 100588 90402391
Stoma site oedema 72.18 13.07 19 125449 95 90502884
Seizure 72.15 13.07 63 125405 152566 90350413
Chronic sinusitis 71.99 13.07 123 125345 23679 90479300
Gastrointestinal infection 71.36 13.07 82 125386 10908 90492071
Suicide attempt 70.97 13.07 10 125458 75389 90427590
Product use issue 70.55 13.07 228 125240 329691 90173288
Enteral nutrition 70.49 13.07 22 125446 219 90502760
Alanine aminotransferase increased 70.37 13.07 38 125430 118300 90384679
Cardiac failure congestive 69.22 13.07 25 125443 98669 90404310
Pain 68.52 13.07 970 124498 995371 89507608
Bradycardia 68.41 13.07 16 125452 83831 90419148
Cardio-respiratory arrest 68.13 13.07 5 125463 63135 90439844
Pouchitis 68.06 13.07 28 125440 649 90502330
Product use in unapproved indication 68.04 13.07 238 125230 335998 90166981
Pregnancy of partner 68 13.07 15 125453 28 90502951
Exposure during pregnancy 67.59 13.07 143 125325 238267 90264712
Hypoxia 67.21 13.07 10 125458 72389 90430590
Hallucination 66.37 13.07 7 125461 65952 90437027
Grip strength decreased 66.29 13.07 279 125189 92297 90410682
Therapy non-responder 66.10 13.07 368 125100 136336 90366643
COVID-19 66.00 13.07 430 125038 168413 90334566
Intentional product misuse 65.79 13.07 21 125447 89583 90413396
Abscess 65.74 13.07 104 125364 18787 90484192
Porphyria acute 65.40 13.07 101 125367 17874 90485105
Intestinal ulcer 64.97 13.07 36 125432 1643 90501336
Dysphagia 63.97 13.07 38 125430 112240 90390739
Mucosal inflammation 63.83 13.07 4 125464 57621 90445358
Agitation 62.91 13.07 9 125459 67089 90435890
Arthralgia 62.75 13.07 1464 124004 777058 89725921
Colostomy 61.51 13.07 32 125436 1285 90501694
Hypokalaemia 60.91 13.07 55 125413 131061 90371918
Swelling 60.33 13.07 337 125131 418721 90084258
Multiple sclerosis relapse 59.88 13.07 3 125465 52302 90450677
Intestinal fistula 59.34 13.07 29 125439 1018 90501961
Intestinal dilatation 59.26 13.07 38 125430 2272 90500707
Tremor 59.18 13.07 75 125393 153098 90349881
Abdominal abscess 58.40 13.07 53 125415 5334 90497645
Hyperkalaemia 58.00 13.07 10 125458 64954 90438025
Lactic acidosis 57.44 13.07 3 125465 50460 90452519
Renal failure 57.30 13.07 58 125410 130949 90372030
Blood iron decreased 57.23 13.07 95 125373 17864 90485115
Gastrointestinal scarring 57.09 13.07 22 125446 427 90502552
Cardiac failure 57.03 13.07 41 125427 109455 90393524
Drug intolerance 56.56 13.07 375 125093 447216 90055763
Joint dislocation 56.09 13.07 162 125306 44420 90458559
Pulmonary fibrosis 55.75 13.07 295 125173 107208 90395771
Myelosuppression 55.73 13.07 5 125463 53586 90449393
Skin exfoliation 55.33 13.07 13 125455 67900 90435079
Gastrointestinal haemorrhage 55.10 13.07 28 125440 90220 90412759
Sedation 54.40 13.07 3 125465 48168 90454811
Paraesthesia oral 54.12 13.07 129 125339 31530 90471449
Infusion site extravasation 53.91 13.07 69 125399 10259 90492720
Somnolence 53.91 13.07 132 125336 208952 90294027
Multiple organ dysfunction syndrome 53.88 13.07 14 125454 68322 90434657
Joint range of motion decreased 53.34 13.07 346 125122 135297 90367682
Hepatitis 52.97 13.07 16 125452 70723 90432256
Stoma closure 52.94 13.07 17 125451 187 90502792
Interstitial lung disease 52.49 13.07 20 125448 76385 90426594
Pleural effusion 51.99 13.07 47 125421 111944 90391035
Faeces hard 51.99 13.07 40 125428 3202 90499777
Faecal volume decreased 51.73 13.07 18 125450 258 90502721
Blood pressure decreased 51.52 13.07 223 125245 74672 90428307
Product distribution issue 51.45 13.07 42 125426 3663 90499316
Suicidal ideation 51.30 13.07 19 125449 73836 90429143
Anastomotic stenosis 51.25 13.07 20 125448 402 90502577
Proctocolectomy 51.05 13.07 14 125454 84 90502895
Gastrointestinal pain 51.00 13.07 70 125398 11136 90491843
Hypoglycaemia 50.17 13.07 17 125451 69831 90433148
Nasopharyngitis 49.46 13.07 815 124653 406289 90096690
Encephalopathy 49.20 13.07 4 125464 46440 90456539
Product storage error 49.02 13.07 95 125373 20146 90482833
Procedural pain 48.69 13.07 128 125340 33232 90469747
Epistaxis 48.22 13.07 29 125439 85096 90417883
Abdominal pain upper 48.09 13.07 686 124782 331988 90170991
Blood glucose increased 47.88 13.07 37 125431 95209 90407770
Gastrointestinal bacterial overgrowth 47.85 13.07 23 125445 778 90502201
Retinitis 47.66 13.07 139 125329 38319 90464660
Heart rate increased 47.49 13.07 293 125175 112609 90390370
Hyperglycaemia 47.41 13.07 7 125461 50963 90452016
Gastrointestinal stoma output increased 47.36 13.07 21 125447 588 90502391
Pancreatitis 47.33 13.07 207 125261 69619 90433360
Dysarthria 47.31 13.07 9 125459 54473 90448506
Gastroenteritis 46.65 13.07 116 125352 29113 90473866
Hepatic cirrhosis 46.35 13.07 192 125276 63061 90439918
Cognitive disorder 46.32 13.07 19 125449 69388 90433591
Femur fracture 46.08 13.07 5 125463 46077 90456902
Illness 46.02 13.07 230 125238 81739 90421240
Renal impairment 45.73 13.07 47 125421 105374 90397605
Injection site discharge 45.17 13.07 27 125441 1424 90501555
Gait inability 45.02 13.07 352 125116 146104 90356875
Enteritis 44.77 13.07 63 125405 10258 90492721
Bowel movement irregularity 44.66 13.07 50 125418 6464 90496515
Product availability issue 44.34 13.07 53 125415 7351 90495628
Mental status changes 44.29 13.07 5 125463 44674 90458305
Cytomegalovirus colitis 44.13 13.07 37 125431 3349 90499630
Therapy interrupted 44.11 13.07 8 125460 50100 90452879
Hepatic function abnormal 43.89 13.07 6 125462 46282 90456697
Seronegative arthritis 43.46 13.07 85 125383 18149 90484830
Stenosis 43.14 13.07 30 125438 2054 90500925
Anal stenosis 42.95 13.07 19 125449 529 90502450
Bone erosion 42.90 13.07 166 125302 52855 90450124
Abdominal adhesions 42.57 13.07 37 125431 3518 90499461
Respiratory distress 42.26 13.07 3 125465 38943 90464036
Injection site pain 42.20 13.07 113 125355 173586 90329393
Plasma cell myeloma 41.94 13.07 4 125464 40824 90462155
Proctitis ulcerative 41.40 13.07 16 125452 313 90502666
Rhabdomyolysis 41.38 13.07 10 125458 51246 90451733
Hypocalcaemia 41.36 13.07 5 125463 42363 90460616
Wrong technique in product usage process 41.08 13.07 24 125444 71547 90431432
Anastomotic ulcer 41.06 13.07 19 125449 589 90502390
Small intestinal stenosis 40.87 13.07 20 125448 704 90502275
Myocardial infarction 40.81 13.07 52 125416 105920 90397059
International normalised ratio increased 40.70 13.07 8 125460 47308 90455671
Angioedema 39.80 13.07 20 125448 64856 90438123
Acute respiratory failure 39.67 13.07 6 125462 42912 90460067
Pulmonary hypertension 39.18 13.07 6 125462 42517 90460462
Unresponsive to stimuli 38.47 13.07 4 125464 38117 90464862
Catheter site injury 38.46 13.07 15 125453 301 90502678
Product quality issue 38.38 13.07 32 125436 79293 90423686
Pseudopolyp 38.22 13.07 16 125452 388 90502591
Appendicitis 37.94 13.07 58 125410 10173 90492806
Colectomy total 37.90 13.07 13 125455 178 90502801
Pus in stool 37.67 13.07 10 125458 52 90502927
Prescribed underdose 37.62 13.07 204 125264 74815 90428164
Transaminases increased 37.28 13.07 4 125464 37188 90465791
Sepsis 37.20 13.07 126 125342 179688 90323291
Faecal calprotectin abnormal 37.13 13.07 13 125455 190 90502789
Large intestine erosion 37.05 13.07 12 125456 136 90502843
Hepatotoxicity 36.90 13.07 9 125459 45833 90457146
Dyskinesia 36.44 13.07 4 125464 36530 90466449
Hypercalcaemia 36.13 13.07 3 125465 34237 90468742
Hyperhidrosis 35.96 13.07 85 125383 136220 90366759
Joint swelling 35.87 13.07 486 124982 502814 90000165
Macular degeneration 35.87 13.07 125 125343 37845 90465134
Coronary artery disease 35.33 13.07 3 125465 33620 90469359
Disorientation 34.85 13.07 9 125459 44105 90458874
Injection site reaction 34.62 13.07 46 125422 92034 90410945
Bacterial vulvovaginitis 34.55 13.07 19 125449 854 90502125
Premature delivery 34.53 13.07 6 125462 38756 90464223
Neck pain 34.29 13.07 66 125402 113897 90389082
Omentoplasty 34.13 13.07 8 125460 22 90502957
Full blood count abnormal 34.10 13.07 5 125463 36592 90466387
Pulmonary oedema 33.98 13.07 22 125446 62058 90440921
Stress at work 33.54 13.07 22 125446 1367 90501612
Injection site extravasation 33.26 13.07 51 125417 8968 90494011
Chronic kidney disease 33.07 13.07 14 125454 50177 90452802
Rash maculo-papular 33.02 13.07 8 125460 40925 90462054
Lower limb fracture 32.89 13.07 216 125252 84797 90418182
Gastrointestinal stoma complication 32.71 13.07 27 125441 2392 90500587
Gastrointestinal mucosa hyperaemia 32.66 13.07 12 125456 203 90502776
Vein rupture 32.27 13.07 23 125445 1638 90501341
Red blood cell count decreased 32.06 13.07 12 125456 46339 90456640
Ear infection 31.84 13.07 185 125283 69590 90433389
Finger deformity 31.82 13.07 4 125464 32893 90470086
Hypervolaemia 31.64 13.07 4 125464 32753 90470226
Dyspnoea exertional 31.61 13.07 32 125436 72256 90430723
Hip arthroplasty 31.56 13.07 197 125271 76011 90426968
Stomal hernia 31.14 13.07 13 125455 313 90502666
Pneumonia aspiration 31.13 13.07 9 125459 40931 90462048
Rectal fissure 31.06 13.07 17 125451 757 90502222
Faecal volume increased 30.68 13.07 11 125457 173 90502806
Loss of consciousness 30.58 13.07 96 125372 140142 90362837
Injection site erythema 30.55 13.07 56 125412 98446 90404533
Stoma site abscess 30.35 13.07 12 125456 250 90502729
Rectal stenosis 30.35 13.07 12 125456 250 90502729
Laryngitis 30.34 13.07 145 125323 50608 90452371
Catarrh 30.31 13.07 22 125446 1612 90501367
Balance disorder 30.28 13.07 55 125413 97025 90405954
Colonic abscess 30.13 13.07 20 125448 1268 90501711
Coeliac disease 30.11 13.07 12 125456 44598 90458381
Device dislocation 30.04 13.07 4 125464 31478 90471501
Bone pain 29.99 13.07 25 125443 61958 90441021
Lymphocyte count decreased 29.99 13.07 6 125462 35044 90467935
Deep vein thrombosis postoperative 29.92 13.07 184 125284 70625 90432354
Stevens-Johnson syndrome 29.85 13.07 3 125465 29373 90473606
Generalised tonic-clonic seizure 29.81 13.07 6 125462 34897 90468082
Anal haemorrhage 29.68 13.07 26 125442 2498 90500481
Uveitis 29.59 13.07 67 125401 15836 90487143
Therapy partial responder 29.58 13.07 82 125386 21961 90481018
Irritable bowel syndrome 29.23 13.07 426 125042 207022 90295957
Rectal cancer metastatic 29.17 13.07 12 125456 278 90502701
Gastrointestinal dysplasia 29.17 13.07 8 125460 48 90502931
Breast cancer female 29.14 13.07 64 125404 14822 90488157
Spondylitis 28.95 13.07 62 125406 14116 90488863
Haematoma 28.93 13.07 9 125459 39039 90463940
Bone marrow failure 28.67 13.07 5 125463 32216 90470763
Drug eruption 28.40 13.07 7 125461 35400 90467579
Gastrointestinal bacterial infection 28.28 13.07 18 125450 1062 90501917
Pneumonitis 28.03 13.07 13 125455 44157 90458822
Septic shock 27.78 13.07 46 125422 84114 90418865
Pain in jaw 27.66 13.07 16 125452 47969 90455010
Chronic obstructive pulmonary disease 27.63 13.07 37 125431 73792 90429187
Short-bowel syndrome 27.51 13.07 15 125453 663 90502316
Pharyngitis streptococcal 27.50 13.07 57 125411 12685 90490294
Anorectal discomfort 27.44 13.07 27 125441 3007 90499972
Drug hypersensitivity 27.09 13.07 465 125003 463144 90039835
Onychomadesis 27.00 13.07 15 125453 45983 90456996
Movement disorder 26.95 13.07 4 125464 29015 90473964
Gastrointestinal obstruction 26.91 13.07 19 125449 1333 90501646
Restlessness 26.89 13.07 8 125460 35712 90467267
Cervix carcinoma stage 0 26.85 13.07 14 125454 565 90502414
Blood urea increased 26.46 13.07 5 125463 30408 90472571
Gastric disorder 26.01 13.07 7 125461 33377 90469602
Mouth ulceration 25.95 13.07 117 125351 39857 90463122
Haemoptysis 25.94 13.07 7 125461 33313 90469666
Joint stiffness 25.89 13.07 191 125277 77851 90425128
Drug specific antibody 25.84 13.07 24 125444 2488 90500491
Blood bilirubin increased 25.77 13.07 14 125454 43456 90459523
Inflammatory marker increased 25.76 13.07 46 125422 9168 90493811
Arthritis 25.75 13.07 349 125119 166966 90336013
Product administered to patient of inappropriate age 25.74 13.07 32 125436 4621 90498358
Gastrointestinal stenosis 25.67 13.07 11 125457 283 90502696
Osteonecrosis of jaw 25.61 13.07 11 125457 39092 90463887
Haematocrit decreased 25.50 13.07 13 125455 41819 90461160
Faeces discoloured 25.41 13.07 76 125392 21244 90481735
Gastrointestinal ulcer 25.40 13.07 25 125443 2786 90500193
Psychotic disorder 25.39 13.07 6 125462 31224 90471755
Fibromyalgia 25.39 13.07 414 125054 205855 90297124
Stoma creation 25.37 13.07 9 125459 137 90502842
Abscess limb 25.28 13.07 36 125432 5926 90497053
Asthma 25.25 13.07 214 125254 241946 90261033
Vascular access site bruising 25.21 13.07 6 125462 18 90502961
Bacillus infection 25.16 13.07 16 125452 943 90502036
Serum ferritin decreased 25.03 13.07 24 125444 2590 90500389
Syncope 24.77 13.07 97 125371 132566 90370413
Granulomatous rosacea 24.51 13.07 6 125462 21 90502958
Burns second degree 24.50 13.07 21 125447 1959 90501020
Agranulocytosis 24.31 13.07 9 125459 34993 90467986
Lupus vulgaris 24.28 13.07 125 125343 44934 90458045
Spinal fusion surgery 24.26 13.07 53 125415 12230 90490749
Acute myocardial infarction 24.19 13.07 9 125459 34881 90468098
Hemiparesis 24.18 13.07 7 125461 31812 90471167
Campylobacter infection 24.05 13.07 17 125451 1195 90501784
Dry skin 23.97 13.07 54 125414 88019 90414960
Onychomycosis 23.72 13.07 11 125457 37365 90465614
Cough 23.55 13.07 364 125104 368598 90134381
Intentional product use issue 22.91 13.07 191 125277 216701 90286278
Arthropathy 22.81 13.07 363 125105 365879 90137100
Epilepsy 22.70 13.07 50 125418 82156 90420823
Hepatocellular injury 22.70 13.07 6 125462 28952 90474027
Intestinal operation 22.58 13.07 13 125455 639 90502340
Food allergy 22.57 13.07 4 125464 25474 90477505
Cryptitis 22.40 13.07 7 125461 70 90502909
Swollen joint count increased 22.35 13.07 244 125224 110962 90392017
Rectal dysplasia 22.34 13.07 4 125464 0 90502979
Dry mouth 22.31 13.07 156 125312 183903 90319076
Vertebral artery occlusion 22.27 13.07 9 125459 199 90502780
Impaired work ability 22.19 13.07 68 125400 19258 90483721
Proteinuria 22.12 13.07 3 125465 23288 90479691
Blood pressure systolic increased 22.08 13.07 29 125439 58316 90444663
Anal skin tags 22.07 13.07 13 125455 667 90502312
Aggression 21.93 13.07 5 125463 26663 90476316
Irritability 21.86 13.07 11 125457 35651 90467328
Decreased appetite 21.86 13.07 679 124789 375861 90127118
Cerebral infarction 21.84 13.07 5 125463 26591 90476388
Blood creatine phosphokinase increased 21.61 13.07 10 125458 34013 90468966
Colon dysplasia 21.52 13.07 8 125460 140 90502839
Angina pectoris 21.27 13.07 14 125454 39146 90463833
Hernia 21.17 13.07 55 125413 14176 90488803
Exostosis 21.16 13.07 136 125332 52998 90449981
Therapy cessation 21.14 13.07 12 125456 36349 90466630
Anastomotic complication 21.06 13.07 10 125458 329 90502650
Obstructive airways disorder 20.97 13.07 5 125463 25864 90477115
Vaginal fistula 20.82 13.07 12 125456 591 90502388
Hyperplastic cholecystopathy 20.72 13.07 8 125460 156 90502823
Infrequent bowel movements 20.68 13.07 17 125451 1497 90501482
Anaplastic large-cell lymphoma 20.67 13.07 7 125461 92 90502887
Cerebral haemorrhage 20.64 13.07 11 125457 34511 90468468
Autoimmune disorder 20.64 13.07 179 125289 76565 90426414
Metastases to bone 20.54 13.07 5 125463 25500 90477479
Swelling face 20.45 13.07 52 125416 81300 90421679
Sinus tachycardia 20.37 13.07 7 125461 28506 90474473
Therapeutic response unexpected 20.36 13.07 3 125465 21877 90481102
Dysphonia 20.34 13.07 35 125433 63049 90439930
Knee arthroplasty 20.32 13.07 190 125278 82992 90419987
Injury 20.31 13.07 385 125083 196964 90306015
Colon operation 20.26 13.07 11 125457 482 90502497
Immunodeficiency 20.23 13.07 18 125450 43216 90459763
Blood alkaline phosphatase increased 20.21 13.07 22 125446 48057 90454922
Visual acuity reduced 20.04 13.07 4 125464 23406 90479573
Dysstasia 20.00 13.07 5 125463 25047 90477932
Intestinal perforation 19.99 13.07 53 125415 13828 90489151
Disseminated intravascular coagulation 19.93 13.07 3 125465 21535 90481444
Oxygen saturation decreased 19.80 13.07 79 125389 107404 90395575
Cardiac disorder 19.80 13.07 30 125438 56842 90446137
Nail disorder 19.76 13.07 32 125436 59035 90443944
Coordination abnormal 19.71 13.07 3 125465 21353 90481626
Cholestasis 19.68 13.07 13 125455 36286 90466693
Cerebrovascular accident 19.61 13.07 96 125372 123437 90379542
Discouragement 19.52 13.07 17 125451 1620 90501359
Cardiac aneurysm 19.38 13.07 14 125454 1018 90501961
Impaired healing 19.24 13.07 442 125026 233757 90269222
Diabetic ketoacidosis 19.24 13.07 5 125463 24402 90478577
Infection parasitic 19.21 13.07 11 125457 535 90502444
Basilar artery occlusion 19.19 13.07 8 125460 192 90502787
Headache 19.08 13.07 1413 124055 861333 89641646
Incontinence 19.05 13.07 51 125417 13384 90489595
Metastases to liver 19.03 13.07 8 125460 28799 90474180
Ileostomy closure 18.99 13.07 9 125459 295 90502684
Blood potassium increased 18.95 13.07 3 125465 20746 90482233
Product prescribing error 18.93 13.07 9 125459 30136 90472843
Acute respiratory distress syndrome 18.90 13.07 8 125460 28678 90474301
Paraesthesia 18.80 13.07 239 125229 250087 90252892
Quality of life decreased 18.78 13.07 47 125421 11842 90491137
Stoma site extravasation 18.71 13.07 9 125459 305 90502674
Product dose omission in error 18.65 13.07 3 125465 20500 90482479
Weight fluctuation 18.64 13.07 65 125403 19684 90483295
Blepharospasm 18.58 13.07 30 125438 55415 90447564
Rheumatoid arthritis 18.58 13.07 372 125096 362242 90140737
Impaired quality of life 18.34 13.07 72 125396 23072 90479907
Gastrointestinal erosion 18.33 13.07 12 125456 743 90502236
Haematuria 18.29 13.07 13 125455 34924 90468055
Hepatic cytolysis 18.27 13.07 10 125458 30906 90472073
Investigation abnormal 18.21 13.07 19 125449 2268 90500711
Taste disorder 18.20 13.07 36 125432 61510 90441469
Dermatitis atopic 18.14 13.07 5 125463 23467 90479512
Osteoporosis 18.12 13.07 209 125259 96322 90406657
Influenza 18.06 13.07 282 125186 138982 90363997
Pruritus 17.99 13.07 592 124876 540933 89962046
B-cell unclassifiable lymphoma high grade 17.95 13.07 4 125464 8 90502971
Coagulopathy 17.93 13.07 5 125463 23284 90479695
Pneumocystis jirovecii pneumonia 17.88 13.07 4 125464 21612 90481367
Mesenteritis 17.85 13.07 9 125459 338 90502641
Skin ulcer 17.83 13.07 26 125442 50049 90452930
Injection site bruising 17.82 13.07 28 125440 52279 90450700
Central obesity 17.73 13.07 15 125453 1375 90501604
Post procedural infection 17.72 13.07 44 125424 11030 90491949
Pericardial effusion 17.64 13.07 15 125453 36818 90466161
Strangulated umbilical hernia 17.63 13.07 4 125464 9 90502970
Vessel puncture site pain 17.63 13.07 4 125464 9 90502970
Oropharyngeal pain 17.61 13.07 240 125228 114947 90388032
Lower respiratory tract infection 17.58 13.07 463 125005 250196 90252783
Small intestine operation 17.57 13.07 5 125463 35 90502944
Infected fistula 17.47 13.07 8 125460 242 90502737
Anal ulcer 17.45 13.07 12 125456 807 90502172
Gastrointestinal polyp 17.44 13.07 7 125461 152 90502827
Atelectasis 17.43 13.07 6 125462 24403 90478576
Pulmonary congestion 17.33 13.07 3 125465 19430 90483549
Aphthous ulcer 17.28 13.07 58 125410 17229 90485750
White coat hypertension 17.21 13.07 13 125455 1012 90501967
Ileocolostomy 17.21 13.07 5 125463 38 90502941
Polyneuropathy 17.21 13.07 3 125465 19338 90483641
Abnormal behaviour 17.15 13.07 5 125463 22623 90480356
Urinary incontinence 17.15 13.07 16 125452 37550 90465429
Asthenia 17.14 13.07 586 124882 533165 89969814
Gastroenteritis eosinophilic 17.10 13.07 7 125461 160 90502819
Respiratory tract infection 17.09 13.07 35 125433 59043 90443936
Myoclonus 17.00 13.07 3 125465 19165 90483814
Spinal osteoarthritis 16.98 13.07 3 125465 19145 90483834
Anal infection 16.81 13.07 6 125462 93 90502886
Anal spasm 16.75 13.07 3 125465 0 90502979
Anal blister 16.75 13.07 3 125465 0 90502979
Contusion 16.75 13.07 461 125007 250755 90252224
Pubic pain 16.75 13.07 7 125461 169 90502810
Nodule 16.71 13.07 8 125460 26678 90476301
Cardiomegaly 16.70 13.07 3 125465 18922 90484057
Live birth 16.65 13.07 55 125413 79052 90423927
Psoriasis 16.51 13.07 292 125176 147462 90355517
Fracture 16.51 13.07 5 125463 22071 90480908
Feeling abnormal 16.44 13.07 150 125318 167085 90335894
Drug resistance 16.38 13.07 11 125457 30438 90472541
Drug level increased 16.37 13.07 9 125459 27753 90475226
Gastrointestinal anastomotic stenosis 16.34 13.07 4 125464 14 90502965
Fistulotomy 16.34 13.07 4 125464 14 90502965
Exposure via breast milk 16.27 13.07 18 125450 2297 90500682
Iron deficiency 16.25 13.07 39 125429 9573 90493406
Drug level below therapeutic 16.22 13.07 29 125439 5785 90497194
Blood sodium decreased 16.21 13.07 9 125459 27604 90475375
Food poisoning 16.21 13.07 27 125441 5091 90497888
Muscle spasticity 16.18 13.07 15 125453 35307 90467672
Urinary retention 16.17 13.07 17 125451 37727 90465252
Blood calcium decreased 16.11 13.07 11 125457 30171 90472808
Rash erythematous 16.07 13.07 42 125426 65062 90437917
Speech disorder 15.91 13.07 24 125444 45561 90457418
Blood lactate dehydrogenase increased 15.89 13.07 8 125460 25924 90477055
Cerebral venous sinus thrombosis 15.88 13.07 18 125450 2358 90500621
Infusion site paraesthesia 15.82 13.07 5 125463 52 90502927
Upper gastrointestinal haemorrhage 15.80 13.07 6 125462 22970 90480009
Skin discolouration 15.79 13.07 23 125445 44292 90458687
Neutropenic sepsis 15.73 13.07 3 125465 18127 90484852
Skin haemorrhage 15.71 13.07 5 125463 21375 90481604
Flushing 15.70 13.07 66 125402 88425 90414554
Muscle injury 15.64 13.07 337 125131 176317 90326662
Enterocolonic fistula 15.57 13.07 5 125463 55 90502924
Red blood cell sedimentation rate abnormal 15.55 13.07 7 125461 24197 90478782
Skin burning sensation 15.49 13.07 4 125464 19607 90483372
Habitual abortion 15.37 13.07 4 125464 19 90502960
Colonic fistula 15.27 13.07 8 125460 326 90502653
Gastrointestinal motility disorder 15.26 13.07 29 125439 6062 90496917
Restless legs syndrome 15.24 13.07 6 125462 22464 90480515
Iron deficiency anaemia 15.17 13.07 69 125399 23593 90479386
Myelodysplastic syndrome 15.16 13.07 5 125463 20898 90482081
Motor dysfunction 15.04 13.07 4 125464 19226 90483753
Device difficult to use 14.99 13.07 3 125465 17522 90485457
Candida infection 14.97 13.07 15 125453 34042 90468937
Mood swings 14.93 13.07 5 125463 20697 90482282
Abdominal tenderness 14.87 13.07 37 125431 9287 90493692
Acute myeloid leukaemia 14.86 13.07 5 125463 20635 90482344
Enzyme level increased 14.81 13.07 9 125459 489 90502490
Gastroenteritis salmonella 14.76 13.07 11 125457 839 90502140
Gastrooesophageal reflux disease 14.75 13.07 153 125315 166184 90336795
Endometriosis 14.73 13.07 29 125439 6219 90496760
Pyelonephritis chronic 14.69 13.07 7 125461 232 90502747
Viral infection 14.68 13.07 103 125365 41311 90461668
Abdominal wall abscess 14.54 13.07 12 125456 1063 90501916
Tooth disorder 14.48 13.07 13 125455 31077 90471902
Musculoskeletal disorder 14.46 13.07 6 125462 21763 90481216
Serum sickness 14.45 13.07 21 125447 3521 90499458
Leukocytosis 14.39 13.07 13 125455 30977 90472002
Skin necrosis 14.29 13.07 3 125465 16938 90486041
Caesarean section 14.28 13.07 4 125464 18573 90484406
Intestinal mass 14.25 13.07 12 125456 1093 90501886
Pemphigus 14.25 13.07 344 125124 326520 90176459
Enterocutaneous fistula 14.22 13.07 14 125454 1560 90501419
Folliculitis 14.19 13.07 377 125091 203976 90299003
Crying 14.16 13.07 9 125459 25636 90477343
Dystonia 14.14 13.07 3 125465 16816 90486163
Tubulointerstitial nephritis 14.14 13.07 71 125397 25272 90477707
Anaemia 14.12 13.07 376 125092 352426 90150553
Incisional hernia 14.04 13.07 15 125453 1841 90501138
Gastrointestinal fistula 14.01 13.07 9 125459 540 90502439
Liver function test abnormal 13.98 13.07 31 125437 50814 90452165
Rectal spasm 13.94 13.07 6 125462 156 90502823
Gastrointestinal anastomotic leak 13.91 13.07 7 125461 262 90502717
Dry eye 13.82 13.07 38 125430 57893 90445086
Hydrosalpinx 13.82 13.07 4 125464 30 90502949
Anal inflammation 13.77 13.07 8 125460 400 90502579
Affect lability 13.68 13.07 4 125464 18059 90484920
Helicobacter infection 13.66 13.07 411 125057 226439 90276540
Sports injury 13.59 13.07 4 125464 32 90502947
Gastrointestinal stoma output abnormal 13.56 13.07 8 125460 412 90502567
Perirectal abscess 13.55 13.07 11 125457 952 90502027
Posterior reversible encephalopathy syndrome 13.53 13.07 7 125461 22332 90480647
Adenocarcinoma of colon 13.49 13.07 18 125450 2788 90500191
Hepatic vascular thrombosis 13.46 13.07 3 125465 6 90502973
Foot deformity 13.46 13.07 134 125334 59517 90443462
Pulmonary embolism 13.45 13.07 116 125352 130704 90372275
Diplopia 13.38 13.07 12 125456 28702 90474277
Mesenteric vein thrombosis 13.38 13.07 12 125456 1189 90501790
Gastrointestinal disorder 13.36 13.07 457 125011 256230 90246749
Diverticulum intestinal 13.26 13.07 35 125433 9107 90493872
Fluid retention 13.24 13.07 183 125285 87908 90415071
Gamma-glutamyltransferase increased 13.23 13.07 20 125448 37932 90465047
Ascites 13.21 13.07 29 125439 47711 90455268
Metastases to lung 13.14 13.07 3 125465 15988 90486991
Breast cancer stage I 13.11 13.07 36 125432 9588 90493391

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
Off label use 4052.86 17.09 4584 53123 633751 41929877
Frequent bowel movements 2500.19 17.09 978 56729 20429 42543199
Therapeutic reaction time decreased 2038.10 17.09 489 57218 1589 42562039
Haematochezia 1835.99 17.09 1082 56625 57354 42506274
Loss of therapeutic response 821.77 17.09 215 57492 1076 42562552
Abdominal pain 807.05 17.09 1132 56575 189339 42374289
Defaecation urgency 792.64 17.09 265 57442 3429 42560199
Drug ineffective 648.24 17.09 2089 55618 628108 41935520
Drug level decreased 517.04 17.09 258 57449 9719 42553909
Inappropriate schedule of product administration 478.09 17.09 618 57089 95284 42468344
Faecal calprotectin increased 475.14 17.09 173 57534 2921 42560707
Mucous stools 446.55 17.09 157 57550 2383 42561245
Rectal haemorrhage 446.01 17.09 435 57272 49171 42514457
Faeces soft 391.12 17.09 171 57536 4741 42558887
Diarrhoea 354.10 17.09 1392 56315 459457 42104171
Anal abscess 345.85 17.09 182 57525 7668 42555960
Colitis ulcerative 320.30 17.09 273 57434 25902 42537726
Blood pressure increased 319.80 17.09 528 57179 101400 42462228
No adverse event 313.45 17.09 322 57385 38699 42524929
Drug interaction 299.81 17.09 15 57692 266984 42296644
Toxicity to various agents 281.37 17.09 6 57701 229130 42334498
Intestinal obstruction 262.52 17.09 248 57459 26910 42536718
Clostridium difficile infection 260.33 17.09 228 57479 22431 42541197
Treatment failure 254.74 17.09 366 57341 62258 42501370
Product dose omission issue 253.78 17.09 610 57097 153755 42409873
Poor venous access 250.00 17.09 143 57564 7109 42556519
Acute kidney injury 248.17 17.09 94 57613 367243 42196385
Intestinal stenosis 237.55 17.09 102 57605 2702 42560926
Large intestinal stenosis 233.26 17.09 91 57616 1872 42561756
Colectomy 231.74 17.09 95 57612 2234 42561394
Gastrointestinal inflammation 229.77 17.09 116 57591 4476 42559152
Neutropenia 227.65 17.09 10 57697 199421 42364207
Stress 218.47 17.09 284 57423 43928 42519700
Febrile neutropenia 194.63 17.09 15 57692 185688 42377940
Anal fistula 186.45 17.09 112 57595 6101 42557527
Steroid dependence 185.90 17.09 115 57592 6607 42557021
Ileostomy 180.94 17.09 65 57642 1053 42562575
Drug effect less than expected 180.10 17.09 93 57614 3764 42559864
Colitis 178.87 17.09 265 57442 46307 42517321
Cholangitis sclerosing 177.12 17.09 74 57633 1828 42561800
Fistula 168.76 17.09 115 57592 7797 42555831
Large intestine polyp 168.17 17.09 122 57585 9143 42554485
Diarrhoea haemorrhagic 166.72 17.09 113 57594 7594 42556034
Ileocaecal resection 161.74 17.09 47 57660 367 42563261
Hypotension 159.19 17.09 75 57632 257556 42306072
Thrombocytopenia 157.25 17.09 33 57674 190246 42373382
Impaired quality of life 153.54 17.09 138 57569 14039 42549589
Ileal stenosis 151.30 17.09 66 57641 1818 42561810
Dyspnoea 149.25 17.09 231 57476 442390 42121238
Therapy non-responder 148.09 17.09 262 57445 53097 42510531
Arthralgia 145.31 17.09 606 57101 204632 42358996
Platelet count decreased 142.90 17.09 12 57695 138569 42425059
Abdominal discomfort 133.86 17.09 307 57400 74948 42488680
Impaired work ability 133.52 17.09 119 57588 11972 42551656
Small intestinal stenosis 129.72 17.09 48 57659 849 42562779
Haemorrhoids 128.08 17.09 136 57571 16961 42546667
Proctitis 126.32 17.09 67 57640 2866 42560762
Weight decreased 124.43 17.09 584 57123 207364 42356264
Hyponatraemia 119.38 17.09 4 57703 101458 42462170
Flatulence 118.66 17.09 158 57549 24994 42538634
Drug specific antibody present 117.06 17.09 71 57636 3935 42559693
Burns second degree 116.88 17.09 83 57624 6013 42557615
Completed suicide 116.43 17.09 3 57704 96462 42467166
Bronchiectasis 115.36 17.09 132 57575 17887 42545741
Disease progression 114.43 17.09 27 57680 143629 42419999
Drug abuse 113.95 17.09 7 57700 104764 42458864
Catarrh 113.61 17.09 81 57626 5905 42557723
Pouchitis 112.78 17.09 44 57663 905 42562723
COVID-19 112.46 17.09 379 57328 115569 42448059
Respiratory failure 108.34 17.09 21 57686 128111 42435517
Inflammatory bowel disease 104.29 17.09 63 57644 3466 42560162
Parosmia 103.93 17.09 85 57622 7606 42556022
Overdose 103.49 17.09 11 57696 105253 42458375
Death 102.29 17.09 314 57393 470871 42092757
Hypopnoea 102.10 17.09 85 57622 7797 42555831
Gingival pain 98.58 17.09 86 57621 8408 42555220
Rhinitis 98.19 17.09 100 57607 11877 42551751
Terminal ileitis 96.97 17.09 35 57672 575 42563053
Systemic lupus erythematosus 95.55 17.09 88 57619 9236 42554392
Arthritis 94.81 17.09 189 57518 41876 42521752
Cardiac arrest 94.37 17.09 17 57690 109303 42454325
Abdominal abscess 90.00 17.09 66 57641 5027 42558601
Therapeutic product effect decreased 89.55 17.09 177 57530 38973 42524655
Abdominal pain lower 88.47 17.09 95 57612 11997 42551631
Oedema peripheral 88.03 17.09 37 57670 136039 42427589
White blood cell count decreased 87.40 17.09 21 57686 110375 42453253
Abscess intestinal 85.62 17.09 44 57663 1762 42561866
Product temperature excursion issue 85.26 17.09 30 57677 456 42563172
Tubulointerstitial nephritis 85.03 17.09 153 57554 31395 42532233
Anal fissure 83.90 17.09 64 57643 5175 42558453
Proctocolectomy 83.32 17.09 24 57683 181 42563447
Dyschezia 83.24 17.09 43 57664 1741 42561887
Pancytopenia 81.14 17.09 29 57678 117714 42445914
Illness 80.49 17.09 131 57576 24799 42538829
Nipple swelling 79.29 17.09 27 57680 370 42563258
Malaise 77.53 17.09 522 57185 211634 42351994
Migraine 77.29 17.09 130 57577 25284 42538344
Anorectal discomfort 76.46 17.09 44 57663 2211 42561417
Gastrointestinal scarring 71.60 17.09 21 57686 170 42563458
Abscess 71.06 17.09 92 57615 14156 42549472
Proctalgia 70.85 17.09 66 57641 7027 42556601
Neuropathy peripheral 70.32 17.09 25 57682 101828 42461800
Renal failure 70.27 17.09 55 57652 143671 42419957
Colectomy total 70.14 17.09 24 57683 334 42563294
Abnormal faeces 69.48 17.09 51 57656 3890 42559738
Abdominal distension 69.05 17.09 234 57473 71501 42492127
Cardiac murmur 67.67 17.09 85 57622 12690 42550938
Fistula discharge 67.43 17.09 32 57675 1076 42562552
Blood iron decreased 65.45 17.09 60 57647 6258 42557370
Rectal discharge 64.51 17.09 22 57685 303 42563325
Product storage error 63.65 17.09 77 57630 11063 42552565
Rectal tenesmus 63.34 17.09 31 57676 1117 42562511
Intestinal fistula 62.48 17.09 31 57676 1151 42562477
Hypoxia 62.09 17.09 10 57697 69776 42493852
Tachycardia 61.43 17.09 30 57677 101057 42462571
Neutrophil count decreased 61.37 17.09 7 57700 63408 42500220
Intestinal resection 59.57 17.09 35 57672 1829 42561799
Stenotrophomonas infection 58.77 17.09 45 57662 3659 42559969
Abdominal pain upper 58.33 17.09 244 57463 82365 42481263
Gastrointestinal mucosa hyperaemia 58.18 17.09 21 57686 345 42563283
Gastrointestinal anastomotic stenosis 58.18 17.09 14 57693 46 42563582
Nephrolithiasis 57.59 17.09 143 57564 36687 42526941
Anal incontinence 57.15 17.09 67 57640 9314 42554314
Hypoglycaemia 56.94 17.09 7 57700 59847 42503781
Aspartate aminotransferase increased 56.67 17.09 17 57690 77146 42486482
Nipple pain 55.96 17.09 28 57679 1059 42562569
Gastrointestinal bacterial infection 54.81 17.09 24 57683 667 42562961
Metabolic acidosis 54.79 17.09 4 57703 51854 42511774
Intentional product misuse 54.78 17.09 9 57698 61891 42501737
Gastrointestinal stoma output increased 54.32 17.09 21 57686 421 42563207
Epistaxis 54.29 17.09 12 57695 66814 42496814
Seizure 54.19 17.09 50 57657 120511 42443117
Heart rate increased 54.15 17.09 177 57530 53078 42510550
Renal impairment 54.09 17.09 42 57665 110186 42453442
Leukopenia 53.94 17.09 17 57690 74729 42488899
Depressed level of consciousness 52.76 17.09 3 57704 47967 42515661
Cardiac failure congestive 52.63 17.09 25 57682 85577 42478051
Blood creatinine increased 52.62 17.09 43 57664 109960 42453668
Social problem 52.56 17.09 28 57679 1208 42562420
Faeces hard 51.85 17.09 31 57676 1673 42561955
Cytomegalovirus colitis 51.70 17.09 43 57664 3938 42559690
Alcohol poisoning 51.05 17.09 57 57650 7517 42556111
Cardiac failure 50.82 17.09 42 57665 106814 42456814
Small intestinal obstruction 50.18 17.09 86 57621 16975 42546653
Agitation 49.40 17.09 13 57694 64301 42499327
Rectal abscess 49.09 17.09 30 57677 1685 42561943
Ileectomy 47.80 17.09 15 57692 156 42563472
Blood creatine phosphokinase increased 47.62 17.09 5 57702 48333 42515295
Alanine aminotransferase increased 46.89 17.09 31 57676 88375 42475253
Lactic acidosis 46.39 17.09 4 57703 45257 42518371
Pseudopolyp 46.19 17.09 17 57690 296 42563332
Gastrointestinal infection 45.88 17.09 51 57656 6692 42556936
Short-bowel syndrome 45.16 17.09 17 57690 316 42563312
Product administered to patient of inappropriate age 45.06 17.09 43 57664 4718 42558910
Fatigue 44.90 17.09 833 56874 434808 42128820
Respiratory distress 44.83 17.09 3 57704 41817 42521811
Anal stenosis 44.57 17.09 17 57690 328 42563300
Enterocutaneous fistula 43.81 17.09 25 57682 1236 42562392
Infusion site extravasation 43.54 17.09 45 57662 5436 42558192
Stenosis 43.52 17.09 30 57677 2071 42561557
Gastrointestinal haemorrhage 43.35 17.09 41 57666 97685 42465943
Pyoderma gangrenosum 42.91 17.09 29 57678 1938 42561690
Intestinal anastomosis 42.51 17.09 18 57689 460 42563168
Appendicectomy 42.41 17.09 26 57681 1469 42562159
Dysarthria 42.25 17.09 3 57704 39804 42523824
Hyperglycaemia 42.10 17.09 6 57701 45853 42517775
Nasopharyngitis 41.67 17.09 224 57483 83772 42479856
Anaemia 41.43 17.09 217 57490 280061 42283567
Myocardial infarction 41.31 17.09 65 57642 123944 42439684
Septic shock 41.20 17.09 38 57669 91634 42471994
Gastrointestinal tract irritation 41.19 17.09 16 57691 325 42563303
Coma 40.80 17.09 11 57696 53543 42510085
Pleural effusion 40.54 17.09 43 57664 97123 42466505
Wrong technique in product usage process 40.52 17.09 5 57702 42630 42520998
Swelling 40.47 17.09 12 57695 54873 42508755
Haemoptysis 40.21 17.09 7 57700 46160 42517468
Suicide attempt 40.13 17.09 7 57700 46093 42517535
Mental status changes 39.88 17.09 5 57702 42110 42521518
Catheter site injury 39.83 17.09 8 57699 7 42563621
Plasma cell myeloma 39.76 17.09 8 57699 47570 42516058
Rectal stenosis 39.71 17.09 14 57693 214 42563414
Dry mouth 39.61 17.09 4 57703 39875 42523753
Hypertension 39.32 17.09 107 57600 167097 42396531
Anastomotic ulcer 38.77 17.09 17 57690 474 42563154
Atrial fibrillation 38.63 17.09 82 57625 139511 42424117
Campylobacter infection 38.59 17.09 24 57683 1391 42562237
Hepatic function abnormal 38.52 17.09 11 57696 51556 42512072
Hypokalaemia 38.23 17.09 25 57682 71696 42491932
Swollen tongue 38.12 17.09 87 57620 21144 42542484
Dysphagia 37.88 17.09 26 57681 72693 42490935
Tinnitus 37.73 17.09 105 57602 28833 42534795
Fistula of small intestine 37.53 17.09 18 57689 620 42563008
Vertigo 37.50 17.09 117 57590 34230 42529398
Gait disturbance 36.97 17.09 47 57660 97953 42465675
Bradycardia 36.60 17.09 37 57670 85447 42478181
Stress at work 36.57 17.09 14 57693 273 42563355
Colon dysplasia 36.05 17.09 13 57694 213 42563415
Mucosal inflammation 36.03 17.09 11 57696 49363 42514265
Acute myocardial infarction 35.72 17.09 17 57690 58148 42505480
Acne 35.27 17.09 65 57642 13579 42550049
Product availability issue 35.25 17.09 33 57674 3534 42560094
Pulmonary oedema 35.21 17.09 14 57693 53258 42510370
Adverse drug reaction 35.02 17.09 121 57586 37313 42526315
Eczema 34.38 17.09 113 57594 33973 42529655
Loss of personal independence in daily activities 34.25 17.09 146 57561 49670 42513958
Rash maculo-papular 34.21 17.09 5 57702 37498 42526130
Colon cancer 34.17 17.09 53 57654 9628 42554000
Gastrointestinal stoma complication 34.13 17.09 23 57684 1530 42562098
Heart rate decreased 34.10 17.09 118 57589 36414 42527214
Haematuria 33.84 17.09 18 57689 57781 42505847
Bone marrow failure 33.71 17.09 3 57704 33090 42530538
Pneumonia aspiration 33.36 17.09 13 57694 50065 42513563
Intestinal intraepithelial lymphocytes increased 32.71 17.09 12 57695 207 42563421
Adenovirus infection 32.45 17.09 43 57664 6766 42556862
Stomal hernia 32.42 17.09 14 57693 376 42563252
Basal cell carcinoma 32.15 17.09 85 57622 22648 42540980
Infected fistula 32.08 17.09 12 57695 219 42563409
Pneumonia 32.02 17.09 392 57315 421757 42141871
Blood bilirubin increased 31.58 17.09 9 57698 42243 42521385
Therapy partial responder 31.57 17.09 78 57629 19943 42543685
Polyp 31.57 17.09 35 57672 4579 42559049
Hernia 31.50 17.09 55 57652 11018 42552610
Neurogenic shock 31.30 17.09 13 57694 316 42563312
Faecal calprotectin abnormal 31.30 17.09 13 57694 316 42563312
Acute graft versus host disease 30.44 17.09 46 57661 8169 42555459
Tremor 30.23 17.09 53 57654 96876 42466752
Hospitalisation 30.19 17.09 188 57519 74142 42489486
Angioedema 30.04 17.09 10 57697 42467 42521161
Iron deficiency anaemia 29.86 17.09 59 57648 12980 42550648
Angiolymphoid hyperplasia with eosinophilia 29.85 17.09 10 57697 130 42563498
Delirium 29.81 17.09 17 57690 52502 42511126
Gastrointestinal anastomotic leak 29.58 17.09 15 57692 584 42563044
Abdominal adhesions 29.49 17.09 22 57685 1720 42561908
Gastrointestinal polyp 29.46 17.09 9 57698 85 42563543
Stomatitis 28.98 17.09 16 57691 50313 42513315
Product distribution issue 28.98 17.09 23 57684 1971 42561657
Encephalopathy 28.76 17.09 10 57697 41323 42522305
Mouth ulceration 28.75 17.09 63 57644 14900 42548728
Arthritis enteropathic 28.72 17.09 10 57697 147 42563481
Orchitis 28.58 17.09 24 57683 2227 42561401
Ascites 28.55 17.09 21 57686 56657 42506971
Muscle abscess 28.27 17.09 17 57690 927 42562701
Enterovesical fistula 27.94 17.09 17 57690 947 42562681
Drug level below therapeutic 27.66 17.09 39 57668 6506 42557122
Hypothyroidism 27.64 17.09 5 57702 32079 42531549
Stoma site abscess 27.47 17.09 8 57699 63 42563565
Enteritis 27.29 17.09 51 57656 10765 42552863
Coronary artery disease 26.94 17.09 20 57687 53700 42509928
Proctitis ulcerative 26.76 17.09 10 57697 182 42563446
Food poisoning 26.68 17.09 25 57682 2681 42560947
Skin cancer 26.41 17.09 52 57655 11410 42552218
Sepsis 26.34 17.09 160 57547 199174 42364454
Colostomy 26.32 17.09 14 57693 602 42563026
Nightmare 26.20 17.09 84 57623 24928 42538700
Pelvi-ureteric obstruction 26.14 17.09 6 57701 15 42563613
Surgery 26.07 17.09 67 57640 17549 42546079
Erythema 26.03 17.09 69 57638 108724 42454904
Cryptitis 26.02 17.09 11 57696 280 42563348
Weight fluctuation 25.95 17.09 36 57671 5915 42557713
Intestinal mass 25.94 17.09 14 57693 620 42563008
Pruritus 25.74 17.09 150 57557 188621 42375007
Ileal ulcer 25.72 17.09 16 57691 928 42562700
Hypomagnesaemia 25.52 17.09 4 57703 28484 42535144
Injection site discharge 25.49 17.09 13 57694 512 42563116
Anal haemorrhage 25.41 17.09 25 57682 2848 42560780
Medication error 25.01 17.09 100 57607 33054 42530574
Headache 24.99 17.09 459 57248 238910 42324718
Unresponsive to stimuli 24.78 17.09 6 57701 31397 42532231
Spondylitis 24.77 17.09 19 57688 1549 42562079
Probiotic therapy 24.60 17.09 9 57698 154 42563474
Irritable bowel syndrome 24.55 17.09 31 57676 4650 42558978
Microvillous inclusion disease 24.47 17.09 10 57697 233 42563395
Enterostomy 24.46 17.09 8 57699 96 42563532
Cataract 24.46 17.09 94 57613 30510 42533118
Gastrointestinal pain 24.38 17.09 30 57677 4385 42559243
Gastrointestinal wall thickening 24.16 17.09 20 57687 1819 42561809
Infusion site coldness 24.10 17.09 5 57702 6 42563622
General physical health deterioration 24.08 17.09 114 57593 151132 42412496
Erythema nodosum 24.08 17.09 20 57687 1828 42561800
Dyskinesia 24.07 17.09 3 57704 25387 42538241
Gastrointestinal dilation procedure 24.01 17.09 6 57701 24 42563604
Influenza like illness 23.99 17.09 96 57611 31744 42531884
Contraindicated product administered 23.92 17.09 3 57704 25269 42538359
Large intestine anastomosis 23.83 17.09 7 57700 57 42563571
Lung disorder 23.82 17.09 18 57689 47905 42515723
Orthostatic hypotension 23.81 17.09 6 57701 30564 42533064
Intestinal ulcer 23.79 17.09 16 57691 1061 42562567
Anorectal disorder 23.76 17.09 17 57690 1246 42562382
Hepatic failure 23.60 17.09 11 57696 38089 42525539
Upper gastrointestinal haemorrhage 23.50 17.09 6 57701 30293 42533335
Intestinal anastomosis complication 22.85 17.09 9 57698 190 42563438
Jejunal stenosis 22.73 17.09 7 57700 68 42563560
Lymphocyte count decreased 22.57 17.09 5 57702 27804 42535824
Restlessness 22.29 17.09 6 57701 29243 42534385
Colonic abscess 22.29 17.09 13 57694 670 42562958
Psychotic disorder 22.24 17.09 6 57701 29202 42534426
Faecal volume decreased 21.90 17.09 9 57698 213 42563415
Rectal prolapse 21.74 17.09 12 57695 556 42563072
Haematemesis 21.54 17.09 7 57700 30192 42533436
Abdominal mass 21.54 17.09 21 57686 2365 42561263
Acute respiratory failure 21.45 17.09 13 57694 38845 42524783
Cachexia 21.44 17.09 39 57668 8065 42555563
Apoptosis 21.26 17.09 12 57695 581 42563047
Fall 21.22 17.09 209 57498 234311 42329317
Subileus 21.20 17.09 25 57682 3496 42560132
Irritability 21.01 17.09 6 57701 28122 42535506
Wheezing 20.94 17.09 26 57681 54755 42508873
Diverticulum intestinal 20.92 17.09 30 57677 5083 42558545
Pharyngitis streptococcal 20.73 17.09 26 57681 3874 42559754
Gamma-glutamyltransferase increased 20.73 17.09 9 57698 32488 42531140
Chronic kidney disease 20.73 17.09 20 57687 47221 42516407
Incorrect route of product administration 20.49 17.09 4 57703 24301 42539327
Musculoskeletal stiffness 20.46 17.09 29 57678 57736 42505892
Gastrointestinal obstruction 20.42 17.09 15 57692 1145 42562483
Cholecystectomy 20.39 17.09 24 57683 3350 42560278
Diabetic ketoacidosis 20.35 17.09 3 57704 22364 42541264
Accidental overdose 20.22 17.09 84 57623 28246 42535382
Syncope 20.20 17.09 68 57639 99338 42464290
Ischaemic stroke 20.19 17.09 3 57704 22230 42541398
Stevens-Johnson syndrome 20.12 17.09 3 57704 22175 42541453
Postoperative wound infection 20.07 17.09 31 57676 5611 42558017
Parenteral nutrition 20.06 17.09 12 57695 648 42562980
Ejection fraction decreased 20.01 17.09 3 57704 22084 42541544
Gastroenteritis viral 19.87 17.09 38 57669 8161 42555467
Hypocalcaemia 19.82 17.09 8 57699 30165 42533463
Incisional hernia 19.81 17.09 16 57691 1406 42562222
Blood glucose increased 19.78 17.09 44 57663 73655 42489973
Blood pressure diastolic increased 19.78 17.09 33 57674 6372 42557256
Small intestinal resection 19.75 17.09 12 57695 667 42562961
Hypersensitivity 19.60 17.09 43 57664 72327 42491301
Oedema 19.54 17.09 25 57682 51976 42511652
Infection parasitic 19.31 17.09 10 57697 407 42563221
Psoriatic arthropathy 19.26 17.09 5 57702 24962 42538666
Osteosarcoma recurrent 19.23 17.09 7 57700 118 42563510
Anastomotic stenosis 19.22 17.09 10 57697 411 42563217
Stricturoplasty 19.19 17.09 4 57703 5 42563623
Blood pressure decreased 19.16 17.09 140 57567 58192 42505436
Disseminated intravascular coagulation 19.06 17.09 5 57702 24789 42538839
Pneumonia streptococcal 19.06 17.09 17 57690 1711 42561917
Intra-abdominal fluid collection 19.03 17.09 16 57691 1487 42562141
Postoperative abscess 19.02 17.09 10 57697 420 42563208
Bile acid malabsorption 19.01 17.09 7 57700 122 42563506
Vomiting 19.01 17.09 277 57430 289446 42274182
Skin exfoliation 18.93 17.09 17 57690 41536 42522092
Abdominal hernia 18.91 17.09 22 57685 3033 42560595
Cerebral haemorrhage 18.91 17.09 15 57692 38951 42524677
Spondyloarthropathy 18.81 17.09 13 57694 901 42562727
Faeces discoloured 18.60 17.09 58 57649 16956 42546672
Foetal exposure during pregnancy 18.56 17.09 22 57685 47289 42516339
Ventricular tachycardia 18.23 17.09 9 57698 30151 42533477
Loss of consciousness 18.21 17.09 64 57643 92290 42471338
Tonsil cancer 18.19 17.09 14 57693 1147 42562481
Post procedural infection 18.12 17.09 30 57677 5755 42557873
Overgrowth bacterial 17.98 17.09 7 57700 143 42563485
Ileostomy closure 17.98 17.09 6 57701 77 42563551
Gastrointestinal viral infection 17.80 17.09 9 57698 348 42563280
Pseudopolyposis 17.77 17.09 6 57701 80 42563548
Leukocytosis 17.76 17.09 9 57698 29699 42533929
Insomnia 17.74 17.09 91 57616 118162 42445466
Hepatotoxicity 17.66 17.09 6 57701 25161 42538467
Pulmonary hypertension 17.65 17.09 5 57702 23564 42540064
Haematoma 17.50 17.09 8 57699 28015 42535613
Hepatosplenic T-cell lymphoma 17.49 17.09 10 57697 496 42563132
Large intestinal ulcer 17.40 17.09 19 57688 2444 42561184
Chest pain 17.38 17.09 114 57593 139416 42424212
Multiple organ dysfunction syndrome 17.34 17.09 70 57637 96965 42466663
Drug withdrawal syndrome 17.23 17.09 4 57703 21545 42542083
Medical device site fistula 17.21 17.09 5 57702 39 42563589
Hypervolaemia 17.14 17.09 5 57702 23120 42540508

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
Off label use 7543.59 13.66 9268 130350 1490917 108958764
Frequent bowel movements 4172.26 13.66 1958 137660 69432 110380249
Therapeutic reaction time decreased 3945.98 13.66 985 138633 4294 110445387
Haematochezia 3844 13.66 2168 137450 113356 110336325
Abdominal pain 1906.27 13.66 2761 136857 510228 109939453
Defaecation urgency 1471.93 13.66 514 139104 8233 110441448
Mucous stools 1251.43 13.66 428 139190 6419 110443262
Loss of therapeutic response 1234.58 13.66 336 139282 2174 110447507
Rectal haemorrhage 969.33 13.66 961 138657 118872 110330809
Poor venous access 903.28 13.66 493 139125 24029 110425652
Faecal calprotectin increased 796.40 13.66 305 139313 6414 110443267
Drug level decreased 759.13 13.66 400 139218 18148 110431533
Diarrhoea 725.46 13.66 3096 136522 1136409 109313272
Inappropriate schedule of product administration 708.13 13.66 1065 138553 202572 110247109
Drug ineffective 661.10 13.66 3703 135915 1516837 108932844
Faeces soft 649.01 13.66 306 139312 10904 110438777
Intestinal obstruction 601.72 13.66 515 139103 52712 110396969
Toxicity to various agents 561.08 13.66 9 139609 480546 109969135
Pregnancy 538.69 13.66 475 139143 50592 110399089
Drug interaction 502.36 13.66 33 139585 500150 109949531
Clostridium difficile infection 491.09 13.66 455 139163 51674 110398007
Acute kidney injury 477.38 13.66 109 139509 635321 109814360
Intestinal stenosis 449.96 13.66 183 139435 4532 110445149
Blood pressure increased 432.44 13.66 986 138632 257387 110192294
Gastrointestinal inflammation 429.95 13.66 219 139399 9250 110440431
Anal abscess 423.04 13.66 232 139386 11406 110438275
Colitis ulcerative 422.96 13.66 505 139113 76858 110372823
Stress 399.04 13.66 574 139044 104774 110344907
Neutropenia 387.28 13.66 21 139597 374599 110075082
Product dose omission issue 351.94 13.66 1047 138571 320735 110128946
Anal fistula 333.30 13.66 178 139440 8295 110441386
Febrile neutropenia 332.95 13.66 16 139602 316751 110132930
Colectomy 331.06 13.66 144 139474 4234 110445447
Large intestinal stenosis 327.77 13.66 137 139481 3643 110446038
Fistula 324.97 13.66 216 139402 15083 110434598
Colitis 322.79 13.66 512 139106 101811 110347870
Flatulence 314.36 13.66 358 139260 51791 110397890
Ileostomy 303.00 13.66 114 139504 2278 110447403
Diarrhoea haemorrhagic 299.29 13.66 207 139411 15432 110434249
Proctitis 291.37 13.66 210 139408 16717 110432964
Hypotension 289.75 13.66 150 139468 523699 109925982
Completed suicide 272.88 13.66 7 139611 242374 110207307
Drug effect less than expected 258.00 13.66 143 139475 7177 110442504
Large intestine polyp 254.40 13.66 185 139433 14932 110434749
Anal fissure 248.11 13.66 155 139463 9726 110439955
Haemorrhoids 235.79 13.66 257 139361 35415 110414266
Weight decreased 233.14 13.66 1187 138431 466870 109982811
Abdominal pain lower 229.88 13.66 259 139359 37024 110412657
Hyponatraemia 225.46 13.66 12 139606 217641 110232040
Overdose 224.32 13.66 19 139599 233775 110215906
Ileal stenosis 216.54 13.66 98 139520 3172 110446509
Steroid dependence 215.54 13.66 134 139484 8335 110441346
Dyschezia 214.46 13.66 102 139516 3705 110445976
Dyspnoea 205.65 13.66 714 138904 1106158 109343523
Platelet count decreased 202.39 13.66 26 139592 230417 110219264
Abdominal distension 200.98 13.66 580 139038 174523 110275158
Malignant neoplasm progression 196.63 13.66 5 139613 174562 110275119
Drug abuse 196.43 13.66 6 139612 177405 110272276
Disease progression 195.07 13.66 36 139582 243998 110205683
Therapy non-responder 192.20 13.66 533 139085 156774 110292907
Drug specific antibody present 191.10 13.66 124 139494 8310 110441371
Thrombocytopenia 189.66 13.66 102 139516 348783 110100898
No adverse event 186.95 13.66 335 139283 73504 110376177
Abnormal faeces 180.85 13.66 124 139494 9112 110440569
Cholangitis sclerosing 180.74 13.66 89 139529 3493 110446188
Rectal tenesmus 169.72 13.66 74 139544 2188 110447493
COVID-19 169.35 13.66 685 138933 244375 110205306
Pancytopenia 167.36 13.66 31 139587 209582 110240099
Female genital tract fistula 166.87 13.66 150 139468 16369 110433312
White blood cell count decreased 166.73 13.66 42 139576 229348 110220333
Malaise 162.69 13.66 1423 138195 670396 109779285
Rectal discharge 161.48 13.66 58 139560 1011 110448670
Cardiac arrest 159.45 13.66 28 139590 196725 110252956
Death 154.32 13.66 416 139202 698453 109751228
Intestinal resection 153.01 13.66 82 139536 3847 110445834
Small intestinal stenosis 149.86 13.66 58 139560 1255 110448426
Respiratory failure 149.75 13.66 43 139575 215289 110234392
Ileocaecal resection 148.48 13.66 47 139571 544 110449137
Anal incontinence 146.47 13.66 159 139459 21805 110427876
Arthralgia 143.44 13.66 1559 138059 778073 109671608
Catarrh 142.49 13.66 98 139520 7237 110442444
Proctalgia 141.39 13.66 124 139494 13098 110436583
Inflammatory bowel disease 141.36 13.66 97 139521 7137 110442544
Burns second degree 140.13 13.66 99 139519 7634 110442047
Vaginal flatulence 130.08 13.66 114 139504 12030 110437651
Abscess intestinal 128.79 13.66 69 139549 3235 110446446
Vaginal discharge 123.56 13.66 132 139486 17776 110431905
Terminal ileitis 122.81 13.66 54 139564 1630 110448051
Impaired work ability 122.73 13.66 159 139459 26260 110423421
Abscess 122.45 13.66 162 139456 27307 110422374
Cardio-respiratory arrest 121.15 13.66 6 139612 115830 110333851
Impaired quality of life 120.13 13.66 168 139450 29849 110419832
Electrocardiogram QT prolonged 119.47 13.66 4 139614 108956 110340725
Neuropathy peripheral 117.14 13.66 40 139578 179237 110270444
Gastrointestinal scarring 115.52 13.66 37 139581 446 110449235
Hypokalaemia 115.30 13.66 43 139575 182405 110267276
Aspartate aminotransferase increased 114.82 13.66 30 139588 159906 110289775
Small intestinal obstruction 113.89 13.66 170 139448 32043 110417638
Depressed level of consciousness 113.76 13.66 7 139611 112271 110337410
Constipation 112.88 13.66 806 138812 356980 110092701
Gastrointestinal infection 112.47 13.66 112 139506 13893 110435788
Pouchitis 112.35 13.66 48 139570 1349 110448332
Hypopnoea 112.32 13.66 102 139516 11278 110438403
Blood iron decreased 110.87 13.66 129 139489 19085 110430596
Renal failure 110.81 13.66 75 139543 226499 110223182
Neutrophil count decreased 110.24 13.66 12 139606 120929 110328752
Rhabdomyolysis 109.61 13.66 12 139606 120389 110329292
Hypoxia 108.11 13.66 17 139601 129498 110320183
Maternal exposure during breast feeding 107.71 13.66 67 139551 4171 110445510
Blood creatinine increased 107.62 13.66 48 139570 182841 110266840
Rectal abscess 107.05 13.66 57 139561 2639 110447042
Coma 106.66 13.66 12 139606 117857 110331824
Intentional product misuse 105.33 13.66 20 139598 132884 110316797
Treatment failure 105.19 13.66 654 138964 276580 110173101
Metabolic acidosis 104.85 13.66 5 139613 99739 110349942
Social problem 101.88 13.66 49 139569 1825 110447856
Parosmia 101.43 13.66 103 139515 13077 110436604
Hallucination 100.76 13.66 7 139611 101425 110348256
Heart rate increased 99.24 13.66 402 139216 143432 110306249
Abdominal pain upper 99.06 13.66 767 138851 348344 110101337
Leukopenia 97.54 13.66 33 139585 148758 110300923
Infusion site extravasation 97.06 13.66 95 139523 11539 110438142
Cardiac failure 95.98 13.66 59 139559 187567 110262114
Myelosuppression 95.22 13.66 6 139612 94334 110355347
Alanine aminotransferase increased 95.11 13.66 57 139561 183716 110265965
Lactic acidosis 93.39 13.66 6 139612 92805 110356876
Intestinal fistula 93.26 13.66 45 139573 1688 110447993
Rhinitis 92.94 13.66 128 139490 22417 110427264
Atrial fibrillation 92.46 13.66 92 139526 229550 110220131
Large intestinal ulcer 91.29 13.66 68 139550 5693 110443988
Cardiac failure congestive 89.83 13.66 39 139579 150961 110298720
Pseudopolyp 89.24 13.66 33 139585 627 110449054
Radiculopathy 89.23 13.66 116 139502 19220 110430461
International normalised ratio increased 89.15 13.66 5 139613 86767 110362914
General symptom 88.70 13.66 80 139538 8766 110440915
Seizure 88.61 13.66 89 139529 221096 110228585
Faeces hard 87.88 13.66 59 139559 4187 110445494
Abdominal abscess 86.95 13.66 79 139539 8740 110440941
Hypoglycaemia 86.80 13.66 20 139598 116084 110333597
Abdominal mass 86.63 13.66 62 139556 4879 110444802
Gingival pain 86.40 13.66 103 139515 15633 110434048
Macular degeneration 86.34 13.66 121 139497 21538 110428143
Agitation 85.47 13.66 19 139599 113032 110336649
Pyoderma gangrenosum 85.35 13.66 64 139554 5412 110444269
Fall 85.18 13.66 432 139186 603050 109846631
Fatigue 84.96 13.66 2070 137548 1213888 109235793
Gastrointestinal pain 84.62 13.66 89 139529 11771 110437910
Anorectal discomfort 84.60 13.66 57 139561 4069 110445612
Bile acid malabsorption 84.14 13.66 29 139589 445 110449236
Suicide attempt 83.13 13.66 15 139603 103379 110346302
X-ray abnormal 82.81 13.66 162 139456 37955 110411726
Gastrointestinal mucosa hyperaemia 82.73 13.66 30 139588 538 110449143
Epistaxis 81.90 13.66 31 139587 130341 110319340
Renal impairment 81.16 13.66 71 139547 188374 110261307
Nipple swelling 81.14 13.66 27 139591 370 110449311
Bradycardia 80.80 13.66 48 139570 155469 110294212
Tubulointerstitial nephritis 80.66 13.66 198 139420 54086 110395595
Angioedema 79.82 13.66 14 139604 98486 110351195
Gastrointestinal stoma output increased 79.11 13.66 34 139584 970 110448711
Illness 79.07 13.66 256 139362 81915 110367766
Gastrointestinal wall thickening 78.99 13.66 52 139566 3571 110446110
Hyperglycaemia 78.68 13.66 8 139610 85082 110364599
Colectomy total 78.60 13.66 28 139590 476 110449205
Gastrointestinal haemorrhage 78.00 13.66 57 139561 165461 110284220
Gastrointestinal bacterial infection 76.85 13.66 37 139581 1381 110448300
Abdominal adhesions 76.75 13.66 54 139564 4136 110445545
Erythema nodosum 76.42 13.66 65 139553 6588 110443093
Porphyria acute 74.98 13.66 105 139513 18675 110431006
Blood pressure decreased 74.92 13.66 316 139302 114775 110334906
Chronic sinusitis 74.24 13.66 122 139496 24962 110424719
Rash 74.19 13.66 671 138947 820293 109629388
Respiratory distress 73.88 13.66 3 139615 68871 110380810
Contraindicated product administered 73.65 13.66 125 139493 248142 110201539
Intestinal ulcer 73.65 13.66 43 139575 2384 110447297
Cytomegalovirus colitis 73.06 13.66 65 139553 6996 110442685
Dysphagia 72.24 13.66 53 139565 153547 110296134
Pleural effusion 71.75 13.66 71 139547 177638 110272043
Arthritis 71.64 13.66 408 139210 167178 110282503
Sedation 71.64 13.66 4 139614 69679 110380002
Swelling 70.70 13.66 218 139400 350823 110098858
Nasopharyngitis 70.61 13.66 785 138833 393576 110056105
Dysarthria 70.29 13.66 11 139607 84110 110365571
Stress at work 70.08 13.66 34 139584 1291 110448390
Hypertension 69.77 13.66 369 139249 509715 109939966
Product administered to patient of inappropriate age 69.63 13.66 67 139551 7969 110441712
Anal stenosis 69.30 13.66 27 139591 595 110449086
Small intestinal resection 68.88 13.66 32 139586 1101 110448580
Mental status changes 68.24 13.66 8 139610 76114 110373567
Ileal ulcer 68.18 13.66 37 139581 1780 110447901
Abortion spontaneous 67.67 13.66 140 139478 34142 110415539
Rash maculo-papular 66.05 13.66 8 139610 74214 110375467
Mucosal inflammation 65.35 13.66 20 139598 96121 110353560
Encephalopathy 64.64 13.66 12 139606 81043 110368638
Anastomotic ulcer 63.94 13.66 30 139588 1056 110448625
Proctocolectomy 63.94 13.66 20 139598 222 110449459
Hepatic function abnormal 63.61 13.66 17 139601 89278 110360403
Sepsis 63.31 13.66 207 139411 327139 110122542
Product availability issue 63.17 13.66 63 139555 7827 110441854
Subcutaneous drug absorption impaired 62.89 13.66 62 139556 7597 110442084
Adjustment disorder with depressed mood 61.98 13.66 157 139461 43726 110405955
Procedural pain 61.88 13.66 138 139480 35427 110414254
Orthostatic hypotension 61.85 13.66 6 139612 66243 110383438
Bowel movement irregularity 61.03 13.66 61 139557 7599 110442082
Paraesthesia oral 60.10 13.66 132 139486 33539 110416142
Tremor 59.81 13.66 102 139516 202130 110247551
Dislocation of vertebra 59.24 13.66 154 139464 43567 110406114
Nipple pain 59.15 13.66 29 139589 1127 110448554
Myocardial infarction 58.55 13.66 95 139523 191988 110257693
Bronchiectasis 58.40 13.66 137 139481 36356 110413325
Septic shock 57.96 13.66 68 139550 157460 110292221
Product temperature excursion issue 57.92 13.66 26 139592 825 110448856
Wrong technique in product usage process 57.89 13.66 19 139599 87329 110362352
Intestinal anastomosis complication 57.64 13.66 21 139597 382 110449299
Gastrointestinal bacterial overgrowth 57.38 13.66 24 139594 639 110449042
Pulmonary oedema 56.76 13.66 28 139590 100631 110349050
Faecal volume decreased 56.55 13.66 21 139597 404 110449277
Arthritis enteropathic 56.26 13.66 21 139597 410 110449271
Rectal stenosis 55.88 13.66 21 139597 418 110449263
Plasma cell myeloma 55.47 13.66 7 139611 62929 110386752
Gastrointestinal anastomotic stenosis 55.32 13.66 14 139604 65 110449616
Proctitis ulcerative 54.15 13.66 21 139597 457 110449224
Unresponsive to stimuli 54.08 13.66 8 139610 63782 110385899
Blood creatine phosphokinase increased 53.81 13.66 13 139605 73064 110376617
Alcohol poisoning 52.78 13.66 61 139557 8959 110440722
Full blood count abnormal 52.53 13.66 5 139613 56047 110393634
Ileectomy 52 13.66 18 139600 280 110449401
Catheter site injury 51.65 13.66 18 139600 286 110449395
Skin exfoliation 51.55 13.66 23 139595 87628 110362053
Hypocalcaemia 51.44 13.66 10 139608 65356 110384325
Hernia 51.30 13.66 90 139528 19410 110430271
Multiple sclerosis relapse 51.29 13.66 3 139615 50237 110399444
Product distribution issue 51.02 13.66 43 139575 4303 110445378
Haemoptysis 50.04 13.66 14 139604 71340 110378341
Pneumonia aspiration 49.89 13.66 20 139598 81213 110368468
Enterocutaneous fistula 49.82 13.66 33 139585 2290 110447391
Pharyngitis streptococcal 49.72 13.66 72 139546 13205 110436476
Hepatotoxicity 49.26 13.66 10 139608 63390 110386291
Back disorder 49.24 13.66 92 139526 20830 110428851
Weight fluctuation 49.18 13.66 95 139523 22050 110427631
Oral candidiasis 49.12 13.66 146 139472 44614 110405067
Cardiac murmur 49.10 13.66 101 139517 24527 110425154
Aggression 48.89 13.66 8 139610 59202 110390479
Blood urea increased 48.71 13.66 6 139612 54951 110394730
Therapy partial responder 48.64 13.66 129 139489 36932 110412749
Anal haemorrhage 48.12 13.66 44 139574 4908 110444773
Acute myocardial infarction 47.70 13.66 23 139595 83754 110365927
Stomal hernia 47.46 13.66 20 139598 543 110449138
Bone marrow failure 47.36 13.66 8 139610 57840 110391841
Stevens-Johnson syndrome 47.28 13.66 3 139615 46898 110402783
Cryptitis 47.14 13.66 18 139600 375 110449306
Acute respiratory failure 47.09 13.66 18 139600 75242 110374439
General physical health deterioration 46.94 13.66 329 139289 424966 110024715
Lymphocyte count decreased 46.68 13.66 8 139610 57235 110392446
Pulmonary hypertension 46.64 13.66 7 139611 55213 110394468
Suicidal ideation 46.03 13.66 31 139587 93906 110355775
Hypomagnesaemia 45.92 13.66 10 139608 60360 110389321
Pustular psoriasis 45.53 13.66 70 139548 13535 110436146
Stenotrophomonas infection 45.48 13.66 46 139572 5812 110443869
Cognitive disorder 45.46 13.66 27 139591 87484 110362197
Agranulocytosis 45.45 13.66 11 139607 61749 110387932
Faecal calprotectin abnormal 45.30 13.66 17 139601 337 110449344
Chronic kidney disease 44.90 13.66 20 139598 76271 110373410
Nephrolithiasis 44.80 13.66 184 139434 66028 110383653
Neoplasm progression 44.70 13.66 13 139605 64582 110385099
Dyskinesia 44.67 13.66 6 139612 51440 110398241
Sinus tachycardia 44.39 13.66 3 139615 44490 110405191
Hypercalcaemia 44.16 13.66 4 139614 46653 110403028
Coronary artery disease 43.46 13.66 18 139600 71672 110378009
Faeces discoloured 43.38 13.66 117 139501 33831 110415850
Hepatitis 42.43 13.66 31 139587 90023 110359658
Disorientation 42.43 13.66 18 139600 70653 110379028
Hypervolaemia 42.40 13.66 6 139612 49454 110400227
Food poisoning 42.26 13.66 46 139572 6326 110443355
Maternal exposure during pregnancy 42.13 13.66 172 139446 254711 110194970
Pruritus 41.55 13.66 502 139116 581058 109868623
Blood bilirubin increased 41.54 13.66 22 139596 75950 110373731
Hepatocellular injury 41.46 13.66 7 139611 50635 110399046
Interstitial lung disease 41.45 13.66 70 139548 139264 110310417
Hospitalisation 41.42 13.66 315 139303 142178 110307503
Pus in stool 41.40 13.66 11 139607 64 110449617
Mouth ulceration 41.02 13.66 144 139474 47994 110401687
Altered state of consciousness 40.99 13.66 11 139607 57615 110392066
Tachycardia 40.64 13.66 148 139470 226497 110223184
Ejection fraction decreased 40.08 13.66 3 139615 40877 110408804
Asthma 40.06 13.66 171 139447 250120 110199561
Mobility decreased 40.01 13.66 159 139459 237263 110212418
Haematuria 39.86 13.66 28 139590 82977 110366704
Injection site pain 39.83 13.66 105 139513 177817 110271864
Dyspepsia 39.72 13.66 392 139226 190573 110259108
Multiple organ dysfunction syndrome 39.17 13.66 83 139535 151627 110298054
Gastrointestinal obstruction 39.02 13.66 28 139590 2212 110447469
Blood glucose increased 39.01 13.66 67 139551 132429 110317252
Intestinal dilatation 38.81 13.66 34 139584 3586 110446095
Stoma site abscess 38.74 13.66 15 139603 325 110449356
Polyp 38.66 13.66 55 139563 9925 110439756
Ventricular tachycardia 38.62 13.66 8 139610 50001 110399680
Therapy interrupted 38.41 13.66 8 139610 49814 110399867
Tachypnoea 38.32 13.66 3 139615 39392 110410289
Lupus-like syndrome 38.25 13.66 126 139492 40666 110409015
Drug hypersensitivity 37.99 13.66 378 139240 453712 109995969
Somnolence 37.98 13.66 220 139398 297229 110152452
Neurogenic shock 37.80 13.66 20 139598 914 110448767
Rash vesicular 37.74 13.66 67 139551 14585 110435096
Restlessness 37.70 13.66 12 139606 56247 110393434
Psychotic disorder 37.62 13.66 9 139609 50928 110398753
Influenza 37.57 13.66 352 139266 168749 110280932
Gastrointestinal stoma complication 37.50 13.66 32 139586 3257 110446424
Ileostomy closure 37.39 13.66 15 139603 358 110449323
Colon dysplasia 37.01 13.66 15 139603 368 110449313
Fistula discharge 36.80 13.66 24 139594 1622 110448059
Upper gastrointestinal haemorrhage 36.71 13.66 9 139609 50087 110399594
Post procedural infection 36.67 13.66 64 139554 13745 110435936
Gastrointestinal stenosis 36.23 13.66 15 139603 389 110449292
Generalised tonic-clonic seizure 36.05 13.66 12 139606 54668 110395013
Syncope 35.82 13.66 133 139485 202403 110247278
Infection parasitic 35.77 13.66 19 139599 875 110448806
Headache 35.62 13.66 1406 138212 880971 109568710
Ascites 35.29 13.66 39 139579 92769 110356912
Joint swelling 35.25 13.66 373 139245 442472 110007209
Cerebral haemorrhage 35.25 13.66 19 139599 64949 110384732
Exposure during pregnancy 35.09 13.66 102 139516 167322 110282359
Circulatory collapse 35.07 13.66 6 139612 42987 110406694
Acute hepatic failure 34.85 13.66 3 139615 36465 110413216
Hepatic failure 34.61 13.66 22 139596 68717 110380964
Migraine 34.56 13.66 350 139268 171302 110278379
Blood lactate dehydrogenase increased 34.43 13.66 7 139611 44327 110405354
Anaemia 34.38 13.66 485 139133 546601 109903080
Anastomotic stenosis 34.24 13.66 17 139601 679 110449002
Drug withdrawal syndrome 34.11 13.66 4 139614 38050 110411631
Intestinal mass 34.09 13.66 22 139596 1460 110448221
Diabetic ketoacidosis 34.02 13.66 6 139612 42052 110407629
Gastrointestinal polyp 33.96 13.66 12 139606 199 110449482
Oedema peripheral 33.96 13.66 259 139359 328401 110121280
Transaminases increased 33.72 13.66 19 139599 63371 110386310
Intentional self-injury 33.38 13.66 4 139614 37425 110412256
Haematoma 33.37 13.66 16 139602 58460 110391221
Drug specific antibody 33.24 13.66 28 139590 2800 110446881
Abscess limb 33.17 13.66 47 139571 8450 110441231
Pneumonia 32.92 13.66 849 138769 875865 109573816
Drug intolerance 32.92 13.66 341 139277 406171 110043510
Coagulopathy 32.74 13.66 6 139612 40905 110408776
Discouragement 32.73 13.66 25 139593 2173 110447508
Fistula of small intestine 32.50 13.66 19 139599 1056 110448625
Short-bowel syndrome 32.49 13.66 17 139601 759 110448922
Intestinal intraepithelial lymphocytes increased 32.31 13.66 12 139606 231 110449450
Colostomy 32.23 13.66 21 139597 1417 110448264
Abdominal discomfort 32.13 13.66 686 138932 393172 110056509
Enterovesical fistula 32.03 13.66 21 139597 1432 110448249
Bacterial vulvovaginitis 31.93 13.66 16 139602 652 110449029
Arthropathy 31.91 13.66 222 139396 287300 110162381
Incisional hernia 31.88 13.66 27 139591 2720 110446961
Serum ferritin decreased 31.69 13.66 28 139590 2986 110446695
Drug eruption 31.68 13.66 14 139604 53645 110396036
Vascular access site bruising 31.64 13.66 8 139610 37 110449644
Rectal fissure 31.41 13.66 19 139599 1125 110448556
Faecal volume increased 31.37 13.66 13 139605 338 110449343
Mitral valve incompetence 31.16 13.66 3 139615 33326 110416355
Disseminated intravascular coagulation 31.08 13.66 7 139611 41279 110408402
Osteonecrosis of jaw 30.86 13.66 11 139607 48006 110401675
Injection site extravasation 30.82 13.66 50 139568 10119 110439562
Cholestasis 30.67 13.66 22 139596 64496 110385185
Mesenteritis 30.61 13.66 13 139605 360 110449321
Quality of life decreased 30.51 13.66 60 139558 14109 110435572
Angiolymphoid hyperplasia with eosinophilia 30.46 13.66 10 139608 131 110449550
Spondyloarthropathy 30.03 13.66 21 139597 1593 110448088
Lymphopenia 29.86 13.66 7 139611 40163 110409518
Skin cancer 29.81 13.66 68 139550 17716 110431965
Postoperative abscess 29.78 13.66 17 139601 903 110448778
Infected fistula 29.76 13.66 14 139604 496 110449185
Full blood count decreased 29.72 13.66 3 139615 32096 110417585
Gastroenteritis 29.62 13.66 112 139506 38688 110410993
Rheumatoid arthritis 29.60 13.66 239 139379 299374 110150307
Colonic abscess 29.52 13.66 22 139596 1843 110447838
Influenza like illness 29.47 13.66 202 139416 88210 110361471
Intestinal anastomosis 29.43 13.66 17 139601 924 110448757
Pneumonitis 29.27 13.66 32 139586 76499 110373182
Vein rupture 29.25 13.66 25 139593 2550 110447131
Stenosis 29.15 13.66 28 139590 3323 110446358
Irritability 28.98 13.66 12 139606 47797 110401884
Gastroenteritis Escherichia coli 28.95 13.66 19 139599 1298 110448383
Product quality issue 28.82 13.66 33 139585 77266 110372415
Angina pectoris 28.63 13.66 22 139596 62273 110387408
Abnormal behaviour 28.63 13.66 7 139611 39032 110410649
Muscular weakness 28.48 13.66 190 139428 248278 110201403
Pancreatitis 28.44 13.66 209 139409 93324 110356357
Finger deformity 28.40 13.66 4 139614 33088 110416593
Acne 28.33 13.66 100 139518 33420 110416261
Hemiparesis 28.31 13.66 10 139608 43893 110405788
Haematemesis 28.30 13.66 20 139598 59088 110390593
Myoclonus 28.29 13.66 4 139614 32994 110416687
Acute respiratory distress syndrome 28.22 13.66 16 139602 53182 110396499
Neutropenic sepsis 28.14 13.66 3 139615 30743 110418938
Gait disturbance 27.91 13.66 221 139397 277987 110171694
Anorectal disorder 27.76 13.66 25 139593 2734 110446947
Appendicitis 27.66 13.66 89 139529 28375 110421306
Ataxia 27.40 13.66 3 139615 30105 110419576
Cataract 27.33 13.66 183 139435 79302 110370379
Drug level increased 27.32 13.66 13 139605 47706 110401975
Femur fracture 27.22 13.66 11 139607 44458 110405223
Anal ulcer 27.20 13.66 21 139597 1855 110447826
Red blood cell count decreased 26.99 13.66 26 139592 65897 110383784
Uveitis 26.91 13.66 74 139544 21636 110428045
Campylobacter infection 26.83 13.66 23 139595 2356 110447325
Oropharyngeal pain 26.83 13.66 275 139343 135001 110314680
Blood alkaline phosphatase increased 26.76 13.66 30 139588 70905 110378776
Gastrointestinal viral infection 26.69 13.66 20 139598 1689 110447992
Adenovirus infection 26.69 13.66 49 139569 10945 110438736
Status epilepticus 26.67 13.66 4 139614 31567 110418114
Gamma-glutamyltransferase increased 26.50 13.66 23 139595 61286 110388395
Enterostomy 26.34 13.66 10 139608 205 110449476
Poisoning 26.23 13.66 3 139615 29102 110420579
Liver function test abnormal 26.19 13.66 29 139589 68921 110380760
Dysstasia 26.05 13.66 5 139613 32981 110416700
Proteinuria 26.00 13.66 9 139609 40009 110409672
Drug level below therapeutic 25.82 13.66 50 139568 11623 110438058
Drug resistance 25.79 13.66 20 139598 56354 110393327
Movement disorder 25.79 13.66 7 139611 36397 110413284
Acute myeloid leukaemia 25.77 13.66 8 139610 38102 110411579
Rectal cancer metastatic 25.76 13.66 13 139605 538 110449143
Gastrointestinal tract irritation 25.72 13.66 15 139603 830 110448851
Lower limb fracture 25.62 13.66 173 139445 75175 110374506
Cytomegalovirus enterocolitis 25.62 13.66 22 139596 2259 110447422
Intestinal perforation 25.58 13.66 71 139547 20873 110428808
Chronic obstructive pulmonary disease 25.52 13.66 63 139555 109095 110340586
Anal skin tags 25.45 13.66 13 139605 552 110449129
Renal tubular necrosis 25.42 13.66 4 139614 30471 110419210
Rectal prolapse 25.35 13.66 23 139595 2540 110447141
Aphthous ulcer 25.17 13.66 71 139547 21065 110428616
Breast cancer stage II 25.17 13.66 84 139534 27291 110422390
Loss of consciousness 25.15 13.66 145 139473 196161 110253520
Polyneuropathy 24.97 13.66 5 139613 32007 110417674
Pain 24.89 13.66 970 138648 953985 109495696
Injection site discharge 24.86 13.66 18 139600 1442 110448239
Large intestine anastomosis 24.86 13.66 8 139610 98 110449583
Leukocytosis 24.75 13.66 19 139599 53809 110395872
Nightmare 24.73 13.66 106 139512 38757 110410924
Hypersensitivity 24.70 13.66 360 139258 403638 110046043
Candida infection 24.67 13.66 15 139603 47994 110401687
Urinary retention 24.65 13.66 31 139587 69652 110380029
Gallbladder polyp 24.54 13.66 17 139601 1270 110448411
Probiotic therapy 24.39 13.66 9 139609 170 110449511
Labelled drug-drug interaction medication error 24.10 13.66 4 139614 29298 110420383
Pneumocystis jirovecii pneumonia 23.92 13.66 12 139606 42723 110406958
Cardiomegaly 23.91 13.66 4 139614 29126 110420555
Melaena 23.90 13.66 31 139587 68726 110380955
Product use in unapproved indication 23.88 13.66 409 139209 446968 110002713
Haematocrit decreased 23.82 13.66 29 139589 66088 110383593
Microvillous inclusion disease 23.81 13.66 10 139608 269 110449412
Product prescribing error 23.76 13.66 18 139600 51313 110398368
Gastrointestinal motility disorder 23.74 13.66 37 139581 7239 110442442
Haemorrhage intracranial 23.73 13.66 4 139614 28965 110420716
Gastroenteritis viral 23.72 13.66 90 139528 31136 110418545
Gastroenteritis eosinophilic 23.64 13.66 11 139607 380 110449301
Injection site reaction 23.60 13.66 48 139570 89022 110360659
Abdominal hernia 23.45 13.66 35 139583 6594 110443087
Premature delivery 23.45 13.66 5 139613 30627 110419054
Hepatic cytolysis 23.38 13.66 21 139597 55032 110394649
Appendicectomy 23.30 13.66 25 139593 3382 110446299
Hypothyroidism 23.21 13.66 35 139583 72864 110376817
Stoma creation 23.20 13.66 9 139609 196 110449485
Visual acuity reduced 23.15 13.66 6 139612 32167 110417514
Adverse drug reaction 23.07 13.66 219 139399 105340 110344341
Hepatic encephalopathy 22.92 13.66 4 139614 28252 110421429
BK polyomavirus test positive 22.74 13.66 10 139608 302 110449379
Muscle twitching 22.68 13.66 5 139613 29930 110419751
Muscle abscess 22.52 13.66 17 139601 1452 110448229
Ischaemic stroke 22.48 13.66 12 139606 41251 110408430
Onychomadesis 22.46 13.66 15 139603 45648 110404033
Dystonia 22.43 13.66 3 139615 25802 110423879
Infusion site paraesthesia 22.43 13.66 6 139612 36 110449645
Iron deficiency anaemia 22.38 13.66 89 139529 31470 110418211
Enteropathic spondylitis 22.29 13.66 6 139612 37 110449644
Hepatic vascular thrombosis 22.28 13.66 5 139613 12 110449669
Wound infection 22.02 13.66 202 139416 96263 110353418
Therapeutic product effect incomplete 21.99 13.66 401 139217 223404 110226277
Gastrointestinal ulcer 21.94 13.66 27 139591 4233 110445448
Umbilical hernia 21.93 13.66 35 139583 6987 110442694
Thrombotic microangiopathy 21.82 13.66 5 139613 29144 110420537
Therapy cessation 21.71 13.66 15 139603 44842 110404839
Infusion site bruising 21.64 13.66 25 139593 3669 110446012
Sacroiliitis 21.63 13.66 29 139589 4949 110444732
Intestinal operation 21.60 13.66 12 139606 605 110449076
Ileocolostomy 21.39 13.66 6 139612 44 110449637
Dry mouth 21.39 13.66 156 139462 199792 110249889
Growth retardation 21.38 13.66 21 139597 2561 110447120
Dyspnoea exertional 21.36 13.66 64 139554 103996 110345685
Synovitis 21.33 13.66 232 139386 273860 110175821
Gastrointestinal disorder 21.21 13.66 426 139192 241526 110208155
Speech disorder 21.15 13.66 28 139590 61541 110388140
Aphasia 21.13 13.66 26 139592 58971 110390710
Epilepsy 21.03 13.66 61 139557 100148 110349533
Atelectasis 21.02 13.66 10 139608 36702 110412979
Diverticulum intestinal 20.98 13.66 46 139572 11673 110438008
Gastric disorder 20.83 13.66 8 139610 33349 110416332
Cerebral infarction 20.58 13.66 21 139597 51817 110397864
Tinnitus 20.58 13.66 139 139479 60401 110389280
Intestinal polyp 20.57 13.66 20 139598 2409 110447272
Subarachnoid haemorrhage 20.51 13.66 6 139612 29696 110419985
Sinus bradycardia 20.28 13.66 6 139612 29477 110420204
Anaphylactic reaction 20.24 13.66 75 139543 114225 110335456
Acute graft versus host disease 20.22 13.66 48 139570 12833 110436848
Breast cancer female 20.16 13.66 47 139571 12421 110437260
Salmonellosis 20.09 13.66 19 139599 2212 110447469
Dysphonia 20.05 13.66 41 139577 75888 110373793
Colonoscopy abnormal 19.98 13.66 8 139610 190 110449491
Parenteral nutrition 19.82 13.66 13 139605 887 110448794
Apoptosis 19.78 13.66 12 139606 714 110448967
Neck pain 19.77 13.66 84 139534 123046 110326635
Breath sounds abnormal 19.75 13.66 4 139614 25400 110424281
Gastrointestinal stoma output abnormal 19.63 13.66 10 139608 422 110449259
Lip swelling 19.58 13.66 21 139597 50646 110399035
White coat hypertension 19.52 13.66 15 139603 1316 110448365
Dry skin 19.48 13.66 70 139548 107583 110342098
IgA nephropathy 19.48 13.66 22 139596 3151 110446530
Cardiomyopathy 19.40 13.66 9 139609 33516 110416165
Colon cancer 19.35 13.66 55 139563 16388 110433293
Jaundice 19.29 13.66 28 139590 59208 110390473
Large intestine erosion 19.23 13.66 7 139611 127 110449554
Drug-induced liver injury 19.22 13.66 82 139536 119985 110329696
Blindness 19.19 13.66 11 139607 36348 110413333
Gastrointestinal anastomotic leak 19.17 13.66 12 139606 755 110448926
Device dislocation 19.15 13.66 8 139610 31696 110417985
Skin haemorrhage 19.11 13.66 4 139614 24823 110424858
Haemodynamic instability 19.10 13.66 3 139615 22885 110426796
Anti-cyclic citrullinated peptide antibody 19.02 13.66 62 139556 19902 110429779
Rales 19.02 13.66 4 139614 24735 110424946
Orchitis 18.99 13.66 17 139601 1845 110447836
Hemiplegia 18.98 13.66 3 139615 22779 110426902
Urinary incontinence 18.93 13.66 20 139598 48567 110401114
Medication error 18.93 13.66 210 139408 105156 110344525
Coeliac disease 18.91 13.66 16 139602 43171 110406510
Amnesia 18.90 13.66 210 139408 105198 110344483
Neuralgia 18.84 13.66 20 139598 48458 110401223
Rectal dysplasia 18.83 13.66 5 139613 29 110449652
Blood pressure systolic increased 18.55 13.66 49 139569 82942 110366739
Onychomycosis 18.50 13.66 13 139605 38518 110411163
Atrial flutter 18.49 13.66 4 139614 24258 110425423
Obstruction 18.42 13.66 29 139589 5723 110443958
Pulmonary congestion 18.41 13.66 8 139610 30958 110418723
Taste disorder 18.40 13.66 34 139584 65353 110384328
Muscle rigidity 18.24 13.66 4 139614 24027 110425654
Adrenal insufficiency 18.20 13.66 16 139602 42374 110407307
Osteosarcoma recurrent 18.19 13.66 7 139611 149 110449532
Perirectal abscess 18.18 13.66 18 139600 2216 110447465
Blood triglycerides increased 18.12 13.66 4 139614 23922 110425759
Confusional state 18.04 13.66 452 139166 468228 109981453
B-cell unclassifiable lymphoma high grade 18.00 13.66 4 139614 9 110449672
Stoma complication 18.00 13.66 13 139605 1038 110448643
Glomerular filtration rate decreased 17.99 13.66 7 139611 28949 110420732
Injection site erythema 17.87 13.66 60 139558 94116 110355565
Balance disorder 17.81 13.66 81 139537 116479 110333202
Lower respiratory tract infection 17.77 13.66 417 139201 242689 110206992
Left ventricular dysfunction 17.65 13.66 4 139614 23489 110426192
Overgrowth bacterial 17.56 13.66 8 139610 263 110449418
Myelodysplastic syndrome 17.53 13.66 13 139605 37471 110412210
Medical device site fistula 17.44 13.66 5 139613 40 110449641
Infusion site pain 17.41 13.66 55 139563 17364 110432317
Bone pain 17.34 13.66 35 139583 65098 110384583
Fear 17.32 13.66 4 139614 23189 110426492
Myopathy 17.31 13.66 5 139613 24955 110424726
Diabetes mellitus inadequate control 17.22 13.66 8 139610 29767 110419914
Strangulated umbilical hernia 17.17 13.66 4 139614 12 110449669
Dysplasia 17.14 13.66 16 139602 1832 110447849
Cardiac disorder 17.08 13.66 45 139573 76235 110373446
Nodule 17.04 13.66 10 139608 32621 110417060
Anal spasm 17.04 13.66 7 139611 178 110449503
Anal blister 17.03 13.66 3 139615 0 110449681
Bacillus infection 16.98 13.66 15 139603 1599 110448082
Hyperhidrosis 16.88 13.66 153 139465 187145 110262536
Abdominal rigidity 16.86 13.66 22 139596 3658 110446023
Basilar artery occlusion 16.78 13.66 8 139610 292 110449389
Infrequent bowel movements 16.74 13.66 17 139601 2158 110447523
Hypertensive crisis 16.69 13.66 5 139613 24367 110425314
Stoma obstruction 16.63 13.66 8 139610 298 110449383
Fistulotomy 16.49 13.66 4 139614 15 110449666
Vertigo 16.46 13.66 175 139443 86695 110362986
Small intestine operation 16.45 13.66 5 139613 50 110449631
Stomatitis 16.44 13.66 241 139377 270001 110179680
Eczema 16.31 13.66 151 139467 72142 110377539
Upper respiratory tract infection 16.29 13.66 98 139520 131230 110318451
Blood potassium increased 16.25 13.66 11 139607 33238 110416443
Psychomotor hyperactivity 16.17 13.66 3 139615 20274 110429407
Enteritis 16.06 13.66 57 139561 19099 110430582
Presyncope 16.02 13.66 23 139595 48864 110400817
Surgery 16.01 13.66 98 139520 41185 110408496
Enteritis infectious 15.94 13.66 22 139596 3860 110445821
Bacteraemia 15.91 13.66 18 139600 42372 110407309
Blood sodium decreased 15.82 13.66 15 139603 38304 110411377
Arteriosclerosis coronary artery 15.72 13.66 6 139612 25112 110424569
Anaplastic large-cell lymphoma 15.72 13.66 7 139611 218 110449463
Granulomatous rosacea 15.69 13.66 7 139611 219 110449462
Arrhythmia 15.61 13.66 41 139577 69534 110380147
Cholecystectomy 15.60 13.66 39 139579 10770 110438911
Nail disorder 15.54 13.66 31 139587 57904 110391777
Vertebral artery occlusion 15.51 13.66 9 139609 493 110449188
Posterior reversible encephalopathy syndrome 15.51 13.66 12 139606 33849 110415832
Myasthenia gravis 15.50 13.66 4 139614 21507 110428174
Hyperplastic cholecystopathy 15.48 13.66 7 139611 226 110449455
Skin ulcer 15.45 13.66 36 139582 63609 110386072
Small intestine ulcer 15.43 13.66 11 139607 860 110448821
Tenderness 15.40 13.66 9 139609 29428 110420253
Small intestinal anastomosis 15.40 13.66 4 139614 21 110449660
Diverticulitis 15.37 13.66 118 139500 53404 110396277
Pseudomonas infection 15.32 13.66 8 139610 27845 110421836
Hypothermia 15.31 13.66 7 139611 26295 110423386
Anal fissure haemorrhage 15.24 13.66 6 139612 136 110449545
Generalised oedema 15.22 13.66 10 139608 30694 110418987
Urosepsis 15.19 13.66 10 139608 30665 110419016
Body temperature decreased 15.17 13.66 89 139529 36846 110412835
Erythema multiforme 15.05 13.66 4 139614 21093 110428588
Pericardial effusion 15.02 13.66 31 139587 57186 110392495
Blepharospasm 15.01 13.66 29 139589 54822 110394859
Drug dependence 14.99 13.66 25 139593 49995 110399686
Precancerous lesion of digestive tract 14.95 13.66 3 139615 3 110449678
Pain in jaw 14.95 13.66 26 139592 51151 110398530
Pubic pain 14.93 13.66 7 139611 246 110449435
Gastroenteritis salmonella 14.91 13.66 13 139605 1362 110448319
Hypophosphataemia 14.89 13.66 12 139606 33170 110416511
Obstructive airways disorder 14.84 13.66 22 139596 46127 110403554
Anal inflammation 14.80 13.66 17 139601 2479 110447202
Acute graft versus host disease in intestine 14.80 13.66 26 139592 5613 110444068
Hepatic enzyme increased 14.74 13.66 301 139317 320591 110129090
Wheezing 14.71 13.66 230 139388 255000 110194681
Hydrosalpinx 14.68 13.66 4 139614 26 110449655
Abdominal hernia obstructive 14.66 13.66 6 139612 151 110449530
Aspergillus infection 14.63 13.66 7 139611 25609 110424072
Strangulated hernia 14.55 13.66 5 139613 76 110449605
Spondylitis 14.41 13.66 39 139579 11299 110438382
Furuncle 14.37 13.66 33 139585 8635 110441046
Skin discolouration 14.25 13.66 25 139593 49021 110400660
Glycosylated haemoglobin increased 14.20 13.66 6 139612 23613 110426068
Myocardial ischaemia 14.19 13.66 8 139610 26676 110423005
Injection site bruising 14.12 13.66 27 139591 51236 110398445
Cardiac aneurysm 14.09 13.66 14 139604 1731 110447950
Endometriosis 14.09 13.66 22 139596 4312 110445369
Osteosarcoma 14.08 13.66 8 139610 421 110449260
Central obesity 14.03 13.66 15 139603 2021 110447660
Atrioventricular block complete 13.97 13.66 4 139614 20078 110429603
Petechiae 13.90 13.66 6 139612 23311 110426370
Pyelonephritis chronic 13.86 13.66 7 139611 290 110449391
Enterocolonic fistula 13.80 13.66 6 139612 176 110449505
Urine output decreased 13.75 13.66 4 139614 19872 110429809
Mechanical ileus 13.70 13.66 12 139606 1265 110448416
Skin necrosis 13.70 13.66 5 139613 21507 110428174
Blood calcium decreased 13.69 13.66 15 139603 35830 110413851

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AG05 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Monoclonal antibodies
MeSH PA D005765 Gastrointestinal Agents
FDA MoA N0000175774 Integrin Receptor Antagonists
FDA EPC N0000175775 Integrin Receptor Antagonist
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:67079 anti-inflammatory agent

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

DiseaseRelationSNOMED_IDDOID
Crohn's disease indication 34000006
Ulcerative colitis indication 64766004 DOID:8577
Chronic antibioticrefractory ileal pouchitis indication 1217704000
Listeriosis contraindication 4241002 DOID:11573
Progressive multifocal leukoencephalopathy contraindication 22255007 DOID:643
Cytomegalovirus infection contraindication 28944009
Sepsis contraindication 91302008
Active tuberculosis contraindication 427099000




🐶 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
Integrin alpha-4/beta-7 Adhesion ANTIBODY BINDING IC50 8.30 IUPHAR DRUG LABEL

External reference:

IDSource
D08083 KEGG_DRUG
4033357 VUID
N0000190759 NUI
4033357 VANDF
CHEBI:750163 CHEBI
CHEMBL1743087 ChEMBL_ID
C543529 MESH_SUPPLEMENTAL_RECORD_UI
7437 IUPHAR_LIGAND_ID
DB09033 DRUGBANK_ID
1538097 RXNORM
221326 MMSL
30329 MMSL
d08265 MMSL
015531 NDDF
704256006 SNOMEDCT_US
704257002 SNOMEDCT_US
C2742797 UMLSCUI
9093 INN_ID
9RV78Q2002 UNII
C438271 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ENTYVIO HUMAN PRESCRIPTION DRUG LABEL 1 64764-107 INJECTION, SOLUTION 108 mg SUBCUTANEOUS BLA 31 sections
ENTYVIO Pen HUMAN PRESCRIPTION DRUG LABEL 1 64764-108 INJECTION, SOLUTION 108 mg SUBCUTANEOUS BLA 31 sections
Entyvio HUMAN PRESCRIPTION DRUG LABEL 1 64764-300 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 300 mg INTRAVENOUS BLA 31 sections