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

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 2628.50 16.29 2302 31684 472124 50099014
Therapeutic reaction time decreased 1500.58 16.29 310 33676 1042 50570096
Pregnancy 1162.12 16.29 508 33478 29069 50542069
Frequent bowel movements 1009.67 16.29 372 33614 13546 50557592
Haematochezia 999.38 16.29 502 33484 39380 50531758
No adverse event 706.39 16.29 376 33610 33202 50537936
Abdominal pain 667.30 16.29 805 33181 235423 50335715
Poor venous access 516.90 16.29 211 33775 10129 50561009
Faecal calprotectin increased 492.67 16.29 138 33848 2017 50569121
Mucous stools 439.34 16.29 135 33851 2767 50568371
Intestinal obstruction 320.07 16.29 207 33779 26176 50544962
Loss of therapeutic response 310.01 16.29 60 33926 128 50571010
Clostridium difficile infection 275.59 16.29 186 33800 25253 50545885
Defaecation urgency 268.36 16.29 94 33892 2939 50568199
Colitis ulcerative 267.50 16.29 157 33829 16697 50554441
Anal abscess 237.11 16.29 91 33895 3700 50567438
Rectal haemorrhage 229.07 16.29 197 33789 38361 50532777
Colectomy 224.51 16.29 75 33911 2025 50569113
Anal fistula 208.65 16.29 76 33910 2666 50568472
Drug level decreased 207.82 16.29 97 33889 6436 50564702
Intestinal stenosis 191.79 16.29 70 33916 2470 50568668
Diarrhoea haemorrhagic 187.11 16.29 95 33891 7580 50563558
Diarrhoea 167.59 16.29 808 33178 587668 49983470
Intestinal resection 166.79 16.29 62 33924 2305 50568833
Fistula 158.54 16.29 87 33899 8131 50563007
Ileostomy 155.67 16.29 49 33937 1089 50570049
Gastrointestinal inflammation 151.59 16.29 70 33916 4530 50566608
Toxicity to various agents 128.41 16.29 3 33983 212496 50358642
Proctitis 116.00 16.29 45 33941 1883 50569255
Abdominal distension 115.54 16.29 189 33797 72714 50498424
Blood pressure increased 114.98 16.29 267 33719 132865 50438273
Abortion spontaneous 110.08 16.29 138 33848 41634 50529504
Flatulence 91.82 16.29 106 33880 29352 50541786
Drug interaction 90.95 16.29 13 33973 199608 50371530
Drug ineffective 88.47 16.29 887 33099 818446 49752692
Dyschezia 80.60 16.29 34 33952 1770 50569368
Rectal abscess 79.72 16.29 29 33957 1013 50570125
Anal fissure 77.32 16.29 39 33947 3066 50568072
Female genital tract fistula 76.80 16.29 41 33945 3625 50567513
Hospitalisation 75.51 16.29 151 33835 67786 50503352
Large intestinal stenosis 75.42 16.29 32 33954 1690 50569448
Arthralgia 74.29 16.29 526 33460 438176 50132962
Hypotension 72.11 16.29 34 33952 235435 50335703
Abscess intestinal 71.53 16.29 29 33957 1364 50569774
Anal incontinence 68.77 16.29 59 33927 11431 50559707
Inflammatory bowel disease 67.85 16.29 37 33949 3413 50567725
Abnormal faeces 66.31 16.29 39 33947 4157 50566981
Glossodynia 64.94 16.29 3 33983 115566 50455572
Cholangitis sclerosing 64.54 16.29 26 33960 1203 50569935
Colitis 63.87 16.29 102 33884 38427 50532711
Infusion site extravasation 63.79 16.29 46 33940 6930 50564208
Abdominal abscess 62.68 16.29 37 33949 3971 50567167
Rheumatoid arthritis 62.38 16.29 29 33957 202521 50368617
Faeces soft 62.03 16.29 37 33949 4047 50567091
Ileal stenosis 60.01 16.29 26 33960 1446 50569692
Abdominal pain lower 59.10 16.29 73 33913 21683 50549455
Contraindicated product administered 58.62 16.29 14 33972 148944 50422194
Swelling 58.48 16.29 31 33955 200841 50370297
COVID-19 55.82 16.29 107 33879 46555 50524583
Vein rupture 54.86 16.29 21 33965 847 50570291
Gastrointestinal scarring 53.41 16.29 15 33971 221 50570917
Febrile neutropenia 53.40 16.29 3 33983 97664 50473474
Intestinal anastomosis complication 53.29 16.29 15 33971 223 50570915
Heart rate increased 51.97 16.29 141 33845 77109 50494029
Rectal tenesmus 51.59 16.29 17 33969 439 50570699
Gastrointestinal stoma output increased 50.78 16.29 14 33972 192 50570946
Neutropenia 50.72 16.29 18 33968 147947 50423191
Abscess 50.71 16.29 55 33931 14217 50556921
Synovitis 50.01 16.29 11 33975 123854 50447284
Death 49.83 16.29 89 33897 325290 50245848
Arthropathy 49.55 16.29 22 33964 157884 50413254
Pyoderma gangrenosum 49.22 16.29 28 33958 2803 50568335
Small intestinal obstruction 48.69 16.29 57 33929 16011 50555127
Gastrointestinal pain 47.47 16.29 41 33945 8015 50563123
Gastrointestinal stoma complication 46.72 16.29 22 33964 1488 50569650
Erythema nodosum 45.76 16.29 30 33956 3873 50567265
Colectomy total 45.46 16.29 12 33974 138 50571000
Terminal ileitis 43.03 16.29 16 33970 595 50570543
Thrombocytopenia 42.96 16.29 16 33970 127657 50443481
Colonic abscess 42.39 16.29 17 33969 777 50570361
Overdose 42.03 16.29 8 33978 99719 50471419
Pancytopenia 41.89 16.29 4 33982 84026 50487112
Appendicitis 41.66 16.29 35 33951 6589 50564549
Proctalgia 41.26 16.29 31 33955 4972 50566166
Pouchitis 40.66 16.29 14 33972 415 50570723
Maternal exposure during pregnancy 40.45 16.29 29 33957 159749 50411389
Arthritis enteropathic 40.34 16.29 12 33974 219 50570919
Bile acid malabsorption 40.02 16.29 11 33975 149 50570989
Intestinal ulcer 39.94 16.29 18 33968 1100 50570038
Disease progression 39.75 16.29 8 33978 95858 50475280
Wound 39.58 16.29 11 33975 105783 50465355
Exposure via breast milk 39.46 16.29 20 33966 1588 50569550
Large intestinal ulcer 39.46 16.29 25 33961 3044 50568094
Rectal cancer metastatic 39.40 16.29 12 33974 238 50570900
Haemorrhoids 38.02 16.29 55 33931 18998 50552140
Acute kidney injury 38.01 16.29 59 33927 227999 50343139
Stress 38 16.29 100 33886 53693 50517445
Colostomy 37.97 16.29 15 33971 659 50570479
Hyponatraemia 37.88 16.29 9 33977 96130 50475008
Confusional state 37.21 16.29 42 33944 185886 50385252
Injection site pain 37.20 16.29 14 33972 111010 50460128
Joint swelling 36.70 16.29 68 33918 245218 50325920
Cytomegalovirus colitis 36.06 16.29 20 33966 1907 50569231
Gastrointestinal infection 35.72 16.29 33 33953 7041 50564097
Rectal discharge 35.52 16.29 13 33973 462 50570676
Headache 35.10 16.29 505 33481 506030 50065108
Fall 35.03 16.29 112 33874 334820 50236318
Gastroenteritis 35.02 16.29 59 33927 23222 50547916
Blood iron decreased 34.85 16.29 41 33945 11574 50559564
Pseudopolyp 34.63 16.29 11 33975 252 50570886
Blood pressure decreased 34.58 16.29 99 33887 55810 50515328
Weight fluctuation 33.52 16.29 32 33954 7116 50564022
SARS-CoV-1 test positive 33.10 16.29 7 33979 27 50571111
Stoma closure 32.35 16.29 6 33980 9 50571129
Blood creatinine increased 32.32 16.29 6 33980 76154 50494984
Therapy non-responder 32.19 16.29 91 33895 50931 50520207
Surgery 32.18 16.29 66 33920 30139 50540999
Steroid dependence 31.39 16.29 11 33975 344 50570794
Depression 31.35 16.29 39 33947 165384 50405754
White blood cell count decreased 31.12 16.29 20 33966 116702 50454436
Pain 30.50 16.29 246 33740 578657 49992481
Gastrointestinal stoma output abnormal 30.41 16.29 7 33979 43 50571095
Platelet count decreased 30.09 16.29 15 33971 100711 50470427
Abscess limb 29.78 16.29 24 33962 4263 50566875
Atrial fibrillation 29.14 16.29 16 33970 101729 50469409
Granulomatous rosacea 29.06 16.29 6 33980 20 50571118
Systemic lupus erythematosus 28.97 16.29 31 33955 140591 50430547
Intestinal operation 28.92 16.29 11 33975 436 50570702
General physical health deterioration 28.68 16.29 32 33954 142402 50428736
Constipation 28.59 16.29 218 33768 185490 50385648
Intestinal anastomosis 28.35 16.29 10 33976 319 50570819
Anal stenosis 28.32 16.29 10 33976 320 50570818
Therapy partial responder 28.08 16.29 28 33958 6563 50564575
Musculoskeletal stiffness 27.97 16.29 27 33959 128454 50442684
Product administered to patient of inappropriate age 27.91 16.29 19 33967 2611 50568527
Cardiac arrest 27.27 16.29 11 33975 83640 50487498
Ileectomy 27.15 16.29 8 33978 141 50570997
Hypertension 27.00 16.29 64 33922 211139 50359999
Vaginal flatulence 26.93 16.29 9 33977 243 50570895
Pharyngeal paraesthesia 26.81 16.29 15 33971 1454 50569684
Stoma site extravasation 26.79 16.29 9 33977 247 50570891
Oropharyngeal pain 26.47 16.29 113 33873 77688 50493450
Dyspnoea 26.01 16.29 239 33747 547369 50023769
Intestinal fistula 26.00 16.29 12 33974 775 50570363
Gastrointestinal dysplasia 25.91 16.29 6 33980 38 50571100
Anaplastic large-cell lymphoma 25.81 16.29 7 33979 90 50571048
Drug hypersensitivity 25.48 16.29 85 33901 250925 50320213
Enzyme level increased 24.83 16.29 9 33977 311 50570827
Ileostomy closure 24.75 16.29 7 33979 106 50571032
Abdominal adhesions 24.66 16.29 18 33968 2762 50568376
Gastrointestinal bacterial infection 24.43 16.29 11 33975 671 50570467
Wrong technique in product usage process 24.37 16.29 4 33982 55506 50515632
Gastrointestinal obstruction 24.23 16.29 12 33974 907 50570231
Neuropathy peripheral 23.91 16.29 18 33968 96739 50474399
Respiratory failure 23.79 16.29 16 33970 91165 50479973
Rectal fissure 23.79 16.29 10 33976 516 50570622
Abdominal wall abscess 23.55 16.29 11 33975 730 50570408
Cardio-respiratory arrest 23.40 16.29 4 33982 53888 50517250
Cardiac failure congestive 23.12 16.29 14 33972 84368 50486770
Stoma creation 23.12 16.29 5 33981 22 50571116
Pericarditis 23.08 16.29 12 33974 78677 50492461
Pharyngitis streptococcal 23.03 16.29 29 33957 8779 50562359
Bowel movement irregularity 22.98 16.29 20 33966 3948 50567190
Injury 22.69 16.29 3 33983 48922 50522216
Fatigue 22.63 16.29 628 33358 706973 49864165
Injection site erythema 22.62 16.29 11 33975 74925 50496213
Polyp 22.55 16.29 23 33963 5539 50565599
Stomatitis 22.40 16.29 21 33965 101323 50469815
Drug intolerance 22.36 16.29 74 33912 219030 50352108
Depressed level of consciousness 22.24 16.29 4 33982 51949 50519189
Stoma complication 22.22 16.29 8 33978 271 50570867
Seizure 22.10 16.29 28 33958 117846 50453292
Blood cholesterol increased 22.08 16.29 5 33981 55210 50515928
Pregnancy of partner 21.97 16.29 5 33981 29 50571109
Obstruction 21.81 16.29 15 33971 2096 50569042
Bradycardia 21.78 16.29 8 33978 64418 50506720
Ill-defined disorder 21.75 16.29 5 33981 54649 50516489
Loss of personal independence in daily activities 21.58 16.29 10 33976 70040 50501098
Intestinal dilatation 21.52 16.29 13 33973 1455 50569683
Adenocarcinoma of colon 21.48 16.29 15 33971 2147 50568991
Infection parasitic 21.40 16.29 8 33978 302 50570836
Malaise 21.39 16.29 330 33656 335202 50235936
Hallucination 21.31 16.29 3 33983 46654 50524484
Aspartate aminotransferase increased 21.29 16.29 13 33973 77985 50493153
Gastrointestinal mucosa hyperaemia 21.23 16.29 7 33979 181 50570957
Hypoglycaemia 21.13 16.29 5 33981 53576 50517562
Agitation 21.02 16.29 5 33981 53379 50517759
Cryptitis 20.92 16.29 5 33981 37 50571101
Mobility decreased 20.90 16.29 14 33972 79934 50491204
B-cell unclassifiable lymphoma high grade 20.84 16.29 4 33982 8 50571130
Infusion site bruising 20.68 16.29 15 33971 2280 50568858
Bacillus infection 20.63 16.29 9 33977 509 50570629
Stoma site abscess 20.46 16.29 6 33980 104 50571034
Hypersensitivity 20.39 16.29 75 33911 215086 50356052
Lupus-like syndrome 19.82 16.29 28 33958 9463 50561675
Gastrointestinal fistula 19.31 16.29 8 33978 398 50570740
Proctectomy 19.15 16.29 5 33981 55 50571083
Intestinal perforation 19.11 16.29 29 33957 10450 50560688
Product dose omission issue 19.07 16.29 198 33788 183640 50387498
Perirectal abscess 18.89 16.29 10 33976 869 50570269
Stomal hernia 18.83 16.29 7 33979 260 50570878
Leukopenia 18.79 16.29 11 33975 67517 50503621
Neutrophil count decreased 18.74 16.29 4 33982 46022 50525116
Bacterial vulvovaginitis 18.67 16.29 9 33977 641 50570497
Dysphagia 18.42 16.29 15 33971 77503 50493635
Skin warm 18.15 16.29 19 33967 4716 50566422
Hypoxia 17.88 16.29 6 33980 51117 50520021
Small intestinal stenosis 17.76 16.29 8 33978 488 50570650
Gastroenteritis viral 17.64 16.29 39 33947 18747 50552391
Drug specific antibody present 17.57 16.29 16 33970 3352 50567786
Infusion related reaction 17.48 16.29 57 33929 169500 50401638
Anal skin tags 17.47 16.29 7 33979 319 50570819
Psoriatic arthropathy 17.38 16.29 5 33981 47027 50524111
Mucosal inflammation 17.38 16.29 3 33983 40139 50530999
Injection site reaction 17.28 16.29 6 33980 50026 50521112
Discomfort 17.13 16.29 29 33957 108351 50462787
Gastrointestinal motility disorder 17.12 16.29 18 33968 4491 50566647
Postoperative abscess 17.03 16.29 7 33979 341 50570797
Gastrointestinal wall thickening 17.00 16.29 10 33976 1066 50570072
Moraxella infection 16.88 16.29 7 33979 349 50570789
Sports injury 16.81 16.29 4 33982 29 50571109
Post procedural infection 16.79 16.29 23 33963 7553 50563585
Pelvic abscess 16.73 16.29 11 33975 1427 50569711
Pleural effusion 16.72 16.29 18 33968 81436 50489702
Hepatic enzyme increased 16.47 16.29 43 33943 137337 50433801
Nasopharyngitis 16.46 16.29 200 33786 192727 50378411

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 2436.72 20.33 1900 20319 298900 29253408
Therapeutic reaction time decreased 1090.11 20.33 216 22003 469 29551839
Frequent bowel movements 953.64 20.33 330 21889 8909 29543399
Haematochezia 626.20 20.33 373 21846 36610 29515698
Faecal calprotectin increased 359.37 20.33 103 22116 1458 29550850
Abdominal pain 352.70 20.33 469 21750 134888 29417420
Loss of therapeutic response 303.71 20.33 66 22153 260 29552048
Drug ineffective 295.80 20.33 759 21460 362411 29189897
Defaecation urgency 258.42 20.33 82 22137 1667 29550641
Anal abscess 240.45 20.33 104 22115 5147 29547161
Colitis ulcerative 237.23 20.33 137 22082 12632 29539676
No adverse event 226.46 20.33 149 22070 17329 29534979
Colectomy 220.13 20.33 70 22149 1433 29550875
Drug level decreased 195.61 20.33 95 22124 6152 29546156
Clostridium difficile infection 193.20 20.33 131 22088 16010 29536298
Mucous stools 174.99 20.33 55 22164 1082 29551226
Intestinal obstruction 167.88 20.33 129 22090 19148 29533160
Poor venous access 159.23 20.33 67 22152 3094 29549214
Blood pressure increased 156.22 20.33 232 21987 73571 29478737
Cholangitis sclerosing 145.20 20.33 47 22172 1020 29551288
Intestinal resection 115.83 20.33 43 22176 1419 29550889
Anal fistula 114.15 20.33 58 22161 4137 29548171
Diarrhoea haemorrhagic 111.65 20.33 64 22155 5810 29546498
Gastrointestinal inflammation 110.26 20.33 51 22168 2957 29549351
Drug interaction 109.11 20.33 11 22208 197374 29354934
Diarrhoea 101.60 20.33 505 21714 332193 29220115
Rectal haemorrhage 99.25 20.33 126 22093 34423 29517885
Ileal stenosis 96.83 20.33 36 22183 1193 29551115
Acute kidney injury 94.03 20.33 41 22178 265226 29287082
Hospitalisation 92.10 20.33 141 22078 45847 29506461
Treatment failure 83.65 20.33 120 22099 36819 29515489
Large intestinal stenosis 82.23 20.33 33 22186 1348 29550960
Fistula 81.97 20.33 50 22169 5089 29547219
Neutropenia 79.23 20.33 5 22214 131706 29420602
Impaired quality of life 76.51 20.33 38 22181 2581 29549727
Thrombocytopenia 73.18 20.33 8 22211 134815 29417493
Colectomy total 71.61 20.33 17 22202 107 29552201
Febrile neutropenia 71.47 20.33 3 22216 112237 29440071
Colitis 71.45 20.33 102 22117 31146 29521162
Arthralgia 70.76 20.33 248 21971 139369 29412939
Therapy non-responder 69.36 20.33 100 22119 30811 29521497
Intestinal stenosis 69.16 20.33 32 22187 1856 29550452
Abscess intestinal 67.59 20.33 29 22190 1405 29550903
Death 66.07 20.33 97 22122 341987 29210321
Hypotension 62.75 20.33 34 22185 194320 29357988
Flatulence 61.27 20.33 71 22148 17638 29534670
Inflammatory bowel disease 60.11 20.33 31 22188 2280 29550028
Pouchitis 55.89 20.33 20 22199 593 29551715
Proctitis 53.89 20.33 28 22191 2091 29550217
Abdominal abscess 52.91 20.33 34 22185 3790 29548518
Platelet count decreased 52.47 20.33 8 22211 104664 29447644
Rectal abscess 50.66 20.33 21 22198 933 29551375
Weight decreased 50 20.33 235 21984 150670 29401638
Infusion site extravasation 48.78 20.33 30 22189 3097 29549211
Bronchiectasis 48.58 20.33 40 22179 6545 29545763
Ileostomy 48.29 20.33 17 22202 480 29551828
Abscess 45.83 20.33 46 22173 9716 29542592
Dyschezia 45.81 20.33 21 22198 1192 29551116
Gastrointestinal mucosa hyperaemia 45.75 20.33 14 22205 251 29552057
Therapy partial responder 45.68 20.33 35 22184 5164 29547144
Fistula discharge 42.40 20.33 15 22204 430 29551878
Cytomegalovirus colitis 41.89 20.33 25 22194 2444 29549864
Gastrointestinal anastomotic leak 41.49 20.33 14 22205 347 29551961
Abdominal pain lower 41.09 20.33 41 22178 8597 29543711
Abdominal distension 39.97 20.33 99 22120 45812 29506496
Abnormal faeces 39.79 20.33 25 22194 2680 29549628
Cardiac arrest 39.70 20.33 8 22211 85583 29466725
Short-bowel syndrome 39.54 20.33 12 22207 209 29552099
Faeces soft 38.64 20.33 24 22195 2521 29549787
Drug specific antibody present 38.50 20.33 24 22195 2537 29549771
Product administered to patient of inappropriate age 37.71 20.33 24 22195 2631 29549677
Enterocutaneous fistula 37.39 20.33 16 22203 770 29551538
Disease progression 37.29 20.33 8 22211 81908 29470400
Anorectal discomfort 37.22 20.33 20 22199 1599 29550709
COVID-19 37.16 20.33 83 22136 35931 29516377
Dyspnoea 37.13 20.33 124 22095 326608 29225700
Stress 36.28 20.33 61 22158 21429 29530879
White blood cell count decreased 36.23 20.33 9 22210 83353 29468955
Colostomy 36.12 20.33 13 22206 392 29551916
Heart rate increased 36.06 20.33 86 22133 38852 29513456
Proctalgia 36.03 20.33 28 22191 4217 29548091
Respiratory failure 35.94 20.33 14 22205 97117 29455191
Small intestinal stenosis 35.24 20.33 13 22206 421 29551887
Nephrolithiasis 35.15 20.33 66 22153 25268 29527040
Oedema peripheral 35.03 20.33 17 22202 103540 29448768
Small intestinal obstruction 34.91 20.33 46 22173 13015 29539293
Haemorrhoids 32.63 20.33 42 22177 11615 29540693
Gastrointestinal stoma output increased 32.12 20.33 7 22212 28 29552280
Overdose 32.11 20.33 10 22209 79809 29472499
Steroid dependence 32.07 20.33 11 22208 287 29552021
Gastrointestinal infection 31.82 20.33 25 22194 3826 29548482
Appendicitis 31.71 20.33 36 22183 8743 29543565
Renal failure 31.17 20.33 26 22193 118573 29433735
Weight fluctuation 30.51 20.33 25 22194 4061 29548247
Rectal stenosis 29.12 20.33 9 22210 167 29552141
Malaise 28.91 20.33 212 22007 159390 29392918
Headache 28.65 20.33 226 21993 173781 29378527
Somnolence 28.05 20.33 18 22201 93937 29458371
Large intestine anastomosis 27.91 20.33 7 22212 57 29552251
Gastrointestinal scarring 27.85 20.33 8 22211 114 29552194
Proctocolectomy 26.81 20.33 7 22212 68 29552240
Neuropathy peripheral 26.66 20.33 10 22209 71017 29481291
Heart rate decreased 26.35 20.33 58 22161 24854 29527454
Abdominal pain upper 26.32 20.33 103 22116 60890 29491418
Surgery 26.24 20.33 38 22181 11741 29540567
Hypoxia 25.20 20.33 3 22216 47376 29504932
Anal fissure 24.88 20.33 19 22200 2789 29549519
Product use issue 24.78 20.33 90 22129 51354 29500954
Blood creatinine increased 24.47 20.33 17 22202 85085 29467223
Appendicectomy 24.28 20.33 12 22207 806 29551502
Gastroenteritis 24.26 20.33 38 22181 12578 29539730
Photophobia 24.10 20.33 26 22193 5969 29546339
Overgrowth bacterial 23.73 20.33 7 22212 110 29552198
Epistaxis 23.62 20.33 5 22214 51699 29500609
Product dose omission issue 23.50 20.33 138 22081 96245 29456063
Colon dysplasia 23.27 20.33 7 22212 118 29552190
Tachycardia 22.83 20.33 13 22206 72397 29479911
Erythema nodosum 22.62 20.33 12 22207 935 29551373
Catheter site injury 22.54 20.33 4 22215 3 29552305
Colon cancer 22.08 20.33 28 22191 7627 29544681
Leukopenia 22.05 20.33 7 22212 55196 29497112
Stoma creation 22.01 20.33 4 22215 4 29552304
Calcium deficiency 21.75 20.33 7 22212 149 29552159
Iron deficiency anaemia 21.62 20.33 30 22189 8912 29543396
Inappropriate schedule of product administration 21.59 20.33 78 22141 44394 29507914
Post procedural infection 21.53 20.33 21 22198 4284 29548024
Hypoglycaemia 21.43 20.33 5 22214 48341 29503967
Spondylitis 21.38 20.33 12 22207 1045 29551263
Renal impairment 21.15 20.33 18 22201 81315 29470993
Cardiac failure congestive 21.10 20.33 16 22203 76565 29475743
Pyoderma gangrenosum 21.05 20.33 12 22207 1077 29551231
C-reactive protein increased 20.95 20.33 77 22142 44186 29508122
Incisional hernia 20.68 20.33 12 22207 1114 29551194
Myocardial infarction 20.48 20.33 32 22187 110264 29442044

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 4868.96 16.51 3782 41762 629024 63824164
Therapeutic reaction time decreased 1989.75 16.51 420 45124 1512 64451676
Frequent bowel movements 1788.94 16.51 618 44926 17687 64435501
Haematochezia 1511.56 16.51 796 44748 65577 64387611
Abdominal pain 937.62 16.51 1125 44419 311250 64141938
Faecal calprotectin increased 793.30 16.51 227 45317 3413 64449775
Poor venous access 630.75 16.51 260 45284 12157 64441031
Mucous stools 558.99 16.51 169 45375 3104 64450084
Defaecation urgency 457.28 16.51 152 45392 3837 64449351
Intestinal obstruction 413.51 16.51 279 45265 36007 64417181
Pregnancy 392.68 16.51 221 45323 20644 64432544
Drug ineffective 327.46 16.51 1311 44233 838936 63614252
Clostridium difficile infection 321.54 16.51 239 45305 35924 64417264
Diarrhoea 317.64 16.51 1172 44372 721532 63731656
Colectomy 304.42 16.51 101 45443 2533 64450655
Drug level decreased 301.59 16.51 152 45392 11351 64441837
Blood pressure increased 291.76 16.51 473 45071 172079 64281109
Anal abscess 269.19 16.51 123 45421 7385 64445803
Intestinal resection 251.39 16.51 91 45453 2977 64450211
Rectal haemorrhage 242.78 16.51 257 45287 61560 64391628
Toxicity to various agents 236.74 16.51 4 45540 363509 64089679
Loss of therapeutic response 231.16 16.51 51 45493 236 64452952
Gastrointestinal inflammation 223.70 16.51 102 45442 6093 64447095
Colitis ulcerative 222.32 16.51 160 45384 22868 64430320
Diarrhoea haemorrhagic 214.12 16.51 120 45424 11107 64442081
Intestinal stenosis 207.33 16.51 80 45464 3134 64450054
Anal fistula 204.00 16.51 91 45453 5162 64448026
No adverse event 202.21 16.51 165 45379 28396 64424792
Ileostomy 199.56 16.51 61 45483 1163 64452025
Fistula 193.44 16.51 107 45437 9654 64443534
Acute kidney injury 181.28 16.51 47 45497 449193 64003995
Drug interaction 177.88 16.51 23 45521 362060 64091128
Abdominal distension 151.03 16.51 255 45289 95739 64357449
Hospitalisation 141.85 16.51 217 45327 74990 64378198
Completed suicide 140.01 16.51 4 45540 224410 64228778
Flatulence 135.92 16.51 146 45398 35520 64417668
Cholangitis sclerosing 128.19 16.51 49 45495 1870 64451318
Neutropenia 123.11 16.51 13 45531 239611 64213577
Hypotension 119.47 16.51 60 45484 380914 64072274
Febrile neutropenia 114.69 16.51 4 45540 187653 64265535
Thrombocytopenia 107.94 16.51 15 45529 223786 64229402
Colectomy total 106.94 16.51 26 45518 197 64452991
Infusion site extravasation 103.70 16.51 63 45481 6774 64446414
Large intestinal stenosis 103.62 16.51 45 45499 2392 64450796
Ileal stenosis 103.49 16.51 43 45501 2047 64451141
Faeces soft 102.00 16.51 59 45485 5796 64447392
Rectal abscess 101.30 16.51 39 45505 1518 64451670
Dyschezia 100.83 16.51 44 45500 2366 64450822
Arthralgia 100.43 16.51 593 44951 441667 64011521
Proctitis 98.50 16.51 47 45497 3112 64450076
Abdominal pain lower 98.47 16.51 107 45437 26362 64426826
Abscess intestinal 95.22 16.51 42 45502 2318 64450870
Abnormal faeces 94.07 16.51 56 45488 5803 64447385
Heart rate increased 93.80 16.51 212 45332 98463 64354725
Death 91.99 16.51 124 45420 482581 63970607
Abscess 87.95 16.51 87 45457 19217 64433971
Stress 86.27 16.51 154 45390 60380 64392808
Hyponatraemia 84.64 16.51 5 45539 148334 64304854
Overdose 83.63 16.51 8 45536 159558 64293630
Inflammatory bowel disease 79.77 16.51 46 45498 4492 64448696
Weight fluctuation 76.39 16.51 56 45488 8226 64444962
Anal fissure 76.19 16.51 46 45498 4890 64448298
Therapy non-responder 75.77 16.51 153 45391 65746 64387442
Colitis 75.70 16.51 143 45401 58531 64394657
Gastrointestinal stoma output increased 71.32 16.51 19 45525 215 64452973
Cardiac arrest 70.44 16.51 12 45532 154052 64299136
Haemorrhoids 67.46 16.51 84 45460 23917 64429271
Gastrointestinal scarring 66.00 16.51 18 45526 224 64452964
Fatigue 65.57 16.51 811 44733 747919 63705269
Disease progression 64.85 16.51 11 45533 141669 64311519
Gastrointestinal mucosa hyperaemia 64.34 16.51 20 45524 404 64452784
COVID-19 64.17 16.51 142 45402 64998 64388190
Colostomy 62.52 16.51 23 45521 788 64452400
Abortion spontaneous 61.27 16.51 82 45462 25061 64428127
Anal incontinence 61.05 16.51 64 45480 15132 64438056
Proctalgia 60.60 16.51 47 45497 7512 64445676
Blood iron decreased 59.58 16.51 57 45487 12085 64441103
Platelet count decreased 59.50 16.51 22 45522 167689 64285499
Weight decreased 58.91 16.51 374 45170 285365 64167823
Pouchitis 58.50 16.51 22 45522 802 64452386
Gastrointestinal pain 58.35 16.51 46 45498 7528 64445660
Gastrointestinal infection 57.75 16.51 47 45497 8049 64445139
Contraindicated product administered 54.95 16.51 6 45538 107823 64345365
Hypokalaemia 54.62 16.51 10 45534 121893 64331295
Abdominal abscess 54.50 16.51 41 45503 6263 64446925
Cardio-respiratory arrest 54.11 16.51 4 45540 98389 64354799
Rectal tenesmus 52.87 16.51 22 45522 1051 64452137
Treatment failure 52.83 16.51 192 45352 116624 64336564
Rheumatoid arthritis 52.73 16.51 25 45519 164269 64288919
Dyspnoea 52.40 16.51 296 45248 718378 63734810
Malaise 51.90 16.51 466 45078 395781 64057407
Small intestinal obstruction 51.60 16.51 73 45471 23500 64429688
Rectal discharge 51.51 16.51 18 45526 530 64452658
Product administered to patient of inappropriate age 51.46 16.51 35 45509 4566 64448622
Pancytopenia 50.49 16.51 19 45525 143290 64309898
Renal failure 49.24 16.51 34 45510 181654 64271534
Erythema nodosum 48.48 16.51 32 45512 3972 64449216
Vein rupture 48.24 16.51 23 45521 1520 64451668
Respiratory failure 48.05 16.51 27 45517 161156 64292032
White blood cell count decreased 47.69 16.51 26 45518 157811 64295377
Cytomegalovirus colitis 46.61 16.51 31 45513 3897 64449291
Blood creatinine increased 46.19 16.51 19 45525 135763 64317425
Swelling 46.12 16.51 28 45516 160190 64292998
Pyoderma gangrenosum 45.41 16.51 28 45516 3090 64450098
Product dose omission issue 45.22 16.51 263 45281 194484 64258704
Abdominal pain upper 45.04 16.51 243 45301 174787 64278401
Pseudopolyp 44.76 16.51 15 45529 388 64452800
Headache 44.68 16.51 570 44974 528897 63924291
Injection site pain 44.15 16.51 12 45532 111396 64341792
SARS-CoV-1 test positive 44.10 16.51 9 45535 26 64453162
Depressed level of consciousness 42.87 16.51 4 45540 81432 64371756
Therapy partial responder 42.67 16.51 44 45500 10204 64442984
Rhabdomyolysis 42.23 16.51 7 45537 91719 64361469
Atrial fibrillation 41.30 16.51 36 45508 171053 64282135
Confusional state 41.17 16.51 76 45468 261068 64192120
Small intestinal stenosis 40.79 16.51 16 45528 655 64452533
Gastrointestinal stoma output abnormal 40.38 16.51 9 45535 44 64453144
Blood pressure decreased 40.09 16.51 143 45401 86056 64367132
Anorectal discomfort 39.73 16.51 25 45519 2860 64450328
Aspartate aminotransferase increased 38.78 16.51 18 45526 119770 64333418
Metabolic acidosis 38.68 16.51 3 45541 70955 64382233
Nephrolithiasis 38.34 16.51 91 45453 43592 64409596
Leukopenia 38.11 16.51 12 45532 101230 64351958
Gastrointestinal obstruction 37.84 16.51 19 45525 1406 64451782
Post procedural infection 37.81 16.51 40 45504 9557 64443631
Gastrointestinal stoma complication 37.63 16.51 22 45522 2204 64450984
Neutrophil count decreased 37.59 16.51 5 45539 77191 64375997
Pharyngitis streptococcal 37.52 16.51 38 45506 8630 64444558
Hallucination 37.21 16.51 4 45540 72784 64380404
Hypertension 36.96 16.51 80 45464 259181 64194007
Synovitis 36.85 16.51 12 45532 99078 64354110
Infusion site bruising 36.54 16.51 19 45525 1513 64451675
Suicide attempt 36.05 16.51 4 45540 71003 64382185
Hypoxia 35.87 16.51 9 45535 88140 64365048
Gastrointestinal bacterial infection 35.72 16.51 14 45530 572 64452616
Rectal cancer metastatic 35.60 16.51 13 45531 436 64452752
Coma 35.55 16.51 9 45535 87606 64365582
Surgery 35.43 16.51 68 45476 28145 64425043
Fall 35.20 16.51 163 45381 416663 64036525
Hypoglycaemia 35.03 16.51 10 45534 89882 64363306
Intestinal ulcer 34.98 16.51 19 45525 1652 64451536
Bradycardia 34.95 16.51 20 45524 118199 64334989
Drug specific antibody present 34.84 16.51 29 45515 5125 64448063
C-reactive protein increased 34.77 16.51 146 45398 94763 64358425
Cardiac failure congestive 34.63 16.51 25 45519 130555 64322633
Neuropathy peripheral 34.57 16.51 20 45524 117505 64335683
Glossodynia 34.53 16.51 3 45541 64693 64388495
Appendicitis 34.20 16.51 45 45499 13524 64439664
Abdominal adhesions 34.03 16.51 23 45521 2969 64450219
Proctocolectomy 33.93 16.51 9 45535 100 64453088
Incisional hernia 33.61 16.51 20 45524 2070 64451118
Gastrointestinal wall thickening 33.48 16.51 20 45524 2085 64451103
Renal impairment 33.08 16.51 28 45516 134989 64318199
Seizure 32.58 16.51 42 45502 166850 64286338
Bowel movement irregularity 32.46 16.51 27 45517 4766 64448422
Drug hypersensitivity 31.77 16.51 76 45468 237739 64215449
Cardiac failure 31.77 16.51 28 45516 132345 64320843
Hepatic function abnormal 31.71 16.51 4 45540 64309 64388879
Female genital tract fistula 31.59 16.51 21 45523 2637 64450551
Ileostomy closure 31.45 16.51 9 45535 135 64453053
Pleural effusion 31.31 16.51 26 45518 126533 64326655
Large intestinal ulcer 31.30 16.51 25 45519 4168 64449020
Agitation 30.64 16.51 12 45532 88355 64364833
Dysphagia 30.26 16.51 19 45525 106793 64346395
Influenza like illness 30.09 16.51 104 45440 61598 64391590
Lactic acidosis 29.85 16.51 4 45540 61406 64391782
Oropharyngeal pain 29.71 16.51 133 45411 88734 64364454
Large intestine anastomosis 29.60 16.51 8 45536 96 64453092
Stoma creation 29.49 16.51 6 45538 17 64453171
Bile acid malabsorption 29.42 16.51 9 45535 172 64453016
Alanine aminotransferase increased 29.24 16.51 33 45511 138998 64314190
Oedema peripheral 29.06 16.51 66 45478 210251 64242937
Stomatitis 29.04 16.51 21 45523 109584 64343604
Rectal fissure 28.89 16.51 13 45531 752 64452436
Intestinal operation 28.74 16.51 11 45533 421 64452767
Stoma site abscess 28.58 16.51 9 45535 190 64452998
Hernia 28.31 16.51 41 45503 13477 64439711
Chronic kidney disease 27.61 16.51 4 45540 57915 64395273
Intestinal anastomosis 27.46 16.51 11 45533 476 64452712
Multiple organ dysfunction syndrome 27.43 16.51 19 45525 101394 64351794
Mental status changes 27.42 16.51 5 45539 61157 64392031
Epistaxis 27.06 16.51 18 45526 98113 64355075
Respiratory arrest 26.86 16.51 3 45541 52982 64400206
General physical health deterioration 26.77 16.51 66 45478 204359 64248829
Neurogenic shock 26.39 16.51 11 45533 528 64452660
Dysarthria 26.33 16.51 5 45539 59401 64393787
Mobility decreased 26.12 16.51 14 45530 85826 64367362
Encephalopathy 25.96 16.51 5 45539 58814 64394374
Intestinal anastomosis complication 25.85 16.51 9 45535 262 64452926
Faeces hard 25.79 16.51 17 45527 2105 64451083
Obstruction 25.61 16.51 20 45524 3228 64449960
Spondyloarthropathy 25.44 16.51 12 45532 774 64452414
Exposure via breast milk 25.33 16.51 12 45532 782 64452406
Nasopharyngitis 25.28 16.51 230 45314 195843 64257345
Hyperglycaemia 25.24 16.51 6 45538 60962 64392226
Arthropathy 25.13 16.51 29 45515 120938 64332250
Rectal stenosis 25.07 16.51 9 45535 287 64452901
Depression 24.93 16.51 58 45486 183233 64269955
Pharyngeal paraesthesia 24.87 16.51 16 45528 1901 64451287
Arthritis 24.76 16.51 121 45423 83693 64369495
Gastrointestinal fistula 24.62 16.51 11 45533 626 64452562
Terminal ileitis 24.57 16.51 11 45533 629 64452559
Drug intolerance 24.37 16.51 61 45483 187931 64265257
Colonic abscess 24.24 16.51 13 45531 1102 64452086
Infusion site swelling 23.73 16.51 24 45520 5441 64447747
Enterostomy 23.55 16.51 8 45536 216 64452972
Catheter site injury 23.27 16.51 7 45537 126 64453062
Stoma closure 23.07 16.51 7 45537 130 64453058
Intestinal fistula 23.06 16.51 13 45531 1216 64451972
Delirium 23.01 16.51 10 45534 69184 64384004
Unresponsive to stimuli 22.85 16.51 4 45540 50389 64402799
Skin warm 22.82 16.51 24 45520 5693 64447495
Enterocutaneous fistula 22.72 16.51 14 45530 1543 64451645
Aphthous ulcer 22.58 16.51 36 45508 12870 64440318
Infection parasitic 22.57 16.51 9 45535 385 64452803
Acute respiratory failure 22.56 16.51 4 45540 49930 64403258
Aggression 22.49 16.51 3 45541 46229 64406959
Overgrowth bacterial 22.31 16.51 7 45537 146 64453042
Spondylitis 22.19 16.51 18 45526 3068 64450120
Myocardial infarction 22.13 16.51 53 45491 165768 64287420
Constipation 21.91 16.51 253 45291 229084 64224104
Systemic lupus erythematosus 21.72 16.51 14 45530 77598 64375590
Large intestine polyp 21.44 16.51 32 45512 10805 64442383
Polyp 21.44 16.51 25 45519 6648 64446540
Stomal hernia 21.21 16.51 8 45536 294 64452894
Fistula of small intestine 21.20 16.51 10 45534 645 64452543
Blood urea increased 21.16 16.51 3 45541 44150 64409038
Gastrointestinal motility disorder 21.14 16.51 22 45522 5157 64448031
Dysplasia 21.09 16.51 12 45532 1142 64452046
Pulmonary oedema 20.93 16.51 15 45529 78659 64374529
Blood glucose increased 20.92 16.51 23 45521 98050 64355138
Injection site erythema 20.89 16.51 12 45532 70788 64382400
Fluid retention 20.82 16.51 8 45536 59598 64393590
Anaplastic large-cell lymphoma 20.82 16.51 7 45537 183 64453005
Cerebrovascular accident 20.82 16.51 41 45503 137542 64315646
Blood cholesterol increased 20.58 16.51 5 45539 50061 64403127
Intestinal perforation 20.58 16.51 38 45506 15275 64437913
Angioedema 20.46 16.51 9 45535 61812 64391376
Medical device site fistula 20.44 16.51 5 45539 39 64453149
Injury 20.43 16.51 7 45537 55985 64397203
Lupus-like syndrome 20.39 16.51 28 45516 8763 64444425
B-cell unclassifiable lymphoma high grade 20.32 16.51 4 45540 9 64453179
Granulomatous rosacea 20.16 16.51 7 45537 202 64452986
Plasma cell myeloma 20.16 16.51 4 45540 46071 64407117
Joint swelling 20.11 16.51 81 45463 215301 64237887
Tachycardia 19.80 16.51 48 45496 149531 64303657
Coronary artery disease 19.68 16.51 9 45535 60424 64392764
Hypocalcaemia 19.64 16.51 3 45541 41750 64411438
Neoplasm progression 19.14 16.51 3 45541 40961 64412227
Clostridium difficile colitis 18.98 16.51 52 45492 27171 64426017
Ill-defined disorder 18.91 16.51 4 45540 44048 64409140
Hypersensitivity 18.90 16.51 73 45471 196379 64256809
Maternal exposure during pregnancy 18.84 16.51 24 45520 95860 64357328
Somnolence 18.75 16.51 77 45467 203568 64249620
Appendicectomy 18.55 16.51 14 45530 2149 64451039
Psoriatic arthropathy 18.44 16.51 4 45540 43277 64409911
Perirectal abscess 18.42 16.51 13 45531 1800 64451388
Iron deficiency 18.40 16.51 24 45520 7153 64446035
Food poisoning 18.35 16.51 17 45527 3461 64449727
Pulmonary hypertension 18.35 16.51 4 45540 43135 64410053
Infected fistula 18.29 16.51 7 45537 268 64452920
Infusion site pain 18.19 16.51 29 45515 10368 64442820
Migraine 18.16 16.51 90 45454 62587 64390601
Acne 18.04 16.51 46 45498 23035 64430153
Abscess limb 18.01 16.51 22 45522 6139 64447049
Gastrointestinal haemorrhage 17.88 16.51 42 45502 132270 64320918
Tremor 17.76 16.51 50 45494 148180 64305008
Pneumonia aspiration 17.55 16.51 10 45534 59261 64393927
Bone marrow failure 17.49 16.51 6 45538 47946 64405242
Fistula discharge 17.21 16.51 10 45534 990 64452198
Blood creatine phosphokinase increased 17.17 16.51 10 45534 58548 64394640
Injection site pruritus 17.16 16.51 3 45541 37823 64415365
Ileal ulcer 17.14 16.51 10 45534 998 64452190
Small intestinal resection 17.09 16.51 9 45535 735 64452453
Pus in stool 16.99 16.51 4 45540 26 64453162
Rash maculo-papular 16.95 16.51 6 45538 47020 64406168
Lymphocyte count decreased 16.86 16.51 4 45540 40695 64412493
Proctectomy 16.84 16.51 5 45539 86 64453102
Adenocarcinoma of colon 16.80 16.51 19 45525 4889 64448299
Sepsis 16.62 16.51 95 45449 230246 64222942
Gait disturbance 16.54 16.51 64 45480 172091 64281097
Urinary retention 16.54 16.51 7 45537 49194 64403994

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AA33 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
MeSH PA D005765 Gastrointestinal Agents
FDA MoA N0000175774 Integrin Receptor Antagonists
FDA EPC N0000175775 Integrin Receptor Antagonist

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




🐶 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
CHEMBL1743087 ChEMBL_ID
C543529 MESH_SUPPLEMENTAL_RECORD_UI
C438271 MESH_SUPPLEMENTAL_RECORD_UI
7437 IUPHAR_LIGAND_ID
9093 INN_ID
DB09033 DRUGBANK_ID
9RV78Q2002 UNII
1538097 RXNORM
221326 MMSL
30329 MMSL
d08265 MMSL
704256006 SNOMEDCT_US
704257002 SNOMEDCT_US
C2742797 UMLSCUI
015531 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Entyvio HUMAN PRESCRIPTION DRUG LABEL 1 64764-300 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 300 mg INTRAVENOUS BLA 28 sections