All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
humanized origin	4982	943609-66-3

Description:

Molecule	Description
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:

Dose	Unit	Route
5.40	mg	P

ADMET properties:

None

Approvals:

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

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Off label use	3679.78	14.30	3579	49625	670883	62764935
Therapeutic reaction time decreased	2218.79	14.30	491	52713	1879	63433939
Frequent bowel movements	1924.54	14.30	724	52480	22298	63413520
Haematochezia	1895.90	14.30	915	52289	52629	63383189
Pregnancy	1268.11	14.30	618	52586	36218	63399600
Abdominal pain	1173.76	14.30	1331	51873	292125	63143693
Mucous stools	770.50	14.30	239	52965	4009	63431809
No adverse event	721.55	14.30	443	52761	40962	63394856
Poor venous access	606.08	14.30	280	52924	14505	63421313
Defaecation urgency	513.45	14.30	175	53029	4000	63431818
Faecal calprotectin increased	501.06	14.30	161	53043	3042	63432776
Loss of therapeutic response	487.08	14.30	112	53092	527	63435291
Rectal haemorrhage	483.09	14.30	369	52835	48661	63387157
Intestinal obstruction	439.58	14.30	291	52913	30608	63405210
Clostridium difficile infection	366.68	14.30	257	52947	29665	63406153
Diarrhoea	332.80	14.30	1328	51876	714038	62721780
Colitis ulcerative	321.78	14.30	225	52979	25866	63409952
Drug level decreased	315.21	14.30	147	53057	7772	63428046
Colectomy	303.94	14.30	105	53099	2501	63433317
Anal fistula	275.81	14.30	106	53098	3445	63432373
Anal abscess	265.20	14.30	111	53093	4521	63431297
Intestinal stenosis	248.96	14.30	93	53111	2791	63433027
Diarrhoea haemorrhagic	227.51	14.30	123	53081	8919	63426899
Abdominal distension	219.03	14.30	314	52890	86301	63349517
Intestinal resection	217.57	14.30	84	53120	2764	63433054
Fistula	216.83	14.30	125	53079	10268	63425550
Gastrointestinal inflammation	207.43	14.30	99	53105	5513	63430305
Ileostomy	201.48	14.30	67	53137	1415	63434403
Proctitis	195.09	14.30	94	53110	5347	63430471
Toxicity to various agents	191.88	14.30	3	53201	247247	63188571
Blood pressure increased	163.16	14.30	395	52809	161667	63274151
Flatulence	161.21	14.30	171	53033	34531	63401287
Female genital tract fistula	157.90	14.30	91	53113	7468	63428350
Faeces soft	147.58	14.30	79	53125	5613	63430205
COVID-19	145.49	14.30	304	52900	112799	63323019
Stress	140.56	14.30	223	52981	66944	63368874
Drug interaction	136.55	14.30	16	53188	229115	63206703
Abdominal pain lower	134.55	14.30	135	53069	25543	63410275
Drug ineffective	127.29	14.30	1383	51821	1043382	62392436
Colitis	127.12	14.30	179	53025	48349	63387469
Pemphigus	125.53	14.30	7	53197	183719	63252099
Abnormal faeces	122.60	14.30	69	53135	5411	63430407
Contraindicated product administered	116.24	14.30	21	53183	217627	63218191
Hypotension	110.65	14.30	45	53159	272559	63163259
Glossodynia	110.35	14.30	11	53193	178865	63256953
Abortion spontaneous	108.95	14.30	164	53040	47031	63388787
Anal fissure	107.77	14.30	59	53145	4384	63431434
Vaginal flatulence	106.41	14.30	53	53151	3240	63432578
Constipation	103.88	14.30	418	52786	224525	63211293
Abscess intestinal	103.67	14.30	42	53162	1572	63434246
Dyschezia	101.99	14.30	46	53158	2248	63433570
Hand deformity	100.49	14.30	9	53195	159448	63276370
Swelling	97.19	14.30	55	53149	275323	63160495
Steroid dependence	96.73	14.30	41	53163	1723	63434095
Anal incontinence	93.37	14.30	83	53121	13493	63422325
Death	93.12	14.30	106	53098	374275	63061543
Rectal abscess	91.48	14.30	36	53168	1247	63434571
Cholangitis sclerosing	89.51	14.30	38	53166	1603	63434215
Large intestinal stenosis	86.13	14.30	39	53165	1924	63433894
Febrile neutropenia	85.85	14.30	3	53201	118446	63317372
Arthropathy	85.59	14.30	45	53159	234747	63201071
Synovitis	84.11	14.30	26	53178	186892	63248926
Acute kidney injury	82.83	14.30	60	53144	263355	63172463
Neutropenia	81.19	14.30	23	53181	174982	63260836
Inflammatory bowel disease	80.77	14.30	47	53157	3926	63431892
Proctalgia	80.72	14.30	55	53149	6055	63429763
Rheumatoid arthritis	78.27	14.30	59	53145	253760	63182058
Drug effect less than expected	75.51	14.30	34	53170	1655	63434163
Wound	72.93	14.30	23	53181	163240	63272578
Vaginal discharge	72.92	14.30	61	53143	9137	63426681
Joint swelling	72.86	14.30	101	53103	327565	63108253
Abdominal abscess	72.60	14.30	46	53158	4480	63431338
Anti-cyclic citrullinated peptide antibody positive	72.03	14.30	7	53197	116205	63319613
Thrombocytopenia	71.73	14.30	19	53185	151138	63284680
Intestinal ulcer	71.45	14.30	31	53173	1380	63434438
Haemorrhoids	70.69	14.30	90	53114	22060	63413758
Hospitalisation	70.63	14.30	193	53011	84888	63350930
Pyoderma gangrenosum	68.75	14.30	41	53163	3584	63432234
Maternal exposure during pregnancy	68.03	14.30	51	53153	220011	63215807
Product dose omission issue	67.57	14.30	380	52824	233933	63201885
Disease progression	67.36	14.30	11	53193	122747	63313071
Inappropriate schedule of product administration	66.49	14.30	215	52989	103750	63332068
Arthralgia	66.43	14.30	749	52455	568961	62866857
Gastrointestinal infection	66.34	14.30	58	53146	9223	63426595
Overdose	66.16	14.30	9	53195	115069	63320749
Ileal stenosis	65.69	14.30	31	53173	1682	63434136
Abscess	65.06	14.30	75	53129	16593	63419225
Arthritis enteropathic	63.50	14.30	19	53185	280	63435538
Hypertension	63.17	14.30	85	53119	279218	63156600
Pancytopenia	62.35	14.30	5	53199	96928	63338890
Gastrointestinal stoma output increased	60.76	14.30	19	53185	327	63435491
Rectal tenesmus	60.49	14.30	24	53180	850	63434968
Radiculopathy	59.92	14.30	53	53151	8558	63427260
Gastrointestinal pain	57.94	14.30	55	53149	9721	63426097
Hyponatraemia	57.16	14.30	12	53192	111888	63323930
Intestinal anastomosis complication	57.16	14.30	17	53187	245	63435573
Heart rate increased	56.78	14.30	191	53013	94047	63341771
Hypersensitivity	56.66	14.30	99	53105	292586	63143232
Drug intolerance	56.55	14.30	108	53096	308553	63127265
Blood iron decreased	55.38	14.30	65	53139	14656	63421162
Erythema nodosum	55.36	14.30	40	53164	4835	63430983
Oral candidiasis	55.15	14.30	81	53123	22717	63413101
White blood cell count decreased	54.72	14.30	24	53180	139080	63296738
Malignant neoplasm progression	53.48	14.30	4	53200	82117	63353701
Large intestinal ulcer	52.76	14.30	34	53170	3410	63432408
Rheumatoid factor positive	52.53	14.30	5	53199	84401	63351417
Dyspnoea	52.03	14.30	333	52871	660980	62774838
Malaise	51.65	14.30	554	52650	415400	63020418
Blood pressure decreased	51.48	14.30	145	53059	64877	63370941
Intestinal anastomosis	51.46	14.30	18	53186	445	63435373
Cytomegalovirus colitis	50.72	14.30	29	53175	2343	63433475
Platelet count decreased	50.71	14.30	17	53187	116105	63319713
Blood creatinine increased	50.19	14.30	7	53197	87837	63347981
Small intestinal obstruction	50.03	14.30	69	53135	18268	63417550
General physical health deterioration	50.02	14.30	57	53147	201345	63234473
Pericarditis	49.74	14.30	24	53180	131555	63304263
Infusion site extravasation	49.51	14.30	52	53152	10374	63425444
Bile acid malabsorption	49.35	14.30	14	53190	169	63435649
Rectal discharge	48.59	14.30	19	53185	647	63435171
Gastrointestinal scarring	48.10	14.30	16	53188	338	63435480
Duodenal ulcer perforation	47.42	14.30	8	53196	87201	63348617
Vein rupture	46.15	14.30	22	53182	1221	63434597
Drug hypersensitivity	46.06	14.30	122	53082	310565	63125253
Gastrointestinal stoma complication	46.00	14.30	25	53179	1830	63433988
Colostomy	45.46	14.30	20	53184	921	63434897
Colectomy total	45.16	14.30	13	53191	166	63435652
Hepatic enzyme increased	44.29	14.30	63	53141	202265	63233553
Systemic lupus erythematosus	43.83	14.30	67	53137	208851	63226967
Terminal ileitis	43.11	14.30	18	53186	728	63435090
Oropharyngeal pain	43.05	14.30	175	53029	94312	63341506
Abdominal adhesions	42.88	14.30	29	53175	3153	63432665
Blood cholesterol increased	42.41	14.30	13	53191	94019	63341799
Rash	42.26	14.30	286	52918	560585	62875233
Abdominal pain upper	42.25	14.30	307	52897	206137	63229681
Gastroenteritis	42.04	14.30	78	53126	26512	63409306
Pregnancy of partner	41.83	14.30	9	53195	29	63435789
Ileectomy	41.28	14.30	12	53192	159	63435659
Neuropathy peripheral	41.06	14.30	22	53182	113645	63322173
Headache	40.93	14.30	751	52453	632490	62803328
Gastrointestinal wall thickening	40.70	14.30	21	53183	1383	63434435
Mobility decreased	40.17	14.30	26	53178	121133	63314685
Confusional state	39.62	14.30	87	53117	236293	63199525
Suicide attempt	39.57	14.30	3	53201	60915	63374903
Fatigue	39.38	14.30	997	52207	887031	62548787
Appendicitis	39.00	14.30	41	53163	8188	63427630
Therapy non-responder	38.98	14.30	146	53058	75755	63360063
Psoriatic arthropathy	38.92	14.30	14	53190	91506	63344312
Musculoskeletal stiffness	38.92	14.30	59	53145	184559	63251259
Catarrh	38.76	14.30	21	53183	1528	63434290
Exposure via breast milk	38.32	14.30	23	53181	2034	63433784
Fall	38.17	14.30	184	53020	392150	63043668
Helicobacter infection	38.11	14.30	15	53189	92770	63343048
Cardiac arrest	37.95	14.30	15	53189	92530	63343288
Colonic abscess	37.78	14.30	18	53186	998	63434820
Ill-defined disorder	37.42	14.30	11	53193	81744	63354074
Product storage error	37.42	14.30	54	53150	14902	63420916
Injury	37.11	14.30	8	53196	73239	63362579
Intentional product misuse	36.88	14.30	4	53200	60913	63374905
Discomfort	36.74	14.30	52	53152	167322	63268496
Intestinal dilatation	36.68	14.30	21	53183	1701	63434117
Pharyngitis streptococcal	36.67	14.30	45	53159	10627	63425191
Intestinal fistula	36.57	14.30	17	53187	891	63434927
Rectal cancer metastatic	36.51	14.30	12	53192	244	63435574
Cardiac failure congestive	36.26	14.30	16	53188	92417	63343401
Atrial fibrillation	36.05	14.30	27	53177	116609	63319209
Bowel movement irregularity	35.83	14.30	32	53172	5232	63430586
Abscess limb	35.79	14.30	31	53173	4867	63430951
Bacterial vulvovaginitis	35.51	14.30	16	53188	780	63435038
Stoma creation	35.45	14.30	8	53196	34	63435784
Pouchitis	35.36	14.30	14	53190	493	63435325
Depressed level of consciousness	35.33	14.30	5	53199	62073	63373745
Blister	35.30	14.30	34	53170	129780	63306038
Pseudopolyp	35.12	14.30	12	53192	276	63435542
Bradycardia	35.11	14.30	9	53195	73218	63362600
Intestinal operation	34.76	14.30	14	53190	516	63435302
Seizure	34.62	14.30	36	53168	132598	63303220
Bacillus infection	34.45	14.30	16	53188	837	63434981
Burns second degree	33.98	14.30	21	53183	1957	63433861
Cardio-respiratory arrest	33.73	14.30	5	53199	59954	63375864
Agitation	33.58	14.30	5	53199	59752	63376066
Muscle injury	33.38	14.30	7	53197	65338	63370480
Ileostomy closure	33.36	14.30	11	53193	226	63435592
Maternal exposure during breast feeding	33.36	14.30	28	53176	4213	63431605
Drug specific antibody present	33.25	14.30	28	53176	4231	63431587
Infection	33.18	14.30	91	53113	229082	63206736
Gastrointestinal dysplasia	33.16	14.30	8	53196	48	63435770
Faeces hard	32.31	14.30	21	53183	2136	63433682
Hallucination	32.19	14.30	4	53200	54813	63381005
Injection site pain	31.92	14.30	37	53167	129763	63306055
Asthma	31.76	14.30	36	53168	127525	63308293
Stomatitis	31.54	14.30	42	53162	138683	63297135
SARS-CoV-1 test positive	31.36	14.30	7	53197	28	63435790
Wrong technique in product usage process	31.19	14.30	7	53197	62333	63373485
Influenza	31.06	14.30	176	53028	108546	63327272
Neutrophil count decreased	31.05	14.30	5	53199	56401	63379417
Respiratory failure	30.94	14.30	24	53180	101834	63333984
Leukopenia	30.92	14.30	13	53191	77277	63358541
Alopecia	30.71	14.30	162	53042	337374	63098444
Gastrointestinal stoma output abnormal	30.63	14.30	8	53196	69	63435749
Therapy partial responder	30.43	14.30	41	53163	10617	63425201
Pain	29.95	14.30	439	52765	740189	62695629
Weight decreased	29.91	14.30	359	52845	276439	63159379
Anal stenosis	29.82	14.30	12	53192	441	63435377
Stoma closure	29.61	14.30	6	53198	13	63435805
Hypoxia	29.35	14.30	7	53197	59785	63376033
Surgery	29.32	14.30	81	53123	35831	63399987
Aspartate aminotransferase increased	29.07	14.30	20	53184	90257	63345561
Small intestinal resection	28.94	14.30	12	53192	477	63435341
Infusion related reaction	28.88	14.30	107	53097	245414	63190404
Mucosal inflammation	28.62	14.30	3	53201	46925	63388893
Rectal fissure	28.41	14.30	13	53191	657	63435161
Stoma site abscess	27.76	14.30	9	53195	175	63435643
Granulomatous rosacea	27.73	14.30	6	53198	20	63435798
Proctocolectomy	27.72	14.30	7	53197	52	63435766
Metabolic acidosis	27.18	14.30	3	53201	45066	63390752
Post procedural infection	26.76	14.30	36	53168	9306	63426512
Dysphagia	26.74	14.30	21	53183	88564	63347254
Musculoskeletal pain	26.47	14.30	23	53181	92254	63343564
Central obesity	26.30	14.30	15	53189	1206	63434612
Liver injury	26.17	14.30	9	53195	60511	63375307
Hypoglycaemia	25.86	14.30	9	53195	60056	63375762
Gastrointestinal bacterial infection	25.41	14.30	13	53191	841	63434977
Intestinal perforation	25.39	14.30	40	53164	11923	63423895
Gastrointestinal obstruction	25.17	14.30	14	53190	1073	63434745
Chronic kidney disease	25.05	14.30	4	53200	45394	63390424
Small intestine operation	24.87	14.30	6	53198	36	63435782
Depression	24.87	14.30	83	53121	196409	63239409
Stoma complication	24.65	14.30	11	53193	524	63435294
Femur fracture	24.63	14.30	3	53201	41753	63394065
Product administered to patient of inappropriate age	24.52	14.30	21	53183	3247	63432571
Renal failure	24.40	14.30	38	53166	117614	63318204
Cryptitis	24.20	14.30	6	53198	41	63435777
Gait disturbance	24.13	14.30	76	53128	183102	63252716
Rhinitis	24.11	14.30	38	53166	11328	63424490
Faeces discoloured	24.05	14.30	50	53154	18459	63417359
Weight fluctuation	23.91	14.30	35	53169	9784	63426034
Interstitial lung disease	23.83	14.30	11	53193	61897	63373921
Small intestinal stenosis	23.78	14.30	11	53193	570	63435248
Multiple organ dysfunction syndrome	23.59	14.30	9	53195	56743	63379075
Anaplastic large-cell lymphoma	23.53	14.30	7	53197	101	63435717
Cardiac failure	23.48	14.30	24	53180	89118	63346700
Injection site reaction	23.16	14.30	10	53194	58514	63377304
Adenocarcinoma of colon	22.79	14.30	18	53186	2486	63433332
Stoma site extravasation	22.75	14.30	9	53195	316	63435502
Large intestine polyp	22.71	14.30	31	53173	8126	63427692
Gastrointestinal fistula	22.60	14.30	10	53194	467	63435351
Proctectomy	22.52	14.30	7	53197	118	63435700
Postoperative wound infection	22.45	14.30	36	53168	10889	63424929
Encephalopathy	22.24	14.30	3	53201	38617	63397201
Sleep disorder due to general medical condition, insomnia type	22.18	14.30	8	53196	52209	63383609
Infected fistula	22.17	14.30	8	53196	217	63435601
Enzyme level increased	22.16	14.30	9	53195	339	63435479
Infection parasitic	22.08	14.30	9	53195	342	63435476
Alanine aminotransferase increased	22.01	14.30	33	53171	103737	63332081
Lactic acidosis	21.98	14.30	3	53201	38284	63397534
Anorectal discomfort	21.96	14.30	18	53186	2621	63433197
Hyperkalaemia	21.87	14.30	9	53195	54194	63381624
Hypopnoea	21.77	14.30	21	53183	3785	63432033
Oedema	21.74	14.30	30	53174	97592	63338226
Dry mouth	21.62	14.30	20	53184	77843	63357975
C-reactive protein abnormal	21.47	14.30	6	53198	46090	63389728
Pleural effusion	21.41	14.30	28	53176	93182	63342636
Oedema peripheral	21.36	14.30	84	53120	189427	63246391
Cognitive disorder	21.36	14.30	10	53194	55805	63380013
Obstruction	21.26	14.30	19	53185	3108	63432710
Rheumatic fever	21.25	14.30	5	53199	43106	63392712
Injection site erythema	21.22	14.30	23	53181	83151	63352667
Hepatic function abnormal	21.11	14.30	3	53201	37139	63398679
Pulmonary hypertension	21.10	14.30	3	53201	37120	63398698
Influenza like illness	20.97	14.30	111	53093	66713	63369105
Catheter site injury	20.84	14.30	8	53196	259	63435559
Hyperplastic cholecystopathy	20.69	14.30	7	53197	156	63435662
Stomal hernia	20.58	14.30	8	53196	268	63435550
Blood glucose increased	20.45	14.30	24	53180	83732	63352086
Tremor	20.27	14.30	51	53153	132188	63303630
Postoperative abscess	20.22	14.30	9	53195	426	63435392
Plasma cell myeloma	20.18	14.30	3	53201	35902	63399916
B-cell unclassifiable lymphoma high grade	19.95	14.30	4	53200	8	63435810
Abdominal wall abscess	19.85	14.30	11	53193	837	63434981
Fluid retention	19.51	14.30	13	53191	59673	63376145
Pharyngeal paraesthesia	19.49	14.30	15	53189	1994	63433824
Type 2 diabetes mellitus	19.46	14.30	15	53189	63853	63371965
Tubulointerstitial nephritis	19.43	14.30	48	53156	19855	63415963
Product use issue	19.39	14.30	107	53097	220413	63215405
Illness	19.35	14.30	87	53117	48972	63386846
Angioedema	19.29	14.30	8	53196	47957	63387861
Sleep disorder	19.25	14.30	24	53180	81542	63354276
Acute respiratory failure	19.11	14.30	3	53201	34482	63401336
Gastrointestinal mucosa hyperaemia	19.09	14.30	7	53197	199	63435619
Dysarthria	19.09	14.30	6	53198	42705	63393113
Gastroenteritis viral	18.89	14.30	53	53151	23647	63412171
Pulmonary fibrosis	18.88	14.30	5	53199	39804	63396014
Stress at work	18.70	14.30	12	53192	1195	63434623
Unresponsive to stimuli	18.61	14.30	3	53201	33813	63402005
Contusion	18.55	14.30	64	53140	149980	63285838
Hyperglycaemia	18.50	14.30	6	53198	41861	63393957
Polyp	18.48	14.30	25	53179	6496	63429322
Pyrexia	18.36	14.30	520	52684	469958	62965860
Fistulotomy	18.34	14.30	4	53200	14	63435804
International normalised ratio increased	18.26	14.30	8	53196	46417	63389401
Rhabdomyolysis	18.22	14.30	7	53197	43944	63391874
Product quality issue	17.99	14.30	4	53200	35861	63399957
Infusion site bruising	17.99	14.30	19	53185	3813	63432005
Pyelonephritis chronic	17.88	14.30	7	53197	239	63435579
Osteoarthritis	17.74	14.30	33	53171	95310	63340508
Intentional product use issue	17.60	14.30	52	53152	127840	63307978
Hernia	17.56	14.30	35	53169	12539	63423279
Arthritis reactive	17.38	14.30	8	53196	410	63435408
Dyspnoea exertional	17.33	14.30	15	53189	60287	63375531
Pruritus	17.19	14.30	207	52997	361246	63074572
Gastrointestinal haemorrhage	17.04	14.30	26	53178	81150	63354668
Nephrolithiasis	16.97	14.30	75	53129	41909	63393909
Impaired healing	16.95	14.30	38	53166	102504	63333314
Haemorrhage	16.90	14.30	98	53106	60924	63374894
Gastrointestinal motility disorder	16.65	14.30	21	53183	5098	63430720
Perirectal abscess	16.37	14.30	10	53194	913	63434905
Gastrointestinal ulcer	16.37	14.30	14	53190	2161	63433657
Subcutaneous drug absorption impaired	16.32	14.30	6	53198	172	63435646
Nausea	16.30	14.30	873	52331	853598	62582220
Vessel puncture site pain	16.18	14.30	3	53201	3	63435815
Inflammatory marker increased	16.11	14.30	24	53180	6815	63429003
Mesenteritis	16.02	14.30	7	53197	317	63435501
Lymphocyte count decreased	15.96	14.30	3	53201	30254	63405564
Neurogenic shock	15.82	14.30	7	53197	327	63435491
Sports injury	15.81	14.30	4	53200	30	63435788
Nasopharyngitis	15.79	14.30	300	52904	253957	63181861
Colon dysplasia	15.78	14.30	5	53199	90	63435728
Product use in unapproved indication	15.68	14.30	87	53117	178993	63256825
Prescribed underdose	15.54	14.30	3	53201	29686	63406132
Skin warm	15.53	14.30	21	53183	5455	63430363
Enteropathic spondylitis	15.47	14.30	4	53200	33	63435785
Hepatitis	15.42	14.30	7	53197	39781	63396037
Impaired quality of life	15.36	14.30	35	53169	13748	63422070
Colonoscopy abnormal	15.32	14.30	6	53198	205	63435613
Feeding intolerance	15.32	14.30	9	53195	765	63435053
Loss of personal independence in daily activities	15.32	14.30	37	53167	97253	63338565
Folliculitis	15.26	14.30	22	53182	70295	63365523
Laparotomy	15.24	14.30	7	53197	357	63435461
Mechanical ileus	15.20	14.30	8	53196	549	63435269
Bursitis	15.19	14.30	6	53198	37035	63398783
Pneumonia aspiration	15.17	14.30	5	53199	34535	63401283
Hypokalaemia	15.17	14.30	41	53163	103763	63332055
Rash maculo-papular	15.14	14.30	4	53200	31892	63403926
Aphthous ulcer	15.10	14.30	35	53169	13903	63421915
Rectal stenosis	15.05	14.30	6	53198	215	63435603
Pelvic abscess	15.01	14.30	12	53192	1686	63434132
Full blood count abnormal	15.01	14.30	4	53200	31713	63404105
Hypocalcaemia	15.01	14.30	4	53200	31709	63404109
Gastrointestinal anastomotic leak	15.00	14.30	6	53198	217	63435601
Campylobacter infection	14.96	14.30	10	53194	1066	63434752
Serum ferritin decreased	14.92	14.30	13	53191	2057	63433761
Neoplasm of appendix	14.88	14.30	4	53200	39	63435779
Nasal congestion	14.78	14.30	100	53104	65560	63370258
Transaminases increased	14.76	14.30	4	53200	31363	63404455
Hip arthroplasty	14.75	14.30	11	53193	47635	63388183
Mesenteric vein thrombosis	14.68	14.30	10	53194	1100	63434718
Arthritis	14.60	14.30	155	53049	115766	63320052
Gastroenteritis eosinophilic	14.59	14.30	5	53199	116	63435702
Wheezing	14.55	14.30	37	53167	95558	63340260
Hypercalcaemia	14.53	14.30	3	53201	28319	63407499
Red blood cell count decreased	14.48	14.30	8	53196	40637	63395181
Bladder neoplasm	14.44	14.30	8	53196	608	63435210
Stenosis	14.42	14.30	11	53193	1443	63434375

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Off label use	3303.13	19.23	2913	31261	416611	34506146
Therapeutic reaction time decreased	1635.16	19.23	351	33823	912	34921845
Frequent bowel movements	1491.24	19.23	535	33639	12252	34910505
Haematochezia	1086.88	19.23	634	33540	45900	34876857
Abdominal pain	580.26	19.23	754	33420	162864	34759893
Loss of therapeutic response	500.69	19.23	117	34057	497	34922260
Drug ineffective	448.41	19.23	1207	32967	455544	34467213
Faecal calprotectin increased	387.06	19.23	130	34044	2414	34920343
Defaecation urgency	361.31	19.23	124	34050	2465	34920292
Anal abscess	293.94	19.23	138	34036	6335	34916422
Mucous stools	271.04	19.23	91	34083	1687	34921070
Drug level decreased	265.84	19.23	137	34037	7709	34915048
Colitis ulcerative	265.71	19.23	178	33996	16342	34906415
Intestinal obstruction	246.16	19.23	193	33981	22629	34900128
No adverse event	236.78	19.23	189	33985	22738	34900019
Rectal haemorrhage	235.72	19.23	241	33933	40008	34882749
Colectomy	228.68	19.23	81	34093	1773	34920984
Blood pressure increased	223.67	19.23	347	33827	87755	34835002
Clostridium difficile infection	215.06	19.23	165	34009	18733	34904024
Diarrhoea	209.63	19.23	842	33332	389070	34533687
Poor venous access	188.64	19.23	95	34079	5088	34917669
Toxicity to various agents	180.88	19.23	3	34171	200359	34722398
Drug interaction	174.57	19.23	12	34162	225934	34696823
Gastrointestinal inflammation	172.28	19.23	79	34095	3432	34919325
Diarrhoea haemorrhagic	162.23	19.23	94	34080	6670	34916087
Cholangitis sclerosing	148.76	19.23	55	34119	1366	34921391
Anal fistula	148.30	19.23	82	34092	5317	34917440
Fistula	148.16	19.23	89	34085	6751	34916006
Acute kidney injury	139.61	19.23	62	34112	304926	34617831
Neutropenia	131.48	19.23	5	34169	156773	34765984
Intestinal resection	130.75	19.23	53	34121	1696	34921061
Inappropriate schedule of product administration	125.13	19.23	221	33953	62075	34860682
Treatment failure	122.63	19.23	187	33987	46510	34876247
Steroid dependence	120.42	19.23	48	34126	1469	34921288
Febrile neutropenia	112.59	19.23	5	34169	136844	34785913
Death	109.01	19.23	138	34036	397911	34524846
Large intestinal stenosis	108.67	19.23	45	34129	1522	34921235
Thrombocytopenia	105.57	19.23	14	34160	156233	34766524
Impaired quality of life	103.99	19.23	67	34107	5751	34917006
Faeces soft	98.32	19.23	54	34120	3454	34919303
Stress	97.87	19.23	134	34040	30213	34892544
Hypotension	96.76	19.23	48	34126	221601	34701156
Flatulence	96.13	19.23	111	34063	21087	34901670
COVID-19	95.90	19.23	225	33949	77325	34845432
Ileal stenosis	93.54	19.23	39	34135	1342	34921415
Hospitalisation	91.98	19.23	184	33990	56718	34866039
Therapy non-responder	90.63	19.23	148	34026	38998	34883759
Arthralgia	86.53	19.23	362	33812	169679	34753078
Intestinal stenosis	85.25	19.23	42	34132	2144	34920613
Colitis	85.06	19.23	141	34033	37609	34885148
Completed suicide	82.70	19.23	3	34171	98165	34824592
Platelet count decreased	82.61	19.23	10	34164	119707	34803050
Weight decreased	81.78	19.23	365	33809	175936	34746821
Bronchiectasis	80.84	19.23	71	34103	9730	34913027
Abscess intestinal	80.63	19.23	37	34137	1609	34921148
Inflammatory bowel disease	79.23	19.23	44	34130	2876	34919881
Proctitis	77.88	19.23	41	34133	2408	34920349
Abnormal faeces	76.53	19.23	45	34129	3280	34919477
Abdominal pain lower	70.50	19.23	68	34106	10503	34912254
Blood iron decreased	68.45	19.23	50	34124	5263	34917494
Hyponatraemia	68.05	19.23	3	34171	82688	34840069
Nipple swelling	67.21	19.23	21	34153	306	34922451
Ileostomy	65.96	19.23	25	34149	666	34922091
Colectomy total	64.90	19.23	18	34156	168	34922589
Disease progression	63.48	19.23	14	34160	108063	34814694
Product dose omission issue	63.28	19.23	258	33916	119453	34803304
Large intestine polyp	62.62	19.23	56	34118	7858	34914899
Abscess	62.37	19.23	67	34107	11750	34911007
Abdominal distension	60.94	19.23	159	34015	58333	34864424
Respiratory failure	59.99	19.23	16	34158	108556	34814201
Cardiac arrest	59.51	19.23	11	34163	96148	34826609
Dyspnoea	59.26	19.23	181	33993	376601	34546156
Drug specific antibody present	59.12	19.23	38	34136	3247	34919510
Pouchitis	58.82	19.23	23	34151	668	34922089
Proctocolectomy	57.76	19.23	15	34159	106	34922651
Dyschezia	56.45	19.23	28	34146	1450	34921307
Overdose	55.11	19.23	11	34163	91048	34831709
Drug effect less than expected	54.91	19.23	26	34148	1215	34921542
White blood cell count decreased	54.78	19.23	13	34161	95432	34827325
Fistula discharge	53.67	19.23	23	34151	848	34921909
Oedema peripheral	53.64	19.23	25	34149	119787	34802970
Abdominal abscess	50.88	19.23	38	34136	4137	34918620
Proctalgia	50.31	19.23	43	34131	5680	34917077
Nephrolithiasis	50.07	19.23	99	34075	30234	34892523
Short-bowel syndrome	49.77	19.23	16	34158	257	34922500
Nipple pain	48.86	19.23	22	34152	915	34921842
Gastrointestinal mucosa hyperaemia	48.55	19.23	16	34158	279	34922478
Gastrointestinal scarring	47.07	19.23	14	34160	171	34922586
Therapy partial responder	46.37	19.23	52	34122	9564	34913193
Rectal abscess	46.31	19.23	24	34150	1364	34921393
Anorectal discomfort	46.30	19.23	27	34147	1937	34920820
Heart rate increased	44.25	19.23	122	34052	46221	34876536
Renal failure	43.71	19.23	38	34136	130519	34792238
Anal fissure	43.47	19.23	35	34139	4255	34918502
Malaise	42.55	19.23	319	33855	185506	34737251
Abdominal discomfort	42.54	19.23	142	34032	59693	34863064
Product administered to patient of inappropriate age	42.46	19.23	31	34143	3260	34919497
Hypoxia	42.24	19.23	3	34171	55092	34867665
Product storage error	41.02	19.23	45	34129	8077	34914680
Infusion site extravasation	40.99	19.23	34	34140	4310	34918447
Enterocutaneous fistula	40.70	19.23	20	34154	1015	34921742
Haemorrhoids	40.54	19.23	60	34114	14515	34908242
Colostomy	39.91	19.23	16	34158	497	34922260
Neuropathy peripheral	39.43	19.23	16	34158	83247	34839510
Pancytopenia	39.38	19.23	22	34152	95135	34827622
Abdominal pain upper	39.26	19.23	156	34018	71334	34851423
Neutrophil count decreased	38.55	19.23	3	34171	51101	34871656
Rectal discharge	38.31	19.23	13	34161	249	34922508
Gastrointestinal infection	38.10	19.23	37	34137	5761	34916996
Blood creatinine increased	37.82	19.23	23	34151	94953	34827804
Cytomegalovirus colitis	37.68	19.23	27	34147	2757	34920000
Renal impairment	37.48	19.23	23	34151	94490	34828267
Catheter site injury	36.68	19.23	7	34167	7	34922750
Appendicectomy	36.29	19.23	19	34155	1103	34921654
Surgery	36.14	19.23	56	34118	14101	34908656
Tachycardia	35.95	19.23	19	34155	84753	34838004
Small intestinal stenosis	35.90	19.23	15	34159	519	34922238
Heart rate decreased	35.85	19.23	89	34085	31656	34891101
Epistaxis	35.31	19.23	7	34167	58244	34864513
Illness	35.22	19.23	54	34120	13475	34909282
Gastrointestinal anastomotic leak	35.07	19.23	14	34160	430	34922327
Cardiac failure congestive	34.82	19.23	19	34155	83251	34839506
Pyoderma gangrenosum	34.60	19.23	20	34154	1411	34921346
Mouth ulceration	34.53	19.23	50	34124	11860	34910897
Alanine aminotransferase increased	34.44	19.23	18	34156	80797	34841960
Aspartate aminotransferase increased	33.80	19.23	12	34162	67771	34854986
Gastrointestinal stoma output increased	32.54	19.23	9	34165	83	34922674
Fatigue	32.03	19.23	524	33650	370129	34552628
Small intestinal obstruction	31.43	19.23	54	34120	14812	34907945
Somnolence	30.79	19.23	38	34136	111078	34811679
Agitation	30.68	19.23	9	34165	57390	34865367
Gastrointestinal polyp	30.63	19.23	8	34166	58	34922699
Hypoglycaemia	30.26	19.23	8	34166	54632	34868125
Weight fluctuation	30.22	19.23	31	34143	5154	34917603
Seizure	29.96	19.23	35	34139	104822	34817935
Myocardial infarction	29.93	19.23	45	34129	121040	34801717
Leukopenia	29.89	19.23	12	34162	62844	34859913
Arthritis	29.39	19.23	82	34092	31264	34891493
Headache	29.16	19.23	312	33862	200323	34722434
Post procedural infection	28.24	19.23	29	34145	4827	34917930
Pulmonary oedema	28.21	19.23	6	34168	47523	34875234
Blood creatine phosphokinase increased	28.02	19.23	5	34169	44852	34877905
Dysphagia	27.92	19.23	13	34161	62368	34860389
Therapeutic product effect decreased	27.90	19.23	86	34088	34657	34888100
Atrial fibrillation	27.89	19.23	48	34126	122345	34800412
Mucosal inflammation	27.18	19.23	3	34171	38619	34884138
Intestinal intraepithelial lymphocytes increased	27.09	19.23	9	34165	161	34922596
Small intestinal resection	26.58	19.23	12	34162	502	34922255
Enterostomy	26.30	19.23	8	34166	106	34922651
Rectal stenosis	26.11	19.23	9	34165	181	34922576
Large intestine anastomosis	26.09	19.23	7	34167	57	34922700
Nasopharyngitis	25.94	19.23	136	34038	69832	34852925
Ileocaecal resection	25.87	19.23	7	34167	59	34922698
Pleural effusion	25.77	19.23	25	34149	81521	34841236
Plasma cell myeloma	25.58	19.23	5	34169	42032	34880725
Gastrointestinal bacterial infection	25.36	19.23	11	34163	418	34922339
Migraine	25.24	19.23	54	34120	17424	34905333
Gastrointestinal tract irritation	25.02	19.23	10	34164	308	34922449
Gastroenteritis	24.97	19.23	48	34126	14352	34908405
Colon dysplasia	24.68	19.23	8	34166	132	34922625
Probiotic therapy	24.68	19.23	8	34166	132	34922625
Impaired work ability	24.47	19.23	32	34142	6898	34915859
Cardiac failure	24.45	19.23	32	34142	91216	34831541
Mental status changes	24.32	19.23	4	34170	38079	34884678
Terminal ileitis	24.32	19.23	9	34165	224	34922533
Cryptitis	24.21	19.23	9	34165	227	34922530
Polyp	24.01	19.23	24	34150	3868	34918889
Stress at work	23.88	19.23	9	34165	236	34922521
Gastrointestinal haemorrhage	23.73	19.23	31	34143	88446	34834311
Faeces hard	23.73	19.23	15	34159	1245	34921512
Lactic acidosis	23.73	19.23	3	34171	34769	34887988
Hypertension	23.20	19.23	63	34111	136380	34786377
Hernia	23.20	19.23	37	34137	9546	34913211
Suicide attempt	23.08	19.23	5	34169	39111	34883646
Bradycardia	22.83	19.23	24	34150	75394	34847363
Photophobia	22.81	19.23	31	34143	6933	34915824
Confusional state	22.73	19.23	69	34105	144091	34778666
Infected fistula	22.58	19.23	8	34166	175	34922582
Loss of personal independence in daily activities	22.04	19.23	77	34097	33102	34889655
Microvillous inclusion disease	21.89	19.23	8	34166	192	34922565
Colon cancer	21.86	19.23	34	34140	8587	34914170
Pneumonia aspiration	21.61	19.23	7	34167	41896	34880861
Hyperglycaemia	21.44	19.23	6	34168	39474	34883283
Multiple organ dysfunction syndrome	21.39	19.23	26	34148	76540	34846217
Acute myocardial infarction	21.39	19.23	13	34161	53706	34869051
Sepsis	21.38	19.23	87	34087	166474	34756283
Overgrowth bacterial	21.35	19.23	7	34167	120	34922637
Pharyngitis streptococcal	21.24	19.23	19	34155	2665	34920092
Intentional product misuse	21.21	19.23	9	34165	45602	34877155
Spondylitis	21.08	19.23	14	34160	1264	34921493
Chronic kidney disease	21.05	19.23	7	34167	41203	34881554
Basal cell carcinoma	21.03	19.23	54	34120	19604	34903153
Abdominal hernia	20.88	19.23	19	34155	2725	34920032
Sinusitis	20.85	19.23	88	34086	41314	34881443
Gastrointestinal surgery	20.83	19.23	6	34168	65	34922692
Gastrointestinal stoma complication	20.65	19.23	14	34160	1308	34921449
Incisional hernia	20.57	19.23	14	34160	1316	34921441
Gastrointestinal obstruction	20.27	19.23	12	34162	885	34921872
Cholecystectomy	20.15	19.23	19	34155	2851	34919906
Haematuria	20.10	19.23	12	34162	50054	34872703
Intestinal anastomosis complication	20.03	19.23	7	34167	147	34922610
Neurogenic shock	19.94	19.23	8	34166	249	34922508
Acrochordon	19.88	19.23	9	34165	379	34922378
Encephalopathy	19.88	19.23	5	34169	35314	34887443
Angioedema	19.71	19.23	6	34168	37368	34885389
Coma	19.71	19.23	10	34164	45668	34877089
Dry mouth	19.64	19.23	3	34171	30162	34892595
Stoma creation	19.42	19.23	5	34169	34	34922723
Appendicitis	19.41	19.23	44	34130	14763	34907994
Apoptosis	19.38	19.23	9	34165	402	34922355
Intestinal anastomosis	19.33	19.23	8	34166	270	34922487
Acne	19.33	19.23	37	34137	11029	34911728

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Off label use	6714.24	14.43	5953	68071	901262	78769102
Therapeutic reaction time decreased	3191.43	14.43	723	73301	2778	79667586
Frequent bowel movements	3122.75	14.43	1134	72890	28405	79641959
Haematochezia	2786.03	14.43	1438	72586	86207	79584157
Abdominal pain	1634.95	14.43	1903	72121	387666	79282698
Mucous stools	963.04	14.43	304	73720	4858	79665506
Faecal calprotectin increased	793.13	14.43	267	73757	5274	79665090
Defaecation urgency	783.99	14.43	268	73756	5556	79664808
Poor venous access	732.45	14.43	351	73673	17798	79652566
Intestinal obstruction	616.27	14.43	423	73601	42597	79627767
Diarrhoea	613.93	14.43	1997	72027	878492	78791872
Rectal haemorrhage	551.22	14.43	501	73523	75799	79594565
Loss of therapeutic response	519.30	14.43	128	73896	756	79669608
Drug ineffective	495.50	14.43	2143	71881	1078770	78591594
Pregnancy	494.37	14.43	309	73715	26542	79643822
Drug level decreased	446.63	14.43	233	73791	14169	79656195
Clostridium difficile infection	431.08	14.43	340	73684	42345	79628019
Blood pressure increased	402.44	14.43	711	73313	210649	79459715
Colectomy	380.11	14.43	136	73888	3238	79667126
Toxicity to various agents	369.99	14.43	4	74020	421536	79248828
Anal abscess	365.47	14.43	177	73847	9178	79661186
Gastrointestinal inflammation	338.41	14.43	157	73867	7387	79662977
Intestinal resection	308.18	14.43	120	73904	3637	79666727
Fistula	306.00	14.43	175	73849	12765	79657599
Diarrhoea haemorrhagic	294.39	14.43	172	73852	13062	79657302
Colitis ulcerative	290.46	14.43	248	73776	34494	79635870
Drug interaction	287.49	14.43	27	73997	415156	79255208
Acute kidney injury	286.07	14.43	66	73958	519338	79151026
Anal fistula	279.17	14.43	134	73890	6810	79663554
Intestinal stenosis	276.75	14.43	111	73913	3643	79666721
Abdominal distension	273.39	14.43	437	73587	119213	79551151
Ileostomy	262.47	14.43	87	73937	1633	79668731
Stress	248.72	14.43	337	73687	79275	79591089
Flatulence	248.40	14.43	249	73775	42475	79627889
Faeces soft	236.37	14.43	127	73897	8196	79662168
COVID-19	208.07	14.43	455	73569	157219	79513145
Neutropenia	206.46	14.43	16	74008	287694	79382670
Completed suicide	204.37	14.43	5	74019	245762	79424602
Abdominal pain lower	199.18	14.43	193	73831	31589	79638775
Hypotension	190.96	14.43	85	73939	440232	79230132
Abnormal faeces	188.73	14.43	106	73918	7465	79662899
Febrile neutropenia	187.27	14.43	6	74018	230993	79439371
No adverse event	179.05	14.43	196	73828	36996	79633368
Thrombocytopenia	169.04	14.43	23	74001	265236	79405128
Death	161.39	14.43	173	73851	566341	79104023
Cholangitis sclerosing	160.53	14.43	68	73956	2569	79667795
Proctitis	157.48	14.43	89	73935	6343	79664021
Steroid dependence	150.79	14.43	65	73959	2565	79667799
Product dose omission issue	144.18	14.43	531	73493	247006	79423358
Hospitalisation	142.93	14.43	288	73736	93948	79576416
Abscess intestinal	141.53	14.43	63	73961	2688	79667676
Overdose	138.67	14.43	8	74016	184198	79486166
Inappropriate schedule of product administration	137.45	14.43	350	73674	133278	79537086
Colitis	134.56	14.43	243	73781	73064	79597300
Hyponatraemia	133.04	14.43	8	74016	177840	79492524
Large intestinal stenosis	132.96	14.43	61	73963	2795	79667569
Drug effect less than expected	127.73	14.43	54	73970	2030	79668334
Dyschezia	127.25	14.43	60	73964	2928	79667436
Anal fissure	122.80	14.43	81	73943	7622	79662742
Blood iron decreased	118.52	14.43	105	73919	15329	79655035
Fatigue	118.20	14.43	1349	72675	928378	78741986
Disease progression	117.38	14.43	16	74008	184346	79486018
Inflammatory bowel disease	116.65	14.43	70	73954	5581	79664783
Proctalgia	112.55	14.43	85	73939	9916	79660448
Ileal stenosis	110.96	14.43	51	73973	2347	79668017
Weight decreased	110.21	14.43	633	73391	354565	79315799
Rectal abscess	109.96	14.43	49	73975	2096	79668268
Haemorrhoids	109.20	14.43	135	73889	28993	79641371
Arthralgia	109.09	14.43	904	73120	570899	79099465
Malignant neoplasm progression	108.53	14.43	4	74020	135986	79534378
Abscess	107.07	14.43	119	73905	22832	79647532
Platelet count decreased	106.42	14.43	25	73999	194639	79475725
Heart rate increased	103.80	14.43	296	73728	120428	79549936
Cardiac arrest	100.43	14.43	19	74005	172077	79498287
Contraindicated product administered	99.51	14.43	14	74010	157524	79512840
Dyspnoea	98.83	14.43	435	73589	856590	78813774
Therapy non-responder	98.25	14.43	245	73779	92060	79578304
Malaise	96.88	14.43	781	73243	489088	79181276
Colectomy total	95.50	14.43	28	73996	343	79670021
Large intestine polyp	94.70	14.43	85	73939	12623	79657741
Gastrointestinal infection	94.10	14.43	81	73943	11380	79658984
Anal incontinence	91.36	14.43	98	73926	18070	79652294
Pancytopenia	91.15	14.43	21	74003	165724	79504640
Abdominal pain upper	89.42	14.43	428	73596	223391	79446973
White blood cell count decreased	88.59	14.43	32	73992	188256	79482108
Gastrointestinal stoma output increased	84.15	14.43	26	73998	385	79669979
Infusion site extravasation	84.13	14.43	72	73952	10036	79660328
Gastrointestinal scarring	83.21	14.43	25	73999	335	79670029
Constipation	81.63	14.43	495	73529	282555	79387809
Proctocolectomy	81.63	14.43	21	74003	151	79670213
Cardio-respiratory arrest	80.77	14.43	5	74019	108505	79561859
Swelling	80.33	14.43	51	73973	216660	79453704
Synovitis	77.31	14.43	22	74002	150712	79519652
Blood creatinine increased	75.27	14.43	25	73999	155032	79515332
Respiratory failure	75.08	14.43	37	73987	180874	79489490
Rectal discharge	74.11	14.43	28	73996	780	79669584
Hypertension	73.73	14.43	121	73903	330871	79339493
Gastrointestinal pain	73.59	14.43	66	73958	9789	79660575
Female genital tract fistula	72.19	14.43	53	73971	5922	79664442
Renal failure	72.17	14.43	49	73975	200919	79469445
Colostomy	72.15	14.43	30	73994	1081	79669283
Hypokalaemia	72.09	14.43	22	74002	144018	79526346
Hand deformity	71.16	14.43	7	74017	103912	79566452
Depressed level of consciousness	70.33	14.43	5	74019	96647	79573717
Drug intolerance	70.31	14.43	85	73939	264034	79406330
Pemphigus	70.08	14.43	6	74018	99576	79570788
Nephrolithiasis	69.29	14.43	153	73871	53138	79617226
Intentional product misuse	69.03	14.43	5	74019	95160	79575204
Nipple swelling	68.66	14.43	21	74003	300	79670064
Pyoderma gangrenosum	66.95	14.43	44	73980	4114	79666250
Rectal tenesmus	66.34	14.43	32	73992	1643	79668721
Abdominal abscess	66.01	14.43	54	73970	7073	79663291
Rheumatoid arthritis	65.76	14.43	58	73966	208412	79461952
Hypoxia	65.60	14.43	9	74015	103234	79567130
Rhabdomyolysis	65.51	14.43	9	74015	103122	79567242
Blood pressure decreased	65.21	14.43	222	73802	99244	79571120
Gastrointestinal mucosa hyperaemia	64.01	14.43	22	74002	463	79669901
Abortion spontaneous	63.53	14.43	105	73919	29402	79640962
Intestinal ulcer	63.25	14.43	33	73991	2005	79668359
Aspartate aminotransferase increased	62.80	14.43	25	73999	138616	79531748
International normalised ratio increased	62.77	14.43	4	74020	84717	79585647
Weight fluctuation	62.30	14.43	65	73959	11610	79658754
Neuropathy peripheral	61.57	14.43	27	73997	141278	79529086
Glossodynia	61.15	14.43	11	74013	103326	79567038
Coma	61.13	14.43	10	74014	100639	79569725
Metabolic acidosis	60.84	14.43	4	74020	82525	79587839
Hallucination	60.79	14.43	5	74019	85740	79584624
Neutrophil count decreased	60.15	14.43	8	74016	93951	79576413
Atrial fibrillation	58.94	14.43	58	73966	197828	79472536
Drug hypersensitivity	57.90	14.43	119	73905	298797	79371567
Faeces hard	57.80	14.43	35	73989	2836	79667528
Cardiac failure congestive	57.77	14.43	30	73994	142372	79527992
Impaired quality of life	57.69	14.43	69	73955	14317	79656047
Cytomegalovirus colitis	57.60	14.43	42	73982	4643	79665721
Seizure	56.64	14.43	55	73969	188779	79481585
Post procedural infection	56.52	14.43	61	73963	11323	79659041
Leukopenia	56.17	14.43	19	74005	116494	79553870
Anti-cyclic citrullinated peptide antibody positive	55.89	14.43	6	74018	83137	79587227
Suicide attempt	55.71	14.43	6	74018	82926	79587438
Treatment failure	55.50	14.43	308	73716	170178	79500186
Pouchitis	55.25	14.43	24	74000	965	79669399
Anorectal discomfort	55.21	14.43	37	73987	3574	79666790
Confusional state	54.75	14.43	135	73889	317862	79352502
Mucosal inflammation	54.73	14.43	4	74020	75576	79594788
Pharyngitis streptococcal	54.23	14.43	58	73966	10656	79659708
Agitation	54.09	14.43	13	74011	99702	79570662
Alanine aminotransferase increased	54.00	14.43	43	73981	162527	79507837
Product administered to patient of inappropriate age	53.38	14.43	43	73981	5510	79664854
Abdominal adhesions	53.17	14.43	36	73988	3537	79666827
Bradycardia	52.88	14.43	30	73994	135527	79534837
Erythema nodosum	52.88	14.43	42	73982	5275	79665089
Gastrointestinal bacterial infection	52.78	14.43	23	74001	932	79669432
Cardiac failure	52.64	14.43	40	73984	154802	79515562
Arthropathy	52.64	14.43	52	73972	177059	79493305
Small intestinal obstruction	52.06	14.43	92	73932	27180	79643184
Therapy partial responder	51.80	14.43	72	73952	17325	79653039
Joint swelling	51.70	14.43	120	73904	288526	79381838
Hypersensitivity	51.12	14.43	104	73920	262135	79408229
Mobility decreased	50.66	14.43	25	73999	122150	79548214
Wrong technique in product usage process	50.51	14.43	5	74019	73870	79596494
Nipple pain	50.20	14.43	22	74002	904	79669460
Oedema peripheral	50.07	14.43	99	73925	252189	79418175
Gastrointestinal wall thickening	49.94	14.43	31	73993	2626	79667738
Hepatic function abnormal	49.85	14.43	5	74019	73102	79597262
Intestinal anastomosis	49.61	14.43	20	74004	665	79669699
Rash	49.55	14.43	324	73700	578034	79092330
Headache	48.89	14.43	865	73159	652907	79017457
General physical health deterioration	48.83	14.43	115	73909	275123	79395241
Drug specific antibody present	48.59	14.43	44	73980	6608	79663756
Renal impairment	48.43	14.43	45	73979	157738	79512626
Hypoglycaemia	48.22	14.43	17	74007	101577	79568787
Lactic acidosis	47.49	14.43	5	74019	70354	79600010
Surgery	47.11	14.43	98	73926	32668	79637696
Intestinal operation	47.06	14.43	18	74006	519	79669845
Bowel movement irregularity	46.47	14.43	42	73982	6292	79664072
Dysphagia	46.27	14.43	28	73996	122108	79548256
Pseudopolyp	46.10	14.43	17	74007	442	79669922
Small intestinal stenosis	45.79	14.43	20	74004	815	79669549
Oropharyngeal pain	45.72	14.43	212	73812	109141	79561223
Bile acid malabsorption	45.46	14.43	14	74010	205	79670159
Cryptitis	45.18	14.43	15	74009	283	79670081
Ileostomy closure	44.83	14.43	15	74009	290	79670074
Gastrointestinal obstruction	44.68	14.43	25	73999	1747	79668617
Mental status changes	44.58	14.43	5	74019	66954	79603410
Hernia	44.06	14.43	66	73958	16993	79653371
Intestinal fistula	43.81	14.43	23	74001	1415	79668949
Small intestinal resection	43.70	14.43	20	74004	911	79669453
Stress at work	42.62	14.43	21	74003	1130	79669234
Stomatitis	42.56	14.43	44	73980	146713	79523651
Encephalopathy	42.52	14.43	6	74018	67391	79602973
Arthritis	42.47	14.43	215	73809	114665	79555699
Catarrh	42.43	14.43	26	73998	2152	79668212
Respiratory arrest	41.80	14.43	3	74021	57547	79612817
Epistaxis	41.63	14.43	26	73998	111489	79558875
Pleural effusion	41.62	14.43	44	73980	145218	79525146
Vein rupture	41.45	14.43	25	73999	2011	79668353
Polyp	41.23	14.43	44	73980	8063	79662301
Rheumatoid factor positive	41.04	14.43	4	74020	59835	79610529
Multiple organ dysfunction syndrome	40.95	14.43	31	73993	120215	79550149
Vaginal flatulence	40.85	14.43	27	73997	2548	79667816
Sepsis	40.64	14.43	122	73902	269306	79401058
Orthostatic hypotension	40.59	14.43	3	74021	56161	79614203
Hyperglycaemia	40.52	14.43	8	74016	70327	79600037
SARS-CoV-1 test positive	40.45	14.43	9	74015	31	79670333
Dysarthria	40.44	14.43	7	74017	67615	79602749
Burns second degree	40.35	14.43	27	73997	2601	79667763
Gastrointestinal stoma output abnormal	40.29	14.43	11	74013	102	79670262
Gastrointestinal stoma complication	40.27	14.43	27	73997	2610	79667754
Large intestinal ulcer	39.57	14.43	34	73990	4763	79665601
Tachycardia	39.53	14.43	65	73959	177703	79492661
Angioedema	39.16	14.43	11	74013	76024	79594340
Catheter site injury	38.87	14.43	13	74011	251	79670113
Fall	38.84	14.43	279	73745	487350	79183014
Stoma creation	38.27	14.43	10	74014	77	79670287
Gastrointestinal polyp	38.19	14.43	11	74013	126	79670238
Blood cholesterol increased	38.07	14.43	15	74009	83705	79586659
Blister	37.95	14.43	33	73991	119443	79550921
Terminal ileitis	37.78	14.43	18	74006	899	79669465
Gastrointestinal haemorrhage	37.75	14.43	49	73975	147670	79522694
Duodenal ulcer perforation	37.17	14.43	8	74016	66203	79604161
Enterocutaneous fistula	37.16	14.43	23	74001	1938	79668426
Chronic kidney disease	37.12	14.43	8	74016	66146	79604218
Bronchiectasis	37.03	14.43	71	73953	22315	79648049
Nasopharyngitis	36.87	14.43	379	73645	253502	79416862
Dry mouth	36.50	14.43	18	74006	88001	79582363
Intestinal anastomosis complication	36.46	14.43	13	74011	306	79670058
Injection site pain	36.45	14.43	40	73984	129798	79540566
Maternal exposure during pregnancy	36.24	14.43	44	73980	136494	79533870
Influenza like illness	36.07	14.43	147	73877	71560	79598804
Hepatic enzyme increased	35.93	14.43	72	73952	182538	79487826
Psoriatic arthropathy	35.42	14.43	14	74010	77985	79592379
Stoma site abscess	35.39	14.43	12	74012	242	79670122
Illness	35.15	14.43	109	73915	46402	79623962
Hypocalcaemia	35.14	14.43	3	74021	49921	79620443
Unresponsive to stimuli	35.11	14.43	5	74019	55783	79614581
Injury	35.05	14.43	14	74010	77482	79592882
Ill-defined disorder	34.92	14.43	9	74015	65866	79604498
Appendicectomy	34.62	14.43	25	73999	2723	79667641
Incisional hernia	34.51	14.43	24	74000	2462	79667902
Acute respiratory failure	33.82	14.43	7	74017	59534	79610830
Neurogenic shock	33.80	14.43	15	74009	635	79669729
Wound	33.49	14.43	35	73989	116144	79554220
Coronary artery disease	32.75	14.43	10	74014	65464	79604900
Gait disturbance	32.71	14.43	92	73932	207414	79462950
Tremor	32.66	14.43	68	73956	170015	79500349
Myocardial infarction	32.58	14.43	77	73947	184052	79486312
Cataract	32.57	14.43	129	73895	61991	79608373
Pulmonary oedema	32.36	14.43	21	74003	88233	79582131
Maternal exposure during breast feeding	32.07	14.43	24	74000	2761	79667603
Blood urea increased	31.59	14.43	4	74020	48786	79621578
Bacterial vulvovaginitis	31.59	14.43	14	74010	591	79669773
Enterostomy	31.55	14.43	11	74013	242	79670122
Blood creatine phosphokinase increased	31.46	14.43	11	74013	66079	79604285
Rectal cancer metastatic	31.41	14.43	13	74011	463	79669901
Migraine	31.12	14.43	162	73862	87331	79583033
Rash maculo-papular	31.02	14.43	7	74017	56071	79614293
Agranulocytosis	30.91	14.43	3	74021	45027	79625337
Rectal fissure	30.86	14.43	16	74008	959	79669405
Plasma cell myeloma	30.80	14.43	6	74018	53253	79617111
Influenza	30.78	14.43	216	73808	129390	79540974
Dyskinesia	30.69	14.43	3	74021	44770	79625594
Exposure via breast milk	30.54	14.43	16	74008	980	79669384
Pneumonia aspiration	30.44	14.43	12	74012	66955	79603409
Lymphocyte count decreased	30.33	14.43	4	74020	47285	79623079
Infected fistula	29.51	14.43	12	74012	408	79669956
Ileectomy	29.48	14.43	10	74014	202	79670162
Arthritis enteropathic	29.40	14.43	11	74013	298	79670066
Helicobacter infection	29.29	14.43	14	74010	69690	79600674
Bone marrow failure	29.05	14.43	6	74018	51101	79619263
Aggression	28.93	14.43	6	74018	50952	79619412
Musculoskeletal stiffness	28.77	14.43	76	73948	174932	79495432
Infusion site bruising	28.67	14.43	23	74001	2929	79667435
Faeces discoloured	28.57	14.43	75	73949	29052	79641312
BK polyomavirus test positive	28.43	14.43	9	74015	145	79670219
Intestinal dilatation	28.30	14.43	22	74002	2678	79667686
Mesenteritis	27.95	14.43	11	74013	343	79670021
Rectal stenosis	27.59	14.43	11	74013	355	79670009
Stoma complication	27.55	14.43	14	74010	805	79669559
Infection parasitic	27.54	14.43	12	74012	486	79669878
Blood glucose increased	27.50	14.43	40	73984	114935	79555429
Large intestine anastomosis	27.44	14.43	8	74016	96	79670268
Acute myocardial infarction	27.35	14.43	19	74005	77017	79593347
Delirium	27.33	14.43	23	74001	84604	79585760
Intestinal perforation	27.28	14.43	54	73970	17372	79652992
Oedema	27.25	14.43	43	73981	119537	79550827
Hypopnoea	27.24	14.43	29	73995	5300	79665064
Intestinal intraepithelial lymphocytes increased	27.05	14.43	9	74015	171	79670193
Abscess limb	27.03	14.43	33	73991	6994	79663370
Vaginal discharge	27.02	14.43	34	73990	7429	79662935
Obstruction	27.02	14.43	27	73997	4583	79665781
Liver function test abnormal	27.02	14.43	13	74011	64462	79605902
Muscle injury	26.99	14.43	6	74018	48555	79621809
Infusion related reaction	26.90	14.43	116	73908	230121	79440243
Pulmonary hypertension	26.60	14.43	6	74018	48074	79622290
Tubulointerstitial nephritis	26.51	14.43	87	73937	38148	79632216
Anaemia	26.32	14.43	275	73749	444740	79225624
Food poisoning	26.25	14.43	27	73997	4742	79665622
Ileocaecal resection	25.92	14.43	8	74016	118	79670246
Bacillus infection	25.65	14.43	15	74009	1140	79669224
Parosmia	25.47	14.43	32	73992	6982	79663382
Gastrointestinal fistula	25.44	14.43	13	74011	756	79669608
Upper gastrointestinal haemorrhage	25.37	14.43	4	74020	41376	79628988
Skin warm	25.27	14.43	31	73993	6601	79663763
Full blood count abnormal	24.62	14.43	4	74020	40470	79629894
Myelosuppression	24.47	14.43	4	74020	40292	79630072
Hepatocellular injury	24.29	14.43	7	74017	47586	79622778
Infusion site swelling	24.21	14.43	33	73991	7793	79662571
Probiotic therapy	24.04	14.43	8	74016	152	79670212
Appendicitis	24.03	14.43	57	73967	20737	79649627
Stomal hernia	23.98	14.43	10	74014	363	79670001
Gastrointestinal motility disorder	23.95	14.43	29	73995	6093	79664271
Cognitive disorder	23.84	14.43	18	74006	69908	79600456
Pruritus	23.69	14.43	243	73781	394405	79275959
Hepatotoxicity	23.68	14.43	9	74015	51343	79619021
Mouth ulceration	23.67	14.43	84	73940	38310	79632054
Exposure during pregnancy	23.40	14.43	36	73988	101096	79569268
Rhinitis	23.32	14.43	46	73978	14761	79655603
Gastroenteritis	23.14	14.43	77	73947	34005	79636359
Sleep disorder due to general medical condition, insomnia type	22.99	14.43	6	74018	43550	79626814
Hypercalcaemia	22.93	14.43	4	74020	38426	79631938
Liver injury	22.84	14.43	12	74012	56602	79613762
Skin cancer	22.82	14.43	46	73978	14994	79655370
Acne	22.69	14.43	66	73958	27124	79643240
Abdominal hernia	22.62	14.43	27	73997	5589	79664775
Fluid retention	22.51	14.43	19	74005	69790	79600574
Obesity	22.45	14.43	3	74021	35122	79635242
Somnolence	22.42	14.43	130	73894	238851	79431513
Hypervolaemia	22.31	14.43	6	74018	42684	79627680
Small intestine operation	22.13	14.43	6	74018	54	79670310
Colonoscopy abnormal	22.10	14.43	8	74016	197	79670167
Ejection fraction decreased	21.99	14.43	3	74021	34574	79635790
Drug level increased	21.83	14.43	5	74019	39646	79630718
Intestinal mass	21.69	14.43	14	74010	1269	79669095
Sinus tachycardia	21.68	14.43	4	74020	36904	79633460
Disorientation	21.60	14.43	16	74008	62760	79607604
Injection site reaction	21.54	14.43	12	74012	54773	79615591
C-reactive protein abnormal	21.44	14.43	9	74015	48358	79622006
Urinary retention	21.42	14.43	13	74011	56617	79613747
Blood bilirubin increased	21.38	14.43	18	74006	66214	79604150
Microvillous inclusion disease	21.37	14.43	8	74016	217	79670147
Musculoskeletal pain	21.31	14.43	39	73985	102315	79568049
Syncope	21.21	14.43	90	73934	179359	79491005
Septic shock	21.20	14.43	52	73972	122749	79547615
Haemoptysis	20.98	14.43	13	74011	55986	79614378
Cerebral haemorrhage	20.77	14.43	14	74010	57659	79612705
Haematuria	20.68	14.43	20	74004	68816	79601548
Bacteraemia	20.52	14.43	3	74021	32821	79637543
Colonic abscess	20.50	14.43	14	74010	1395	79668969
Gastrointestinal stenosis	20.43	14.43	8	74016	246	79670118
Hypomagnesaemia	20.37	14.43	9	74015	46902	79623462
Gait inability	20.30	14.43	15	74009	58902	79611462
Aphthous ulcer	20.29	14.43	47	73977	16842	79653522
Gastrointestinal anastomotic leak	20.26	14.43	10	74014	540	79669824
Sacroiliitis	20.21	14.43	21	74003	3733	79666631
Incorrect route of product administration	20.06	14.43	4	74020	34925	79635439
Restlessness	20.06	14.43	9	74015	46483	79623881
Treatment delayed	19.93	14.43	6	74018	81	79670283
Ventricular tachycardia	19.92	14.43	7	74017	41928	79628436
Contusion	19.90	14.43	71	73953	148705	79521659
Central obesity	19.89	14.43	15	74009	1746	79668618
Postoperative abscess	19.87	14.43	11	74013	753	79669611
Blood calcium decreased	19.68	14.43	3	74021	31816	79638548
Altered state of consciousness	19.68	14.43	8	74016	43814	79626550
Systemic lupus erythematosus	19.61	14.43	53	73971	121096	79549268
Cholecystectomy	19.55	14.43	33	73991	9399	79660965
Psychotic disorder	19.52	14.43	7	74017	41395	79628969
Gastroenteritis viral	19.51	14.43	59	73965	24772	79645592
Spondylitis	19.48	14.43	23	74001	4708	79665656
Diabetic ketoacidosis	19.40	14.43	4	74020	34118	79636246
Neoplasm progression	19.35	14.43	12	74012	51670	79618694
Hepatic failure	19.32	14.43	17	74007	61195	79609169
Depression	19.24	14.43	120	73904	216670	79453694
B-cell unclassifiable lymphoma high grade	19.23	14.43	4	74020	9	79670355
Spondyloarthropathy	19.16	14.43	12	74012	1033	79669331
Medical device site fistula	19.08	14.43	5	74019	39	79670325
Asthma	19.06	14.43	63	73961	135032	79535332
Fistula of small intestine	19.05	14.43	11	74013	816	79669548
Heart rate decreased	18.98	14.43	121	73903	70195	79600169
Pain	18.95	14.43	503	73521	703299	78967065
Stoma closure	18.91	14.43	8	74016	301	79670063
Postoperative wound infection	18.90	14.43	39	73985	12922	79657442
Injection site erythema	18.90	14.43	27	73997	78170	79592194
Product prescribing error	18.83	14.43	9	74015	44804	79625560
Pneumonia	18.80	14.43	468	73556	659778	79010586
Faecal volume decreased	18.73	14.43	7	74017	189	79670175
Umbilical hernia	18.62	14.43	25	73999	5820	79664544
Anal skin tags	18.55	14.43	9	74015	468	79669896
Discouragement	18.51	14.43	14	74010	1636	79668728
Fistula discharge	18.51	14.43	13	74011	1355	79669009
Cytomegalovirus enterocolitis	18.47	14.43	14	74010	1641	79668723
Faecal calprotectin abnormal	18.46	14.43	7	74017	197	79670167
Nasal congestion	18.41	14.43	128	73896	76424	79593940
Circulatory collapse	18.40	14.43	6	74018	37662	79632702
Overgrowth bacterial	18.39	14.43	7	74017	199	79670165
Dysplasia	18.36	14.43	13	74011	1373	79668991
Ileal ulcer	18.30	14.43	12	74012	1118	79669246
Proctectomy	18.26	14.43	7	74017	203	79670161
Haematocrit decreased	18.20	14.43	18	74006	61294	79609070
Drug eruption	18.19	14.43	9	74015	43926	79626438
Granulomatous rosacea	18.07	14.43	7	74017	209	79670155
Intentional self-injury	18.03	14.43	4	74020	32415	79637949
Gastrointestinal bacterial overgrowth	18.01	14.43	10	74014	688	79669676
Gingival pain	18.01	14.43	31	73993	8967	79661397
Drug withdrawal syndrome	17.92	14.43	5	74019	34713	79635651
Hyperplastic cholecystopathy	17.85	14.43	7	74017	216	79670148
Apoptosis	17.81	14.43	9	74015	511	79669853
Enterovesical fistula	17.80	14.43	12	74012	1170	79669194
Prescribed underdose	17.77	14.43	3	74021	29511	79640853
Colon dysplasia	17.76	14.43	7	74017	219	79670145
Gastrointestinal anastomotic stenosis	17.71	14.43	4	74020	15	79670349
Fistulotomy	17.71	14.43	4	74020	15	79670349
Abdominal mass	17.61	14.43	19	74005	3526	79666838
Osteoarthritis	17.53	14.43	34	73990	87275	79583089
Anastomotic ulcer	17.51	14.43	10	74014	727	79669637
Gamma-glutamyltransferase increased	17.48	14.43	15	74009	54665	79615699
Anaplastic large-cell lymphoma	17.47	14.43	7	74017	229	79670135
Wheezing	17.44	14.43	53	73971	116611	79553753
Abnormal behaviour	17.44	14.43	6	74018	36415	79633949
Procedural pain	17.35	14.43	54	73970	23030	79647334
Coagulopathy	17.12	14.43	6	74018	36000	79634364
Short-bowel syndrome	17.05	14.43	9	74015	560	79669804
Disseminated intravascular coagulation	17.00	14.43	6	74018	35836	79634528
Interstitial lung disease	16.95	14.43	51	73973	112549	79557815
Pulmonary fibrosis	16.86	14.43	10	74014	44102	79626262
Transaminases increased	16.78	14.43	14	74010	51729	79618635
Pericarditis	16.57	14.43	46	73978	104190	79566174
Infusion site pain	16.54	14.43	39	73985	14137	79656227
Pus in stool	16.44	14.43	5	74019	70	79670294
Laparotomy	16.33	14.43	8	74016	425	79669939
Blood pressure systolic increased	16.32	14.43	23	74001	66963	79603401
Myoclonus	16.24	14.43	3	74021	27657	79642707
Alopecia	16.21	14.43	137	73887	231218	79439146
Irritability	16.19	14.43	9	74015	41135	79629229
Anal ulcer	16.14	14.43	12	74012	1366	79668998
Pharyngeal paraesthesia	16.06	14.43	16	74008	2705	79667659
Pyelonephritis chronic	16.05	14.43	7	74017	284	79670080
Loss of consciousness	15.94	14.43	91	73933	167852	79502512
Hepatic vascular thrombosis	15.87	14.43	3	74021	3	79670361
Haematoma	15.87	14.43	15	74009	52180	79618184
Gastrointestinal surgery	15.83	14.43	7	74017	294	79670070
Red blood cell count decreased	15.83	14.43	18	74006	57495	79612869
Haemorrhoidal haemorrhage	15.74	14.43	25	73999	6770	79663594
Enteropathic spondylitis	15.64	14.43	4	74020	28	79670336
Product quality issue	15.56	14.43	6	74018	33934	79636430
Full blood count decreased	15.55	14.43	3	74021	26816	79643548
Ascites	15.54	14.43	29	73995	75533	79594831
Gastrointestinal tract irritation	15.47	14.43	9	74015	677	79669687
Mechanical ileus	15.47	14.43	10	74014	909	79669455
Gastrointestinal sounds abnormal	15.45	14.43	22	74002	5413	79664951
Anal stenosis	15.44	14.43	8	74016	479	79669885
Anorectal swelling	15.44	14.43	5	74019	87	79670277
Generalised tonic-clonic seizure	15.36	14.43	11	74013	43899	79626465
Feeling cold	15.33	14.43	60	73964	28669	79641695
Suicidal ideation	15.09	14.43	30	73994	76310	79594054
Leukocytosis	15.05	14.43	11	74013	43444	79626920
Underdose	14.97	14.43	6	74018	33145	79637219
Acute myeloid leukaemia	14.94	14.43	5	74019	30880	79639484
Rheumatic fever	14.92	14.43	4	74020	28521	79641843
Device dislocation	14.86	14.43	3	74021	25967	79644397
Enteritis	14.76	14.43	38	73986	14545	79655819
Hepatitis	14.74	14.43	18	74006	55709	79614655
Pneumonitis	14.72	14.43	21	74003	60839	79609525
Anal spasm	14.66	14.43	3	74021	6	79670358
Vessel puncture site pain	14.66	14.43	3	74021	6	79670358
Radiculopathy	14.61	14.43	28	73996	8796	79661568
Clostridium difficile colitis	14.54	14.43	64	73960	32219	79638145
Femur fracture	14.44	14.43	9	74015	38643	79631721

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Integrin alpha-4/beta-7	Adhesion	P13612 P26010	ITA4_HUMAN ITB7_HUMAN	ANTIBODY BINDING	IC50	8.30		IUPHAR	DRUG LABEL

External reference:

ID	Source
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
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

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Entyvio	HUMAN PRESCRIPTION DRUG LABEL	1	64764-300	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	300 mg	INTRAVENOUS	BLA	29 sections
Entyvio	HUMAN PRESCRIPTION DRUG LABEL	1	64764-300	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	300 mg	INTRAVENOUS	BLA	29 sections