Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Vedolizumab
Drug ID BADD_D02342
Description Vedolizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte α4β7 integrin, a key mediator of gastrointestinal inflammation. It is used in the treatment of moderate to severe active ulcerative colitis and Crohn's disease for patients who have had an inadequate response with, lost response to, or were intolerant to inhibitors of tumor necrosis factor-alpha (TNF-alpha) or other conventional therapies. By blocking its primary target, α4β7 integrin, vedolizumab reduces inflammation in the gut. Vedolizumab is administered by IV infusion over a period of 30 minutes; after the first dose, it is given again at two and six weeks and then every 8 weeks thereafter.
Indications and Usage Vedolizumab is indicated for adult patients with moderately to severely active UC or CD who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids.
Marketing Status approved
ATC Code L04AA33
DrugBank ID DB09033
KEGG ID D08083
MeSH ID C543529
PubChem ID Not Available
TTD Drug ID D0PK5M
NDC Product Code 64764-300; 0051-2638; 11532-3002
UNII 9RV78Q2002
Synonyms vedolizumab | Entyvio | MLN0002 | MLN02 | MLN-0002 | MLN-02
Chemical Information
Molecular Formula Not Available
CAS Registry Number 943609-66-3
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Renal cancer20.01.04.002; 16.08.02.001--Not Available
Sepsis11.01.11.003--
Septic shock24.06.02.011; 11.01.11.004--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Squamous cell carcinoma16.16.01.002--Not Available
Transitional cell carcinoma20.08.01.010; 16.08.04.002--Not Available
Tuberculosis11.04.01.006--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vomiting07.01.07.003--
Anal abscess11.01.07.015; 07.19.04.004--Not Available
Cytomegalovirus colitis07.19.01.007; 11.05.01.004--Not Available
Infusion related reaction10.01.01.017; 08.01.03.002; 12.02.05.009--
Bacterial sepsis11.02.01.029--Not Available
Transaminases increased13.03.04.036--Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.001--Not Available
Salmonella sepsis11.02.19.002--Not Available
Antibody test13.06.03.009--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Hepatic cancer16.07.02.004; 09.04.02.008--Not Available
Carcinoid tumour in the large intestine16.24.04.006; 07.21.04.011; 05.08.01.016--Not Available
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