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)
Abdominal pain07.01.05.002--
Alanine aminotransferase increased13.03.04.005--
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
B-cell lymphoma01.15.01.001; 16.28.01.001---
Back pain15.03.04.005--
Blood bilirubin increased13.03.04.018--
Breast cancer16.10.01.001; 21.05.01.003---
Bronchitis11.01.09.001; 22.07.01.001--
Colon cancer07.21.01.001; 16.13.01.001---
Cough22.02.03.001--
Death08.04.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Fatigue08.01.01.002--
Giardiasis07.19.01.015; 11.06.06.001---
Headache17.14.01.001--
Hepatitis09.01.07.004---
Influenza11.05.03.001; 22.07.02.001---
Malaise08.01.01.003--
Malignant melanoma16.03.01.001; 23.08.01.001---
Meningitis listeria11.02.11.002; 17.06.10.003---
Nasopharyngitis11.01.13.002; 22.07.03.002---
Nausea07.01.07.001--
Pain in extremity15.03.04.010--
Progressive multifocal leukoencephalopathy11.05.05.001; 17.16.02.002---
Pruritus23.03.12.001--
Pulmonary tuberculosis11.04.01.003; 22.07.06.002---
Pyrexia08.05.02.003--
Rash23.03.13.001---
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