Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Nivolumab
Drug ID BADD_D01581
Description Nivolumab is a fully human IgG4 antibody targeting the immune checkpoint programmed death receptor-1 (PD-1).[L12129] This antibody was produced entirely in mice and grafted onto human kappa and IgG4 Fc region with the mutation _S228P_ for additional stability and reduced variability.[A35203] It was developed by Bristol Myers Squibb.[L12129] Nivolumab was granted FDA approval on 22 December 2014.[L12129]
Indications and Usage Nivolumab is indicated to treat unresectable or metastatic melanoma, adjuvant treatment of melanoma, metastatic non-small cell lung cancer, small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, and hepatocellular carcinoma.[L12129] Nivolumab is also approved for the treatment of HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma when used in combination with a fluoropyrimidine- and platinum-containing chemotherapy regimen.[L39040]
Marketing Status approved
ATC Code L01FF01
DrugBank ID DB09035
KEGG ID D10316
MeSH ID D000077594
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 67643-0021; 0003-3734; 0952-3772; 0003-3756; 0003-3774; 83157-3772; 70409-7125; 71124-0002; 68806-3772; 0003-3772
UNII 31YO63LBSN
Synonyms Nivolumab | Opdivo | ONO-4538 | ONO 4538 | ONO4538 | MDX-1106 | MDX 1106 | MDX1106 | BMS-936558 | BMS 936558 | BMS936558
Chemical Information
Molecular Formula Not Available
CAS Registry Number 946414-94-4
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 impairment20.01.03.010---
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