Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Vinorelbine tartrate
Drug ID BADD_D02364
Description Vinorelbine is an anti-mitotic chemotherapy drug that is used in the treatment of several types of malignancies, including breast cancer and non-small cell lung cancer (NSCLC) [L1998]. It was initially approved in the USA in 1990's for the treatment of NSCLC [L2010]. It is a third-generation vinca alkaloid. The introduction of third-generation drugs (vinorelbine, gemcitabine, taxanes) in platinum combination improved survival of patients with advanced NSCLC, with very similar results from the various drugs. Treatment toxicities are considerable in the combination treatment setting [A32347]. A study was done on the clearance rate of vinorelbine on individuals with various single polymorphonuclear mutations. It was found that there was 4.3-fold variation in vinorelbine clearance across the cohort, suggesting a strong influence of genetics on the clearance of this drug [L2002].
Indications and Usage Vinorelbine tartrate is indicated for adults in the treatment of advanced non-small cell lung cancer (NSCLC), as a single therapy or in combination with other chemotherapeutic drugs [L1998]. Used in relapsed or refractory Hodgkin lymphoma, in combination with other chemotherapy agents [L2011]. For the treatment of desmoid tumor or aggressive fibromatosis, in combination with methotrexate [L2011]. For the treatment of recurrent or metastatic squamous cell head and neck cancer [L2011]. For the treatment of recurrent ovarian cancer [L2011]. For the treatment of metastatic breast cancer, in patients previously treated with anthracyline and/or taxane therapy [L2011]. For the treatment of HER2-positive, trastuzumab-resistant, advanced breast cancer in patients previously treated with a taxane, in combination with trastuzumab and everolimus [L2011].
Marketing Status approved; investigational
ATC Code L01CA04
DrugBank ID DB00361
KEGG ID D01935
MeSH ID D000077235
PubChem ID 16051941
TTD Drug ID D01HTL
NDC Product Code 66529-0001; 69910-0004; 62158-0001; 66529-0012
UNII 253GQW851Q
Synonyms Vinorelbine | 5'-Nor-anhydrovinblastine | 5' Nor anhydrovinblastine | KW 2307 | KW-2307 | KW2307 | Navelbine | Vinorelbine Tartrate
Chemical Information
Molecular Formula C53H66N4O20
CAS Registry Number 125317-39-7
SMILES CCC1=CC2CC(C3=C(CN(C2)C1)C4=CC=CC=C4N3)(C5=C(C=C6C(=C5)C78CCN9C7C(C=CC9)(C(C(C8N 6C)(C(=O)OC)O)OC(=O)C)CC)OC)C(=O)OC.C(C(C(=O)O)O)(C(=O)O)O.C(C(C(=O)O)O)(C(=O)O) O
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)
Pancytopenia01.03.03.003---
Paraesthesia17.02.06.005; 23.03.03.094--
Paresis17.01.04.008---
Peripheral coldness08.01.09.010; 23.06.04.008; 24.04.03.006---
Phlebitis12.02.01.002; 24.12.03.004--
Pneumonia11.01.09.003; 22.07.01.003---
Polyuria20.02.03.002---
Pruritus23.03.12.001--
Pulmonary embolism22.06.02.001; 24.01.06.001---
Pulmonary oedema02.05.02.003; 22.01.03.003--
Rash23.03.13.001---
Respiratory failure14.01.04.003; 22.02.06.002--
Sensory loss17.02.07.007---
Sepsis11.01.11.003--
Skin disorder23.03.03.007---
Skin exfoliation23.03.07.003---
Skin necrosis23.03.03.011---
Small cell lung cancer16.19.08.003; 22.08.01.013---
Stomatitis07.05.06.005--
Tachycardia02.03.02.007---
Thrombocytopenia01.08.01.002---
Thrombophlebitis24.01.02.001---
Thrombosis24.01.01.006---
Tumour pain16.32.03.003--
Urticaria10.01.06.001; 23.04.02.001--
Vein discolouration24.03.02.004---
Vertigo04.04.01.003; 17.02.12.002--
Vestibular disorder04.04.02.001; 17.02.02.008--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
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