Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lenvatinib
Drug ID BADD_D01254
Description Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. These receptor tyrosine kinases (RTKs) located in the cell membrane play a central role in the activation of signal transduction pathways involved in the normal regulation of cellular processes, such as cell proliferation, migration, apoptosis and differentiation, and in pathogenic angiogenesis, lymphogenesis, tumour growth and cancer progression. In particular, VEGF has been identified as a crucial regulator of both physiologic and pathologic angiogenesis and increased expression of VEGF is associated with a poor prognosis in many types of cancers. Lenvatinib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer. Most patients with thyroid cancer have a very good prognosis with treatment (98% 5 year survival rate) involving surgery and hormone therapy. However, for patients with RAI-refractory thyroid cancer, treatment options are limited and the prognosis is poor, leading to a push for the development of more targeted therapies such as lenvatinib.
Indications and Usage Lenvatinib is indicated for the treatment of following conditions. - Treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. - Treatment of advanced renal cell carcinoma (RCC) in combination with everolimus following one prior antiangiogenic therapy. - First-line treatment of unresectable hepatocellular carcinoma (HCC).
Marketing Status approved; investigational
ATC Code L01EX08
DrugBank ID DB09078
KEGG ID D09919
MeSH ID C531958
PubChem ID 9823820
TTD Drug ID D0R0FO
NDC Product Code 62856-704; 62856-710; 62856-712; 63285-758; 54893-0080; 62856-708; 62856-718; 11071-912; 11071-913; 63285-757; 62856-714; 62856-724; 62856-720
UNII EE083865G2
Synonyms lenvatinib | 4-(3-chloro-4-((cyclopropylaminocarbonyl)amino)phenoxy)-7-methoxy-6-quinolinecarboxamide | 4-(3-chloro-4-(N'-cyclopropylureido)phenoxy)-7-methoxyquinoline-6-carboxamide | lenvatinib mesylate | E7080 mesylate | N-(4-((6-carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)-N'-cyclopropylurea monomethanesulfonate | lenvatinib mesilate | lenvatinib methanesulfonate | Lenvima | E-7080 mesylate | E 7080 | E-7080 | ER-203492-00 | E7080 | lenvatinib metabolite M2 | 4-(3-chloro-4-(((cyclopropylamino)carbonyl)amino)phenoxy)-7-hydroxy-6-quinolinecarboxamide
Chemical Information
Molecular Formula C21H19ClN4O4
CAS Registry Number 417716-92-8
SMILES COC1=CC2=NC=CC(=C2C=C1C(=O)N)OC3=CC(=C(C=C3)NC(=O)NC4CC4)Cl
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)
Coagulopathy01.01.02.0010.000358%-
Colitis07.08.01.0010.000828%
Colitis ischaemic07.08.01.004; 24.04.08.0120.000168%-
Coma hepatic09.01.03.005; 17.02.09.0020.000112%-
Confusional state17.02.03.005; 19.13.01.001--
Constipation07.02.02.001--
Coronary artery stenosis02.02.01.010; 12.02.01.037; 24.04.04.0170.000112%-
Cough22.02.03.001--
Death08.04.01.001--
Decreased activity08.01.01.006; 19.11.01.0020.000112%-
Decubitus ulcer23.03.11.0060.000112%-
Dehydration14.05.05.0010.004567%
Depressed mood19.15.02.001---
Depression19.15.01.001--
Diarrhoea07.02.01.0010.023001%
Diplegia17.01.04.0150.000112%-
Disseminated intravascular coagulation01.01.02.002; 24.01.01.0100.000560%
Disturbance in attention17.03.03.001; 19.21.02.002--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Drug eruption08.01.06.015; 10.01.01.005; 23.03.05.0010.000616%-
Dry mouth07.06.01.002--
Duodenal perforation07.04.02.0010.000582%
Duodenal ulcer07.04.02.0020.000392%
Duodenal ulcer haemorrhage07.04.02.004; 24.07.02.0200.000392%-
Duodenitis07.08.03.0010.000112%-
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.001--
Dysphagia07.01.06.003--
Dysphonia17.02.08.004; 19.19.03.002; 22.12.03.0060.004477%
Dyspnoea02.11.05.003; 22.02.01.004--
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