Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sunitinib malate
Drug ID BADD_D02101
Description Sunitinib is a small-molecule multi-targeted receptor tyrosine kinase (RTK) inhibitor. On January 26, 2006, the agent was formally approved by the US FDA for the indications of treating renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST). For these purposes, sunitinib is generally available as an orally administered formulation. Sunitinib inhibits cellular signaling by targeting multiple RTKs. These include all platelet-derived growth factor receptors (PDGF-R) and vascular endothelial growth factor receptors (VEGF-R). Sunitinib also inhibits KIT (CD117), the RTK that drives the majority of GISTs. In addition, sunitinib inhibits other RTKs including RET, CSF-1R, and flt3.
Indications and Usage For the treatment of advanced renal cell carcinoma as well as the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate.
Marketing Status approved; investigational
ATC Code L01EX01
DrugBank ID DB01268
KEGG ID D06402
MeSH ID D000077210
PubChem ID 6456015
TTD Drug ID D0R0MW
NDC Product Code 53296-0091; 43598-048; 0378-6679; 0378-6681; 68554-0078; 0093-8199; 0093-8224; 63304-091; 0378-6678; 16714-678; 0093-8229; 0069-0830; 53183-4012; 16714-677; 63304-092; 43598-047; 63304-094; 63539-017; 0378-6680; 0069-0770; 0069-0980; 54893-0081; 68724-1234; 63304-093; 63539-019; 16436-0091; 16714-676; 16714-679; 43598-045; 43598-046; 0069-0550; 0093-8231
UNII LVX8N1UT73
Synonyms Sunitinib | 5-(5-Fluoro-2-oxo-1,2-dihydroindolylidenemethyl)-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylaminoethyl)amide | Sunitinib Malate | Sutent | SU 11248 | SU011248 | SU 011248 | SU-011248 | SU11248 | SU-11248
Chemical Information
Molecular Formula C26H33FN4O7
CAS Registry Number 341031-54-7
SMILES CCN(CC)CCNC(=O)C1=C(NC(=C1C)C=C2C3=C(C=CC(=C3)F)NC2=O)C.C(C(C(=O)O)O)C(=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)
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Blood phosphorus decreased13.11.01.015--Not Available
Ejection fraction decreased13.14.02.003--
Perineum stimulation25.10.02.002--Not Available
Tumour necrosis24.04.02.013; 16.32.03.009--Not Available
Haemorrhage24.07.01.002--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Decreased appetite14.03.01.005; 08.01.09.028--
White blood cell morphology abnormal13.01.06.038--Not Available
Renal impairment20.01.03.010--Not Available
Ischaemic limb pain24.04.03.014--Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Posterior reversible encephalopathy syndrome17.13.02.007--
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