Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Sunitinib
Drug ID BADD_D02100
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 D08552
MeSH ID D000077210
PubChem ID 5329102
TTD Drug ID D0R0MW
NDC Product Code Not Available
UNII V99T50803M
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 C22H27FN4O2
CAS Registry Number 557795-19-4
SMILES CCN(CC)CCNC(=O)C1=C(NC(=C1C)C=C2C3=C(C=CC(=C3)F)NC2=O)C
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)
Cellulitis gangrenous23.11.02.005; 11.02.01.016--Not Available
Cerebral artery embolism17.08.01.001; 24.01.04.0010.000168%Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.003--Not Available
Cerebral infarction24.04.06.002; 17.08.01.004--Not Available
Cerebral ischaemia24.04.06.003; 17.08.01.0050.000168%
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Cerebrovascular disorder24.03.05.002; 17.08.02.0020.000168%Not Available
Cheilitis23.03.03.025; 07.05.01.0010.000414%
Chest pain08.01.08.002; 02.02.02.011; 22.12.02.003--Not Available
Chills15.05.03.016; 08.01.09.0010.004097%
Choking22.12.03.0030.000638%Not Available
Cholangitis09.02.01.0020.001007%Not Available
Cholecystitis09.03.01.0010.000672%
Cholecystitis acute09.03.01.0030.000728%Not Available
Cholelithiasis09.03.01.0020.000672%Not Available
Chromaturia20.02.01.0020.003772%
Chronic myeloid leukaemia16.01.07.001; 01.10.07.0010.000392%Not Available
Cold sweat23.02.03.002; 08.01.03.0240.000795%Not Available
Colitis07.08.01.0010.001724%
Colitis ischaemic24.04.08.012; 07.08.01.0040.000224%Not Available
Conduction disorder02.03.01.0080.000112%
Conjunctival haemorrhage24.07.05.001; 06.07.01.0010.000728%Not Available
Constipation07.02.02.0010.013387%
Coronary artery occlusion12.02.01.036; 24.04.04.013; 02.02.01.0060.000112%Not Available
Coronary artery stenosis24.04.04.017; 02.02.01.010; 12.02.01.0370.000112%Not Available
Cough22.02.03.001--
Cushing's syndrome24.08.04.001; 19.07.03.002; 14.11.01.007; 05.01.01.0010.000112%Not Available
Cutaneous vasculitis23.06.02.001; 10.02.02.003; 24.12.04.0080.000112%Not Available
Cyst16.02.02.002; 08.03.05.0010.001007%Not Available
Cystitis haemorrhagic20.03.02.0030.000112%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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