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)
Malignant neoplasm of renal pelvis20.08.01.009; 16.08.05.0010.000381%Not Available
Mallory-Weiss syndrome24.07.02.038; 07.12.01.0040.000112%Not Available
Mastication disorder15.03.05.022; 17.05.03.006; 07.01.06.0160.000168%Not Available
Melaena07.12.02.004; 24.07.02.0130.001007%Not Available
Melanocytic naevus23.10.01.007; 16.26.01.0070.000168%Not Available
Memory impairment19.20.01.003; 17.03.02.003--
Menopausal symptoms21.02.02.002--Not Available
Microangiopathic haemolytic anaemia24.03.02.019; 01.06.02.0020.000280%Not Available
Micturition disorder20.02.02.0050.000302%Not Available
Migraine with aura17.14.02.002; 24.03.05.0050.000246%Not Available
Mitral valve incompetence02.07.01.0020.000224%Not Available
Monoparesis17.01.04.0110.000112%Not Available
Monoplegia17.01.04.0030.000504%Not Available
Mouth haemorrhage24.07.02.014; 07.05.02.0010.000728%
Mouth ulceration07.05.06.0040.004365%Not Available
Mucosal dryness08.01.06.0010.000302%Not Available
Mucosal inflammation08.01.06.0020.013252%Not Available
Muscle spasms15.05.03.004--
Muscular weakness17.05.03.005; 15.05.06.0010.003850%
Musculoskeletal pain15.03.04.0070.001824%
Mutism19.19.01.001; 17.02.08.0070.000112%Not Available
Myalgia15.05.02.001--
Myocardial infarction02.02.02.007; 24.04.04.0090.003716%
Myocardial ischaemia24.04.04.010; 02.02.02.008--Not Available
Myopathy15.05.05.001--Not Available
Myxoedema23.07.04.007; 05.02.03.0020.000168%Not Available
Nail discolouration23.02.05.0010.000817%
Nail disorder23.02.05.002--
Nasal congestion22.04.04.001--
Nasal dryness22.04.03.0020.000224%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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