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)
Bronchopneumopathy22.02.07.0100.000112%Not Available
Acquired haemophilia01.01.01.0020.000112%Not Available
Cerebral haematoma24.07.04.006; 17.08.01.0140.000224%Not Available
Tumour necrosis16.32.03.009; 24.04.02.0130.000112%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.000739%Not Available
Haemorrhoidal haemorrhage07.15.03.002; 24.10.02.0010.000504%
Throat lesion22.12.03.0300.000381%Not Available
Vascular insufficiency24.04.02.0140.000381%Not Available
Haemorrhage24.07.01.0020.003783%Not Available
Haemorrhage urinary tract24.07.01.007; 20.02.03.0050.000224%Not Available
Varices oesophageal24.10.02.004; 09.01.06.009; 07.15.05.0010.000112%Not Available
Fluid intake reduced14.05.10.0010.000168%Not Available
Vulvovaginal pruritus21.08.02.004; 23.03.12.0090.000246%Not Available
Pneumatosis intestinalis07.11.01.0430.001623%Not Available
Temperature intolerance08.01.09.0220.000302%Not Available
Urine odour abnormal20.02.01.0200.000246%Not Available
Hypoaesthesia oral07.05.05.003; 17.02.06.0210.000795%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.000772%Not Available
Cancer pain16.32.03.0040.000582%Not Available
Abdominal sepsis11.01.11.011; 07.19.02.012--Not Available
Dyslipidaemia14.08.04.0150.000224%Not Available
Ocular icterus09.01.01.007; 06.08.03.009; 01.06.04.0070.001310%Not Available
Dysgraphia17.02.03.0060.000112%Not Available
Dermatitis psoriasiform23.03.14.004--Not Available
Eyelash discolouration06.06.04.0090.000246%Not Available
Bicytopenia01.03.03.0100.000168%Not Available
Gastrointestinal toxicity12.03.01.019; 07.08.03.0060.001220%Not Available
Ventricular dysfunction02.04.02.0050.000168%Not Available
Angiopathy24.03.02.0070.000336%Not Available
Apoptosis14.11.02.002--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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