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)
Renal cancer20.01.04.002; 16.08.02.0010.034765%Not Available
Renal colic20.02.03.0100.000112%
Renal disorder20.01.02.0020.003000%Not Available
Renal failure20.01.03.0050.004108%Not Available
Renal tubular disorder20.05.03.0040.000112%Not Available
Renal tubular necrosis20.01.07.0030.000168%Not Available
Renal vein thrombosis24.01.11.002; 20.01.07.0110.000112%Not Available
Respiratory failure22.02.06.002; 14.01.04.003--
Retching07.01.07.0020.001130%Not Available
Retinal detachment12.01.04.004; 06.09.03.0030.000392%
Retinal haemorrhage24.07.05.003; 06.10.01.0010.000224%Not Available
Rhabdomyolysis15.05.05.002--
Rhinorrhoea22.12.03.0210.001836%
Scab23.03.03.0040.000873%Not Available
Scrotal pain21.12.02.0040.000112%
Second primary malignancy16.16.01.0140.005876%
Seizure17.12.03.001--
Sepsis11.01.11.003--
Septic shock24.06.02.011; 11.01.11.004--Not Available
Shock24.06.02.002--Not Available
Skin atrophy23.01.05.0010.000851%
Skin depigmentation23.05.02.0020.000437%Not Available
Skin discolouration23.03.03.0050.012838%Not Available
Skin disorder23.03.03.0070.004097%Not Available
Skin erosion23.07.03.0020.000492%Not Available
Skin exfoliation23.03.07.0030.010062%Not Available
Skin fissures23.03.03.0080.002082%Not Available
Skin hyperpigmentation23.05.01.0030.000571%
Skin hypertrophy23.01.04.0020.000548%Not Available
Skin hypopigmentation23.05.02.0030.000381%
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ADReCS-Target
Drug Name ADR Term Target
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