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)
Exposed bone in jaw15.02.04.0340.000448%Not Available
Systolic dysfunction02.04.02.0350.000168%Not Available
Spinal pain17.10.01.020; 15.02.01.008; 08.01.08.0300.000414%Not Available
Bandaemia01.02.01.0150.000112%Not Available
Prerenal failure24.06.02.025; 20.01.03.0220.000112%Not Available
Clear cell renal cell carcinoma20.01.04.008; 16.08.02.0040.001186%Not Available
Mucosal toxicity12.03.01.056; 08.01.06.0240.000112%Not Available
Internal haemorrhage24.07.01.0720.000336%Not Available
Soft tissue sarcoma16.33.01.003; 15.09.03.0210.001880%Not Available
Hyperinsulinaemic hypoglycaemia05.06.03.010; 14.06.03.0100.000112%Not Available
Tongue discomfort07.14.02.0190.001992%Not Available
Biliary obstruction09.02.02.0050.000112%Not Available
Cardiac dysfunction02.11.01.0040.000280%Not Available
Central hypothyroidism14.11.01.049; 05.02.03.0090.000224%Not Available
Congestive hepatopathy09.01.06.027; 02.05.04.0180.000112%Not Available
Connective tissue neoplasm16.33.08.002; 15.09.02.0050.000571%Not Available
Decompensated hypothyroidism14.11.01.050; 05.02.03.0100.000168%Not Available
Dilated cardiomyopathy02.04.01.0170.000392%Not Available
Discoloured vomit07.01.07.0170.000246%Not Available
Disease complication08.01.03.0870.000414%Not Available
Drug effective for unapproved indication12.09.02.001; 08.06.01.037--Not Available
Gait inability08.01.02.011; 17.02.05.0690.000895%Not Available
Graves' disease10.04.08.014; 06.09.04.009; 05.02.02.0090.000112%Not Available
Haemoperitoneum24.07.02.065; 12.01.17.007; 07.07.02.0070.000224%Not Available
Hypophysitis10.02.01.079; 05.03.04.0100.000112%
Illness08.01.03.091--Not Available
Immune thrombocytopenia10.02.01.083; 01.08.01.0130.000616%Not Available
Intermenstrual bleeding21.01.01.015--Not Available
Limb mass15.03.05.0190.000112%Not Available
Mucosal disorder08.01.06.0290.000392%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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