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 cancer stage IV20.01.04.014; 16.08.02.0080.000571%Not Available
Renal cell carcinoma stage IV20.01.04.016; 16.08.02.0100.000492%Not Available
Salivary gland calculus07.06.02.0030.000112%Not Available
Senile dementia19.20.02.009; 17.03.01.0080.000112%Not Available
Splenic vein thrombosis01.09.02.019; 24.01.03.0050.000112%Not Available
Thyroid atrophy05.02.03.0080.000224%Not Available
Terminal state08.01.03.0790.000168%Not Available
Anaemia of malignant disease01.03.04.0030.000112%Not Available
Tongue haemorrhage24.07.02.058; 07.14.01.0150.000246%Not Available
Renal cancer metastatic20.01.04.012; 16.08.02.0060.003682%Not Available
Neuroendocrine tumour16.24.01.009; 05.08.01.0130.000851%Not Available
Palatal disorder07.05.01.0190.000112%Not Available
Small intestinal haemorrhage24.07.02.019; 07.12.03.0020.000168%
Thyroid cancer metastatic16.24.03.006; 05.02.05.0090.000548%Not Available
Necrotising oesophagitis07.04.05.0060.000112%Not Available
Cell death14.11.02.005; 08.03.03.0030.000112%Not Available
Neuroendocrine carcinoma16.24.01.007; 05.08.01.0110.000627%Not Available
Gastrointestinal oedema07.11.01.0120.000280%Not Available
Nephrogenic anaemia20.01.01.007; 01.03.04.0010.000112%Not Available
Putamen haemorrhage24.07.04.031; 17.08.01.0580.000112%Not Available
Malignant peritoneal neoplasm16.13.04.005; 07.21.03.005--Not Available
Malignant urinary tract neoplasm20.08.01.005; 16.08.04.0010.002205%Not Available
Vascular encephalopathy24.04.06.042; 19.20.04.002; 17.08.02.0250.000112%Not Available
Peritoneal perforation12.02.03.021; 07.07.01.0110.000112%Not Available
Oroantral fistula22.04.06.005; 07.11.05.0150.000112%Not Available
Stress cardiomyopathy02.04.01.012; 24.04.04.0260.000224%Not Available
Oral mucosal erythema07.05.05.0230.000492%Not Available
Pancreatic neuroendocrine tumour16.24.02.005; 07.21.09.009; 05.08.01.0140.001075%Not Available
Pancreatic neuroendocrine tumour metastatic16.24.02.006; 07.21.09.010; 05.08.01.0150.000112%Not Available
Tumour rupture16.32.03.0330.000672%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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