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)
Nasal ulcer22.04.03.0110.000492%Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.0010.063620%
Neck pain15.03.04.009--
Necrosis24.04.02.006; 08.03.03.0010.000280%Not Available
Necrotising fasciitis15.03.03.004; 11.01.17.002--Not Available
Neoplasm16.16.02.001--Not Available
Neoplasm malignant16.16.01.0010.022509%Not Available
Nephritis20.05.02.0010.000168%Not Available
Nephropathy20.05.03.0010.000358%Not Available
Nephrotic syndrome20.05.01.0020.001007%
Nervous system disorder17.02.10.001--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Neutropenia01.02.03.0040.009279%Not Available
Night sweats23.02.03.006; 08.01.03.0310.001343%Not Available
Nocturia20.02.03.0010.000414%Not Available
Normochromic normocytic anaemia01.03.02.0050.000112%Not Available
Odynophagia07.01.06.0360.001175%Not Available
Oedema14.05.06.010; 08.01.07.0060.005014%Not Available
Oedema peripheral08.01.07.007; 02.05.04.007; 14.05.06.0110.006134%
Oesophageal candidiasis11.03.03.008; 07.19.06.001--Not Available
Oesophageal haemorrhage24.07.02.021; 07.12.01.0020.000168%
Oesophageal perforation07.04.05.0010.000112%
Oesophageal ulcer07.04.05.0020.000806%
Oesophagitis07.08.05.0010.000996%
Oral candidiasis11.03.03.004; 07.05.07.001--Not Available
Oral discomfort07.05.05.0010.004813%Not Available
Oral mucosal blistering07.05.05.0170.002216%Not Available
Oral mucosal eruption07.05.05.0180.000246%Not Available
Oral pain07.05.05.0340.017651%
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ADReCS-Target
Drug Name ADR Term Target
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