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 Prescription
ATC Code L01EX01
DrugBank ID DB01268
KEGG ID D08552
MeSH ID D000077210
PubChem ID 5329102
TTD Drug ID D0R0MW
NDC Product Code Not Available
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
DiarrhoeaBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134
DiarrhoeaBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134; 25515134
HypertensionBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134; 25515134
HypertensionBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134
Palmar-plantar erythrodysaesthesia syndromeBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134; 25515134
Palmar-plantar erythrodysaesthesia syndromeBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134
VomitingBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134
VomitingBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134; 25515134
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Epilepsy17.12.03.002--Not Available
Epistaxis24.07.01.005; 22.04.03.0010.032502%
Eructation07.01.02.0030.002664%
Erysipelas23.09.01.002; 11.02.06.0010.000533%Not Available
Erythema23.03.06.0010.016251%Not Available
Erythema multiforme23.03.01.003; 10.01.03.015--
Escherichia sepsis11.02.10.0020.000533%Not Available
Essential hypertension24.08.02.0080.000533%Not Available
Extrasystoles02.03.02.0030.000799%Not Available
Eye disorder06.08.03.001--Not Available
Eye haemorrhage24.07.05.002; 06.07.02.0010.002664%Not Available
Eye pain06.08.03.002--
Eye swelling06.08.03.0030.004795%Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.0040.005328%Not Available
Face oedema08.01.07.003; 23.04.01.004; 10.01.05.0020.011456%
Facial pain08.01.08.0120.001066%
Facial paralysis17.04.03.008--Not Available
Faeces discoloured07.01.03.0020.003730%Not Available
Failure to thrive18.04.01.003; 19.07.05.001; 14.03.02.0080.000278%Not Available
Fatigue08.01.01.0020.191283%
Febrile neutropenia08.05.02.004; 01.02.03.002--
Feeling abnormal08.01.09.014--Not Available
Feeling cold08.01.09.0080.003463%Not Available
Feeling hot08.01.09.009--Not Available
Femur fracture15.08.03.003; 12.04.01.003--Not Available
Fistula15.03.02.0010.001865%Not Available
Flank pain15.03.04.003; 08.01.08.007; 20.02.03.0060.001598%
Flatulence07.01.04.0020.010124%
Fluid overload14.05.06.001; 02.05.04.004--Not Available
Fluid retention20.01.02.003; 14.05.06.0020.005861%Not Available
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