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; 25515134
DiarrhoeaBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134
HypertensionBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134
HypertensionBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134; 25515134
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; 25515134
VomitingBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Cholelithiasis09.03.01.0020.003197%Not Available
Cholestasis09.01.01.001--Not Available
Chromaturia20.02.01.0020.006927%
Chronic myeloid leukaemia16.01.07.001; 01.10.07.0010.000417%Not Available
Chronic obstructive pulmonary disease22.03.01.007--Not Available
Circulatory collapse24.06.02.001--Not Available
Coagulopathy01.01.02.001--Not Available
Cold sweat23.02.03.002; 08.01.03.0240.001865%Not Available
Colitis07.08.01.0010.005595%
Colitis ischaemic24.04.08.012; 07.08.01.0040.000799%Not Available
Colitis ulcerative10.02.01.004; 07.08.01.0050.002131%Not Available
Colon cancer07.21.01.001; 16.13.01.001--Not Available
Coma17.02.09.001--Not Available
Completed suicide19.12.01.001; 08.04.01.010--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Conjunctival haemorrhage24.07.05.001; 06.07.01.0010.003197%Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.0010.030104%
Coronary artery disease24.04.04.006; 02.02.01.001--Not Available
Coronary artery stenosis24.04.04.017; 02.02.01.0100.000533%Not Available
Cough22.02.03.001--
Crohn's disease10.02.01.005; 07.08.01.015--Not Available
Cushing's syndrome24.08.04.001; 19.07.03.002; 14.11.01.007; 05.01.01.0010.000533%Not Available
Cyst16.02.02.002; 08.03.05.0010.001598%Not Available
Cystitis20.03.02.002; 11.01.14.0010.002398%
Cystitis haemorrhagic20.03.02.0030.000533%Not Available
Deafness04.02.01.0010.002398%Not Available
Death08.04.01.0010.080201%
Decreased immune responsiveness10.02.01.0410.000799%Not Available
Decubitus ulcer23.03.11.0060.002664%Not Available
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