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
HypertensionBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134; 25515134
Palmar-plantar erythrodysaesthesia syndromeBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134
Palmar-plantar erythrodysaesthesia syndromeBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134; 25515134
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)
Urinary bladder haemorrhage24.07.01.086; 20.03.01.0230.000533%Not Available
Atrial thrombosis24.01.05.005; 02.01.01.013--Not Available
Terminal state08.01.03.079--Not Available
Lower extremity mass15.03.01.0150.000533%Not Available
Fungal oesophagitis11.03.05.021; 07.19.06.0040.000533%Not Available
Tongue haemorrhage07.14.01.015; 24.07.02.0580.000533%Not Available
Renal cancer metastatic20.01.04.012; 16.08.02.0060.002571%Not Available
Neuroendocrine tumour16.24.01.009; 05.08.01.0130.000417%Not Available
Palatal disorder07.05.01.0190.000533%Not Available
Small intestinal haemorrhage24.07.02.019; 07.12.03.0020.000799%
Abscess jaw15.02.05.004; 11.01.01.0050.000533%Not Available
Clostridium difficile infection11.02.02.009--Not Available
Genital erythema23.03.06.019; 21.10.01.0150.000533%Not Available
Thyroid cancer metastatic16.24.03.006; 05.02.05.0090.000347%Not Available
Necrotising oesophagitis07.04.05.0060.000139%Not Available
Cell death14.11.02.005; 08.03.03.0030.000533%Not Available
Neuroendocrine carcinoma05.08.01.011; 16.24.01.0070.001332%Not Available
Biliary sepsis11.01.18.005; 09.02.01.0050.000139%Not Available
Gastrointestinal oedema07.11.01.0120.000799%Not Available
Nephrogenic anaemia01.03.04.001; 20.01.01.0070.000533%Not Available
Putamen haemorrhage24.07.04.031; 17.08.01.0580.000533%Not Available
Myxoedema coma14.11.01.042; 17.02.09.009; 05.02.03.0060.000799%Not Available
Communication disorder19.19.01.0080.000533%Not Available
Foot deformity15.10.03.005--Not Available
Malignant urinary tract neoplasm16.08.04.001; 20.08.01.0050.003463%Not Available
Biliary tract infection11.01.18.003; 09.02.01.0040.000533%
Vascular encephalopathy17.08.02.025; 24.04.06.042; 19.20.04.0020.000533%Not Available
Peritoneal perforation12.02.03.021; 07.07.01.0110.000139%Not Available
Oroantral fistula22.04.06.005; 07.11.05.0150.000533%Not Available
Dental fistula11.01.04.017; 07.11.05.0080.000799%Not Available
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