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)
Amyotrophic lateral sclerosis17.05.05.0040.000139%Not Available
Anaemia01.03.02.0010.051417%
Anaemia macrocytic14.12.01.002; 01.03.02.0020.000533%Not Available
Anaemia megaloblastic14.12.01.003; 01.03.02.0030.000533%Not Available
Anal fissure07.03.01.0020.000533%
Anal fistula07.11.05.0020.002398%
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Aneurysm24.02.01.0010.000533%Not Available
Anger19.04.02.001--Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema23.04.01.001; 10.01.05.009--Not Available
Angular cheilitis23.03.03.054; 11.01.04.014; 07.05.07.0130.001332%Not Available
Anorectal disorder07.03.01.0010.000533%Not Available
Anuria20.01.03.0020.001332%Not Available
Anxiety19.06.02.002--
Aortic aneurysm rupture24.02.03.0030.000139%Not Available
Aortic dissection24.02.03.0020.001598%Not Available
Aphasia19.21.01.001; 17.02.03.001--
Aphonia22.02.05.024; 19.19.01.002; 17.02.08.009--
Aphthous ulcer07.05.06.0020.002931%Not Available
Appendicitis07.19.01.001; 11.01.07.0010.001066%
Arrhythmia02.03.02.001--Not Available
Arterial thrombosis24.01.01.0020.000139%Not Available
Arteriospasm coronary02.02.02.005; 24.04.04.005--Not Available
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Arthropathy15.01.01.003--Not Available
Ascites02.05.04.002; 09.01.05.003; 07.07.01.0010.025309%
Aspartate aminotransferase increased13.03.01.0060.009058%
Asphyxia22.02.02.001; 12.01.08.0110.000208%Not Available
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