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
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)
Abdominal discomfort07.01.06.0010.026641%Not Available
Abdominal distension07.01.04.0010.015985%
Abdominal pain07.01.05.0020.032769%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.026375%
Abdominal rigidity07.01.05.0110.000533%Not Available
Abnormal faeces07.01.03.0010.000799%Not Available
Abortion spontaneous18.01.04.001--Not Available
Abscess11.01.08.0010.003197%Not Available
Accelerated hypertension24.08.01.0030.000533%Not Available
Acidosis14.01.03.002--
Acne23.02.01.0010.004263%Not Available
Acute abdomen07.01.06.0150.001066%Not Available
Acute hepatic failure09.01.03.0010.000486%Not Available
Acute myeloid leukaemia16.01.05.001; 01.10.05.001--Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.002131%Not Available
Acute respiratory distress syndrome22.01.03.001--
Acute respiratory failure14.01.04.004; 22.02.06.001--Not Available
Adrenal insufficiency14.11.01.004; 05.01.02.0010.002664%
Ageusia17.02.07.001; 07.14.03.0030.021579%Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.01.003--
Albuminuria20.02.01.0010.000533%Not Available
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.0030.004795%Not Available
Ammonia increased13.03.01.0230.001332%Not Available
Amnesia17.03.02.001; 19.20.01.001--
Amylase increased13.05.01.0090.002131%
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