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
Palmar-plantar erythrodysaesthesia syndromeBroad substrate specificity ATP-binding cassette transporter ABCG2Q9UNQ0T5655625515134; 25515134
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)
Anal incontinence17.05.01.021; 07.01.06.0290.001066%
Liver function test increased13.03.01.0440.004263%Not Available
Abscess intestinal11.01.07.027; 07.19.01.0160.000533%Not Available
Anal ulcer07.04.01.0010.001066%
Appendicitis perforated11.01.07.028; 07.04.06.0110.000533%
Blood blister23.03.01.028; 12.01.06.0130.001332%Not Available
Bone cancer16.29.02.002; 15.09.03.0120.000278%Not Available
Burn oesophageal12.05.04.005; 07.11.02.0040.000799%Not Available
Carcinoid syndrome16.32.02.004; 05.08.02.0050.000533%Not Available
Cholangitis acute09.02.01.0060.000533%Not Available
Chronic gastritis11.07.01.016; 10.04.04.011; 07.08.02.0050.000799%Not Available
Dermatitis exfoliative generalised10.01.01.029; 23.03.07.0020.000533%Not Available
Ejection fraction abnormal13.14.02.0180.000533%Not Available
Full blood count abnormal13.01.07.0030.001332%Not Available
Full blood count decreased13.01.07.004--Not Available
Hand-foot-and-mouth disease11.05.08.004; 07.05.07.016; 23.09.03.0120.000533%Not Available
Intestinal fistula07.11.05.0120.000533%Not Available
Intracranial tumour haemorrhage24.07.04.028; 17.08.01.052; 16.32.03.0230.000139%Not Available
Lymphadenopathy mediastinal22.09.03.006; 01.09.01.0250.000533%Not Available
Malignant pleural effusion22.05.04.001; 16.32.03.0140.000278%Not Available
Metastases to bone16.22.02.005; 15.09.03.006--Not Available
Pancreatic carcinoma metastatic16.13.10.003; 07.21.09.0060.000139%Not Available
Purulent discharge11.01.08.061; 08.01.03.0760.000799%Not Available
Rectal perforation07.04.01.0040.000139%
Renal cancer stage IV20.01.04.014; 16.08.02.0080.000208%Not Available
Renal cell carcinoma stage IV20.01.04.016; 16.08.02.0100.000347%Not Available
Salivary gland calculus07.06.02.0030.000533%Not Available
Secondary hypothyroidism05.02.03.007; 14.11.01.0440.001066%Not Available
Senile dementia19.20.02.009; 17.03.01.0080.000139%Not Available
Splenic vein thrombosis24.01.03.005; 01.09.02.0190.000533%Not Available
The 36th Page    First    Pre   36 37 38    Next   Last    Total 38 Pages