Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Regorafenib
Drug ID BADD_D01922
Description Regorafenib is an orally-administered inhibitor of multiple kinases. It is used for the treatment of metastatic colorectal cancer, advanced gastrointestinal stromal tumours, and hepatocellular carcinoma. FDA approved on September 27, 2012. Approved use of Regorafenib was expanded to treat Hepatocellular Carcinoma in April 2017.
Indications and Usage Regorafenib is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. Regorafenib is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.
Marketing Status Prescription
ATC Code L01EX05
DrugBank ID DB08896
KEGG ID D10138
MeSH ID C559147
PubChem ID 11167602
TTD Drug ID D09GDD
NDC Product Code 12527-0171; 50419-171; 54893-0033; 63415-0522
Synonyms regorafenib | 4-(4-(((4-chloro-3-(trifluoromethyl)phenyl)carbamoyl)amino)-3-fluorophenoxy)-n-methylpyridine-2-carboxamide | Stivarga | BAY 73-4506 | BAY73-4506 | BAY-73-4506
Chemical Information
Molecular Formula C21H15ClF4N4O3
CAS Registry Number 755037-03-7
SMILES CNC(=O)C1=NC=CC(=C1)OC2=CC(=C(C=C2)NC(=O)NC3=CC(=C(C=C3)Cl)C(F)(F)F)F
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Blood potassium decreased13.11.01.0100.002931%Not Available
Blood potassium increased13.11.01.0110.001066%Not Available
Blood pressure abnormal13.14.03.0010.001066%Not Available
Blood pressure decreased13.14.03.002--Not Available
Blood pressure diastolic increased13.14.03.0040.000799%Not Available
Blood pressure fluctuation24.06.01.0020.002664%Not Available
Blood pressure increased13.14.03.0050.038630%Not Available
Blood pressure systolic increased13.14.03.0060.002131%Not Available
Blood sodium decreased13.11.01.0120.002131%Not Available
Blood thyroid stimulating hormone abnormal13.10.03.0050.000533%Not Available
Blood thyroid stimulating hormone increased13.10.03.0060.001598%
Blood uric acid increased13.02.04.001--Not Available
Body temperature increased13.15.01.0010.001865%Not Available
Bone pain15.02.01.0010.003197%
Breast tenderness21.05.05.0040.000533%Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Burning sensation17.02.06.001; 08.01.09.0290.008259%Not Available
C-reactive protein increased13.09.01.0070.009058%Not Available
Cachexia16.32.03.011; 14.03.02.001; 08.01.01.0090.000278%Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.0010.001598%
Cardiac failure congestive02.05.01.002--Not Available
Cardio-respiratory arrest22.02.06.007; 02.03.04.002--Not Available
Cardiomyopathy02.04.01.0010.001332%Not Available
Cataract06.06.01.001--
Cerebellar syndrome17.02.02.0020.000799%Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.0030.000973%Not Available
Cerebral infarction24.04.06.002; 17.08.01.0040.004529%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Change of bowel habit07.02.03.0020.001066%Not Available
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