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)
Cheilitis23.03.03.025; 07.05.01.0010.000799%
Chest discomfort22.02.08.001; 08.01.08.019; 02.02.02.009--Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.0110.013054%Not Available
Chest X-ray abnormal13.19.02.0010.000799%Not Available
Chills15.05.03.016; 08.01.09.0010.006927%
Cholangitis09.02.01.0020.003197%Not Available
Cholecystitis09.03.01.0010.000625%
Cholecystitis acute09.03.01.0030.000533%Not Available
Cholelithiasis09.03.01.002--Not Available
Cholestasis09.01.01.0010.002664%Not Available
Chromaturia20.02.01.0020.005861%
Chronic obstructive pulmonary disease22.03.01.007--Not Available
Clostridium difficile colitis07.19.01.004; 11.02.02.0040.000533%Not Available
Coagulopathy01.01.02.001--Not Available
Colitis07.08.01.0010.001332%
Colon cancer16.13.01.001; 07.21.01.0010.010842%Not Available
Coma17.02.09.001--Not Available
Coma hepatic17.02.09.002; 09.01.03.0050.000347%Not Available
Confusional state19.13.01.001; 17.02.03.0050.013321%
Constipation07.02.02.0010.028772%
Coronary artery stenosis24.04.04.017; 02.02.01.0100.000799%Not Available
Cough22.02.03.0010.016784%
Cyst16.02.02.002; 08.03.05.001--Not Available
Cystitis20.03.02.002; 11.01.14.001--
Deafness04.02.01.0010.001066%Not Available
Death08.04.01.001--
Decreased activity19.11.01.002; 08.01.01.0060.002664%Not Available
Decubitus ulcer23.03.11.0060.000533%Not Available
Dehydration14.05.05.0010.036765%
Delirium19.13.02.0010.003197%
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