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 tumour (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. Regorafenib is also indicated for the treatment of patients with hepatocellular carcinoma (HCC) previously treated with sorafenib.[L16835]
Marketing Status approved
ATC Code L01EX05
DrugBank ID DB08896
KEGG ID D10138
MeSH ID C559147
PubChem ID 11167602
TTD Drug ID D09GDD
NDC Product Code 50419-171; 54893-0033; 12527-0171; 63415-0522
UNII MGN125FS9D
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Back pain15.03.04.0050.006402%
Bile duct stone09.02.02.0030.000168%Not Available
Biliary colic09.02.01.0010.000302%Not Available
Blister23.03.01.001; 12.01.06.0020.015457%Not Available
Blood pressure fluctuation24.06.01.0020.001164%Not Available
Blood uric acid increased13.02.04.001--Not Available
Body temperature increased13.15.01.001--Not Available
Bone pain15.02.01.0010.001377%
Breast tenderness21.05.05.0040.000112%Not Available
Burning sensation17.02.06.001; 08.01.09.0290.002418%Not Available
Cachexia14.03.02.001; 08.01.01.009; 16.32.03.0110.000280%Not Available
Cardiac failure02.05.01.0010.001455%
Cardiomyopathy02.04.01.0010.000280%Not Available
Cataract06.06.01.001--
Cerebellar syndrome17.02.02.0020.000168%Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.0030.000839%Not Available
Cerebral infarction24.04.06.002; 17.08.01.0040.001063%Not Available
Change of bowel habit07.02.03.0020.000280%Not Available
Cheilitis23.03.03.025; 07.05.01.0010.000224%
Chest discomfort22.12.02.002; 08.01.08.019; 02.02.02.0090.000895%Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.003850%Not Available
Chills15.05.03.016; 08.01.09.0010.002474%
Cholangitis09.02.01.0020.000672%Not Available
Cholecystitis09.03.01.0010.000504%
Cholecystitis acute09.03.01.0030.000168%Not Available
Cholecystitis chronic09.03.01.0040.000112%Not Available
Cholestasis09.01.01.0010.000560%Not Available
Chromaturia20.02.01.0020.002149%
Colitis07.08.01.0010.000448%
Colon cancer16.13.01.001; 07.21.01.0010.010801%Not Available
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