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)
Biliary dilatation09.02.03.0040.000112%Not Available
Cell death14.11.02.005; 08.03.03.0030.000168%Not Available
Gastrointestinal oedema07.11.01.0120.000504%Not Available
Hyperphosphatasaemia15.02.04.011; 14.11.01.002; 09.01.08.0020.000112%Not Available
Female genital tract fistula20.08.01.007; 07.11.05.004; 12.02.14.010; 23.07.04.015; 21.10.05.0090.000280%Not Available
Hypercreatininaemia20.01.02.016; 14.11.01.0390.000112%Not Available
Genital erosion21.10.05.0150.000112%Not Available
Nail growth abnormal23.02.05.0240.000112%Not Available
Tumour perforation16.32.03.0310.000168%Not Available
Weight bearing difficulty15.03.05.0340.000112%Not Available
Stomach mass07.11.01.0300.000246%Not Available
Retroperitoneal lymphadenopathy07.07.01.012; 01.09.01.0290.000168%Not Available
Hypercreatinaemia15.05.03.021; 14.11.01.0240.000168%Not Available
Oral mucosal erythema07.05.05.0230.000246%Not Available
Tumour rupture16.32.03.0330.000168%Not Available
Metastases to pelvis21.07.04.008; 16.22.02.0210.000224%Not Available
Prerenal failure24.06.02.025; 20.01.03.0220.000112%Not Available
Appendix cancer16.13.01.011; 07.21.01.0090.000168%Not Available
Blister rupture23.03.01.027; 12.01.06.0120.000112%Not Available
Abdominal lymphadenopathy07.11.01.018; 01.09.01.0200.000168%Not Available
Mucosal toxicity12.03.01.056; 08.01.06.0240.000112%Not Available
Internal haemorrhage24.07.01.0720.000358%Not Available
Tongue discomfort07.14.02.0190.000437%Not Available
Biliary obstruction09.02.02.0050.000616%Not Available
Blood loss anaemia24.07.01.088; 01.03.02.0180.000336%Not Available
Cardiac dysfunction02.11.01.0040.000112%Not Available
Colorectal cancer recurrent07.21.01.003; 16.13.01.0040.000224%Not Available
Dilated cardiomyopathy02.04.01.0170.000112%Not Available
Disease complication08.01.03.0870.000168%Not Available
Food refusal19.09.03.003; 14.03.01.0140.000224%Not Available
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