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)
Metastatic neoplasm16.16.01.0070.000168%Not Available
Motor dysfunction15.05.06.006; 17.01.02.0310.000504%Not Available
Neoplasm progression16.16.02.005--Not Available
Abnormal behaviour19.01.01.001--Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.027355%
Colorectal cancer16.13.01.002; 07.21.01.0020.010465%Not Available
Renal injury20.01.03.015; 12.01.05.0010.000168%Not Available
Polyp16.02.02.005; 08.01.06.010--Not Available
Urinary tract obstruction20.08.01.0040.000168%
Blood disorder01.05.01.004--Not Available
Immunodeficiency10.03.02.0020.000168%Not Available
Adverse drug reaction08.06.01.0090.003324%Not Available
Disease progression08.01.03.0380.005988%
Drug intolerance08.06.01.0130.003929%Not Available
Obstruction08.01.03.0230.000224%Not Available
Food intolerance14.02.01.0050.000168%Not Available
Hepatic lesion09.01.08.0050.000470%Not Available
Hepatobiliary disease09.01.08.003--Not Available
Lung neoplasm16.19.04.001; 22.08.01.006--Not Available
Large intestinal obstruction07.13.03.0030.000168%
Pigmentation disorder23.05.03.0010.000112%Not Available
Metastasis16.22.01.0010.000560%Not Available
Renal impairment20.01.03.0100.003190%Not Available
Sinus disorder22.04.06.002--
Unevaluable event08.01.03.051--Not Available
Poor quality sleep17.15.04.002; 19.02.05.0050.000560%Not Available
Haemorrhagic diathesis24.07.01.020; 01.01.03.0030.000112%Not Available
Increased upper airway secretion22.12.03.0070.000112%Not Available
Bowel movement irregularity07.02.03.0030.000112%Not Available
Hypophagia14.03.01.006; 07.01.06.010; 19.09.01.0040.001533%Not Available
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