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)
Joint swelling15.01.02.0040.001768%Not Available
Keratoacanthoma23.08.02.007; 16.03.02.007--Not Available
Large intestine perforation12.02.03.005; 07.04.06.0050.000280%
Laryngeal oedema23.04.01.005; 22.04.02.001; 10.01.05.0030.000112%
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.001030%
Leukopenia01.02.02.001--Not Available
Lip dry07.06.01.0030.000168%Not Available
Lip pain07.05.05.0290.000112%
Lipase increased13.05.01.003--
Liver disorder09.01.08.0010.002127%Not Available
Lung disorder22.02.07.0010.000895%Not Available
Lung infiltration22.01.02.0040.000112%Not Available
Lymphadenopathy01.09.01.0020.000750%Not Available
Lymphoedema24.09.01.001; 01.09.01.0060.000112%
Lymphopenia01.02.02.002--Not Available
Malaise08.01.01.0030.009995%
Mass08.03.05.0030.000302%Not Available
Melaena24.07.02.013; 07.12.02.0040.000783%Not Available
Mental impairment19.21.02.003; 17.03.03.0020.000504%Not Available
Metastases to liver16.22.02.001; 09.04.02.0040.006660%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.007163%Not Available
Metastases to spine16.22.02.007; 15.09.03.0070.000392%Not Available
Micturition urgency20.02.02.0060.000224%
Middle insomnia19.02.01.003; 17.15.03.0030.000112%Not Available
Miliaria23.02.03.0140.000112%Not Available
Mitral valve incompetence02.07.01.0020.000112%Not Available
Mouth haemorrhage07.05.02.001; 24.07.02.0140.000112%
Mouth ulceration07.05.06.0040.000895%Not Available
Mucosal inflammation08.01.06.0020.003794%Not Available
Muscle haemorrhage12.01.07.016; 24.07.01.037; 15.05.03.017--Not Available
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