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)
Infection11.01.08.0020.001529%Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Influenza like illness08.01.03.0100.002931%
Insomnia19.02.01.002; 17.15.03.002--
International normalised ratio increased13.01.02.008--
Interstitial lung disease22.01.02.003; 10.02.01.0330.004263%Not Available
Intestinal obstruction07.13.01.0020.007726%Not Available
Intestinal perforation07.04.06.0020.001598%Not Available
Irritability19.04.02.013; 08.01.03.011--
Jaundice09.01.01.004; 01.06.04.004; 23.03.03.0300.010656%Not Available
Jaundice cholestatic09.01.01.0050.001865%Not Available
Joint stiffness15.01.02.003--Not Available
Joint swelling15.01.02.0040.004529%Not Available
Keratoacanthoma23.08.02.007; 16.03.02.007--Not Available
Kidney infection20.01.09.004; 11.01.14.0060.000799%
Laboratory test abnormal13.18.01.001--Not Available
Large intestine perforation07.04.06.005; 12.02.03.0050.000278%
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Leukocytosis01.02.01.002--
Leukopenia01.02.02.001--Not Available
Lip pain07.05.03.0070.000533%
Lipase increased13.05.01.0030.001865%
Liver abscess09.01.11.001; 11.01.18.0010.000533%Not Available
Liver disorder09.01.08.0010.007460%Not Available
Liver function test abnormal13.03.01.0130.007726%Not Available
Local swelling08.01.03.0130.003197%Not Available
Localised infection11.01.08.0060.000799%Not Available
Loss of consciousness17.02.04.004--Not Available
Lower respiratory tract infection22.07.01.002; 11.01.09.002--Not Available
Lung disorder22.02.07.0010.002931%Not Available
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