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)
Aphasia19.21.01.001; 17.02.03.001--
Aphonia22.02.05.024; 19.19.01.002; 17.02.08.0090.005328%
Aphthous ulcer07.05.06.0020.001066%Not Available
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.0010.014386%
Arthritis15.01.01.001--
Arthropathy15.01.01.003--Not Available
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.017583%
Aspartate aminotransferase increased13.03.01.0060.015718%
Aspiration22.02.07.0070.000278%
Asthenia08.01.01.0010.074861%Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Atrial fibrillation02.03.03.002--
Back pain15.03.04.0050.020780%
Bile duct stone09.02.02.0030.000533%Not Available
Biliary colic09.02.01.0010.000533%Not Available
Bilirubin conjugated increased13.03.01.0070.000799%Not Available
Blindness17.17.01.003; 06.02.02.001--Not Available
Blister23.03.01.001; 12.01.06.0020.041027%Not Available
Blood albumin decreased13.09.01.0010.002131%Not Available
Blood bilirubin increased13.03.01.0080.029572%
Blood bilirubin unconjugated increased13.03.01.0240.000533%Not Available
Blood calcium decreased13.11.01.0020.000799%Not Available
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.0040.005062%
Blood glucose decreased13.02.02.0010.001332%Not Available
Blood glucose increased13.02.02.0020.002398%Not Available
Blood iron decreased13.11.01.0060.000533%Not Available
Blood lactate dehydrogenase increased13.04.02.0020.004795%
Blood magnesium decreased13.11.01.0080.002664%Not Available
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