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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.006660%
Abdominal pain07.01.05.0020.039429%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.026908%
Abdominal tenderness07.01.05.0040.001598%Not Available
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Abscess11.01.08.0010.000533%Not Available
Acne23.02.01.001--Not Available
Acute hepatic failure09.01.03.0010.000208%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute prerenal failure20.01.03.001; 24.06.02.0030.000533%Not Available
Acute respiratory distress syndrome22.01.03.001--
Ageusia17.02.07.001; 07.14.03.0030.001332%Not Available
Aggression19.05.01.001--Not Available
Alanine aminotransferase increased13.03.01.0030.013054%
Alopecia23.02.02.0010.011988%
Altered state of consciousness17.02.04.001; 19.07.01.0030.001865%Not Available
Ammonia increased13.03.01.0230.003730%Not Available
Amnesia19.20.01.001; 17.03.02.0010.002664%
Amylase increased13.05.01.0090.000799%
Anaemia01.03.02.0010.010923%
Anal fissure07.03.01.0020.000799%
Anal fistula07.11.05.0020.001066%
Angina pectoris24.04.04.002; 02.02.02.0020.001865%
Angina unstable24.04.04.004; 02.02.02.0040.000799%Not Available
Angioedema10.01.05.009; 23.04.01.001--Not Available
Anuria20.01.03.0020.000799%Not Available
Anxiety19.06.02.002--
Aortic dissection24.02.03.0020.001066%Not Available
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