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
NDC Product Code 50419-171; 54893-0033; 12527-0171; 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
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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.002283%
Abdominal pain07.01.05.0020.013096%
Abdominal pain upper07.01.05.0030.008327%
Abdominal tenderness07.01.05.0040.000526%Not Available
Abnormal faeces07.01.03.001--Not Available
Acute hepatic failure09.01.03.0010.000280%Not Available
Acute myocardial infarction24.04.04.001; Available
Ageusia17.02.07.001; Available
Alanine aminotransferase increased13.03.04.005--
Altered state of consciousness19.07.01.003; Available
Amylase increased13.05.01.009--
Anal fissure07.03.01.0020.000168%
Anal fistula07.11.05.0020.000280%
Angina pectoris24.04.04.002;
Angina unstable24.04.04.004; Available
Anuria20.01.03.0020.000168%Not Available
Aortic dissection24.02.03.0020.000280%Not Available
Aphthous ulcer07.05.06.0020.000280%Not Available
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.0010.021569%Not Available
Atrial fibrillation02.03.03.0020.001175%
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