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)
Metastatic neoplasm16.16.01.0070.000168%-
Motor dysfunction15.05.06.006; 17.01.02.0310.000504%-
Neoplasm progression16.16.02.005---
Abnormal behaviour19.01.01.001---
Decreased appetite08.01.09.028; 14.03.01.0050.027355%
Colorectal cancer07.21.01.002; 16.13.01.0020.010465%-
Renal injury12.01.05.001; 20.01.03.0150.000168%-
Polyp08.01.06.010; 16.02.02.005---
Urinary tract obstruction20.08.01.0040.000168%
Blood disorder01.05.01.004---
Immunodeficiency10.03.02.0020.000168%-
Adverse drug reaction08.06.01.0090.003324%-
Disease progression08.01.03.0380.005988%
Drug intolerance08.06.01.0130.003929%-
Obstruction08.01.03.0230.000224%-
Food intolerance14.02.01.0050.000168%-
Hepatic lesion09.01.08.0050.000470%-
Hepatobiliary disease09.01.08.003---
Lung neoplasm16.19.04.001; 22.08.01.006---
Large intestinal obstruction07.13.03.0030.000168%
Pigmentation disorder23.05.03.0010.000112%-
Metastasis16.22.01.0010.000560%-
Renal impairment20.01.03.0100.003190%-
Sinus disorder22.04.06.002--
Unevaluable event08.01.03.051---
Poor quality sleep17.15.04.002; 19.02.05.0050.000560%-
Haemorrhagic diathesis01.01.03.003; 24.07.01.0200.000112%-
Increased upper airway secretion22.12.03.0070.000112%-
Bowel movement irregularity07.02.03.0030.000112%-
Hypophagia07.01.06.010; 14.03.01.006; 19.09.01.0040.001533%-
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