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)
Hair colour changes23.02.06.0010.000358%
Hair growth abnormal23.02.06.0060.000224%Not Available
Hair texture abnormal23.02.06.0040.000168%
Head discomfort17.02.05.0270.000112%Not Available
Headache17.14.01.0010.012032%
Hemiparesis17.01.04.0010.000224%
Hemiplegia17.01.04.0020.000168%Not Available
Hepatic cirrhosis09.01.04.0010.000336%Not Available
Hepatic cyst16.06.02.001; 09.01.08.0080.000112%Not Available
Hepatic encephalopathy17.13.01.003; 09.01.03.0060.002350%Not Available
Hepatic failure09.01.03.0020.002653%
Hepatic function abnormal09.01.02.0010.004667%Not Available
Hepatic neoplasm16.07.03.001; 09.04.03.0010.000224%Not Available
Hepatic pain09.01.05.0050.000526%
Hepatitis09.01.07.0040.000783%Not Available
Hepatitis fulminant11.07.01.003; 09.01.07.0070.000224%Not Available
Hepatocellular injury09.01.07.0080.000336%Not Available
Hepatomegaly09.01.05.0010.000560%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.001007%Not Available
Hiccups22.12.01.001; 07.01.06.0090.000112%
Hydronephrosis20.01.05.0010.000504%Not Available
Hyperaesthesia23.03.03.080; 17.02.06.0040.000638%Not Available
Hyperammonaemia14.10.01.001; 09.01.02.0020.000168%Not Available
Hyperbilirubinaemia09.01.01.003; 01.06.04.003; 14.11.01.0100.001589%Not Available
Hypercalcaemia14.04.01.003; 05.04.01.0020.000224%
Hyperkeratosis23.01.01.0010.004656%
Hyperpyrexia08.05.02.0020.000112%Not Available
Hypersomnia19.02.05.001; 17.15.01.0010.001421%
Hypertension24.08.02.0010.017539%
Hypertensive crisis24.08.01.0010.000638%Not Available
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