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)
Plantar erythema23.03.06.0120.000392%Not Available
Dyschezia07.02.03.0050.000112%Not Available
Central nervous system lesion17.02.10.0110.000224%Not Available
Exercise tolerance decreased08.01.03.0360.001567%Not Available
Bile duct stenosis09.02.02.0010.000112%
Systemic inflammatory response syndrome24.06.03.008; 10.02.01.008; 08.01.05.0050.000224%Not Available
Malignant neoplasm progression16.16.01.005--Not Available
Rhinalgia22.12.03.0200.000112%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Metastases to peritoneum07.21.03.003; 16.22.02.0080.001007%Not Available
Skin induration23.03.03.0200.000504%
Ear discomfort04.03.01.0050.000358%Not Available
Respiratory tract congestion22.02.07.0030.000112%Not Available
Lymphatic disorder01.09.01.003--Not Available
Colorectal cancer metastatic16.13.01.005; 07.21.01.0050.008339%Not Available
Paranasal sinus discomfort22.12.03.0180.000112%Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Protein urine present13.13.02.006--Not Available
Epigastric discomfort07.01.02.004--Not Available
Musculoskeletal discomfort15.03.04.0010.000392%Not Available
Secretion discharge08.01.03.0190.000224%Not Available
Extraocular muscle disorder15.05.05.004; 06.05.02.0050.000112%Not Available
Tumour necrosis16.32.03.009; 24.04.02.0130.000448%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.000392%Not Available
Haemorrhoidal haemorrhage24.10.02.001; 07.15.03.0020.000112%
Lipase abnormal13.05.01.005--Not Available
Scrotal erythema21.12.02.008; 23.03.06.0130.000246%Not Available
Haemorrhage24.07.01.002--Not Available
Haemorrhage urinary tract24.07.01.007; 20.02.03.0050.000112%Not Available
Fluid intake reduced14.05.10.0010.000448%Not Available
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