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)
Colorectal cancer stage IV16.13.01.015; 07.21.01.0130.000280%Not Available
Dermatitis exfoliative generalised23.03.07.002; 10.01.01.0290.000112%Not Available
Faeces pale07.01.03.0050.000112%Not Available
Intestinal fistula07.11.05.0120.000280%Not Available
Lymphadenopathy mediastinal22.09.03.006; 01.09.01.0250.000280%Not Available
Malignant pleural effusion16.32.03.014; 22.05.04.0010.000112%Not Available
Metastases to abdominal cavity16.22.02.010; 07.21.03.0060.000336%Not Available
Metastases to adrenals16.22.02.012; 05.01.04.0070.000336%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.000895%Not Available
Metastases to kidney16.22.02.017; 20.01.04.010--Not Available
Metastases to lymph nodes01.09.01.015; 16.22.02.0060.001455%Not Available
Metastases to pleura16.22.02.022; 22.05.04.0020.000112%Not Available
Metastases to skin23.07.04.026; 16.22.02.0230.000168%Not Available
Palmoplantar keratoderma23.01.01.0070.000907%Not Available
Rectal adenocarcinoma07.21.05.005; 16.13.01.0160.000392%Not Available
Slow response to stimuli17.02.05.0630.000112%Not Available
Tumour embolism16.32.03.030; 24.01.01.0340.000112%Not Available
Urinary bladder haemorrhage24.07.01.086; 20.03.01.0230.000112%Not Available
Ventricle rupture12.01.11.012; 02.04.02.037--Not Available
Terminal state08.01.03.0790.000224%Not Available
Metastases to heart16.22.02.016; 02.10.01.0020.000112%Not Available
Metastases to pancreas16.22.02.020; 07.21.09.0050.000112%Not Available
Liver carcinoma ruptured16.07.02.007; 09.04.02.0120.000168%Not Available
Metastases to abdominal wall16.22.02.011; 07.16.05.0070.000168%Not Available
Pulmonary cavitation22.01.02.0220.000336%Not Available
Tumour associated fever16.32.03.0290.000168%Not Available
Lymphangiosis carcinomatosa01.09.01.027; 24.09.02.007; 16.22.02.0090.000224%Not Available
Rectal cancer metastatic16.13.01.007; 07.21.05.0030.000504%Not Available
Colon cancer metastatic16.13.01.012; 07.21.01.0100.001679%Not Available
Hepatic mass09.01.08.0150.000112%Not Available
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