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)
Faecaloma07.01.03.0040.000112%Not Available
Pulmonary mass22.02.07.0040.000392%Not Available
Pneumatosis intestinalis07.11.01.0430.000168%Not Available
Temperature intolerance08.01.09.0220.000806%Not Available
Urine odour abnormal20.02.01.0200.000112%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000168%Not Available
Paraesthesia oral17.02.06.008; 07.05.05.0350.000526%Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000560%Not Available
Cancer pain16.32.03.0040.000839%Not Available
Ocular icterus09.01.01.007; 01.06.04.007; 06.08.03.0090.000504%Not Available
Gastrointestinal toxicity12.03.01.019; 07.08.03.0060.000414%Not Available
Intestinal haemorrhage07.12.03.005; 24.07.02.0310.000280%Not Available
Early satiety14.03.01.010; 08.01.09.004; 07.01.06.0270.000280%Not Available
Angiopathy24.03.02.007--Not Available
Metastases to central nervous system17.02.10.013; 16.22.02.0040.002261%Not Available
Skin toxicity23.03.03.032; 12.03.01.0200.001477%Not Available
Adverse event08.06.01.010--Not Available
Appetite disorder19.09.01.002; 14.03.01.0040.000504%Not Available
Brain neoplasm16.30.01.003; 17.20.01.0030.000112%Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.001399%Not Available
Embolism24.01.01.0090.000280%
Gastrointestinal motility disorder07.02.03.0010.000280%Not Available
Infarction24.04.02.0170.000168%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Inflammation10.02.01.089; 08.01.05.0070.000672%Not Available
Limb discomfort15.03.04.0140.001030%Not Available
Malnutrition14.03.02.0040.000224%Not Available
Mediastinal disorder22.09.03.001--Not Available
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