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)
Gait inability17.02.05.069; 08.01.02.0110.004007%Not Available
Illness08.01.03.091--Not Available
Immune thrombocytopenia01.08.01.013; 10.02.01.0830.000112%Not Available
Infected neoplasm16.32.03.012; 11.01.08.0420.000112%Not Available
Intestinal metastasis16.22.02.029; 07.21.01.0210.000112%Not Available
Intra-abdominal fluid collection07.07.01.014; 21.07.04.0140.000168%Not Available
Joint noise15.01.02.0120.000112%Not Available
Metastases to retroperitoneum16.22.02.041; 07.21.03.0120.000112%Not Available
Mucosal disorder08.01.06.0290.000526%Not Available
Myelosuppression01.03.03.0150.001231%Not Available
Nasal discharge discolouration22.12.03.011--Not Available
Necrotic lymphadenopathy16.32.03.042; 01.09.01.0350.000112%Not Available
Oral hyperaesthesia17.02.06.053; 07.05.05.0320.000168%Not Available
Paratracheal lymphadenopathy22.09.03.014; 01.09.01.0380.000112%Not Available
Pharyngeal swelling22.04.05.0280.000302%Not Available
Physical deconditioning08.01.03.0960.000168%Not Available
Rectal cancer recurrent16.13.01.022; 07.21.05.0070.000112%Not Available
Rectal cancer stage IV16.13.01.023; 07.21.05.0080.000168%Not Available
Rectosigmoid cancer16.13.01.024; 07.21.01.0230.000224%Not Available
Scrotal exfoliation23.03.07.013; 21.12.02.0100.000112%Not Available
Sensitive skin23.03.03.0970.000224%Not Available
Sinus pain22.12.03.023--
Skin weeping23.03.03.1010.000168%Not Available
Taste disorder17.02.07.029; 07.14.03.0040.000728%Not Available
Therapeutic product ineffective08.06.01.0570.000582%Not Available
Therapy partial responder08.06.01.0640.000112%Not Available
Thermohyperaesthesia17.02.06.0560.000112%Not Available
Thrombophlebitis migrans24.01.01.043; 16.32.01.0160.000112%Not Available
Tongue erythema07.14.02.0240.000112%Not Available
Tumour cavitation16.32.03.0480.000168%Not Available
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