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)
Yellow skin23.03.03.042; 09.01.01.009; 08.01.03.0460.000224%Not Available
Pneumoperitoneum07.07.01.0080.000168%Not Available
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.001623%Not Available
Musculoskeletal disorder15.03.05.0250.000638%Not Available
Joint range of motion decreased15.01.02.0060.000112%
Axillary pain08.01.08.0150.000112%Not Available
Energy increased08.01.03.0170.000168%Not Available
Onychoclasis23.02.05.0050.000112%Not Available
Performance status decreased08.01.03.0420.000750%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.004992%Not Available
Brain oedema17.07.02.003; 12.01.10.0100.000336%
Weight fluctuation14.03.02.0020.000302%Not Available
Rectal discharge07.03.03.0050.000112%Not Available
General physical health deterioration08.01.03.0180.005540%Not Available
Anal haemorrhage24.07.02.029; 07.12.03.0040.000302%
Muscle fatigue15.05.03.0060.000224%Not Available
Left ventricular dysfunction02.04.02.0110.000168%
Tongue dry07.14.02.0090.000112%Not Available
Tumour haemorrhage24.07.01.028; 16.32.03.0080.000280%
Muscle tightness15.05.03.0070.000112%Not Available
Balance disorder17.02.02.007; 08.01.03.0810.001366%Not Available
Dysstasia08.01.03.089; 17.02.02.012; 15.03.05.0110.000895%Not Available
Intervertebral disc protrusion15.10.01.0040.000112%Not Available
Subileus07.13.01.0040.000224%Not Available
Ventricular hypokinesia02.04.02.0130.000224%Not Available
Skin tightness23.03.03.0180.000112%Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.0120.000616%
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.0300.000168%
Gastrointestinal stromal tumour16.13.04.008; 07.21.04.0030.003246%Not Available
Blood pressure inadequately controlled24.06.01.0070.000302%Not Available
The 14th Page    First    Pre   14 15 16 17 18    Next   Last    Total 22 Pages