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)
Sciatica17.10.03.001; 15.10.01.001--Not Available
Scrotal pain21.12.02.004--
Scrotal swelling21.12.02.005--Not Available
Scrotal ulcer23.07.03.007; 21.12.02.0070.000112%Not Available
Sensory disturbance17.02.07.0060.000548%Not Available
Sensory loss17.02.07.0070.000246%Not Available
Sinus congestion22.04.06.0010.000224%Not Available
Sinus headache22.12.03.022; 17.14.01.0020.000112%
Skin discolouration23.03.03.0050.001366%Not Available
Skin discomfort23.03.03.0060.000246%Not Available
Skin disorder23.03.03.0070.002597%Not Available
Skin exfoliation23.03.07.0030.007768%Not Available
Skin fissures23.03.03.0080.003089%Not Available
Skin irritation23.03.04.0090.000638%Not Available
Skin lesion23.03.03.0100.001533%Not Available
Skin papilloma16.26.01.002; 11.05.07.001; 23.10.01.002--
Skin reaction10.01.03.019; 23.03.03.0130.000672%Not Available
Skin ulcer24.04.03.007; 23.07.03.0030.001657%
Skin warm23.03.03.0140.000224%Not Available
Sluggishness08.01.01.0040.000168%Not Available
Small intestinal obstruction07.13.06.0010.000224%
Sneezing22.12.03.0240.000224%
Speech disorder19.19.02.002; 17.02.08.003; 22.12.03.0270.000616%Not Available
Squamous cell carcinoma16.16.01.002--Not Available
Squamous cell carcinoma of skin23.08.02.005; 16.03.02.0050.000168%Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.0050.000504%
Stomatitis07.05.06.0050.010029%
Swelling08.01.03.0150.001791%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.003--Not Available
Systolic hypertension24.08.02.0070.000112%Not Available
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