Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cabozantinib
Drug ID BADD_D00330
Description Cabozantinib was first approved in 2012 and is a non-specific tyrosine kinase inhibitor. It was initially approved in the US under the brand name Cometriq, which is indicated for the treatment of metastatic medullary thyroid cancer.[L15123] In 2016, a capsule formulation (Cabometyx) was approved for the treatment of advanced renal cell carcinoma, and this same formulation gained additional approval in both the US and Canada in 2019 for the treatment of hepatocellular carcinoma in previously treated patients.[L15128,L15133]
Indications and Usage Cabozantinib is indicated for the treatment of progressive, metastatic medullary thyroid cancer.[L15123] It is also indicated for the treatment of advanced renal cell carcinoma and for hepatocellular carcinoma in patients previously treated with sorafenib.[L15128,L15133]
Marketing Status approved; investigational
ATC Code L01EX07
DrugBank ID DB08875
KEGG ID D10062
MeSH ID C558660
PubChem ID 25102847
TTD Drug ID D0IQ6P
NDC Product Code 42388-012; 42388-013; 64918-1924; 42388-025; 42388-024; 42388-011; 42388-023
UNII 1C39JW444G
Synonyms cabozantinib | Cometriq | XL 184 | XL184 cpd | XL-184 | BMS 907351 | BMS907351 | BMS-907351
Chemical Information
Molecular Formula C28H24FN3O5
CAS Registry Number 849217-68-1
SMILES COC1=CC2=C(C=CN=C2C=C1OC)OC3=CC=C(C=C3)NC(=O)C4(CC4)C(=O)NC5=CC=C(C=C5)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)
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.000660%Not Available
Pneumothorax spontaneous22.05.02.0070.000168%Not Available
Renal cancer recurrent16.08.02.007; 20.01.04.0130.000246%Not Available
Varicose vein ruptured24.10.04.0050.000470%Not Available
Pancreatic mass07.18.02.0070.000246%Not Available
Neck mass15.03.02.0070.000381%Not Available
Metastases to pancreas16.22.02.020; 07.21.09.0050.000112%Not Available
Renal cancer metastatic20.01.04.012; 16.08.02.0060.000672%Not Available
Liver carcinoma ruptured16.07.02.007; 09.04.02.0120.000168%Not Available
Pulmonary cavitation22.01.02.0220.000638%Not Available
Lymphangiosis carcinomatosa24.09.02.007; 16.22.02.009; 01.09.01.0270.000168%Not Available
Cardiac ventricular thrombosis02.11.01.008; 24.01.05.0060.000112%Not Available
Cell death08.03.03.003; 14.11.02.0050.000851%Not Available
Sarcopenia15.05.06.0040.000381%Not Available
Anal erosion07.04.01.0030.000246%Not Available
Exposed bone in jaw15.02.04.0340.000381%Not Available
Clear cell renal cell carcinoma20.01.04.008; 16.08.02.0040.000168%Not Available
Mucosal toxicity12.03.01.056; 08.01.06.0240.000246%Not Available
Remission not achieved08.06.01.0330.000246%Not Available
End stage renal disease20.01.03.0190.000112%Not Available
Tongue discomfort07.14.02.0190.000381%Not Available
Anal erythema23.03.06.023; 07.03.03.0100.000246%Not Available
Biliary obstruction09.02.02.0050.000224%Not Available
Cardiac dysfunction02.11.01.0040.000112%Not Available
Hepatic cytolysis09.01.07.0360.000302%Not Available
Hypophysitis10.02.01.079; 05.03.04.0100.000246%
Intestinal metastasis07.21.01.021; 16.22.02.0290.000224%Not Available
Mucosal disorder08.01.06.0290.000817%Not Available
Myelosuppression01.03.03.0150.000783%Not Available
Pharyngeal swelling22.04.05.0280.000246%Not Available
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