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)
Oesophageal rupture12.01.17.015; 07.04.05.0050.000112%Not Available
Respiratory tract congestion22.02.07.0030.000246%Not Available
Wound23.03.11.043; 12.01.08.009--Not Available
Drug tolerance08.06.01.0030.000817%Not Available
Protein urine present13.13.02.006--Not Available
Musculoskeletal discomfort15.03.04.0010.000492%Not Available
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.0010.000224%Not Available
Tumour necrosis24.04.02.013; 16.32.03.0090.000358%Not Available
Nodule08.03.05.0020.000381%Not Available
Cardiac discomfort02.11.04.0010.000112%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.000627%Not Available
Haemorrhoidal haemorrhage24.10.02.001; 07.15.03.0020.000112%
Scrotal erythema23.03.06.013; 21.12.02.0080.000381%Not Available
Haemorrhage24.07.01.002--Not Available
Varices oesophageal24.10.02.004; 09.01.06.009; 07.15.05.0010.000302%Not Available
Fluid intake reduced14.05.10.0010.000302%Not Available
Pulmonary mass22.02.07.0040.000437%Not Available
Intra-abdominal haematoma07.12.02.005; 24.07.02.0340.000112%Not Available
Pneumatosis intestinalis07.11.01.0430.000694%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000795%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.000761%Not Available
Toxic skin eruption12.03.01.073; 10.01.01.008; 23.03.05.0030.000358%Not Available
Cancer pain16.32.03.0040.000526%Not Available
Gastrointestinal toxicity12.03.01.019; 07.08.03.0060.001668%Not Available
Angiopathy24.03.02.007--Not Available
Metastases to central nervous system17.02.10.013; 16.22.02.0040.001612%Not Available
Skin toxicity23.03.03.032; 12.03.01.0200.005899%Not Available
Blood alkaline phosphatase increased13.04.02.004--
Adverse event08.06.01.0100.012390%Not Available
Appetite disorder19.09.01.002; 14.03.01.0040.000683%Not Available
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