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)
Urethral disorder20.07.01.002---
Urinary tract disorder20.08.01.001---
Vaginal haemorrhage21.08.01.001; 24.07.03.005--
Venous thrombosis24.01.01.008---
Vision blurred06.02.06.007; 17.17.01.010--
Vocal cord paralysis17.04.06.002; 22.04.01.0020.000246%
Vomiting07.01.07.0030.018222%
Vulvovaginal discomfort21.08.02.0050.000381%-
Weight decreased13.15.01.005--
Xeroderma23.01.02.0030.000246%-
Xerosis08.01.03.0160.000246%-
Yellow skin08.01.03.046; 09.01.01.009; 23.03.03.0420.000381%-
Pneumoperitoneum07.07.01.0080.000224%-
Musculoskeletal disorder15.03.05.0250.000302%-
Hypoacusis04.02.01.006--
Performance status decreased08.01.03.0420.001489%-
Localised oedema02.05.04.006; 08.01.07.011; 14.05.06.009--
Brain oedema12.01.10.010; 17.07.02.0030.000224%
Weight fluctuation14.03.02.0020.003806%-
General physical health deterioration08.01.03.0180.006738%-
Left ventricular dysfunction02.04.02.0110.000381%
Tumour haemorrhage16.32.03.008; 24.07.01.0280.000504%
Pneumomediastinum22.09.03.004---
Anal inflammation07.03.03.004--
Metastatic renal cell carcinoma16.08.02.003; 20.01.04.0050.001231%-
Musculoskeletal chest pain15.03.04.012; 22.09.01.0010.000358%
Dyschezia07.02.03.0050.000246%-
Malignant neoplasm progression16.16.01.0050.062187%-
Rhinalgia22.12.03.0200.000246%-
Metastases to peritoneum07.21.03.003; 16.22.02.0080.000795%-
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