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)
Oral mucosal exfoliation07.05.05.0110.000112%-
Exfoliative rash23.03.07.0060.000302%-
Osteonecrosis of jaw15.02.04.010; 24.04.05.0050.001981%
Tracheal fistula22.04.07.0070.000112%
Prehypertension24.08.02.011---
Hyperammonaemic encephalopathy14.10.01.006; 17.13.01.0050.000112%-
Adverse reaction08.06.01.0180.001578%-
Type 1 diabetes mellitus05.06.01.010; 10.04.08.007; 14.06.01.0100.000168%-
Oral disorder07.05.01.0050.000929%-
Renal cell carcinoma16.08.02.002; 20.01.04.0030.009962%-
Hypertransaminasaemia09.01.02.0050.001399%-
Anorectal discomfort07.03.03.0030.000761%-
Oropharyngeal discomfort07.05.05.008; 22.12.03.0150.000437%-
Oropharyngeal pain07.05.05.004; 22.12.03.0160.004712%
Acute kidney injury20.01.03.016--
Gastrointestinal tract irritation07.08.03.0080.000381%-
Posterior reversible encephalopathy syndrome17.13.02.0070.000728%
Hepatic cancer09.04.02.008; 16.07.02.0040.000504%-
Hepatocellular carcinoma09.04.02.010; 16.07.02.0050.005652%-
Faeces soft07.01.03.0080.002283%-
Noninfective gingivitis07.09.13.0160.000246%-
Perforation08.01.03.0580.000358%-
Stenosis08.01.03.0600.000112%-
Colonic fistula07.11.05.0070.000112%
Dermatitis exfoliative generalised10.01.01.029; 23.03.07.0020.000112%-
Intracranial tumour haemorrhage16.32.03.023; 17.08.01.052; 24.07.04.0280.000112%-
Malignant ascites07.07.01.004; 16.32.03.0130.000224%-
Malignant pleural effusion16.32.03.014; 22.05.04.0010.000168%-
Metastases to adrenals05.01.04.007; 16.22.02.0120.000168%-
Metastases to bone15.09.03.006; 16.22.02.0050.003268%-
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