Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cabozantinib s-malate
Drug ID BADD_D00331
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 D10095
MeSH ID C558660
PubChem ID 25102846
TTD Drug ID D0IQ6P
NDC Product Code 55679-116; 59057-013; 83137-0002
UNII DR7ST46X58
Synonyms cabozantinib | Cometriq | XL 184 | XL184 cpd | XL-184 | BMS 907351 | BMS907351 | BMS-907351
Chemical Information
Molecular Formula C32H30FN3O10
CAS Registry Number 1140909-48-3
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.C(C(C(= O)O)O)C(=O)O
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)
Haemorrhoids24.10.02.002; 07.15.03.001--
Hair colour changes23.02.06.001--
Headache17.14.01.001--
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.003--Not Available
Hyperkeratosis23.01.01.001--
Hypertension24.08.02.001--
Hypocalcaemia14.04.01.004--
Hypokalaemia14.05.03.002--
Hypomagnesaemia14.04.02.001--
Hyponatraemia14.05.04.002--
Hypophosphataemia14.04.03.001--
Hypotension24.06.03.002--
Impaired healing08.03.02.001--Not Available
Lymphopenia01.02.02.002--Not Available
Mouth ulceration07.05.06.004--Not Available
Mucosal inflammation08.01.06.002--Not Available
Muscle spasms15.05.03.004--
Nausea07.01.07.001--
Neuropathy peripheral17.09.03.003--Not Available
Neutropenia01.02.03.004--Not Available
Oesophageal pain07.01.05.012--
Oral pain07.05.05.034--
Osteitis15.02.04.015--Not Available
Osteomyelitis15.02.05.001; 11.01.01.001--
Pain in jaw15.02.01.003--Not Available
Palmar-plantar erythrodysaesthesia syndrome23.03.05.009; 17.02.07.009--
Paraesthesia23.03.03.094; 17.02.06.005--
Periodontitis11.01.04.012; 07.09.01.002--Not Available
Peripheral sensory neuropathy17.09.03.005--
Proteinuria20.02.01.011--
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