Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bosutinib
Drug ID BADD_D00286
Description Bosutinib is a Bcr-Abl kinase inhibitor for the treatment of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). Compared to other tyrosine kinase inhibitors, it has a more favourable hematologic toxicity profile. FDA approved on September 4, 2012.
Indications and Usage Treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy in adult patients.
Marketing Status approved
ATC Code L01EA04
DrugBank ID DB06616
KEGG ID D03252
MeSH ID C471992
PubChem ID 5328940
TTD Drug ID D0OB0F
NDC Product Code 54893-0042; 54893-0041; 54893-0048; 63539-193; 63539-117
UNII 5018V4AEZ0
Synonyms bosutinib | SKI606 | SKI-606
Chemical Information
Molecular Formula C26H29Cl2N5O3
CAS Registry Number 380843-75-4
SMILES CN1CCN(CC1)CCCOC2=C(C=C3C(=C2)N=CC(=C3NC4=CC(=C(C=C4Cl)Cl)OC)C#N)OC
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)
Vomiting07.01.07.0030.023796%
Vomiting projectile07.01.07.0120.000381%Not Available
Cardiotoxicity02.11.01.009; 12.03.01.0070.000168%Not Available
Hydrothorax22.05.02.0040.000224%Not Available
Hypoacusis04.02.01.0060.000492%
Peripheral swelling08.01.03.053; 02.05.04.0150.002921%Not Available
Intervertebral disc protrusion15.10.01.0040.000246%Not Available
Chylothorax22.05.02.0060.000280%
Large intestine polyp16.05.02.006; 07.20.01.0100.000246%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.000112%Not Available
Ear pruritus04.03.01.0110.000437%Not Available
Eye oedema06.08.03.0130.000381%Not Available
Eye pruritus06.04.05.0060.000381%Not Available
Lymphatic disorder01.09.01.003--Not Available
Epigastric discomfort07.01.02.0040.000246%Not Available
Musculoskeletal discomfort15.03.04.0010.000381%Not Available
Nodule08.03.05.0020.000112%Not Available
Fluid intake reduced14.05.10.0010.000112%Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000392%Not Available
Aortic disorder24.03.04.0040.000112%Not Available
Gastrointestinal toxicity12.03.01.019; 07.08.03.006--Not Available
Intestinal haemorrhage24.07.02.031; 07.12.03.0050.000112%Not Available
Pleuropericarditis22.05.01.002; 02.06.02.0030.000112%Not Available
Cardiac disorder02.11.01.0030.001489%Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Feeding disorder14.03.02.003; 19.09.01.0030.000280%Not Available
Haematotoxicity12.03.01.025; 01.05.01.0070.000280%Not Available
Infarction24.04.02.0170.000112%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Limb discomfort15.03.04.0140.000414%Not Available
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