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)
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Neoplasm progression16.16.02.0050.018356%Not Available
Cardiac valve disease02.07.02.0010.000112%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.006268%
Ill-defined disorder08.01.03.049--Not Available
Intervertebral disc disorder15.10.01.0030.000112%Not Available
Inner ear disorder04.04.02.002--Not Available
Ulcer haemorrhage24.07.01.040; 08.03.06.0030.000112%Not Available
Blood disorder01.05.01.0040.000414%Not Available
Disease progression08.01.03.0380.007208%
Disease recurrence08.01.03.0500.000604%Not Available
Drug intolerance08.06.01.0130.005238%Not Available
Neoplasm recurrence16.16.02.0040.000112%Not Available
Hepatobiliary disease09.01.08.0030.000112%Not Available
Respiratory tract infection viral22.07.07.002; 11.05.04.003--Not Available
Renal impairment20.01.03.0100.001511%Not Available
Sinus disorder22.04.06.0020.000168%
Respiratory tract infection22.07.07.001; 11.01.08.017--Not Available
Peripheral arterial occlusive disease24.04.03.0100.000302%Not Available
Exfoliative rash23.03.07.006--Not Available
Chronic kidney disease20.01.03.0170.000392%
Pulmonary arterial hypertension22.06.01.002; 24.08.03.0030.000224%Not Available
Bone marrow failure01.03.03.005--
Cytopenia01.03.03.0120.000895%Not Available
Liver injury09.01.07.022; 12.01.17.0120.000280%Not Available
Oral disorder07.05.01.0050.000302%Not Available
Gastrointestinal sounds abnormal07.01.01.0020.000492%Not Available
Traumatic liver injury12.01.17.027; 09.01.08.010--Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.000929%
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