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)
Atrioventricular block complete02.03.01.0030.000112%
Atypical pneumonia22.07.01.010; 11.01.09.012--Not Available
Back pain15.03.04.0050.005126%
Blindness06.02.10.003; 17.17.01.0030.000280%Not Available
Blister12.01.06.002; 23.03.01.0010.000851%Not Available
Blood bilirubin increased13.03.04.018--
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.004--
Blood pressure fluctuation24.06.01.0020.000224%Not Available
Body temperature increased13.15.01.001--Not Available
Bone pain15.02.01.0010.002216%
Bronchitis22.07.01.001; 11.01.09.001--
Cardiac failure02.05.01.0010.002239%
Cardiac failure acute02.05.01.0050.000112%Not Available
Cardiac failure congestive02.05.01.0020.001007%Not Available
Cardiac tamponade02.06.01.0010.000224%
Cardiomegaly02.04.02.0010.000224%Not Available
Cardiovascular disorder02.11.01.010; 24.03.02.0090.000246%Not Available
Chest discomfort22.12.02.002; 08.01.08.019; 02.02.02.0090.001444%Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.002798%Not Available
Cholecystitis09.03.01.0010.000112%
Chronic lymphocytic leukaemia16.01.06.001; 01.10.06.0010.000246%Not Available
Chronic myeloid leukaemia01.10.07.001; 16.01.07.0010.005328%Not Available
Chronic obstructive pulmonary disease22.03.01.0070.000526%Not Available
Constipation07.02.02.0010.005496%
Cough22.02.03.0010.004264%
Death08.04.01.001--
Decreased activity19.11.01.002; 08.01.01.0060.000381%Not Available
Dehydration14.05.05.0010.003604%
Dementia19.20.02.001; 17.03.01.0010.000224%Not Available
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