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)
Erythema nodosum23.07.02.001; 10.02.01.0200.000246%Not Available
Eye swelling06.08.03.0030.000437%Not Available
Face oedema10.01.05.002; 08.01.07.003; 23.04.01.0040.000168%
Faeces discoloured07.01.03.0020.000168%Not Available
Fatigue08.01.01.0020.031362%
Febrile neutropenia08.05.02.004; 01.02.03.002--
Feeling abnormal08.01.09.0140.003224%Not Available
Feeling drunk08.01.09.0150.000246%Not Available
Flatulence07.01.04.0020.002071%
Fluid retention20.01.02.003; 14.05.06.0020.003694%Not Available
Food poisoning12.03.01.024; 11.07.02.001; 07.11.01.0070.000246%Not Available
Gallbladder disorder09.03.02.0010.000246%Not Available
Gamma-glutamyltransferase increased13.03.04.024--
Gastric haemorrhage24.07.02.007; 07.12.01.001--
Gastric ulcer07.04.03.0020.000336%
Gastritis07.08.02.0010.000604%
Gastritis erosive07.04.03.0030.000168%Not Available
Gastrooesophageal reflux disease07.02.02.0030.002485%
Gastrointestinal disorder07.11.01.0010.005171%Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal pain07.01.05.0050.000246%
Generalised oedema14.05.06.007; 08.01.07.0040.000168%
Gingival pain07.09.13.0100.000381%
Gout15.01.06.001; 14.09.01.0010.000683%Not Available
Haemorrhage subcutaneous24.07.06.010; 23.06.07.0020.000112%Not Available
Headache17.14.01.0010.012413%
Hepatic cirrhosis09.01.04.0010.000112%Not Available
Hepatic function abnormal09.01.02.0010.000996%Not Available
Hepatitis09.01.07.004--Not Available
Hepatitis toxic12.03.01.016; 09.01.07.017--Not Available
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