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)
Malaise08.01.01.0030.007007%
Marasmus14.03.02.0130.000112%Not Available
Melaena24.07.02.013; 07.12.02.0040.000224%Not Available
Memory impairment19.20.01.003; 17.03.02.0030.002071%
Mental impairment19.21.02.003; 17.03.03.0020.000302%Not Available
Migraine17.14.02.001; 24.03.05.0030.001175%Not Available
Miliaria23.02.03.0140.000381%Not Available
Muscle disorder15.05.03.0140.000381%Not Available
Muscle spasms15.05.03.0040.004287%
Musculoskeletal pain15.03.04.0070.000548%
Myalgia15.05.02.0010.004656%
Myelodysplastic syndrome16.01.04.001; 01.10.04.0010.000168%
Myocardial infarction24.04.04.009; 02.02.02.0070.001086%
Myocarditis02.04.03.0010.000112%
Nasal congestion22.04.04.0010.000873%
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.0010.045488%
Neck pain15.03.04.0090.001746%
Neoplasm malignant16.16.01.0010.001254%Not Available
Nervous system disorder17.02.10.001--Not Available
Neuralgia17.02.07.0050.000548%
Neutropenia01.02.03.004--Not Available
Ocular hyperaemia06.04.05.0040.000492%Not Available
Oedema14.05.06.010; 08.01.07.0060.003794%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oesophageal stenosis07.13.02.0010.000112%
Oral pain07.05.05.0340.000571%
Pain08.01.08.004--
Pain in extremity15.03.04.0100.003425%
Pain of skin23.03.03.0030.000381%
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