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)
Dermatitis23.03.04.0020.000112%Not Available
Dermatitis allergic23.03.04.003; 10.01.03.0140.000302%Not Available
Dermatitis bullous23.03.01.0020.000112%
Dermatitis exfoliative23.03.07.001; 10.01.01.0040.000112%
Diabetes mellitus05.06.01.001; 14.06.01.0010.000336%Not Available
Diabetes mellitus inadequate control14.06.01.004; 05.06.01.0040.000112%Not Available
Diarrhoea07.02.01.0010.108559%
Diarrhoea haemorrhagic24.07.02.004; 07.02.01.0020.000112%Not Available
Discomfort08.01.08.003--Not Available
Dizziness17.02.05.003; 02.11.04.006; 24.06.02.007--
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.015--Not Available
Drug hypersensitivity10.01.01.001--Not Available
Dry mouth07.06.01.0020.001310%
Dry skin23.03.03.0010.001802%
Duodenal ulcer07.04.02.0020.000112%
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.0010.003335%
Dysphagia07.01.06.0030.001623%
Dysphonia22.12.03.006; 19.19.03.002; 17.02.08.0040.000739%
Dyspnoea02.11.05.003; 22.02.01.0040.009480%
Dyspnoea exertional02.11.05.005; 22.02.01.0050.000582%Not Available
Dysuria20.02.02.0020.000683%
Ear disorder04.03.01.001--Not Available
Ear pain04.03.01.0030.000381%
Eating disorder19.09.01.008; 14.03.01.0080.000414%Not Available
Eczema23.03.04.0060.000302%
Electrocardiogram QT prolonged13.14.05.004--
Electrolyte imbalance14.05.01.0020.000224%Not Available
Eosinophilia01.02.04.0010.000806%
Erythema multiforme23.03.01.003; 10.01.03.0150.000168%
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