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)
Hepatocellular injury09.01.07.0080.000280%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.001153%Not Available
Hernia08.01.04.0010.000246%Not Available
Hyperaesthesia23.03.03.080; 17.02.06.0040.000381%Not Available
Hyperbilirubinaemia09.01.01.003; 01.06.04.003; 14.11.01.0100.000112%Not Available
Hypercalcaemia14.04.01.003; 05.04.01.0020.000571%
Hyperkalaemia14.05.03.0010.000280%
Hypersomnia19.02.05.001; 17.15.01.0010.000302%
Hypertensive crisis24.08.01.0010.000112%Not Available
Hypervolaemia14.05.06.003; 02.05.04.0190.000414%Not Available
Hypoaesthesia23.03.03.081; 17.02.06.0230.001836%Not Available
Hypophosphataemia14.04.03.001--
Hypotension24.06.03.002--
Immune system disorder10.02.01.0010.000302%Not Available
Impaired gastric emptying07.02.02.0040.000112%
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Interstitial lung disease22.01.02.003; 10.02.01.0330.000672%Not Available
Iron deficiency14.13.02.0020.000112%Not Available
Iron deficiency anaemia01.03.01.002; 14.13.02.0010.000302%Not Available
Joint swelling15.01.02.0040.001444%Not Available
Keratitis06.04.02.0020.000168%
Leukocytosis01.02.01.0020.000224%
Leukopenia01.02.02.001--Not Available
Lip swelling10.01.05.005; 23.04.01.007; 07.05.04.0050.000470%Not Available
Lipase increased13.05.01.003--
Liver disorder09.01.08.0010.001701%Not Available
Long QT syndrome02.03.01.017--Not Available
Lower respiratory tract infection22.07.01.002; 11.01.09.002--Not Available
Lymphoma16.20.01.001; 01.12.01.0010.000112%Not Available
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