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)
Abdominal discomfort07.01.06.0010.008439%Not Available
Abdominal distension07.01.04.0010.003626%
Abdominal pain07.01.05.0020.010577%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.010208%
Abdominal tenderness07.01.05.004--Not Available
Acne23.02.01.0010.001388%Not Available
Acute lymphocytic leukaemia16.01.01.001; 01.10.01.0010.000414%Not Available
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.000168%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.000280%Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.000112%Not Available
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.0010.003727%
Amnesia19.20.01.001; 17.03.02.0010.001421%
Amylase increased13.05.01.009--
Anaemia01.03.02.0010.002899%
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Angina pectoris02.02.02.002; 24.04.04.0020.000448%
Aphonia22.12.03.001; 19.19.01.002; 17.02.08.0090.000571%
Arrhythmia02.03.02.0010.000336%Not Available
Arteriospasm coronary02.02.02.005; 12.02.01.031; 24.04.04.0050.000168%Not Available
Arthralgia15.01.02.0010.010465%
Arthritis15.01.01.0010.000548%
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000582%
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.0010.005563%Not Available
Asthma22.03.01.002; 10.01.03.0100.000604%Not Available
Atelectasis22.01.02.001--
Atrial fibrillation02.03.03.0020.001869%
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