Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bosutinib monohydrate
Drug ID BADD_D00287
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 D09728
MeSH ID C471992
PubChem ID 11990828
TTD Drug ID D0OB0F
NDC Product Code 0069-0135; 0069-0193; 0069-0136
UNII 844ZJE6I55
Synonyms bosutinib | SKI606 | SKI-606
Chemical Information
Molecular Formula C26H31Cl2N5O4
CAS Registry Number 918639-08-4
SMILES CN1CCN(CC1)CCCOC2=C(C=C3C(=C2)N=CC(=C3NC4=CC(=C(C=C4Cl)Cl)OC)C#N)OC.O
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 pain07.01.05.002--
Acne23.02.01.001--Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.004--Not Available
Alanine aminotransferase increased13.03.04.005--
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.004--
Bronchitis22.07.01.001; 11.01.09.001--
Chest pain02.02.02.011; 22.12.02.003; 08.01.08.002--Not Available
Cough22.02.03.001--
Dehydration14.05.05.001--
Diarrhoea07.02.01.001--
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
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspnoea02.11.05.003; 22.02.01.004--
Electrocardiogram QT prolonged13.14.05.004--
Erythema multiforme23.03.01.003; 10.01.03.015--
Fatigue08.01.01.002--
Febrile neutropenia08.05.02.004; 01.02.03.002--
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Gastritis07.08.02.001--
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Headache17.14.01.001--
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