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---
Acute pulmonary oedema02.05.02.004; 22.01.03.005---
Alanine aminotransferase increased13.03.04.005--
Anaemia01.03.02.001--
Anaphylactic shock10.01.07.002; 24.06.02.004---
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001---
Back pain15.03.04.005--
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.004--
Bronchitis11.01.09.001; 22.07.01.001--
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Cough22.02.03.001--
Dehydration14.05.05.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Drug eruption08.01.06.015; 10.01.01.005; 23.03.05.001---
Drug hypersensitivity10.01.01.001---
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspnoea02.11.05.003; 22.02.01.004--
Electrocardiogram QT prolonged13.14.05.004--
Erythema multiforme10.01.03.015; 23.03.01.003--
Fatigue08.01.01.002--
Febrile neutropenia01.02.03.002; 08.05.02.004--
Fluid retention14.05.06.002; 20.01.02.003---
Gastritis07.08.02.001--
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Headache17.14.01.001--
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