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)
Hepatic function abnormal09.01.02.001---
Hepatotoxicity09.01.07.009; 12.03.01.008---
Hyperkalaemia14.05.03.001--
Influenza11.05.03.001; 22.07.02.001---
Myalgia15.05.02.001--
Nasopharyngitis11.01.13.002; 22.07.03.002---
Nausea07.01.07.001--
Neutropenia01.02.03.004---
Oedema08.01.07.006; 14.05.06.010---
Pain08.01.08.004--
Pancreatitis acute07.18.01.002---
Pericardial effusion02.06.01.002--
Pericarditis02.06.02.001--
Pleural effusion22.05.02.002--
Pneumonia11.01.09.003; 22.07.01.003---
Pruritus23.03.12.001--
Pulmonary hypertension22.06.01.001; 24.08.03.002--
Pyrexia08.05.02.003--
Rash23.03.13.001---
Renal failure20.01.03.005---
Respiratory failure14.01.04.003; 22.02.06.002--
Thrombocytopenia01.08.01.002---
Tinnitus04.04.01.002; 17.04.07.004--
Urticaria10.01.06.001; 23.04.02.001--
Vomiting07.01.07.003--
Gastrointestinal toxicity07.08.03.006; 12.03.01.019---
Decreased appetite08.01.09.028; 14.03.01.005--
Respiratory tract infection11.01.08.017; 22.07.07.001---
Exfoliative rash23.03.07.006---
Bone marrow failure01.03.03.005--
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