Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ponatinib
Drug ID BADD_D01799
Description Ponatinib is a novel Bcr-Abl tyrosine kinase inhibitor that is especially effective against the T315I mutation for the treatment of chronic myeloid leukemia. FDA approved on December 14, 2012.
Indications and Usage Ponatinib is indicated for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy.
Marketing Status approved; investigational
ATC Code L01EA05
DrugBank ID DB08901
KEGG ID D09950
MeSH ID C545373
PubChem ID 24826799
TTD Drug ID D0H0EQ
NDC Product Code Not Available
UNII 4340891KFS
Synonyms ponatinib | 3-(2-(imidazo(1,2-b)pyridazin-3-yl)ethynyl)-4-methyl-N-(4-((4-methylpiperazin-y-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide | ponatinib hydrochloride | AP24534 | AP-24534 | AP 24534 | Iclusig
Chemical Information
Molecular Formula C29H27F3N6O
CAS Registry Number 943319-70-8
SMILES CC1=C(C=C(C=C1)C(=O)NC2=CC(=C(C=C2)CN3CCN(CC3)C)C(F)(F)F)C#CC4=CN=C5N4N=CC=C5
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)
Moyamoya disease24.01.04.016; 17.08.02.0230.000168%Not Available
Myocardial fibrosis02.04.02.0160.000112%Not Available
Terminal state08.01.03.0790.000112%Not Available
Subclavian artery stenosis24.04.03.0230.000112%Not Available
Blast crisis in myelogenous leukaemia16.01.08.002; 01.10.08.0020.001063%Not Available
Secondary immunodeficiency10.03.03.0090.000112%Not Available
Leukaemia recurrent01.10.03.005; 16.01.03.0050.000392%Not Available
Acute lymphocytic leukaemia recurrent16.01.01.003; 01.10.01.0030.001623%Not Available
Graft versus host disease in skin23.07.04.025; 12.02.09.031; 10.02.01.0620.000280%Not Available
Central nervous system leukaemia01.10.03.004; 17.02.10.019; 16.01.03.0040.000280%Not Available
Stress cardiomyopathy24.04.04.026; 02.04.01.0120.000112%Not Available
Carotid arteriosclerosis24.04.06.031; 17.08.02.0150.000224%Not Available
Chronic myeloid leukaemia transformation16.01.07.004; 01.10.07.0040.000448%Not Available
Chronic myeloid leukaemia recurrent16.01.07.003; 01.10.07.0030.000560%Not Available
Graft versus host disease in gastrointestinal tract12.02.09.028; 10.02.01.059; 07.11.01.0270.000168%Not Available
Dilated cardiomyopathy02.04.01.0170.000168%Not Available
Disease complication08.01.03.0870.000336%Not Available
Gait inability17.02.05.069; 08.01.02.0110.000168%Not Available
Graves' disease10.04.08.014; 06.09.04.009; 05.02.02.0090.000112%Not Available
Myelosuppression01.03.03.0150.000504%Not Available
Philadelphia positive acute lymphocytic leukaemia16.01.01.006; 01.10.01.0060.000280%Not Available
Superficial vein thrombosis24.01.02.0160.000112%Not Available
Therapy non-responder08.06.01.0630.000728%Not Available
Treatment noncompliance12.09.02.006; 08.06.01.0670.000504%Not Available
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