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)
Therapeutic response decreased08.06.01.0160.000414%-
Thrombocytopenia01.08.01.0020.002541%-
Thrombosis24.01.01.0060.000694%-
Tumour lysis syndrome14.05.01.004; 16.32.03.0020.000280%
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urinary hesitation20.02.02.0090.000112%-
Urinary retention20.02.02.0110.000224%
Urinary tract infection11.01.14.004; 20.08.02.001--
Uveitis06.04.03.003; 10.02.01.0230.000112%
Venous thrombosis24.01.01.0080.000302%-
Ventricular tachycardia02.03.04.0100.000112%
Vision blurred06.02.06.007; 17.17.01.0100.000772%
Visual acuity reduced06.02.10.012; 17.17.01.0110.000246%
Visual impairment06.02.10.013---
Vitamin B12 deficiency14.12.02.0040.000112%-
VIth nerve paralysis06.05.02.009; 17.04.02.0020.000112%-
Vitreous floaters06.09.01.0050.000112%
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight gain poor14.03.02.0180.000112%-
White blood cell count decreased13.01.06.012--
Mental status changes19.07.01.0010.000168%-
Mobility decreased08.01.03.030; 15.03.05.023; 17.02.05.0180.000224%-
Ischaemic cardiomyopathy02.04.01.004; 24.04.04.019---
Chapped lips07.05.01.0040.000112%-
General physical health deterioration08.01.03.0180.000504%-
Blood phosphorus decreased13.11.01.015---
Left ventricular dysfunction02.04.02.011--
Ventricular hypokinesia02.04.02.0130.000224%-
Ejection fraction decreased13.14.02.003--
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