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%Not Available
Thrombocytopenia01.08.01.0020.002541%Not Available
Thrombosis24.01.01.0060.000694%Not Available
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000280%
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary hesitation20.02.02.0090.000112%Not Available
Urinary retention20.02.02.0110.000224%
Urinary tract infection20.08.02.001; 11.01.14.004--
Uveitis10.02.01.023; 06.04.03.0030.000112%
Venous thrombosis24.01.01.0080.000302%Not Available
Ventricular tachycardia02.03.04.0100.000112%
Vision blurred17.17.01.010; 06.02.06.0070.000772%
Visual acuity reduced06.02.10.012; 17.17.01.0110.000246%
Visual impairment06.02.10.013--Not Available
Vitamin B12 deficiency14.12.02.0040.000112%Not Available
VIth nerve paralysis17.04.02.002; 06.05.02.0090.000112%Not Available
Vitreous floaters06.09.01.0050.000112%
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight gain poor14.03.02.0180.000112%Not Available
White blood cell count decreased13.01.06.012--
Mental status changes19.07.01.0010.000168%Not Available
Mobility decreased17.02.05.018; 15.03.05.023; 08.01.03.0300.000224%Not Available
Ischaemic cardiomyopathy24.04.04.019; 02.04.01.004--Not Available
Chapped lips07.05.01.0040.000112%Not Available
General physical health deterioration08.01.03.0180.000504%Not Available
Blood phosphorus decreased13.11.01.015--Not Available
Left ventricular dysfunction02.04.02.011--
Ventricular hypokinesia02.04.02.0130.000224%Not Available
Ejection fraction decreased13.14.02.003--
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