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)
Erectile dysfunction19.08.04.001; 21.03.01.0070.000280%
Ill-defined disorder08.01.03.0490.000168%-
Blood disorder01.05.01.0040.000246%-
Immunodeficiency10.03.02.0020.000112%-
Adverse drug reaction08.06.01.009---
Disease progression08.01.03.0380.001645%
Drug intolerance08.06.01.013---
Hepatobiliary disease09.01.08.003---
Immunosuppression10.03.02.0010.000168%-
Hyperlipidaemia14.08.03.0010.000280%
Non-cardiac chest pain08.01.08.006; 22.12.02.009--
Peripheral arterial occlusive disease24.04.03.0100.000750%-
Arterial occlusive disease24.04.02.0210.000168%-
Effusion08.01.03.052---
Cerebral artery stenosis17.08.02.010; 24.04.06.023---
Exfoliative rash23.03.07.006---
Chronic kidney disease20.01.03.0170.000168%
Pulmonary arterial hypertension22.06.01.002; 24.08.03.0030.000280%-
Ulcerative keratitis06.04.02.004; 10.02.01.0210.000112%
Bone marrow failure01.03.03.0050.000448%
Cardiovascular insufficiency02.11.01.011; 24.06.03.0050.000112%-
Cytopenia01.03.03.0120.000616%-
Treatment failure08.06.01.017---
Liver injury09.01.07.022; 12.01.17.0120.000414%-
Posterior reversible encephalopathy syndrome17.13.02.0070.000392%
Central nervous system haemorrhage17.08.01.035; 24.07.04.0160.000112%-
Peripheral artery stenosis24.04.03.0170.000168%-
Peripheral artery thrombosis24.01.02.0100.000168%-
Multiple organ dysfunction syndrome08.01.03.0570.000448%
Dermatitis exfoliative generalised10.01.01.029; 23.03.07.0020.000112%-
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