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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.000280%
Abdominal pain07.01.05.0020.001925%
Abdominal pain upper07.01.05.0030.000750%
Accelerated hypertension24.08.01.0030.000112%Not Available
Acute lymphocytic leukaemia16.01.01.001; 01.10.01.0010.001231%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.000392%Not Available
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.0010.000112%
Acute respiratory failure22.02.06.001; 14.01.04.0040.000224%Not Available
Agranulocytosis01.02.03.0010.000112%Not Available
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.0010.000168%Not Available
Amylase decreased13.05.01.001--Not Available
Amylase increased13.05.01.009--
Anaemia01.03.02.0010.001533%
Angina pectoris24.04.04.002; 02.02.02.0020.000336%
Angina unstable02.02.02.004; 24.04.04.0040.000280%Not Available
Angiocentric lymphoma16.17.04.002; 01.11.04.0020.000168%Not Available
Aphasia19.21.01.001; 17.02.03.0010.000224%
Arrhythmia02.03.02.0010.000168%Not Available
Arterial thrombosis24.01.01.0020.000112%Not Available
Arteriosclerosis24.04.02.0010.000470%Not Available
Arteriosclerosis coronary artery02.02.01.011; 24.04.04.0120.000112%Not Available
Arteritis24.12.02.0010.000246%Not Available
Arthralgia15.01.02.0010.001276%
Arthritis15.01.01.0010.000168%
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000168%
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.0010.001444%Not Available
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