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)
Mitral valve incompetence02.07.01.0020.000336%Not Available
Mucosal inflammation08.01.06.002--Not Available
Muscle atrophy17.05.03.004; 15.05.03.0030.000246%Not Available
Muscle spasms15.05.03.004--
Muscular weakness17.05.03.005; 15.05.06.0010.000604%
Musculoskeletal pain15.03.04.0070.000414%
Myalgia15.05.02.0010.001108%
Myocardial infarction02.02.02.007; 24.04.04.0090.000951%
Myocardial ischaemia24.04.04.010; 02.02.02.0080.000224%Not Available
Myositis15.05.01.0010.000112%
Nasal congestion22.04.04.0010.000168%
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neck pain15.03.04.009--
Neoplasm malignant16.16.01.001--Not Available
Nephrolithiasis20.04.01.0020.000112%
Nervous system disorder17.02.10.0010.000168%Not Available
Neuralgia17.02.07.0050.000246%
Neuropathy peripheral17.09.03.0030.000448%Not Available
Neutropenia01.02.03.0040.001142%Not Available
Neutrophil count decreased13.01.06.010--
Night sweats23.02.03.006; 08.01.03.0310.000224%Not Available
Nocturia20.02.03.0010.000112%Not Available
Oedema08.01.07.006; 14.05.06.010--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.000728%
Pain08.01.08.004--
Pain in extremity15.03.04.0100.001242%
Pain in jaw15.02.01.0030.000168%Not Available
Pain of skin23.03.03.0030.000112%
Palpitations02.11.04.0120.000739%
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