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)
Rash maculo-papular23.03.13.0040.000336%
Rash pruritic23.03.13.0300.000358%Not Available
Rash vesicular23.03.13.0090.000112%Not Available
Raynaud's phenomenon24.04.03.0030.000437%Not Available
Renal artery stenosis24.04.11.001; 20.01.07.0050.000280%Not Available
Renal disorder20.01.02.0020.000168%Not Available
Renal failure20.01.03.0050.000616%Not Available
Respiratory distress22.02.01.0120.000168%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000560%
Retinal artery occlusion24.01.07.003; 06.10.01.0050.000112%Not Available
Retinal vein occlusion24.01.07.006; 06.10.01.010--Not Available
Retinal vein thrombosis24.01.07.002; 06.10.01.003--Not Available
Sepsis11.01.11.003--
Sinus tachycardia02.03.03.0100.000112%
Skin discolouration23.03.03.0050.000358%Not Available
Skin disorder23.03.03.0070.000224%Not Available
Skin exfoliation23.03.07.0030.001086%Not Available
Skin hyperpigmentation23.05.01.0030.000112%
Skin lesion23.03.03.0100.000168%Not Available
Skin necrosis23.03.03.0110.000112%Not Available
Skin reaction23.03.03.013; 10.01.03.0190.000112%Not Available
Skin ulcer23.07.03.003; 24.04.03.0070.000168%
Skin wrinkling23.01.03.0010.000168%Not Available
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.000168%Not Available
Splenic infarction24.04.08.024; 01.09.02.004--Not Available
Splenomegaly01.09.02.0010.000168%Not Available
Stomatitis07.05.06.005--
Subarachnoid haemorrhage24.07.04.004; 17.08.01.010; 12.01.10.0110.000112%Not Available
Sudden death02.03.04.013; 08.04.01.0030.000168%
Supraventricular tachycardia02.03.03.0120.000224%
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