Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Ponatinib hydrochloride
Drug ID BADD_D01800
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 D09951
MeSH ID C545373
PubChem ID 46908927
TTD Drug ID D0H0EQ
NDC Product Code 42973-242; 63020-535; 63020-536; 63020-533; 63020-534; 48957-0070; 54893-0124
UNII 96R6PU3D8J
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 C29H28ClF3N6O
CAS Registry Number 1114544-31-8
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.Cl
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)
Cardiac failure02.05.01.001--
Cardiac failure congestive02.05.01.002--Not Available
Cardiogenic shock24.06.02.006; 02.05.01.003--Not Available
Cellulitis23.11.02.004; 11.02.01.001--Not Available
Cerebral ischaemia24.04.06.003; 17.08.01.005--
Chills15.05.03.016; 08.01.09.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry skin23.03.03.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Embolism venous24.01.01.003--Not Available
Fatigue08.01.01.002--
Febrile neutropenia08.05.02.004; 01.02.03.002--
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Gastric haemorrhage24.07.02.007; 07.12.01.001--
Gastric ulcer haemorrhage24.07.02.003; 07.04.03.005--Not Available
Gastritis haemorrhagic24.07.02.008; 07.08.02.002--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Haematemesis24.07.02.011; 07.12.02.002--Not Available
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Headache17.14.01.001--
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hyperaesthesia23.03.03.080; 17.02.06.004--Not Available
Hypertension24.08.02.001--
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Leukopenia01.02.02.001--Not Available
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