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)
Lipase increased13.05.01.003--
Lymphopenia01.02.02.002--Not Available
Melaena24.07.02.013; 07.12.02.004--Not Available
Mouth ulceration07.05.06.004--Not Available
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Myocardial ischaemia24.04.04.010; 02.02.02.008--Not Available
Nasopharyngitis11.01.13.002; 22.07.03.002--Not Available
Nausea07.01.07.001--
Neuralgia17.02.07.005--
Neuropathy peripheral17.09.03.003--Not Available
Neutropenia01.02.03.004--Not Available
Neutrophil count decreased13.01.06.010--
Oedema peripheral02.05.04.007; 14.05.06.011; 08.01.07.007--
Oral mucosal eruption07.05.05.018--Not Available
Oral pain07.05.05.034--
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pancreatitis07.18.01.001--
Paraesthesia23.03.03.094; 17.02.06.005--
Pericardial effusion02.06.01.002--
Peripheral ischaemia24.04.03.002--
Peripheral motor neuropathy17.09.03.004--
Peripheral sensory neuropathy17.09.03.005--
Pharyngeal ulceration22.04.05.004--Not Available
Platelet count decreased13.01.04.001--
Pleural effusion22.05.02.002--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Polyneuropathy17.09.03.012--Not Available
Pulmonary oedema22.01.03.003; 02.05.02.003--
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