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)
Gastric haemorrhage24.07.02.007; 07.12.01.001--
Gastritis07.08.02.0010.000112%
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal pain07.01.05.005--
Generalised oedema14.05.06.007; 08.01.07.0040.000168%
Generalised tonic-clonic seizure17.12.01.0020.000168%Not Available
Gout15.01.06.001; 14.09.01.0010.000168%Not Available
Graft versus host disease10.02.01.027; 12.02.09.0010.000504%Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.0060.000168%
Haemoglobin13.01.05.018--Not Available
Headache17.14.01.0010.002474%
Hemiplegia17.01.04.0020.000112%Not Available
Hepatic cirrhosis09.01.04.0010.000112%Not Available
Hepatic failure09.01.03.0020.000168%
Hepatic function abnormal09.01.02.0010.000392%Not Available
Hepatocellular injury09.01.07.0080.000112%Not Available
Hepatomegaly09.01.05.0010.000112%Not Available
Hepatosplenomegaly01.09.03.001; 09.01.05.0020.000168%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.000660%Not Available
Hyperaesthesia23.03.03.080; 17.02.06.0040.000112%Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.0030.000246%Not Available
Hypercalcaemia14.04.01.003; 05.04.01.002--
Hypercholesterolaemia14.08.01.0010.000112%Not Available
Hyperglycaemia14.06.02.002; 05.06.02.0020.000112%
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperkeratosis23.01.01.0010.000112%
Hypersensitivity10.01.03.0030.000907%
Hypertension24.08.02.0010.002988%
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