Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ibrutinib
Drug ID BADD_D01119
Description Ibrutinib is a small molecule that acts as an irreversible potent inhibitor of Burton's tyrosine kinase. It is designated as a targeted covalent drug and it presents a very promising activity in B cell malignancies.[A32299] Ibrutinib was developed by Pharmacyclics Inc and in November 2013 was FDA-approved for the treatment of mantle cell lymphoma. Later, in February 2014, ibrutinib was approved for the treatment of chronic lymphocytic leukemia and it is also indicated for the treatment of patients with Waldenström's Macroglobulinemia.[L1926] Ibrutinib has also been approved by the EMA for the treatment of chronic lymphocytic leukemia and mantle cell lymphoma.[A32299] Ibrutinib was approved for use in chronic graft versus host disease in August 2017 [L937].
Indications and Usage Ibrutinib is indicated for the treatment of patients with Waldenstrom's Macroglobulinemia (WM).[FDA label] WM, also called lymphoplasmacytic lymphoma, is a type of non-Hodgkin lymphoma in which the cancer cells make large amounts of macroglobulin. The macroglobulin is a monoclonal protein that corresponds to the type of IgM antibodies and the unrestricted formation of this protein causes typical symptoms such as excessive bleeding and effects in vision and nervous system.[L1934]
Marketing Status Prescription
ATC Code L01EL01
DrugBank ID DB09053
KEGG ID D10223
MeSH ID C551803
PubChem ID 24821094
TTD Drug ID D09KTS
NDC Product Code 46708-909; 40006-040; 63759-0031; 55111-982; 63850-8089; 11014-0417; 11014-0397; 11014-0327; 57962-140; 43744-241; 57962-420; 11014-0328; 58175-0602; 68554-0109; 57962-014; 57962-560; 11014-0329; 42185-7078; 11014-0326; 65129-1377; 57962-280; 11014-0163; 57962-070
Synonyms ibrutinib | 1-((3R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo(3,4-d)pyrimidin-1-yl)piperidin-1- yl)prop-2-en-1-one | PCI 32765 | PCI32765 | PCI-32765 | Imbruvica
Chemical Information
Molecular Formula C25H24N6O2
CAS Registry Number 936563-96-1
SMILES C=CC(=O)N1CCCC(C1)N2C3=NC=NC(=C3C(=N2)C4=CC=C(C=C4)OC5=CC=CC=C5)N
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Blood thyroid stimulating hormone increased13.10.03.0060.001332%
Blood uric acid increased13.02.04.0010.001598%Not Available
Body temperature increased13.15.01.0010.001332%Not Available
Bone pain15.02.01.0010.003197%
Bowen's disease23.08.02.004; 16.03.02.0040.000799%Not Available
Bradycardia02.03.02.002--Not Available
Brain abscess17.06.07.001; 11.01.03.0030.001332%Not Available
Breast cancer21.05.01.003; 16.10.01.001--Not Available
Breast mass21.05.04.0020.000533%Not Available
Bronchiectasis22.03.02.0050.001066%Not Available
Bronchitis22.07.01.001; 11.01.09.0010.007460%
Bronchopulmonary aspergillosis22.07.08.001; 11.03.01.0020.000764%Not Available
Bundle branch block left02.03.01.0070.001332%Not Available
Bundle branch block right02.03.01.0110.000533%Not Available
Burning sensation17.02.06.001; 08.01.09.029--Not Available
Bursitis15.04.01.0010.000799%Not Available
C-reactive protein increased13.09.01.007--Not Available
Cachexia16.32.03.011; 14.03.02.001; 08.01.01.0090.000208%Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.0010.007228%
Cardiac failure acute02.05.01.0050.000417%Not Available
Cardiac failure congestive02.05.01.002--Not Available
Cardiac tamponade02.06.01.0010.001865%
Cardio-respiratory arrest22.02.06.007; 02.03.04.002--Not Available
Cardiogenic shock02.05.01.003; 24.06.02.006--Not Available
Cardiomyopathy02.04.01.0010.005595%Not Available
Cardiovascular disorder02.01.01.001; 24.03.02.009--Not Available
Cataract06.06.01.0010.007193%
Cellulitis23.09.01.001; 11.02.01.0010.009324%Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.0030.006811%Not Available
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