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)
Atypical pneumonia22.07.01.010; 11.01.09.0120.000799%Not Available
Autoimmune hepatitis10.04.09.001; 09.01.07.0190.000533%Not Available
Back disorder15.03.01.0140.001332%Not Available
Back pain15.03.04.005--
Bacteraemia11.01.11.0010.002398%
Basal cell carcinoma16.03.02.001; 23.08.02.0010.003996%Not Available
Benign prostatic hyperplasia21.04.02.0010.001066%Not Available
Bladder cancer20.03.04.001; 16.08.01.001--Not Available
Blindness17.17.01.003; 06.02.02.0010.002664%Not Available
Blindness unilateral06.02.02.009; 17.17.01.0160.000799%Not Available
Blister23.03.01.001; 12.01.06.0020.004795%Not Available
Blood albumin decreased13.09.01.0010.000533%Not Available
Blood bilirubin increased13.03.01.0080.005328%
Blood calcium increased13.11.01.0030.000533%Not Available
Blood creatinine abnormal13.13.01.0020.001066%Not Available
Blood creatinine increased13.13.01.0040.006394%
Blood glucose abnormal13.02.02.0080.000533%Not Available
Blood glucose decreased13.02.02.0010.001332%Not Available
Blood glucose increased13.02.02.0020.003996%Not Available
Blood immunoglobulin G decreased13.06.05.0010.000799%Not Available
Blood iron decreased13.11.01.0060.002131%Not Available
Blood lactate dehydrogenase increased13.04.02.0020.002398%
Blood potassium decreased13.11.01.010--Not Available
Blood potassium increased13.11.01.0110.001865%Not Available
Blood pressure abnormal13.14.03.0010.001066%Not Available
Blood pressure decreased13.14.03.002--Not Available
Blood pressure increased13.14.03.005--Not Available
Blood pressure systolic increased13.14.03.006--Not Available
Blood sodium decreased13.11.01.0120.001598%Not Available
Blood sodium increased13.11.01.0130.000799%Not Available
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