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)
Anal incontinence17.05.01.021; 07.01.06.029--
Liver function test increased13.03.01.044--Not Available
Frustration tolerance decreased19.04.02.0160.000533%Not Available
Abdominal mass07.01.01.0030.000533%Not Available
Adenocarcinoma of colon16.13.01.010; 07.21.01.0080.000533%Not Available
Adjustment disorder with depressed mood19.23.01.0020.000533%Not Available
Anal ulcer07.04.01.0010.000533%
Appendicitis perforated11.01.07.028; 07.04.06.0110.000533%
Bacterial diarrhoea11.02.01.034; 07.19.02.0150.000533%Not Available
Biopsy13.18.02.0030.001066%Not Available
Blood blister23.03.01.028; 12.01.06.0130.003730%Not Available
Blood immunoglobulin M increased13.06.05.0100.001332%Not Available
Breast haemorrhage24.07.03.021; 21.05.05.0140.000533%Not Available
Chronic lymphocytic leukaemia recurrent16.01.06.003; 01.10.06.0030.000533%Not Available
Chronic lymphocytic leukaemia refractory16.01.06.004; 01.10.06.0040.000208%Not Available
Colonoscopy13.05.05.0040.000533%Not Available
Disseminated cryptococcosis11.03.04.0040.000208%Not Available
Full blood count abnormal13.01.07.0030.000799%Not Available
Hepatitis E11.05.06.009; 09.01.09.0130.000533%Not Available
Intracranial tumour haemorrhage16.32.03.023; 24.07.04.028; 17.08.01.0520.000139%Not Available
Iodine uptake abnormal13.10.06.0150.001332%Not Available
Lung adenocarcinoma16.19.01.002; 22.08.01.0070.000208%Not Available
Malignant pleural effusion22.05.04.001; 16.32.03.0140.000533%Not Available
Mantle cell lymphoma recurrent16.28.05.002; 01.15.05.0020.000486%Not Available
Mucocutaneous ulceration23.07.03.0180.000139%Not Available
Nosocomial infection11.07.02.0060.000533%Not Available
Penile ulceration23.07.03.020; 21.12.01.0190.000533%Not Available
Pneumonia haemophilus22.07.06.013; 11.02.15.0020.000533%Not Available
Pneumonia pseudomonal11.02.12.004; 22.07.06.0140.000799%Not Available
Pulmonary mycosis22.07.08.013; 11.03.05.0270.000533%Not Available
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