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 acquired an accelerated approval for the treatment of mantle cell lymphoma who have received at least one prior therapy.[FDA label] Mantle cell lymphoma (MCL) is a B-cell non-Hodgkin lymphoma that develops in the outer edge of a lymph node. MCL is usually diagnosed at late stages and it is easily spread into bone marrow, spleen, liver and gastrointestinal tract.[L1929] Ibrutinib is indicated for the treatment of chronic lymphocytic leukemia (CLL) who have at least one prior therapy.[FDA label] CLL is a type of cancer caused by an overproduction of lymphocytes by the bone marrow. Some of the symptoms include swollen lymph nodes and tiredness.[L1931] Ibrutinib is indicated for the treatment of chronic lymphocytic leukemia (CLL) with 17p deletion.[FDA label] CLL with 17p is a type of leukemia in which a deletion in 17p disrupts the tumor suppressor p53 by deleting one allele of the TP53 gene. The remaining allele is mainly inactivated and thus, this type of leukemia is unresponsive to p53-dependent treatments.[A32305] 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 approved
ATC Code L01EL01
DrugBank ID DB09053
KEGG ID D10223
MeSH ID C551803
PubChem ID 24821094
TTD Drug ID D09KTS
NDC Product Code 42185-7078; 55111-982; 65129-1377; 83137-0004; 57962-007; 57962-560; 11014-0328; 57962-070; 11014-0327; 68554-0109; 57962-420; 11014-0329; 65129-1460; 65129-1471; 11014-0326; 71796-053; 11014-0397; 40006-040; 11014-0163; 11014-0417; 58175-0602; 63850-8089; 82920-031; 57962-014; 57962-140; 57962-280
UNII 1X70OSD4VX
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
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)
Ear neoplasm04.03.01.017; 16.16.05.0010.000112%-
Gait inability08.01.02.011; 17.02.05.069---
Haematoma muscle12.01.07.015; 15.05.03.036; 24.07.01.0910.000112%-
Haemoperitoneum07.07.02.007; 12.01.17.007; 24.07.02.0650.000448%-
Haemophagocytic lymphohistiocytosis01.05.01.026; 10.02.01.077; 16.32.03.0380.001119%-
Hyperleukocytosis01.02.01.0180.000504%-
Hypoglobulinaemia01.05.01.0290.000112%-
Immune thrombocytopenia01.08.01.013; 10.02.01.0830.000728%-
Intra-abdominal fluid collection07.07.01.014; 21.07.04.0140.000246%-
Limb mass15.03.05.0190.000224%-
Loss of therapeutic response08.06.01.0410.000112%-
Marginal zone lymphoma01.15.09.001; 16.28.09.0010.000224%-
Mucosal disorder08.01.06.0290.000112%-
Myelosuppression01.03.03.0150.000783%-
Myocardial injury02.04.02.0460.000112%-
Nail bed bleeding12.01.09.022; 23.02.05.029; 24.07.01.1020.000358%-
Prostatic mass21.04.01.0120.000112%-
Renal tubular injury20.01.07.0200.000112%-
Scrotal haematocoele21.12.02.011; 24.07.03.0350.000112%-
Skin laceration12.01.06.016; 23.03.11.041---
Subcapsular renal haematoma12.01.05.008; 20.01.02.021; 24.07.07.0060.000112%-
Superficial vein thrombosis24.01.02.0160.000112%-
Swelling of eyelid06.04.04.018; 10.01.05.026; 23.04.01.0260.000112%-
Taste disorder07.14.03.004; 17.02.07.029---
Therapeutic product effect decreased08.06.01.0500.001791%-
Therapeutic product ineffective08.06.01.057---
Therapy partial responder08.06.01.0640.000604%-
Treatment noncompliance08.06.01.067; 12.09.02.006---
Vein collapse12.02.01.040; 24.03.02.0390.000112%-
Brain fog16.32.03.050; 17.02.05.077; 19.21.02.017---
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