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)
Respiratory rate increased13.15.01.0040.000533%Not Available
Splenic haemorrhage24.07.01.080; 12.01.02.014; 01.09.02.0150.001066%Not Available
Splenic vein thrombosis24.01.03.005; 01.09.02.0190.000533%Not Available
Temporal lobe epilepsy17.12.02.0040.000533%Not Available
Tibia fracture15.08.03.016; 12.04.01.0160.000533%Not Available
Urinary bladder haemorrhage24.07.01.086; 20.03.01.0230.001332%Not Available
Lower extremity mass15.03.01.0150.000533%Not Available
Axillary mass15.03.02.0140.000533%Not Available
Neck mass15.03.02.0070.001332%Not Available
Cerebral fungal infection17.06.09.005; 11.03.05.0200.000799%Not Available
Tongue haemorrhage24.07.02.058; 07.14.01.0150.000533%Not Available
Lumbar vertebral fracture12.04.04.007; 15.08.05.0070.001066%Not Available
Consciousness fluctuating17.02.04.0190.000799%Not Available
Blood viscosity increased13.01.03.0100.000533%Not Available
Haematoma infection24.07.01.068; 11.01.15.0040.000139%Not Available
Cerebral aspergillosis17.06.09.004; 11.03.01.0050.000417%Not Available
Pulmonary sepsis22.07.01.014; 11.01.11.0140.000208%Not Available
Brain contusion24.07.06.020; 17.11.01.010; 12.01.10.0140.000533%Not Available
Pneumococcal sepsis11.02.06.0070.000533%Not Available
Clostridium difficile infection11.02.02.0090.003730%Not Available
Secondary immunodeficiency10.03.03.0090.000139%Not Available
Autoimmune neutropenia10.04.01.010; 01.02.03.0130.000533%Not Available
Gastric infection11.01.07.008; 07.19.03.0030.000799%Not Available
Periorbital cellulitis06.04.11.004; 11.02.01.0450.000533%Not Available
Bladder mass20.03.01.0180.000533%Not Available
Chronic lymphocytic leukaemia transformation16.01.06.005; 01.10.06.0050.000208%Not Available
Richter's syndrome16.28.02.005; 01.15.02.0050.002085%Not Available
General physical condition abnormal13.15.01.0400.000208%Not Available
Scedosporium infection11.03.05.0290.000533%Not Available
Paraneoplastic syndrome16.32.01.0090.000533%Not Available
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