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)
Wound infection staphylococcal12.02.05.051; 11.02.05.0140.000799%Not Available
Tongue injury07.14.01.016; 12.01.09.0200.000533%Not Available
Respiratory tract infection fungal22.07.07.004; 11.03.05.0280.000208%Not Available
Embolic cerebral infarction24.01.04.009; 17.08.01.0290.000139%Not Available
Escherichia infection11.02.10.0040.001865%Not Available
Traumatic intracranial haemorrhage24.07.04.034; 17.08.05.005; 12.01.10.0170.000139%Not Available
Glomerulosclerosis20.05.03.0080.000278%Not Available
Metastatic squamous cell carcinoma16.16.01.0100.000139%Not Available
Multimorbidity08.01.03.0750.001251%Not Available
Angina bullosa haemorrhagica24.07.02.040; 07.05.01.0130.000799%Not Available
Lymphoma transformation16.20.01.006; 01.12.01.0060.000208%Not Available
Breast haematoma24.07.03.020; 21.05.05.0130.000533%Not Available
Stress cardiomyopathy24.04.04.026; 02.04.01.0120.000799%Not Available
Superinfection bacterial11.02.01.0500.000533%Not Available
Retroperitoneal lymphadenopathy07.07.01.012; 01.09.01.0290.000533%Not Available
Pneumonia cryptococcal22.07.08.012; 11.03.04.0050.001332%Not Available
Oropharyngeal plaque22.02.05.041; 07.05.05.0250.000799%Not Available
Aortic intramural haematoma24.02.03.0040.000208%Not Available
Bone abscess15.02.05.005; 11.01.01.0060.000533%Not Available
Mastoid effusion04.05.05.0030.000533%Not Available
Coma scale abnormal13.07.03.0120.001332%Not Available
Aspergillus test positive13.08.06.0030.000533%Not Available
Systolic dysfunction02.04.02.0350.000533%Not Available
Spinal pain08.01.08.030; 17.10.01.020; 15.02.01.0080.001598%Not Available
Eye contusion24.07.06.022; 12.01.04.024; 06.11.01.0110.000533%Not Available
Spontaneous haemorrhage24.07.01.081; 01.01.03.0070.000533%Not Available
Internal haemorrhage24.07.01.0720.002931%Not Available
Cutaneous symptom23.07.04.0230.000533%Not Available
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