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
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
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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.005595%
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abscess11.01.08.0010.001066%Not Available
Acne23.02.01.0010.002931%Not Available
Acne cystic23.02.01.0050.000533%Not Available
Actinic keratosis23.01.06.0010.001066%Not Available
Acute febrile neutrophilic dermatosis23.03.03.033; Available
Acute myeloid leukaemia16.01.05.001; Available
Acute myocardial infarction24.04.04.001; Available
Acute pulmonary oedema22.01.03.005; Available
Acute respiratory distress syndrome22.01.03.0010.000347%
Acute respiratory failure14.01.04.004; Available
Adenocarcinoma16.16.01.0040.000799%Not Available
Adrenal insufficiency14.11.01.004;
Ageusia17.02.07.001; Available
Aggression19.05.01.001--Not Available
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.01.003--
Altered state of consciousness19.07.01.003; Available
Anaphylactic reaction24.06.03.006;
Anaphylactic shock24.06.02.004; Available
Angina pectoris24.04.04.002;
Angioedema23.04.01.001; Available
Ankle fracture15.08.03.005;
Anuria20.01.03.002--Not Available
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