Potential Signals Associated with Ibrutinib- A Pharmacovigilance Study Using FDA Adverse Event Reporting System (FAERS)




Ibrutinib is an inhibitor of Bruton’s tyrosine kinase, which acquired an accelerated approval for the treatment of mantle cell lymphoma. It is also designated for the treatment of Waldenstrom's Macroglobulinemia, also called lymphoplasmacytic lymphoma. This study aims to identify possible adverse events of ibrutinib using disproportionality analysis.


Publicly available FAERS data from 2013 Q1 to 2020 Q3 was used in the study. Disproportionality analyses with Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) with 95% confidence intervals (95% CI) were calculated. A value of ROR-1.96SE>1, PRR≥2, count of co-occurrences is 3 or more, with an associated χ2 value of 4 or more were considered as a positive signal.


The FAERS database had a total of 900 reports associated with ibrutinib. The highest signal strength associated with ibrutinib was haematotympanum with PRR 234.379 (95% CI 112.316-489.097) and ROR 234.496 (95% CI 112.345-489.458), followed by angina bullosa haemorrhagica with PRR 69.658 (41.722-116.301) and ROR 69.711 (41.739-116.429). Haemarthrosis with PRR of 5.484 (3.667-8.201) and ROR 5.489(3.669-8.212), Gullian Barre syndrome with PRR 2.69 and ROR 2.675425, facial paralysis with PRR 2.88 (1.812-4.578) and ROR 2.882 (1.813-4.582), erysipelas with PRR 2.658 (1.507-4.691) and ROR 2.659 (1.507-4.691) and haemothorax with PRR 18.154 (13.931-23.731) and ROR 18.199 (13.956-23.731) were the other possible signals.


Our analysis revealed potential association of ibrutinib with hematotympanum, angina bullosa haemorrhagica, haemarthrosis, Gullian Barre syndrome, facial paralysis, erysipelas and haemothorax. Although a causal relation cannot be definitively proved, the number of cases reported suggests that there might be an association. Increased awareness of these risks among healthcare professionals may help to reduce the number and early identification of adverse events.

Conference/Value in Health Info

2021-05, ISPOR 2021, Montreal, Canada

Value in Health, Volume 24, Issue 5, S1 (May 2021)




Clinical Outcomes, Epidemiology & Public Health, Health Policy & Regulatory

Topic Subcategory

Clinical Outcomes Assessment, Risk-sharing Approaches, Safety & Pharmacoepidemiology


Oncology, Rare and Orphan Diseases, Systemic Disorders/Conditions

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