82/100 · Critical
Manufactured by Pharmacyclics LLC
High Serious Adverse Events with IBRUTINIB: Focus on Hematological and Cardiovascular Risks
129,122 FDA adverse event reports analyzed
Last updated: 2026-05-12
IBRUTINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pharmacyclics LLC. Based on analysis of 129,122 FDA adverse event reports, IBRUTINIB has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for IBRUTINIB include DEATH, OFF LABEL USE, FATIGUE, DIARRHOEA, ATRIAL FIBRILLATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IBRUTINIB.
Ibrutinib has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 129,122 adverse event reports for this medication, which is primarily manufactured by Pharmacyclics Llc.
The most commonly reported adverse events include Death, Off Label Use, Fatigue. Of classified reports, 77.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High incidence of serious adverse events, particularly hematological and cardiovascular issues.
Significant reports of infections and hematological abnormalities, including thrombocytopenia and neutropenia. Cardiovascular events such as atrial fibrillation and congestive heart failure are notable.
Patients taking Ibrutinib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. IBRUTINIB can cause significant drug interactions, including those with warfarin and other anticoagulants, necessitating careful monitoring. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ibrutinib received a safety concern score of 82/100 (high concern). This is based on a 77.3% serious event ratio across 78,797 classified reports. The score accounts for 129,122 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 44,683, Female: 27,882, Unknown: 16. The most frequently reported age groups are age 74 (1,424 reports), age 75 (1,424 reports), age 70 (1,402 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 78,797 classified reports for IBRUTINIB:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
IBRUTINIB can cause significant drug interactions, including those with warfarin and other anticoagulants, necessitating careful monitoring.
If you are taking Ibrutinib, here are important things to know. The most commonly reported side effects include death, off label use, fatigue, diarrhoea, atrial fibrillation. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of infection, particularly in elderly patients, and report any symptoms promptly. Regularly check blood counts and monitor for hematological and cardiovascular adverse events. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with regular updates on safety profiles and new warnings issued.
The FDA has received approximately 129,122 adverse event reports associated with Ibrutinib. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Ibrutinib include Death, Off Label Use, Fatigue, Diarrhoea, Atrial Fibrillation. By volume, the top reported reactions are: Death (8,367 reports), Off Label Use (5,878 reports), Fatigue (4,668 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ibrutinib.
Out of 78,797 classified reports, 60,886 (77.3%) were classified as serious and 17,911 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Ibrutinib break down by patient sex as follows: Male: 44,683, Female: 27,882, Unknown: 16. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Ibrutinib adverse events are: age 74: 1,424 reports, age 75: 1,424 reports, age 70: 1,402 reports, age 76: 1,393 reports, age 72: 1,392 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Ibrutinib adverse event reports is Pharmacyclics Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Ibrutinib include: Pneumonia, Contusion, Incorrect Dose Administered, Fall, Asthenia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Ibrutinib to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Ibrutinib has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High incidence of serious adverse events, particularly hematological and cardiovascular issues.
Key safety signals identified in Ibrutinib's adverse event data include: Atrial fibrillation and other cardiac disorders are frequent.. Hematological issues like thrombocytopenia and neutropenia are common.. Infections, particularly pneumonia, are a significant concern.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
IBRUTINIB can cause significant drug interactions, including those with warfarin and other anticoagulants, necessitating careful monitoring. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ibrutinib.
Monitor for signs of infection, particularly in elderly patients, and report any symptoms promptly. Regularly check blood counts and monitor for hematological and cardiovascular adverse events.
Ibrutinib has 129,122 adverse event reports on file with the FDA. Significant reports of infections and hematological abnormalities, including thrombocytopenia and neutropenia. The volume of reports for Ibrutinib reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with regular updates on safety profiles and new warnings issued. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with IBRUTINIB:
Drugs related to IBRUTINIB based on therapeutic use, drug class, or shared indications: