95/100 · Critical
Manufactured by Gilead Sciences, Inc.
Highly Serious Adverse Events for IDELALISIB
Last updated: 2026-05-12
IDELALISIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Gilead Sciences, Inc.. Based on analysis of FDA adverse event reports, IDELALISIB has a safety score of 95 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IDELALISIB.
Idelalisib has a safety concern score of 95 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately N/A adverse event reports for this medication, which is primarily manufactured by Gilead Sciences, Inc..
Of classified reports, 96.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. 96.7% of reports are serious, indicating a high risk of severe adverse events.
The majority of reports (7041) highlight the drug's safety concerns. Age distribution shows a concentration of reports among older adults, aged 65 and above.
Patients taking Idelalisib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. No specific drug interactions are noted, but caution is advised for use in older adults due to the high number of reports. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Idelalisib received a safety concern score of 95/100 (high concern). This is based on a 96.7% serious event ratio across 7,041 classified reports. The score accounts for N/A total adverse event reports and 0 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
The most frequently reported age groups are age 67 (226 reports), age 69 (225 reports), age 76 (218 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 7,041 classified reports for IDELALISIB:
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.
No specific drug interactions are noted, but caution is advised for use in older adults due to the high number of reports.
If you are taking Idelalisib, here are important things to know. Patients should report any new or worsening symptoms to their healthcare provider immediately. Close monitoring is recommended, especially for older adults. 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 IDELALISIB requiring close monitoring for serious adverse events.
The FDA has received approximately N/A adverse event reports associated with Idelalisib. 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.
Out of 7,041 classified reports, 6,806 (96.7%) were classified as serious and 235 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.
The most frequently reported age groups for Idelalisib adverse events are: age 67: 226 reports, age 69: 225 reports, age 76: 218 reports, age 75: 216 reports, age 72: 215 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 Idelalisib adverse event reports is Gilead Sciences, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
You can report adverse events from Idelalisib 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.
Idelalisib has a safety concern score of 95 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. 96.7% of reports are serious, indicating a high risk of severe adverse events.
Key safety signals identified in Idelalisib's adverse event data include: High percentage of serious adverse events (96.7%). Age distribution with a significant number of reports from older adults. Lack of non-serious reports (only 235 out of 7041). These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
No specific drug interactions are noted, but caution is advised for use in older adults due to the high number of reports. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Idelalisib.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Close monitoring is recommended, especially for older adults.
Idelalisib has N/A adverse event reports on file with the FDA. The majority of reports (7041) highlight the drug's safety concerns. The volume of reports for Idelalisib reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with IDELALISIB requiring close monitoring for serious adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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