ABSTRACT Background Immune checkpoint inhibitors (ICIs) frequently cause severe adverse events (AEs) in elderly lung cancer patients due to age‐related immune decline. This study combines pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) with real‐world data to explore safety profiles in geriatric lung cancer patients. Methods AE reports for geriatric lung cancer patients (≥ 65 years) on FDA‐approved ICIs from FAERS (Q3 2014–Q3 2024) were analyzed using the Reporting Odds Ratio. Single‐center retrospective data was used for clinical contextualization. Results A total of 16 062 AE reports were identified, along with 260 AE signals in the FAERS database. The median age of reports was 72 years, with a male predominance (70.8%). Median onset time was 50 days. Reports with fatal outcomes (not causally adjudicated) accounted for 27.6% of cases. The geriatric group had significantly higher odds of reported fatal outcomes compared to the non‐elderly group (OR = 1.13, p < 0.001). Further analysis revealed elevated odds of fatal outcomes were associated with reports concerning male patients (OR = 1.46), those originating from Asian geographic regions (OR = 1.36), and anti‐PD‐1 recipients (OR = 1.22) (all p < 0.001) in geriatric patients. A complementary single‐center cohort ( n = 225) provided clinical context, identifying immune‐mediated pneumonia (21.3%) as the most common AE, predominantly in males (89.6%) and anti ‐ PD‐1 users (93.8%). Conclusion A higher reported rate of fatal outcomes was observed in geriatric lung cancer patients, especially those reports pertaining to males, Asian regions, and recipients of anti‐PD‐1 therapy.
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