Fall Reporting with GLP-1 Receptor Agonists in Older Adults: A FDA Adverse Event Reporting System (FAERS) Disproportionality Analysis

<title>Abstract</title> <p>Purpose This study characterize age-related differences in falls, syncope, and orthostatic hypotension reporting among users of GLP-1 receptor agonists (GLP-1 RAs), and to test whether falls are disproportionately reported in older adults independent of hemodynamic mechanisms. Methods We performed a disproportionality analysis of FAERS individual case safety reports for semaglutide, tirzepatide, liraglutide, and dulaglutide. Reporting odds ratios (RORs) compared patients aged 65–84 years with patients aged &lt; 65 years for Fall and a secondary hemodynamic cluster (Syncope, Presyncope, Orthostatic Hypotension, Dizziness, Postural Hypotension). Multivariable adjustment, Fisher's exact/Bonferroni correction, Bayesian credibility intervals, and a supplementary ≥ 85-year analysis were performed. Results Among 186,942 eligible reports, Fall was strongly overrepresented in older patients (ROR 2.75, 95% CI 2.47–3.06), unlike Syncope (ROR 0.96, 95% CI 0.83–1.12) or Orthostatic Hypotension (ROR 1.36, non-significant). This pattern was persisted after multivariable adjustment (adjusted OR 2.34, 95% CI 2.09–2.61). Fall ROR increased with age: 2.30 (65–74y), 3.91 (75–84y), 7.13 (≥ 85y). Conclusion Falls, but not syncope or orthostatic hypotension, show a strong, age-related reporting signal in GLP-1 RA users. These hypothesis-generating findings warrant confirmation with patient studies incorporating frailty and polypharmacy adjustment.</p>