A large pharmacovigilance analysis of reports submitted to the US Food and Drug Administration has found that Wegovy (semaglutide) showed a stronger-than-expected reporting signal for ischemic optic neuropathy, a rare condition that can cause sudden vision loss, compared with other semaglutide products. The study was published in the British Journal of Ophthalmology.
Researchers analyzed adverse event reports in the FDA’s Adverse Event Reporting System (FAERS) from December 2017 through December 2024, examining more than 30.6 million reports in total.
Within that dataset, the study identified 31,774 reports involving semaglutide products. Among these, investigators found 28 reports of ischemic optic neuropathy (ION) associated with Wegovy and 47 associated with Ozempic. No ION cases were reported for oral semaglutide (Rybelsus).
Using a standard disproportionality approach to detect potential safety signals in spontaneous-reporting databases, the authors reported that Wegovy had a substantially stronger reporting signal for ION than Ozempic. The study reported a reporting odds ratio of about 75 for Wegovy versus about 19 for Ozempic—roughly a five-fold difference in signal strength.
The authors cautioned that FAERS reports cannot establish that a drug caused an event, nor do they provide a reliable estimate of how often a side effect occurs, because reporting is voluntary and can be influenced by media attention and other factors. They called for prospective studies to better assess whether any risk varies by formulation or dose.
