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. 2025 Apr 7;23(1):203.
doi: 10.1186/s12916-025-04031-z.

Increased vision impairment reports linked to semaglutide: analysis of FDA adverse event data

Marine Massy  1   2   3 , Stefanie Marti  1 , Helly Hammer  1 , Robert Hoepner  4
Affiliations

Increased vision impairment reports linked to semaglutide: analysis of FDA adverse event data

Marine Massy et al. BMC Med. .

Abstract

Background: Semaglutide, a GLP-1 receptor agonist widely prescribed for type 2 diabetes and obesity, has recently raised concerns about its ocular safety. This study aimed to investigate the association between semaglutide use and vision impairment using data from the FDA Adverse Event Reporting System (FAERS).

Methods: We conducted an analysis of FAERS data, comparing reports of vision impairment associated with semaglutide to those associated with other antidiabetic and weight loss medications. The main outcome measure was the reporting odds ratio (rOR) for vision impairment linked to semaglutide use compared to other medications.

Results: Semaglutide showed significantly higher reporting of vision impairment compared to other GLP-1 receptor agonists (rOR 1.95, 95% CI 1.75-2.17, p < 0.0001), DPP-4 inhibitors (rOR 2.46, 95% CI 2.12-2.86, p < 0.0001), SGLT2 inhibitors (rOR 3.89, 95% CI 3.35-4.51, p < 0.0001), and metformin (rOR 2.23, 95% CI 1.90-2.62, p < 0.0001). Similar findings were observed when compared to phentermine (rOR 1.57, 95% CI 1.07-2.31, p = 0.026) and orlistat (rOR 3.77, 95% CI 2.96-4.81, p < 0.0001). Topiramate was the sole exception, showing higher vision impairment reporting than semaglutide (rOR 0.30, 95% CI 0.20-0.45, p < 0.0001).

Conclusions: These findings suggest a potentially elevated risk of vision impairment with semaglutide use compared to other diabetes and weight loss medications, warranting further investigation and vigilant post-marketing surveillance. Future studies should assess the clinical impact of this potential increased risk on an absolute scale to better inform treatment decisions.

Keywords: Diabetes; Obesity; Semaglutide; Vision impairment.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: Massy M reports no competing interests. Marti S reports no competing interests. Hammer H received research support and travel grants within the last 5 years from Biogen, Merck, Roche & Bristol Myers Squibb, Teva, Johnson&Johnson, Novartis. All not related to that work. Hoepner R received speaker/advisor honorary from Merck, Novartis, Roche, Biogen, Alexion, Sanofi, Janssen, Bristol-Myers Squibb, Teva/Mepha and Almirall. He received research support within the last 5 years from Roche, Merck, Sanofi, Biogen, Chiesi, and Bristol-Myers Squibb. He also received research grants from the Swiss MS Society, the SITEM Insel Support Fund and is a member of the Advisory Board of the Swiss and International MS Society. He also serves as deputy editor in chief for Journal of Central Nervous System disease and is part of the ECTRIMS Young Investigator Committee.

Figures

Fig. 1
Fig. 1
Semaglutide is associated with visual impairment or optic neuropathy compared to other substances, except topiramate. Analysis of FAERS reports of visual impairment (terms in Additional file 1: Table S3) in filtered reports with T2D or obesity as main indication for semaglutide and Comparator Substance (monotherapy). Numbers of reports for comparator substance are displayed in the graph (report for visual impairment/total number of reports), except for semaglutide (n = 417/11,558). rORs were calculated with 95% CI and corresponding p-value (with Yates’ correction). Abbreviations: CI: confidence interval, FAERS: Food and Drug Administration (FDA) adverse event reporting system, rOR: reporting odds ratio, T2D: type 2 diabetes
Fig. 2
Fig. 2
The observed association between semaglutide and higher risk for visual impairment also holds for individual GLP-1 receptor agonists. Analysis of FAERS reports of visual impairment in filtered reports with obesity or T2D as main indication for semaglutide and Comparator Substance (monotherapy). Numbers of reports are displayed in the graph as: report for visual impairment/total number of reports, except for semaglutide (n = 417/11,558). Lixisenatide was excluded due to too low case numbers (see Additional file 1: Table S5 for number of reports). rORs were calculated with 95% CI and corresponding p-value (with Yates’ correction). Abbreviations: CI: confidence interval, FAERS: Food and Drug Administration (FDA) adverse event reporting system, rOR: reporting odds ratio, T2D: type 2 diabetes
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References

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