Association between glucagon-like peptide-1 agonists and risk of diabetic retinopathy: a disproportionality analysis using FDA adverse event reporting system data
Abstract
BACKGROUND: Glucagon-like peptide-1 (GLP-1) agonists are commonly prescribed for type 2 diabetes mellitus (T2DM). Concerns have emerged regarding their potential link to diabetic retinopathy (DR). METHODS: To evaluate the association between GLP-1 agonists and DR, a disproportionality analysis was conducted using FDA Adverse Event Reporting System (FAERS) data from Q4/2003 to Q2/2024 via OpenVigil 2.1 software. We focused on GLP-1 agonists and glucose-dependent insulinotropic polypeptide (GIP) agonist: Semaglutide, liraglutide, dulaglutide, lixisenatide, and tirzepatide, as primary suspect drugs. 'Diabetic retinopathy' was the key search term mapped to Medical Dictionary for Regulatory Activities (MedDRA) Lower-Level Terms (LLTs). We calculated Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR), with 95% confidence intervals (CI) and the Evans' criteria were applied to check the significant associations. RESULTS: Semaglutide (PRR: 19.43, 95% CI: 15.17-24.88; ROR: 19.48, 95% CI: 15.20-24.96; Chi-square: 1078.08) and dulaglutide (PRR: 9.01, 95% CI: 7.11-11.42; ROR: 9.02, 95% CI: 7.11-11.44; Chi-square: 478.31) showed a strong association with DR. Tirzepatide and liraglutide showed a weaker but significant association while lixisenatide showed no significant association. CONCLUSION: GLP-1 agonists (except lixisenatide) were found to be associated with DR. These findings emphasize the need for close monitoring and further research to clarify these associations.
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Analysis of FAERS data from 2003 to 2024 showed a significant association between diabetic retinopathy and dulaglutide (PRR 9.01).
“dulaglutide (PRR, 9.01), and liraglutide (PRR, 4.4) [95].”
From Exploring the Side Effects of GLP-1 Receptor Agonist: To Ensure Its Optimal Positioning (2025) · cites this paper as [95]
Analysis of FAERS data from 2003 to 2024 showed a significant association between diabetic retinopathy and semaglutide (PRR 19.43).
“Analysis of FAERS data from 2003 to 2024 showed significant associations between diabetic retinopathy and semaglutide (PRR, 19.43), dulaglutide (PRR, 9.01), and liraglutide (PRR, 4.4) [95].”
From Exploring the Side Effects of GLP-1 Receptor Agonist: To Ensure Its Optimal Positioning (2025) · cites this paper as [95]
Analysis of FAERS data from 2003 to 2024 showed a significant association between diabetic retinopathy and liraglutide (PRR 4.4).
“and liraglutide (PRR, 4.4) [95].”
From Exploring the Side Effects of GLP-1 Receptor Agonist: To Ensure Its Optimal Positioning (2025) · cites this paper as [95]
Cites
Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes
Marso, S. P., Daniels, G. H., Brown-Frandsen, K., Kristensen, P., Mann, J. F. E., Nauck, M. A., Nissen, S. E., Pocock, S., Poulter, N. R., Ravn, L. S., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1603827 · Cited by 7,629 · see citing works
Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes
Marso, S. P., Bain, S. C., Consoli, A., Eliaschewitz, F. G., Jódar, E., Leiter, L. A., Lingvay, I., Rosenstock, J., Seufert, J., Warren, M. L., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1607141 · Cited by 6,900 · see citing works
9. Pharmacologic Approaches to Glycemic Treatment: <i>Standards of Care in Diabetes—2023</i>
ElSayed, N. A., Aleppo, G., Aroda, V. R., Bannuru, R. R., Brown, F. M., Bruemmer, D., Collins, B. S., Hilliard, M. E., Isaacs, D., Johnson, E. L., et al. (2023) · Diabetes Care · doi:10.2337/dc23-s009 · Cited by 851 · see citing works
Zheng, D., Li, N., Hou, R., Zhang, X., Wu, L., Sundquist, J., Sundquist, K., & Ji, J. (2023) · BMC Medicine · doi:10.1186/s12916-023-02753-6 · Cited by 74 · see citing works
Glucagon-like peptide 1 receptor agonists and the risk of incident diabetic retinopathy
Douros, A., Filion, K. B., Yin, H., Yu, O. H., Etminan, M., Udell, J. A., & Azoulay, L. (2018) · Diabetes Care · doi:10.2337/dc17-2280 · Cited by 70 · cited 2× · see citing works
“However, when compared to insulin, GLP-1 receptor agonists were associated with a lower risk of DR (HR 0.67, 95% CI 0.51–0.90) [9 ].”
InfluentialCaruso, I., Di Gioia, L., Di Molfetta, S., Caporusso, M., Cignarelli, A., Sorice, G. P., Laviola, L., & Giorgino, F. (2024) · Journal of Endocrinological Investigation · doi:10.1007/s40618-024-02441-z · Cited by 49 · see citing works
Joo, J. H., Sharma, N., Shaia, J., Wu, A. K., Skugor, M., Singh, R. P., & Rachitskaya, A. V. (2024) · Ophthalmology Science · doi:10.1016/j.xops.2024.100547 · Cited by 37 · see citing works
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Exploring the Side Effects of GLP-1 Receptor Agonist: To Ensure Its Optimal Positioning
Kim, J. A., & Yoo, H. J. (2025) · Diabetes & Metabolism Journal · doi:10.4093/dmj.2025.0242 · Cited by 71 · see citing works
“Analysis of FAERS data from 2003 to 2024 showed significant associations between diabetic retinopathy and semaglutide (PRR, 19.43), dulaglutide (PRR, 9.01), and liraglutide (PRR, 4.4) [95].”
Influential
- Authors
- Singh, H., Natt, N. K., & Nim, D. K.
- Affiliations
- Government Medical College and Hospital (IN)
- CHC Manawala
- Motilal Nehru Medical College (IN)
- Corresponding author
- Singh, Harmanjit
- Venue
- Expert Review of Endocrinology & Metabolism
- Publisher
- Informa UK Limited
- Published
- 2025-01-28
- Volume
- 20
- Issue
- 2
- Pages
- 147-152
- ISSN
- 1744-6651 (ISSN-L)
- 1744-8417
- OpenAlex
- W4406825069
- Cited by
- 10
- References
- 7
- Citations by year
- 2026: 6 · 2025: 4
- FWCI
- 5.10
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Expert Review of Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Ophthalmology › Drug-Induced Ocular Toxicity
- Keywords
- GLP-1 receptor agonists, diabetic retinopathy, type 2 diabetes, semaglutide, dulaglutide, tirzepatide, liraglutide, lixisenatide, adverse drug reactions, drug safety, disproportionality analysis
- MeSH terms
- Glucagon-Like Peptide-2 Receptor, Liraglutide, Tirzepatide, Semaglutide, Diabetes Mellitus, Type 2, Diabetic Retinopathy, Glucagon-Like Peptides, Humans, Hypoglycemic Agents, Immunoglobulin Fc Fragments, Peptides, Recombinant Fusion Proteins, United States, United States Food and Drug Administration, Adverse Drug Reaction Reporting Systems, Glucagon-Like Peptide 1
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