{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,21]],"date-time":"2026-01-21T21:37:40Z","timestamp":1769031460606,"version":"3.49.0"},"reference-count":54,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,1,21]],"date-time":"2026-01-21T00:00:00Z","timestamp":1768953600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study aimed to detect risk signals of drug-related ocular injuries, delineate their real-world epidemiological features, and provide evidence-based guidance for safe clinical use by utilizing the US Food and Drug Administration Adverse Event Reporting System (FAERS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adverse event reports classified under \u201cEye disorders\u201d (System Organ Class, SOC) were extracted from the FAERS database covering Q1 2004 to Q4 2024. Disproportionality analyses were employed to identify drug-ocular injury associations, and the time-to-onset (TTO) of adverse reactions was analyzed using Weibull distribution modeling.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 1,242,518 reports from 832,314 patients were included, with females accounting for 60.56% and elderly patients (\u226565 years) for 21.63%. Serious outcomes comprised 62.80% of the reports. In total, 2,696 primary suspect drugs were identified, of which 359 met the signal detection criteria. High-risk drug categories included sensory organ drugs (ATC: S class, ROR = 4.93) and antineoplastic\/immunomodulating agents (ATC: L class, most reports but ROR = 0.84). The top three drugs by signal strength were brolucizumab (ROR = 132.15), macrogol 400 (ROR = 117.96), and cenegermin (ROR = 60.19). The most common ocular injury types were blurred vision (121,517 cases), visual impairment (113,320 cases), and cataract (51,826 cases). TTO analysis indicated that most drugs exhibited an \u201cearly failure type\u201d (\u03b2 &amp;lt; 1), such as dupilumab (\u03b2 = 0.68); only two drugs exhibited a random failure type.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The risk of drug-related ocular injuries is primarily associated with sensory organ drugs and biologics, with the greatest risk occurring during the early treatment phase. Clinical monitoring should prioritize female and elderly patients, especially regarding ocular symptoms at the onset of drug therapy, to strengthen pharmacovigilance and inform personalized medication.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fphar.2026.1731545","type":"journal-article","created":{"date-parts":[[2026,1,21]],"date-time":"2026-01-21T06:40:29Z","timestamp":1768977629000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-world landscape of drug-related ocular injuries: a retrospective pharmacovigilance study"],"prefix":"10.3389","volume":"17","author":[{"given":"Guangyao","family":"Li","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University","place":["Beijing, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhihui","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University","place":["Beijing, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shuning","family":"Li","sequence":"additional","affiliation":[{"name":"Beijing Tongren Eye Center, Beijing Key Laboratory of Ophthalmology and Visual Science, Beijing Tongren Hospital, Capital Medical University","place":["Beijing, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiawei","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University","place":["Beijing, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2026,1,21]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"e74976","DOI":"10.7759\/cureus.74976","article-title":"Systemic medications and their ocular side effects","volume":"16","author":"Al-Namaeh","year":"2024","journal-title":"Cureus"},{"key":"B2","doi-asserted-by":"publisher","first-page":"2079","DOI":"10.2147\/CIA.S71178","article-title":"A systematic review of the prevalence and risk factors for adverse drug reactions in the elderly in the acute care setting","volume":"9","author":"Alhawassi","year":"2014","journal-title":"Clin. Interv. Aging"},{"key":"B3","doi-asserted-by":"publisher","first-page":"2036","DOI":"10.1038\/s41433-025-03808-z","article-title":"Drug-induced tubulointerstitial nephritis and uveitis syndrome in a nationwide surveillance","volume":"39","author":"Ali","year":"2025","journal-title":"Eye (Lond)"},{"key":"B4","doi-asserted-by":"publisher","first-page":"62","DOI":"10.1097\/MAJ.0b013e3181f06b21","article-title":"Ocular complications of systemic medications","volume":"342","author":"Blomquist","year":"2011","journal-title":"Am. J. Med. Sci."},{"key":"B5","doi-asserted-by":"publisher","first-page":"2660","DOI":"10.1016\/j.jid.2022.03.013","article-title":"T helper 2 IL-4\/IL-13 dual blockade with dupilumab is linked to some emergent T helper 17\u2012Type diseases, including seronegative arthritis and enthesitis\/enthesopathy, but not to humoral autoimmune diseases","volume":"142","author":"Bridgewood","year":"2022","journal-title":"J. Invest Dermatol"},{"key":"B6","doi-asserted-by":"publisher","first-page":"1480269","DOI":"10.3389\/fphar.2024.1480269","article-title":"Drug-induced retinal vein occlusion: a disproportionality analysis from the FDA adverse event reporting system (2004-2023)","volume":"15","author":"Chen","year":"2024","journal-title":"Front. Pharmacol."},{"key":"B7","doi-asserted-by":"publisher","first-page":"1220","DOI":"10.1038\/s41598-024-84679-4","article-title":"Real world pharmacovigilance assessment of drug related macular degeneration risks","volume":"15","author":"Chen","year":"2025","journal-title":"Sci. Rep."},{"key":"B8","doi-asserted-by":"publisher","first-page":"e0217780","DOI":"10.1371\/journal.pone.0217780","article-title":"Efficacy of pentosan polysulfate in in vitro models of lysosomal storage disorders: Fabry and Gaucher Disease","volume":"14","author":"Crivaro","year":"2019","journal-title":"PLoS One"},{"key":"B9","doi-asserted-by":"publisher","first-page":"e250482","DOI":"10.1530\/EC-25-0482","article-title":"Bisphosphonate-related ocular adverse events: a pharmacovigilance study based on the FAERS database","volume":"14","author":"Cui","year":"2025","journal-title":"Endocr. Connect."},{"key":"B10","doi-asserted-by":"publisher","first-page":"889","DOI":"10.1007\/s40123-020-00280-8","article-title":"Corneal epithelial findings in patients with multiple myeloma treated with antibody-drug conjugate Belantamab Mafodotin in the pivotal, randomized, DREAMM-2 Study","volume":"9","author":"Farooq","year":"2020","journal-title":"Ophthalmol. Ther."},{"key":"B11","doi-asserted-by":"publisher","first-page":"350","DOI":"10.3389\/fphar.2018.00350","article-title":"Adverse drug reactions in hospitalized patients: results of the FORWARD (facilitation of reporting in Hospital ward) Study","volume":"9","author":"Giardina","year":"2018","journal-title":"Front. Pharmacol."},{"key":"B12","doi-asserted-by":"publisher","first-page":"2620","DOI":"10.3390\/jcm10122620","article-title":"Sex hormones related ocular dryness in breast cancer women","volume":"10","author":"Grasso","year":"2021","journal-title":"J. Clin. Med."},{"key":"B13","doi-asserted-by":"publisher","first-page":"309","DOI":"10.1080\/17512433.2019.1591274","article-title":"Ocular dysfunctions and toxicities induced by antiepileptic medications: types, pathogenic mechanisms, and treatment strategies","volume":"12","author":"Hamed","year":"2019","journal-title":"Expert Rev. Clin. Pharmacol."},{"key":"B14","doi-asserted-by":"publisher","first-page":"785","DOI":"10.2147\/CIA.S137580","article-title":"Association of dry eye disease with psychiatric or neurological disorders in elderly patients","volume":"12","author":"Han","year":"2017","journal-title":"Clin. Interv. Aging"},{"key":"B15","doi-asserted-by":"publisher","first-page":"1399998","DOI":"10.3389\/fphar.2024.1399998","article-title":"Signal mining and analysis of trifluridine\/tipiracil adverse events based on real-world data from the FAERS database","volume":"15","author":"Hu","year":"2024","journal-title":"Front. Pharmacol."},{"key":"B16","doi-asserted-by":"publisher","first-page":"84","DOI":"10.1097\/j.jcrs.0000000000001573","article-title":"Keratoconus cases associated with medication use: population-based pharmacovigilance study","volume":"51","author":"Huang","year":"2025","journal-title":"J. Cataract. Refract Surg."},{"key":"B17","doi-asserted-by":"publisher","first-page":"1436405","DOI":"10.3389\/fphar.2024.1436405","article-title":"Data mining and safety analysis of dual orexin receptor antagonists (DORAs): a real-world pharmacovigilance study based on the FAERS database","volume":"15","author":"Jiang","year":"2024","journal-title":"Front. Pharmacol."},{"key":"B18","doi-asserted-by":"publisher","first-page":"w20085","DOI":"10.4414\/smw.2019.20085","article-title":"Pharmacovigilance in ophthalmology in Switzerland: an analysis of the most frequently reported ocular adverse drug reactions within the last 25 years","volume":"149","author":"Karrer","year":"2019","journal-title":"Swiss Med. Wkly."},{"key":"B19","doi-asserted-by":"publisher","first-page":"4290","DOI":"10.3390\/ma14154290","article-title":"Recent advances in the excipients used for modified ocular drug delivery","volume":"14","author":"Koutsoviti","year":"2021","journal-title":"Mater. (Basel)"},{"key":"B20","doi-asserted-by":"publisher","first-page":"3645","DOI":"10.2147\/OPTH.S439255","article-title":"A pharmacovigilance Study of drug-induced glaucoma utilizing the Japanese adverse event reporting System","volume":"17","author":"Kozaru","year":"2023","journal-title":"Clin. Ophthalmol."},{"key":"B21","doi-asserted-by":"publisher","first-page":"682","DOI":"10.1017\/S1092852924002360","article-title":"Association of antidepressants with cataracts and glaucoma: a disproportionality analysis using the reports to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) pharmacovigilance database","volume":"29","author":"Le","year":"2024","journal-title":"#N\/A"},{"key":"B22","doi-asserted-by":"publisher","first-page":"535","DOI":"10.1002\/cpt.3139","article-title":"Drug-Induced acute pancreatitis: a real-world pharmacovigilance Study using the FDA adverse event reporting System database","volume":"115","author":"Li","year":"2024","journal-title":"Clin. Pharmacol. Ther."},{"key":"B23","doi-asserted-by":"publisher","first-page":"13407","DOI":"10.1038\/s41598-025-92796-x","article-title":"Real-World pharmacovigilance analysis of drug-related conjunctivitis using the FDA adverse event reporting system database","volume":"15","author":"Li","year":"","journal-title":"Sci. Rep."},{"key":"B24","doi-asserted-by":"publisher","first-page":"1498191","DOI":"10.3389\/fphar.2025.1498191","article-title":"Real-world pharmacovigilance analysis of drug-related cataracts using the FDA adverse event reporting system database","volume":"16","author":"Li","year":"","journal-title":"Front. Pharmacol."},{"key":"B25","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1080\/14740338.2024.2446430","article-title":"Real-world analysis of medications inducing meibomian gland dysfunction: based on the FDA adverse event reporting system database","author":"Li","year":"","journal-title":"Expert Opin. Drug Saf."},{"key":"B26","doi-asserted-by":"publisher","first-page":"810","DOI":"10.1111\/1759-7714.13327","article-title":"Clinical diagnosis and treatment recommendations for ocular toxicities of targeted therapy and immune checkpoint inhibitor therapy","volume":"11","author":"Liu","year":"2020","journal-title":"Thorac. Cancer"},{"key":"B27","doi-asserted-by":"publisher","first-page":"300","DOI":"10.6004\/jadpro.2023.14.4.4","article-title":"Management of ocular toxicity in patients receiving Belantamab mafodotin","volume":"14","author":"Lu","year":"2023","journal-title":"J. Adv. Pract. Oncol."},{"key":"B28","doi-asserted-by":"publisher","first-page":"NP23","DOI":"10.1177\/1120672119850080","article-title":"Corneal sterile infiltration induced by topical use of ocular hypotensive agent","volume":"30","author":"Manabe","year":"2020","journal-title":"Eur. J. Ophthalmol."},{"key":"B29","doi-asserted-by":"publisher","first-page":"1425617","DOI":"10.3389\/fphar.2024.1425617","article-title":"Ocular adverse events associated with antibody-drug conjugates in oncology: a pharmacovigilance study based on FDA adverse event reporting system (FAERS)","volume":"15","author":"Mao","year":"2024","journal-title":"Front. Pharmacol."},{"key":"B30","doi-asserted-by":"publisher","first-page":"1281","DOI":"10.1080\/14712598.2021.1948529","article-title":"The impact of anti-TNFalpha agents on weight-related changes: new insights from a real-world pharmacovigilance study using the FDA adverse event reporting system (FAERS) database","volume":"21","author":"Mazhar","year":"2021","journal-title":"Expert Opin. Biol. Ther."},{"key":"B31","doi-asserted-by":"publisher","first-page":"3133","DOI":"10.1111\/jocd.14361","article-title":"Botulinum toxin-induced blepharoptosis: anatomy, etiology, prevention, and therapeutic options","volume":"20","author":"Nestor","year":"2021","journal-title":"J. Cosmet. Dermatol"},{"key":"B32","first-page":"309","article-title":"Biologic agents in inflammatory eye disease","volume":"6","author":"Posarelli","year":"2011","journal-title":"J. Ophthalmic Vis. Res."},{"key":"B33","doi-asserted-by":"publisher","first-page":"e249019","DOI":"10.1136\/bcr-2022-249019","article-title":"Dupilumab-induced ocular surface disease: a primer","volume":"15","author":"Reji","year":"2022","journal-title":"BMJ Case Rep."},{"key":"B34","doi-asserted-by":"publisher","first-page":"519","DOI":"10.1097\/ICU.0000000000000103","article-title":"Common ocular effects reported to a poison control center after systemic absorption of drugs in therapeutic and toxic doses","volume":"25","author":"Slattery","year":"2014","journal-title":"Curr. Opin. Ophthalmol."},{"key":"B35","doi-asserted-by":"publisher","first-page":"801","DOI":"10.1016\/j.jaad.2011.06.005","article-title":"3rd: eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study","volume":"66","author":"Smith","year":"2012","journal-title":"J. Am. Acad. Dermatol"},{"key":"B36","doi-asserted-by":"publisher","first-page":"71","DOI":"10.3109\/09286586.2015.1090004","article-title":"Severe ocular inflammation following ranibizumab or aflibercept injections for age-related macular degeneration: a retrospective claims database analysis","volume":"23","author":"Souied","year":"2016","journal-title":"Ophthalmic Epidemiol."},{"key":"B37","doi-asserted-by":"publisher","first-page":"8182","DOI":"10.3390\/ijms23158182","article-title":"Retinal toxicity induced by chemical agents","volume":"23","author":"Souza Monteiro de Araujo","year":"2022","journal-title":"Int. J. Mol. Sci."},{"key":"B38","doi-asserted-by":"publisher","first-page":"425","DOI":"10.1016\/j.mcna.2021.02.003","article-title":"Ocular side effects of common systemic medications and systemic side effects of ocular medications","volume":"105","author":"Syed","year":"2021","journal-title":"Med. Clin. North Am."},{"key":"B39","doi-asserted-by":"publisher","first-page":"4439","DOI":"10.21873\/anticanres.15944","article-title":"Analyses of ocular adverse reactions associated with anticancer drugs based on the Japanese pharmacovigilance database","volume":"42","author":"Tanaka","year":"2022","journal-title":"Anticancer Res."},{"key":"B40","doi-asserted-by":"publisher","first-page":"172","DOI":"10.1111\/jdv.16724","article-title":"Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study","volume":"35","author":"Touhouche","year":"2021","journal-title":"J. Eur. Acad. Dermatol Venereol."},{"key":"B41","doi-asserted-by":"publisher","first-page":"100188","DOI":"10.1016\/j.eclinm.2019.10.001","article-title":"Reported adverse drug reactions in women and men: aggregated evidence from globally collected individual case reports during half a century","volume":"17","author":"Watson","year":"2019","journal-title":"EClinicalMedicine"},{"key":"B42","doi-asserted-by":"publisher","first-page":"1387","DOI":"10.1136\/bjo.2007.128454","article-title":"Long-term efficacy and safety of bimatoprost for intraocular pressure lowering in glaucoma and ocular hypertension: year 4","volume":"92","author":"Williams","year":"2008","journal-title":"Br. J. Ophthalmol."},{"key":"B43","doi-asserted-by":"publisher","first-page":"731","DOI":"10.1002\/pds.3805","article-title":"Standardisation of the FAERS database: a systematic approach to manually recoding drug name variants","volume":"24","author":"Wong","year":"2015","journal-title":"Pharmacoepidemiol Drug Saf."},{"key":"B44","doi-asserted-by":"publisher","first-page":"100104","DOI":"10.1016\/j.apjo.2024.100104","article-title":"Real-World large sample assessment of drug-related dry eye risk: based on the FDA adverse event reporting System database","volume":"13","author":"Wu","year":"","journal-title":"Asia-Pacific Journal Ophthalmology Phila. Pa"},{"key":"B45","doi-asserted-by":"publisher","first-page":"17","DOI":"10.1167\/tvst.13.9.17","article-title":"Drug-Related keratitis: a real-world FDA adverse event reporting System database Study","volume":"13","author":"Wu","year":"","journal-title":"Transl. Vis. Sci. Technol."},{"key":"B46","doi-asserted-by":"publisher","first-page":"140","DOI":"10.1111\/ceo.14454","article-title":"Drug-associated glaucoma: a real-world study based on the Food and drug Administration adverse event reporting system database","volume":"53","author":"Wu","year":"","journal-title":"#N\/A"},{"key":"B47","doi-asserted-by":"publisher","DOI":"10.1097\/JS9.0000000000003603","article-title":"Retrospective cohort study of ocular adverse reactions to systemic drugs: insights from a multi-country spontaneous reporting database","author":"Wu","year":"","journal-title":"Int. J. Surg."},{"key":"B48","doi-asserted-by":"publisher","first-page":"177820","DOI":"10.1016\/j.ejphar.2025.177820","article-title":"Drug-related visual blurring: findings from the U.S. Food and drug Administration Adverse Event Reporting System database","volume":"1002","author":"Wu","year":"","journal-title":"Eur. J. Pharmacol."},{"key":"B49","doi-asserted-by":"publisher","first-page":"1447","DOI":"10.1080\/14740338.2024.2322712","article-title":"Adverse events associated with brolucizumab: a disproportionality analysis of the FDA adverse event reporting system (FAERS)","volume":"23","author":"Xiong","year":"2024","journal-title":"Expert Opin. Drug Saf."},{"key":"B50","doi-asserted-by":"publisher","first-page":"19555","DOI":"10.1038\/s41598-022-23834-1","article-title":"A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib","volume":"12","author":"Yin","year":"2022","journal-title":"Sci. Rep."},{"key":"B51","doi-asserted-by":"publisher","first-page":"1393940","DOI":"10.3389\/fphar.2024.1393940","article-title":"Adverse event reporting of the IGF-1R monoclonal antibody teprotumumab: a real-world study based on the US food and drug administration adverse event reporting system","volume":"15","author":"Zhao","year":"2024","journal-title":"Front. Pharmacol."},{"key":"B52","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1186\/s40360-025-00866-7","article-title":"Assessment the real-world safety of intravitreal dexamethasone implant (Ozurdex): novel insights from a comprehensive pharmacovigilance analysis utilizing the FAERS database","volume":"26","author":"Zhao","year":"2025","journal-title":"BMC Pharmacol. Toxicol."},{"key":"B53","doi-asserted-by":"publisher","first-page":"45","DOI":"10.1016\/j.jad.2023.11.076","article-title":"Mining and analysis of adverse event signals of Cariprazine based on the real-world data of FAERS database","volume":"347","author":"Zhu","year":"2024","journal-title":"J. Affect Disord."},{"key":"B54","doi-asserted-by":"publisher","first-page":"32","DOI":"10.1186\/s13293-020-00308-5","article-title":"Sex differences in pharmacokinetics predict adverse drug reactions in women","volume":"11","author":"Zucker","year":"2020","journal-title":"Biol. Sex. Differ."}],"container-title":["Frontiers in Pharmacology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2026.1731545\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,21]],"date-time":"2026-01-21T06:40:31Z","timestamp":1768977631000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2026.1731545\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1,21]]},"references-count":54,"alternative-id":["10.3389\/fphar.2026.1731545"],"URL":"https:\/\/doi.org\/10.3389\/fphar.2026.1731545","relation":{},"ISSN":["1663-9812"],"issn-type":[{"value":"1663-9812","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,21]]},"article-number":"1731545"}}