Abstract
Background
Blepharitis, meibomian gland dysfunction (MGD), and chalazia are common disorders impacting quality of life. This population-based, pharmacovigilance study aims to identify systemic drugs disproportionately linked to these disorders.
Methods
Data from the Food and Drug Administration Adverse Event Reporting System (FAERS) were analysed (Q4 2003 to Q2 2024). Disproportionality analyses were conducted to identify drugs with ≥10 primary suspect reports for which cases of blepharitis, MGD, or chalazion were overreported, using reporting odds ratios (RORs).
Results
1923 blepharitis, 202 MGD, and 290 chalazion reports were identified. MGD was overreported for finasteride (ROR = 71.6, 95% CI = 37.9–135.3), while chalazion was overreported for bortezomib (ROR = 73.9, 95% CI = 51.4–106.2). All three conditions were overreported for dupilumab (blepharitis: ROR = 35.7, 95% CI = 22.8–55.9; MGD: ROR = 15.4, 95% CI = 7.3–32.5; chalazion: ROR = 12.6, 95% CI = 5.6–28.5). Safety signals, predominantly associated with blepharitis, were also identified for isotretinoin, docetaxel, panitumumab, cetuximab, tretinoin, alendronate, erlotinib, zoledronate, daxibotulinumtoxinA, and infliximab.
Conclusions
This pharmacovigilance study identified associations between several systemic medications with reports of blepharitis, MGD, and chalazion. MGD and chalazion were overreported for finasteride and bortezomib, respectively, whereas all three conditions were overreported for dupilumab. These findings highlight systemic medications as often overlooked contributors to localised eyelid inflammation. Nonetheless, these drugs are known to reduce morbidity and mortality across many diseases. Therefore, while risks may not necessarily outweigh benefits to warrant changes in prescribing practices, clinicians should remain vigilant for such side effects, particularly in patients at higher risk, and to consider prophylactic measures when appropriate, such as educating patients about eyelid hygiene and counselling them to promptly report symptoms.
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Data availability
All data generated or analysed during this study are included in this published article and its supplementary information files. Further enquiries can be directed to the corresponding author.
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Authors and Affiliations
Contributions
Dana Taghaddos was responsible for interpreting results and writing the manuscript. Andrew Mihalache was responsible for the conception of the study’s design, analysing data, interpreting results, and writing the manuscript. Ryan S. Huang was responsible for analysing data and interpreting results. Marko M Popovic was responsible for revision of the manuscript and supervision of the study. Clara C. Chan was responsible for revision of the manuscript and supervision of the study. All authors fulfil ICMJE Criteria for authorship.
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Competing interests
DT: None; AM: None; RSH: None; MMP: Financial support (to institution)—PSI Foundation, Fighting Blindness Canada; CCC: Consultant—Aequus, Abbvie, Admare Bioinnovations, Allergan Inc., Aurion, Bausch & Lomb, Johnson & Johnson Vision, Kala Ophthalmics, Labtician Ophthalmics Inc., Novartis, Santen Inc., Sun Ophthalmics, Thea, Valeo Pharma. Shareholder—Abbott, Pfizer. Financial support (to institution)—Aurion, Corneat, Claris Bio. Lecture fees—Abbvie, Allergan Inc., Johnson & Johnson Vision, Labtician Ophthalmics Inc., Thea.
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An ethics statement was not required for this study type, no human or animal subjects or materials were used.
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Taghaddos, D., Mihalache, A., Huang, R.S. et al. Drugs linked to blepharitis, meibomian gland dysfunction, and chalazion: a real-world, population-based pharmacovigilance analysis. Eye (2025). https://doi.org/10.1038/s41433-025-03985-x
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DOI: https://doi.org/10.1038/s41433-025-03985-x
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