Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Article
  • Published:

Drugs linked to blepharitis, meibomian gland dysfunction, and chalazion: a real-world, population-based pharmacovigilance analysis

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.

This is a preview of subscription content, access via your institution

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

Fig. 1: Forest plots of primary suspect drugs overreported in the pharmacovigilance analysis.

Similar content being viewed by others

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.

References

  1. Kudasiewicz-Kardaszewska A, Grant-Kels JM, Grzybowski A. Meibomian gland dysfunction and blepharitis: a common and still unsolved ophthalmic problem. Clin Dermatol. 2023;41:491–502.

    Article  PubMed  Google Scholar 

  2. Driver PJ, Lemp MA. Meibomian gland dysfunction. Surv Ophthalmol. 1996;40:343–67.

    Article  PubMed  CAS  Google Scholar 

  3. Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O’Brien T, et al. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011;52:2050–64.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Evans J, Vo KBH, Schmitt M. Chalazion: racial risk factors for formation, recurrence, and surgical intervention. Can J Ophthalmol. 2022;57:242–6.

    Article  PubMed  Google Scholar 

  5. Fadini GP, Avogaro A. SGTL2 inhibitors and amputations in the US FDA Adverse Event Reporting System. Lancet Diabetes Endocrinol. 2017;5:680–1.

    Article  PubMed  Google Scholar 

  6. Dores GM, Bryant-Genevier M, Perez-Vilar S. Adverse events associated with the use of sipuleucel-T reported to the US Food and Drug Administration’s adverse event reporting system, 2010-2017. JAMA Netw Open. 2019;2:e199249.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Zhou C, Peng S, Lin A, Jiang A, Peng Y, Gu T, et al. Psychiatric disorders associated with immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database. EClinicalMedicine. 2023;59:101967.

    Article  PubMed  PubMed Central  Google Scholar 

  8. Cortes J, Mauro M, Steegmann JL, Saglio G, Malhotra R, Ukropec JA, et al. Cardiovascular and pulmonary adverse events in patients treated with BCR-ABL inhibitors: data from the FDA Adverse Event Reporting System. Am J Hematol. 2015;90:E66–E72.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  9. McGwin G, Maclennan P, Owsley C. Association between pentosan polysulfate sodium and retinal disorders. JAMA Ophthalmol. 2022;140:37–42.

    Article  PubMed  Google Scholar 

  10. Montastruc JL, Sommet A, Bagheri H, Lapeyre-Mestre M. Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharm. 2011;72:905–8.

    Article  CAS  Google Scholar 

  11. Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001;10:483–6.

    Article  PubMed  CAS  Google Scholar 

  12. Bate A. Bayesian confidence propagation neural network. Drug Saf. 2007;30:623–5.

    Article  PubMed  Google Scholar 

  13. Santaella RM, Fraunfelder FW. Ocular adverse effects associated with systemic medications: recognition and management. Drugs. 2007;67:75–93.

    Article  PubMed  CAS  Google Scholar 

  14. Nguyen LH, Makino A, Namkoong P, Yiannakou Y, Narain K. Finasteride-induced clinical ocular toxicity. Invest Ophthalmol Vis Sci. 2018;59:2655.

    Google Scholar 

  15. Traish AM. Health risks associated with long-term finasteride and dutasteride use: it's time to sound the alarm. World J Men’s Health. 2020;38:323–37.

    Article  Google Scholar 

  16. Zakrzewska A, Wiącek MP, Słuczanowska-Głąbowska S, Safranow K, Machalińska A. The effect of oral isotretinoin therapy on meibomian gland characteristics in patients with acne vulgaris. Ophthalmol Ther. 2023;12:2187–97.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Fraunfelder FT, Fraunfelder FW, Edwards R. Ocular side effects possibly associated with isotretinoin usage. Am J Ophthalmol. 2001;132:299–305.

    Article  PubMed  CAS  Google Scholar 

  18. Zhang P, Tian L, Bao J, Li S, Li A, Wen Y, et al. Isotretinoin impairs the secretory function of meibomian gland via the PPARγ signaling pathway. Invest Ophthalmol Vis Sci. 2022;63:29.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  19. Tanriverdi C, Nurozler Tabakci B, Donmez S. Longitudinal assessment of meibomian glands and tear film layer in systemic isotretinoin treatment. Eur J Ophthalmol. 2022;32:885–93.

    Article  Google Scholar 

  20. Gupta S, Silliman CG, Trump DL. Docetaxel-induced meibomian duct inflammation and blockage leading to chalazion formation. Prostate Cancer Prostatic Dis. 2007;10:396–7.

    Article  PubMed  CAS  Google Scholar 

  21. Fraunfelder FW, Yang HK. Association between bortezomib therapy and eyelid chalazia. JAMA Ophthalmol. 2016;134:88–90.

    Article  PubMed  Google Scholar 

  22. Veys MC, Delforge M, Mombaerts I. Treatment with doxycycline for severe bortezomib-associated blepharitis. Clin Lymphoma Myeloma Leuk. 2016;16:e109–e112.

    Article  PubMed  Google Scholar 

  23. Paravathaneni M, Thota V, Mulla S, Thirumaran R, Thar YY. A case report on bortezomib-induced bilateral chalazion. Cureus. 2020;12:e10062.

    PubMed  PubMed Central  Google Scholar 

  24. Gallenga CE, Mura M, Gallenga PE. Suggestions on gut-eye cross-talk: about the chalazion. Int J Ophthalmol. 2022;15:1566.

    Article  PubMed  PubMed Central  Google Scholar 

  25. Vingopoulos F, Lazzaro DR. Dupilumab-associated blepharoconjunctivits with giant papillae. Int Med Case Rep. J. 2020;13:303–5.

    PubMed  PubMed Central  Google Scholar 

  26. Levine RM, Tattersall IW, Gaudio PA, King BA. Cicatrizing blepharoconjunctivitis occurring during dupilumab treatment and a proposed algorithm for its management. JAMA Dermatol. 2018;154:1485–6.

    Article  PubMed  Google Scholar 

  27. Popiela MZ, Barbara R, Turnbull AMJ, Corden E, Martinez-Falero BS, O’Driscoll D, et al. Dupilumab-associated ocular surface disease: presentation, management and long-term sequelae. Eye. 2021;35:3277–84.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  28. Wang Y, Jorizzo JL. Retrospective analysis of adverse events with dupilumab reported to the United States Food and Drug Administration. J Am Acad Dermatol. 2021;84:1010–4.

    Article  PubMed  CAS  Google Scholar 

  29. Foley P, Kerdraon YA, Hogden JP, Shumack S, Spelman L, Sebaratnam DF, et al. Dupilumab-associated ocular surface disease: an interdisciplinary decision framework for prescribers in the Australian setting. Australasian J Dermatol. 2022;63:421–36.

    Article  Google Scholar 

  30. Medicines and Healthcare products Regulatory Agency. Dupilumab (Dupixent): risk of ocular adverse reactions and need for prompt management. 2022. Available at: https://www.gov.uk/drug-safety-update/dupilumab-dupixentv-risk-of-ocular-adverse-reactions-and-need-for-prompt-management#dupilumab.

Download references

Author information

Authors and Affiliations

Authors

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.

Corresponding author

Correspondence to Clara C. Chan.

Ethics declarations

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.

Ethical approval

An ethics statement was not required for this study type, no human or animal subjects or materials were used.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary information

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1038/s41433-025-03985-x

This article is cited by

Search

Quick links