FAERS Analysis Links Several Pediatric Drugs to Reports of Dry Eye

Researchers recommend routine ocular surface assessments for children and adolescents taking dupilumab, retinoids, antihistamines or hormonal contraceptives, as dry eye may be a side effect of these drugs. Seen here is a pediatric case of dupilumab-associated keratoconjunctivitis. Photo: Sarah Lopez, OD. Click image to enlarge. A new pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) data finds that several routinely prescribed medications are significantly associated with reports of dry eye in children and adolescents. Namely, dupilumab and retinoid therapies showed the strongest signals of ocular surface toxicity in the pediatric population, while systemic antihistamines and some hormonal contraceptives also carried moderate associations. The study findings were showcased last week at the ARVO 2026 meeting in Denver.After scouring FAERS reports from 2004 to 2024 for patients aged zero to 18 years, researchers identified 919 pediatric reports containing the MedDRA low-level term “dry eye.” Using OpenVigil—a pharmacovigilance data‑mining tool used to query and analyze spontaneous adverse event reporting databases, such as FAERS—the team calculated the proportional reporting ratio and reporting odds ratio (ROR) for each drug.Dupilumab products produced the strongest signals: dupilumab overall showed an ROR of 28.7, while the specific formulation, Dupixent (Sanofi/Regeneron), showed an ROR of 26.6. These values indicate substantially higher reporting of dry eye relative to other pediatric reports in FAERS.Retinoid therapies also showed prominent associations: Accutane (isotretinoin brand) ROR: 19.2; tretinoin ROR: 11.3; isotretinoin generic ROR: 7.65. Other isotretinoin generics had RORs ranging from 3.9 to 7.6. Lastly, moderate but consistent signals were identified for systemic antihistamines (fexofenadine ROR: 2.55; cetirizine ROR: 3.14) and for at least one hormonal contraceptive (norgestimate ROR: 6.53).“This is the first nationwide study to investigate drug-induced dry eye within the pediatric population,” the study authors wrote in their ARVO abstract. Given that they observed significant associations between dupilumab, retinoids, antihistamines, hormonal contraceptives and dry eye in children and adolescents, they concluded, “Routine ocular surface assessment is important for these patients, and further studies are warranted to define mechanisms, risk factors and long-term clinical outcomes.”Original abstract ©2026 Association for Research in Vision and Ophthalmology.Click here for the source. Jain T. Drug-induced dry eye in children and adolescents: a FAERS disproportionality analysis. ARVO 2026 annual meeting. This article was developed by the editorial staff in conjunction with experts in the field. In the process, AI may have been among the editorial tools used to meet the goals of human editors, who approved all content.