Safety Analysis of Oxymetazoline Eye Drops for Blepharoptosis Using the FDA Adverse Event Reporting System.

PURPOSE: To analyze the safety of oxymetazoline hydrochloride ophthalmic solution 0.1% for blepharoptosis using real-world Food and Drug Administration Adverse Event Reporting System data.

METHODS

This retrospective pharmacovigilance study queried the Food and Drug Administration Adverse Event Reporting System database utilizing OpenVigil 2.1 for oxymetazoline eye drop adverse drug events (ADEs) from Food and Drug Administration approval on January 7, 2020, through April 30, 2025. Disproportionality analysis employed standard methodologies, including reporting odds ratios (RORs) and chi-squared analyses.

RESULTS

Three hundred six patients with 658 ADEs from oxymetazoline eye drop were analyzed, revealing 30 significant safety signals. All ADEs on the drug label were identified in this cohort (multiple RORs, all p < 0.001): ocular surface disease (N = 129, 34.5%), conjunctival hyperemia (N = 43, 11.5%), temporary visual blurring (N = 33, 8.8%), instillation site pain (N = 27, 7.2%), headache (N = 32, 8.6%). Novel ADEs (not on the drug label) were vitreoretinal complications (N = 12, 3.2%, multiple RORs, all p < 0.001)-retinal detachment (N = 3, 0.8%), vitreous detachment (N = 3, 0.8%), vitreous floaters (N = 3, 0.8%), and vitreous hemorrhage (N = 3, 0.8%)-mydriasis (N = 21, 5.6%, ROR 175.4 [112.4-273.7], p < 0.001), hypertension (N = 6, 1.6%, ROR 3.2 [1.4-7.2], p = 0.009), and tachyphylaxis (N = 5, 1.3%, ROR 5.1 [2.1-12.4], p < 0.001).

CONCLUSIONS

This Food and Drug Administration Adverse Event Reporting System analysis of oxymetazoline eye drops corroborated prior ADEs, including ocular surface disease, conjunctival hyperemia, transient blurred vision, instillation site pain, and headache. The study revealed new safety signals for vitreoretinal complications, hypertension, mydriasis, and tachyphylaxis. Further studies are warranted to confirm these associations and describe mechanisms such as vitreoretinal traction.