Ocular adverse reactions occurring in 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2-0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection and photophobia. Other ocular adverse reactions occurring in <5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae and uveitis. Some of these events were similar to the underlying ocular disease being studied.
Non-ocular adverse reactions occurred in <15% of patients. These include headache, rhinitis and pharyngitis.
In a summation of controlled, randomized studies of individuals treated for ≥28 days with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving prednisolone acetate 1% and 0.5% (3/583) among patients receiving placebo.
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