What the label lists and what reports show
Loteprednol side effects
Loteprednol's FDA label lists its adverse reactions in its own words. FAERS holds 5,309 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is eye pain (701 reports).
- Generic listed
Check it at the source: the loteprednol FDA label on DailyMed (effective February 7, 2026, Bausch & Lomb Americas Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsReactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. 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 less than 5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, and uveitis. …
Source: FDA drug label, Bausch & Lomb Americas Inc., effective February 7, 2026 (SPL set 7714824b-29ed-442a-ad2d-13ee2fc6bc42), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,309 reports list loteprednol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 134 are coded as a death and 625 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Loteprednol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions