What the label lists and what reports show
Fluorometholone side effects
Fluorometholone's FDA label lists its adverse reactions in its own words. FAERS holds 3,406 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 (279 reports).
- Generic listed
Check it at the source: the fluorometholone FDA label on DailyMed (effective March 31, 2025, Harrow Eye, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsGlaucoma with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur. Postmarketing Experience The following reaction has been identified during post-marketing use of FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1% in clinical practice. Because reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reaction, which has been chosen for inclusion due to either its seriousness, frequency of reporting, possible causal connection to FLAREX, or a combination of these factors, includes: dysgeusia. The following rare adverse reactions have been reported: Cushing's syndrome and adrenal suppression may occur after very frequent use of topical ophthalmic corticosteroids, particularly in very young children.
Source: FDA drug label, Harrow Eye, LLC, effective March 31, 2025 (SPL set f060dec4-09dc-4266-ab4c-a6ed49cd8126), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,406 reports list fluorometholone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 299 are coded as a death and 826 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 21 reactions below, none is 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?
- Fluorometholone: 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