Prescription medicine
Fluorometholone Brand names: Fml, Flarex
Fluorometholone (Fml) is a prescription medicine with an FDA approval on record since 1972. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $11.49 per mL (Fluorometholone 0.1% eye drop) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $32.17 per mL (Fml forte 0.25% eye drops).
- Generic listed
Check it at the source: the fluorometholone FDA label on DailyMed (effective March 31, 2025, Harrow Eye, LLC); the NDA 16851 record on Drugs@FDA; every fluorometholone label on DailyMed.
Highlights of the record
FDA label of March 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.
Forms and strengths
- 1 mg/ml
- 2.5 mg/ml
Suspension/ drops; solution/ drops.
On the market
- Earliest approval on file
- January 12, 1972 Fml, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first February 27, 1986; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 2 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $11.49 per mL Fluorometholone 0.1% eye drop
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,406 through July 30, 2026
What is fluorometholone used for?
From the label: indications and usageFLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (Flarex), Harrow Eye, LLC, effective March 31, 2025 (SPL set f060dec4-09dc-4266-ab4c-a6ed49cd8126), via openFDA; the full label on DailyMed
Is there a generic for fluorometholone (Fml)?
The FDA approved the first generic fluorometholone on February 27, 1986. 3 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists fluorometholone from 2 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1972 earliest approval on file
- 1986 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fluorometholone (Fml)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $11.49 per mL (Fluorometholone 0.1% eye drop), down 10% from $12.85 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fluorometholone 0.1% eye drop (generic)
- Fml forte 0.25% eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fluorometholone 0.1% eye drop | Generic | $11.49 per mL | n/a | -10% |
| Flarex 0.1% eye drops | Brand | $23.95 per mL | n/a | -0.1% |
| Fml forte 0.25% eye drops | Brand | $32.17 per mL | n/a | -0.4% |
| Fml liquifilm 0.1% eye drop | Brand | $32.16 per mL | n/a | -0.4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for fluorometholone?
The FDA Adverse Event Reporting System holds 3,406 reports that list fluorometholone among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Fluorometholone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other