Fluorometholone

Pronunciation: flor-oh-METH-oh-lone.

Generic name
fluorometholone
Drug class
Ophthalmic corticosteroid (topical anti-inflammatory, synthetic glucocorticoid, desoxyprednisolone derivative)
Form
Ophthalmic suspension (0.1% and 0.25% strengths)
Route
Topical ophthalmic (eye drops)
Legal status
Prescription-only in all markets where it is authorised

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: FML (5) · Full directory

What fluorometholone is and how it works

Fluorometholone is a corticosteroid eye drop used to reduce inflammation of the eyelid lining, the white of the eye, the cornea, and the front part of the eye when the inflammation is known to respond to steroid treatment. (1) (2)

This medicine does not carry a boxed warning, but like all corticosteroid eye medicines, it carries real, well-documented risks with prolonged use: increased eye pressure that can lead to glaucoma and optic nerve damage, cataract formation, slower wound healing, thinning of the cornea or the white of the eye, and a higher chance of eye infections (including fungal and viral) because it reduces the eye's local immune response. This is why eye drops containing corticosteroids should not be used for longer than about a week unless an eye specialist is closely monitoring your eye pressure.

Mechanism of action: how fluorometholone works

Fluorometholone is a synthetic glucocorticoid (a derivative of desoxyprednisolone) that reduces inflammation locally in ocular tissue by suppressing the inflammatory response, similarly to other topical ophthalmic corticosteroids, with the same class-wide real risks of raised intraocular pressure, cataract, delayed healing, and infection-masking with prolonged use. (1) (2)

What fluorometholone is used for

Corticosteroid-responsive eye inflammation

Used to treat corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva (the lining of the eyelid and the white of the eye), the cornea, and the anterior segment of the eye. (1) (2) (6)

Before taking fluorometholone

Do not take / not appropriate for

  • Do not use if you have most viral infections of the cornea or conjunctiva, including active herpes simplex keratitis (dendritic keratitis), vaccinia, or varicella. (all countries) (1) (2)
  • Do not use if you have a mycobacterial eye infection, an untreated fungal eye infection, or (UK/Ireland source) an untreated bacterial infection or undiagnosed red eye. (all countries) (1) (2)
  • Do not use if you are allergic (hypersensitive) to fluorometholone or any ingredient in the product. (all countries) (2)

Tell your clinician about

  • Any history of glaucoma, elevated eye pressure, or cataracts.
  • Any current or recent eye infection, including cold sores or shingles near the eye.
  • Whether you wear contact lenses -- this product contains benzalkonium chloride, which can be absorbed by soft contact lenses.
  • Whether you use other eye drops, especially for glaucoma.
  • Whether you are pregnant, plan to become pregnant, or are breastfeeding.
(1) (2)

How to take fluorometholone

  • Shake the bottle before use.
  • Used only in the eye, exactly as your eye doctor directs.
  • Wash your hands before use and avoid letting the dropper tip touch your eye, eyelid, or any other surface.
  • If you wear soft contact lenses, remove them before applying the drops and wait at least 15 minutes before putting them back in.
  • Eye drops containing corticosteroids should not be used for longer than about a week unless an eye specialist is closely monitoring your eye pressure.
  • Do not stop treatment abruptly for chronic conditions -- your eye doctor will usually direct you to taper the frequency of use gradually.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, use it as soon as you remember unless it is nearly time for your next dose -- do not use two doses at once. Contact your eye doctor if you are unsure or if you miss several doses.

Overdose

An eye-drop overdose is unlikely to cause serious harm beyond temporary eye irritation, but seek medical advice from your eye doctor, pharmacist, or an emergency service if the product is swallowed or if you experience severe eye symptoms after using more than directed. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Eye irritation, redness (hyperaemia), pain, or a foreign-body sensation.

What to notice: Eye irritation, redness (hyperaemia), pain, or a foreign-body sensation.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Blurred vision, increased tear production, discharge, or itching.

What to notice: Blurred vision, increased tear production, discharge, or itching.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Eyelid swelling or drooping (ptosis); dilated pupil (mydriasis).

What to notice: Eyelid swelling or drooping (ptosis); dilated pupil (mydriasis).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Increased eye pressure (see serious warnings below).

What to notice: Increased eye pressure (see serious warnings below).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Serious warnings

Signs of raised eye pressure or glaucoma — serious

Symptoms: Eye pain, gradual vision changes, or halos around lights, especially with use for 10 days or longer.

Action: Contact your eye doctor -- prolonged use of fluorometholone, like other corticosteroid eye medicines, can raise eye pressure and cause glaucoma with optic nerve damage and visual field defects. Your eye doctor should monitor your eye pressure routinely if you use this medicine for 10 days or longer. (1) (2)

Signs of a new or worsening eye infection — serious

Symptoms: Increasing redness, pain, discharge, or vision changes that do not improve or that worsen during treatment.

Action: Contact your eye doctor promptly -- corticosteroid eye medicines can mask or worsen some eye infections (including fungal and viral infections) with prolonged use. Do not continue treatment on your own if your symptoms change or worsen; your eye doctor needs to reassess you. (1) (2)

Signs of cataract — serious

Symptoms: Gradual blurring or clouding of vision, especially with long-term use.

Action: Report new or worsening vision changes to your eye doctor -- prolonged corticosteroid eye drop use may result in posterior subcapsular cataract formation. (1) (2)

Signs of delayed healing or corneal/scleral thinning — serious

Symptoms: Slow-healing wounds, persistent redness, or unusual eye pain, particularly after eye surgery or injury.

Action: Report this to your eye doctor -- prolonged corticosteroid use may delay wound healing and, rarely, may cause thinning of the cornea or the white of the eye, which carries a risk of perforation in eyes with pre-existing thinning. (1)

Interactions

  • No formal drug-interaction studies have been performed with fluorometholone eye drops. (2)
  • Strong CYP3A inhibitors (including cobicistat-containing products): may increase the small amount of corticosteroid effect absorbed into the body; used with caution together. (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Animal studies have shown embryocidal and teratogenic effects at multiples of the recommended human dose. The US source reviewed advises use only if the potential benefit justifies the potential risk to the fetus; the UK/Ireland source reviewed advises against use in pregnancy unless clearly necessary. Discuss with your eye doctor and obstetric care team. (1) (2) (3) (4) (5) (6)

Breastfeeding

Systemically administered corticosteroids are known to appear in human breast milk; caution is advised when this medicine is used by a nursing mother, per the US source reviewed. The UK/Ireland source reviewed advises avoiding use during breastfeeding since excretion in milk with topical ophthalmic use is not established. Discuss with your eye doctor. (1) (2) (3) (4) (5) (6)

Children

Safety and effectiveness have not been established in children below the age of 2, per the US source reviewed. (1) (2) (3) (4) (5) (6)

Elderly

No significant differences in safety or effectiveness were identified between elderly and younger patients in the sources reviewed. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Not specifically addressed in the sources reviewed, consistent with this medicine's very low systemic absorption as a topical eye product. (1) (2) (3) (4) (5) (6)

Renal_impairment

Not specifically addressed in the sources reviewed, consistent with this medicine's very low systemic absorption as a topical eye product. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Assessment for active eye infection (viral, fungal, mycobacterial, or untreated bacterial)
  • Baseline eye pressure if there is a history of glaucoma or ocular hypertension

During treatment

  • Intraocular pressure monitoring if used for 10 days or longer, or beyond about a week without specialist supervision.
  • Periodic eye examination for cataract changes with prolonged use.
  • Monitoring for signs of new or worsening eye infection, delayed healing, or corneal/scleral thinning.
(1) (2)

Storage

Store as directed on the product label, typically at room temperature, tightly closed, out of reach of children. Discard 28 days after first opening per the UK/Ireland source reviewed. Do not use after the labelled expiry date.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and the UK emc SmPC reviewed for this dossier; verify against the current full label before prescribing.

United States

Indication: Corticosteroid-responsive eye inflammation

Dose summary: 1 drop 2-4 times daily; up to hourly during the first 24-48 hours if directed; taper gradually rather than stopping abruptly. Prescriptions beyond 20 mL, or renewal, should involve slit-lamp examination.

Renal context: Not applicable -- topical ophthalmic product with minimal systemic absorption. (1)

United Kingdom / European Union (Ireland) / New Zealand

Indication: Corticosteroid-responsive eye inflammation

Dose summary: 1-2 drops 2-4 times daily; up to hourly during the first 24-48 hours if directed; not for use beyond about a week except under specialist surveillance with IOP monitoring.

Renal context: Not applicable -- topical ophthalmic product with minimal systemic absorption. (2) (6)

Mechanism of action

Hepatic guidance

Not applicable given minimal systemic absorption from topical ophthalmic use.

Overdose note

No specific antidote is described in the sources reviewed; manage topical overexposure with supportive eye care and seek medical advice if ingested. (1) (2)

Frequently asked questions

Is fluorometholone (FML) available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes. This review confirmed fluorometholone eye drops are authorised and marketed in all six markets reviewed: the United States (FML, FML Forte), the United Kingdom (FML Liquifilm), the European Union (confirmed directly via Ireland's HPRA national marketing authorisation), Canada (FML 0.1% and Sandoz Fluorometholone), Australia (FML, TGA ARTG 23212), and New Zealand (FML, Medsafe-registered). (1) (2) (3) (4) (5) (6)

Does fluorometholone have a boxed warning?

No. A direct review of the current US FDA label confirms fluorometholone does not carry a boxed warning. It does carry real, standard corticosteroid-class ophthalmic precautions -- raised eye pressure/glaucoma risk, cataract risk, delayed wound healing, corneal/scleral thinning, and increased infection risk with prolonged use -- which are documented on this page, but none of these rises to boxed-warning level in the label reviewed. (1)

Why shouldn't I use these eye drops for more than about a week on my own?

Because prolonged corticosteroid eye drop use carries real risks -- raised eye pressure that can progress to glaucoma, cataract formation, delayed healing, and masking or worsening of eye infections. UK and Irish product information states explicitly that corticosteroid eye drops should not be used for longer than about a week except under an eye specialist's careful surveillance with regular eye-pressure checks, and US labelling recommends routine intraocular pressure monitoring at 10 days or longer. (2) (1)

Is the fluorometholone/neomycin combination product (FML-NEO) still available?

Not in Canada -- this review found FML-NEO (fluorometholone/neomycin) was cancelled post-market there in 2011. This affects only that combination product; plain fluorometholone eye drops (FML 0.1% and the generic Sandoz Fluorometholone) remain marketed in Canada. (4)

What is the mechanism of action of fluorometholone?

Fluorometholone is a synthetic glucocorticoid (a derivative of desoxyprednisolone) that reduces inflammation locally in ocular tissue by suppressing the inflammatory response, similarly to other topical ophthalmic corticosteroids, with the same class-wide real risks of raised intraocular pressure, cataract, delayed healing, and infection-masking with prolonged use. (1) (2)

What is the generic name of Fluorometholone?

The generic name is fluorometholone. (1) (2)

What class of drug is fluorometholone?

Fluorometholone is classed as: Ophthalmic corticosteroid (topical anti-inflammatory, synthetic glucocorticoid, desoxyprednisolone derivative). (1) (2)

References

  1. FML FORTE (fluorometholone ophthalmic suspension, USP) 0.25% -- full prescribing informationDailyMed (U.S. National Library of Medicine) -- FDA-approved drug labeling · United States · accessed 2026-07-30 · source 1
  2. FML Liquifilm 1 mg/ml eye drops, suspension -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom -- AbbVie Ltd · United Kingdom · accessed 2026-07-30 · source 2
  3. FML 0.1% w/v eye drops, suspension -- HPRA product/licence documents (PA1824-008-001)Health Products Regulatory Authority (HPRA), Ireland -- national marketing authorisation · European Union (Ireland, as a directly confirmed EU member state) · accessed 2026-07-30 · source 3
  4. FML 0.1% (fluorometholone ophthalmic suspension) -- DIN 00247855, Allergan IncHealth Canada Drug Product Database (DPD) · Canada · accessed 2026-07-30 · source 4
  5. FML fluorometholone 1mg/mL eye drops bottle -- ARTG entry 23212Therapeutic Goods Administration (TGA), Australia -- Australian Register of Therapeutic Goods (ARTG) · Australia · accessed 2026-07-30 · source 5
  6. FML (fluorometholone) 0.1% w/v eye drops -- New Zealand Data Sheet (DS v9, CCDS v7.0, 16 May 2024)Medsafe (New Zealand regulator) -- New Zealand Data Sheet · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient fluorometholone names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Flarex1 mg/mL · harrow eye, llc
  • FML1 mg/mL · allergan, inc.
  • FML FORTE2.5 mg/mL · allergan, inc.

United Kingdom

  • FML Liquifilm (2)MHRA licensed emc smpc confirmed · 1 mg/ml (0.1%) · AbbVie Ltd (PL 41042/0065)

Canada

  • FML
  • FLAREX

Australia

  • FML (5)TGA ARTG registered 1991-10-14 confirmed · 1 mg/mL (0.1%) · AbbVie Pty Ltd (ARTG 23212)

New Zealand

  • FML (6)Medsafe registered confirmed · 0.1% w/v · AbbVie
View brands in additional countries.

European Union

FML 0.1% w/v eye drops (3)

This page provides general reference information about fluorometholone and is not a substitute for advice from the eye doctor (ophthalmologist or optometrist) or prescriber managing your treatment. All dosing and treatment decisions should be made with your eye-care prescriber.

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