Topical ophthalmic corticosteroid Pregnancy: US label: fluorometholone has been shown to be embryocidal and teratogenic in rabbits at low multiples of the human ocular dose (dose-related fetal loss, cleft palate, deformed rib cage, anomalous limbs, encephalocele, craniorachischisis, spina bifida). There are no adequate and well controlled studies in pregnant women and it is not known whether fluorometholone can cause fetal harm. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Fluorometholone

Brand names: FML

Fluorometholone is a topical corticosteroid eye drop used to treat steroid-responsive ocular surface and anterior segment inflammation.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One to two drops instilled into the conjunctival sac(s)

Route: Topical ocular (instil into the conjunctival sac; shake well before using)

Frequency: Four times daily. During the initial 24 to 48 hours the dosage may be safely increased to two drops every two hours

NO UK SPC IN BUNDLE — dose taken from US labelling for Flarex (fluorometholone acetate ophthalmic suspension 0.1%, Eyevance Pharmaceuticals, label date 2025-01-17); verify against the UK SPC, and note UK products are commonly fluorometholone alcohol 0.1% rather than the acetate salt. Label instructions: if no improvement after two weeks, consult physician; care should be taken not to discontinue therapy prematurely; not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation. Paediatric: safety and effectiveness in paediatric patients have not been established — no paediatric dose is stated; verify against a children's formulary. Geriatric: no overall differences in safety or effectiveness have been observed between elderly and younger patients.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva
Mycobacterial infection of the eye
Fungal diseases of the eye
Acute purulent untreated infections, which may be masked or enhanced by the presence of the steroid
Known hypersensitivity to any component of the preparation

Side effects

Glaucoma with optic nerve damage, and visual acuity and field defects
Cataract formation
Secondary ocular infection following suppression of host response
Perforation of the globe
Dysgeusia (post-marketing report); rarely Cushing's syndrome and adrenal suppression after very frequent use of topical ophthalmic corticosteroids, particularly in very young children

Clinical monograph

How it works

It is a glucocorticoid that binds corticosteroid receptors to suppress inflammatory mediators and reduce vascular permeability and leucocyte activity in the eye, with a relatively lower propensity to raise intraocular pressure than some other steroids.

Prescribing in practice

Even with its comparatively lower pressure-raising tendency, prolonged use can still increase intraocular pressure and promote cataract and may mask or worsen infection, so ophthalmic supervision is needed.
It is contraindicated in untreated infective eye conditions, including herpes simplex (dendritic) keratitis and most acute purulent infections.
Prolonged courses should be tapered rather than stopped abruptly.

Monitoring

Monitor intraocular pressure with prolonged use and review for signs of infection or lens changes.

Counselling the patient

Shake the bottle if instructed and use the drops exactly as prescribed.
Report any eye pain, reduced vision or worsening redness.
Attend follow-up so your eye pressure can be checked.

Evidence & guidelines

Topical corticosteroids such as fluorometholone are established for steroid-responsive ocular inflammation, with use guided by the SPC.

Reference: RCOphth guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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