pharmacopeia
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/api/v1/drug/fluorometholone

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.

Corticosteroid Hormone ReceptorGlucocorticoid ReceptorLipoxygenase

Indications

Sourced from openFDA
  • FLAREX (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.

Contraindications

Sourced from openFDA
  • Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation.contraindicated

Dosage & administration

Sourced from openFDA

Shake Well Before Using. One to two drops instilled into the conjunctival sac(s) four times daily. During the initial 24 to 48 hours the dosage may be safely increased to two drops every two hours. 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 [see PRECAUTIONS ] .

Warnings & precautions

Sourced from openFDA

FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION. Use in the treatment of herpes simplex infection requires great caution. Prolonged use may result in glaucoma, damage to the optic nerve, defect in visual acuity and visual field, cataract formation and/or may aid in the establishment of secondary ocular infections from pathogens due to suppression of host response. Acute purulent infections of the eye may be masked or exacerbated by presence of steroid medication. Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids. If these products are used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients.

Adverse reactions

Sourced from openFDA

Glaucoma 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.

Use in specific populations

Sourced from openFDA

Pregnancy Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Approval history

Sourced from openFDA
  • Jan 12, 1972NDANDA016851Abbvie
  • Feb 11, 1986NDANDA019079Harrow Eye
  • Apr 23, 1986NDANDA019216Abbvie
  • Jan 9, 2024ANDAANDA216348Amneal
  • Feb 12, 2026ANDAANDA218819Difgen Pharms

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,296 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Treatment Failure36311%
  2. 2Eye Pain2758.3%
  3. 3Drug Ineffective2507.6%
  4. 4Off Label Use2337.1%
  5. 5Fatigue2216.7%
  6. 6Diarrhoea1925.8%
  7. 7Headache1895.7%
  8. 8Eye Irritation1885.7%
  9. 9Dyspnoea1725.2%
  10. 10Arthralgia1645.0%
  11. 11Dizziness1634.9%
  12. 12Condition Aggravated1614.9%
  13. 13Nausea1584.8%
  14. 14Asthenia1494.5%
  15. 15Rash1494.5%

Literature

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Recent PubMed references pinned to Fluorometholone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 36 ClinicalTrials.gov registrations naming Fluorometholone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Fluorometholone work?
Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.
What is Fluorometholone used for?
According to FDA labeling, Fluorometholone carries indications including: FLAREX (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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Fluorometholone?
Fluorometholone is classified as Corticosteroids, Corticosteroids/antiinfectives/mydriatics in combination, Corticosteroids, combinations for treatment of acne, Corticosteroids, moderately potent (group II), Corticosteroids, moderately potent, other combinations, Corticosteroids, plain, Corticosteroid, Corticosteroid Hormone Receptor Agonists, Glucocorticoid Receptor Agonists, Lipoxygenase Inhibitors, Decreased Glucocorticoid Secretion, Decreased Leukotriene Activity, Decreased Prostaglandin Activity, Decreased Thromboxane Activity.
What are the brand names for Fluorometholone?
Fluorometholone is marketed under brand names including FML, FML Forte Liquifilm, Flarex.
What are the contraindications for Fluorometholone?
Fluorometholone labeling lists contraindications including: Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation.. Always consult the full prescribing information and a clinician.
Note. Data for fluorometholone is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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