{ "query": "fluorometholone", "ingredient": "fluorometholone", "slug": "fluorometholone", "rxcui": "4491", "brands": [ "Flarex", "FML", "FML Forte Liquifilm" ], "names": [ "fluorometholone", "fluorometholone acetate" ], "classes": [ { "id": "C05AA", "name": "Corticosteroids" }, { "id": "D07AB", "name": "Corticosteroids, moderately potent (group II)" }, { "id": "S01BA", "name": "Corticosteroids, plain" } ], "alternatives": [ "alclometasone", "betamethasone", "clobetasol", "clobetasone", "clocortolone", "cortisone", "desonide", "dexamethasone", "difluprednate", "flumethasone", "fluocinolone acetonide", "fluocinonide", "fluocortolone", "fluprednidene", "hydrocortisone", "hydrocortisone butyrate", "hydrocortisone probutate", "loteprednol", "medrysone", "prednisolone", "rimexolone", "triamcinolone" ], "label": { "route_mode": "OPHTHALMIC", "route_counts": { "OPHTHALMIC": 7 }, "boxed_warning": "", "indications_and_usage": "INDICATIONS AND USAGE 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": "CONTRAINDICATIONS 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.", "warnings_and_cautions": "", "warnings": "WARNINGS 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": "ADVERSE REACTIONS 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 \u00ae (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.", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Information for Patients Do not touch dropper tip to any surface, as this may contaminate the suspension. The preservative in FLAREX \u00ae (fluorometholone acetate ophthalmic suspension) 0.1%, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% but may be reinserted 15 minutes after instillation. Patients should be advised that their vision may be temporarily blurred following dosing with FLAREX \u00ae (fluorometholone acetate ophthalmic suspension) 0.1%. Care should be exercised in operating machinery or driving a motor vehicle.", "spl_medguide": "", "clinical_studies": "", "brand_name": "Flarex", "manufacturer": "Eyevance Pharmaceuticals", "application_number": "NDA019079", "pharm_class_epc": [], "route": [ "OPHTHALMIC" ], "effective_time": "20250117", "set_id": "19918ea5-8568-44d6-b8ee-7b2197cee85c", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 3433, "serious": 1666, "death": 309, "hospitalization": 824, "primary_suspect": 3433, "top_reactions": [ [ "Treatment Failure", 386 ], [ "Drug Ineffective", 292 ], [ "Eye Pain", 273 ], [ "Off Label Use", 252 ], [ "Fatigue", 225 ], [ "Headache", 202 ], [ "Eye Irritation", 194 ], [ "Diarrhoea", 193 ], [ "Dyspnoea", 175 ], [ "Condition Aggravated", 165 ], [ "Arthralgia", 162 ], [ "Dizziness", 162 ], [ "Nausea", 152 ], [ "Asthenia", 151 ], [ "Rash", 151 ] ], "by_year": { "2019": 237, "2020": 548, "2021": 317, "2022": 275, "2023": 309, "2024": 334, "2025": 378, "2026": 174 }, "by_year_primary": { "2019": 237, "2020": 548, "2021": 317, "2022": 275, "2023": 309, "2024": 334, "2025": 378, "2026": 174 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 8, "nda": 5, "anda": 3, "first_approval": "19720112", "rems": false, "rems_last": "", "labeling_supplements": 26, "labeling_recent": 3, "sponsors": [ "ABBVIE", "ALLERGAN", "AMNEAL", "HARROW EYE", "NOVARTIS", "PHARMACIA AND UPJOHN", "SANDOZ" ], "unapproved": false, "first_approval_fmt": "01/12/1972" }, "trials": { "total": 37, "completed": 15, "terminated": 6, "with_results": 3, "industry": 8, "phase3": 5, "results_share": 0.2, "terminated_share": 0.16216216216216217 }, "pubmed": { "rct": 40, "meta": 1, "recent_rct": 7, "cochrane": [] }, "payments": { "year": "2024", "usd": 12249.9, "records": 200, "by_name": [ [ "Flarex", 12249.9 ] ], "names_checked": [ "fluorometholone", "Flarex", "FML", "FML Forte Liquifilm" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 417600, "beneficiaries": 209675, "spend": 34586715.36, "by_brand": [ { "brand": "Fluorometholone", "claims": 393837, "per_claim": 78.554700041, "is_generic": true }, { "brand": "Flarex", "claims": 19312, "per_claim": 136.63364281, "is_generic": false }, { "brand": "Fml Forte", "claims": 3778, "per_claim": 237.5759423, "is_generic": false }, { "brand": "Fml", "claims": 673, "per_claim": 167.51432392, "is_generic": false } ], "per_claim": 82.82259425287356 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 886, "fills": 417600, "per_million": 2121.647509578544, "ratio": 0.7662282447249905, "median": 2768.949753790441 }, "scores": { "safety": { "score": 95, "letter": "A", "why": [ "2,122 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site", "Death share in reports is near or below the FAERS average (1.0x)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 23, "letter": "F", "why": [ "40 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "Only 20% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 96, "letter": "A", "why": [ "No recalls on record since 2016", "3 label changes approved since 2021 (-4)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $12,250 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 100, "letter": "A", "why": [ "Generic versions approved (3 applications)", "22 same-class alternatives exist" ], "weight": 0.1 } }, "total": 78, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are treatment failure, eye pain. How would we recognize and handle those?", "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?", "Why this one over alclometasone, betamethasone, clobetasol? What would make you pick one of those instead?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }