Active substance
Fluorometholone
- SFDA 5
- US FDA 8
- Health Canada 2
- US price lines 5
- NHS prices 2
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| FML 0.1% ophthalmic suspension | 0.1 % | Eye drops, suspension · Ophthalmic use | 1 Dropper Container | SAR 14.50 | NCE · Prescription | AbbVie Inc | Valid |
| OPTILONE 0.1% OPTHALMIC SUSPENTION | 0.1 % | Eye drops, suspension · Ophthalmic use | 1 Dropper Container | SAR 13.75 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| FLUCON OPTH SUSP 0.1% | 0.1 % | Eye drops, suspension · Ocular use | 1 Dropper Container | SAR 19.35 | Generic · Prescription | ALCON COUVREUR | Withdrawn by MAH · Not Marketed |
| FLUMETOL | 0.1 % | Eye ointment · Ocular use | 1 Tube | SAR 10.40 | Generic · Prescription | RIYADH PHARMA | Withdrawn by MAH · Not Marketed |
| FML LIQUIFILM 0.1% | 0.1 % | Eye drops, suspension · Ocular use | 1 Dropper Container | SAR 8.90 | Generic · Prescription | ALLERGAN PHARMACEUTICALS LTD | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ALLERGIC RHINITIS-ALLERGIC RHINO-CONJUNCTIVITIS; CYSTOID MACULAR EDEMA; HERPESVIRAL KERATITIS, KERATITIS, OTHER CYTOMEGALOVIRAL DISEASES, ADENOVIRAL KERATOCONJUNCTIVITIS; NON-INFECTIOUS UVEITIS; SJOGREN'S SYNDROME
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FML | 0.1% | suspension/drops · ophthalmic | ABBVIE | Prescription | 12 Jan 1972 |
| FLAREX | 0.1% | suspension/drops · ophthalmic | HARROW EYE | Prescription | 11 Feb 1986 |
| FML FORTE | 0.25% | suspension/drops · ophthalmic | ABBVIE | Prescription | 23 Apr 1986 |
| FLUOROMETHOLONE | 0.1% | suspension/drops · ophthalmic | AMNEAL | Prescription | 9 Jan 2024 |
| FLUOROMETHOLONE | 0.1% | suspension/drops · ophthalmic | SANDOZ | Prescription | 12 Feb 2026 |
| FML | 0.1% | ointment · ophthalmic | ALLERGAN | Discontinued | 4 Sep 1985 |
| FLUOR-OP | 0.1% | suspension/drops · ophthalmic | NOVARTIS | Discontinued | 27 Feb 1986 |
| OXYLONE | 0.025% | cream · topical | PHARMACIA AND UPJOHN | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| FML | 00247855 | 0.1 % / W/V | SUSPENSION · OPHTHALMIC | ABBVIE CORPORATION |
| SANDOZ FLUOROMETHOLONE | 00432814 | 0.1 % | SUSPENSION · OPHTHALMIC | SANDOZ CANADA INCORPORATED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | FLAREX 0.1% EYE DROPS | $23.94627 | per ML | 23 Sep 2026 |
| US NADAC | FLUOROMETHOLONE 0.1% EYE DROP | $11.43126 | per ML | 23 Sep 2026 |
| US NADAC | FLUOROMETHOLONE 0.1% EYE DROP | $11.55194 | per ML | 23 Sep 2026 |
| US NADAC | FML FORTE 0.25% EYE DROPS | $32.1483 | per ML | 23 Sep 2026 |
| US NADAC | FML FORTE 0.25% EYE DROPS | $32.1856 | per ML | 22 Jul 2026 |
| NHS Drug Tariff | Fluorometholone 0.1% eye drops | £1.71 | 5 ml | 1 Oct 2026 |
| NHS Drug Tariff | Fluorometholone 0.1% eye drops | £2.95 | 10 ml | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 23 Sep 2025 FLAREX — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Combinations containing Fluorometholone
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.