
fml forte
Pharmaranks rates Fml Forte 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Fml Forte (Fluorometholone) is a corticosteroid used to treat Conjunctivitis, Inflammation, Keratitis.
Fluorometholone · by Abbvie
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Fluorometholone
- Drug class
- Corticosteroid
- Form
- Drops
- Strength
- Fluorometholone 0.25%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- conjunctivitis, inflammation, keratitis
- Manufacturer
- Abbvie
- What the pharmacy pays
- ~$12.87 per ml — not your price
- FDA application
- NDA019216
What is Fml Forte?
From the FDA label:FML FORTE ® (fluorometholone ophthalmic suspension, USP) 0.25% is a sterile, topical anti-inflammatory agent for ophthalmic use. Chemical N ame Fluorometholone: 9-Fluoro-11ß, 17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione Structural Formula Contains Active: fluorometholone 0.25%. Preservative: benzalkonium chloride 0.005%. Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust pH. FML FORTE ® suspension is formulated with a pH from 6.2 to 7.5. The Structural Formula for Fluorometholone is 9-Fluoro-11ß, 17-dihydroxy-6-methylpregna-1,4-diene-3,20-dione.
How to use
Shake well before using. Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS ). The dosing of FML FORTE ® suspension may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.
Side effects
Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical dermatologic steroids applied to the skin. Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids. The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see WARNINGS ). Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of FML FORTE ® suspension. Other adverse events reported with the use of fluorometholone include: allergic reactions; foreign body sensation; erythema of eyelid; eyelid…
Warnings
Important safety information
Prolonged use of corticosteroids may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
Who should not take Fml Forte
FML FORTE ® suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. FML FORTE ® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Fml Forte ranks — best-rated corticosteroid for:
Dosage forms
Drops
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Fml Forte treat?
- Fml Forte (Fluorometholone) may be used to treat conjunctivitis, inflammation, keratitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Fml Forte work?
- Fml Forte is a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response.
- How is Fml Forte rated?
- pharmaranks gives Fml Forte a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Fml Forte cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $12.87 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Pred Forte — about $0.60 on the same basis.
- Is there a coupon or discount for Fml Forte?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Fml Forte. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Fml Forte?
- Fml Forte is marketed by Abbvie. You can see Abbvie's full profile, rating, and other products on pharmaranks.
- Is Fml Forte a brand-name or generic drug?
- Fml Forte is a brand-name product with the active ingredient Fluorometholone.
- Is Fml Forte available over the counter?
- No. Fml Forte is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Fml Forte come in?
- Fml Forte is currently marketed as drops, per the FDA's National Drug Code Directory.
- What class of drug is Fml Forte?
- Fml Forte is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Fml Forte FDA-registered?
- Fml Forte is on record with the U.S. FDA under application number NDA019216. You can verify this on its official FDA label.
- Has Fml Forte been recalled by the FDA?
- Fml Forte has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Fml Forte safe?
- There's no single safe-or-not verdict. pharmaranks gives Fml Forte a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Fml Forte?
- Fml Forte's side effects are taken directly from its FDA label. From the label: Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. Although systemic effects are extremely uncommon,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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fml forte
72/100