Medicine guide

Fluorometholone

1 mg/mL · Solution/ Drops

Prescription only
Corticosteroid

Active substance: Fluorometholone
Used in: Hormones, such as thyroid and steroids
Made by: Pacific Pharma, Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2023-12-01

What it is

Corticosteroid

Used for

Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Do not take it if

Fluorometholone ophthalmic suspension 0.1% 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…

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

4other products contain Fluorometholone — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

From the official label · 2023-12-01 · DailyMed

How it works

From this product’s own US prescribing label.

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing.
They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-12-01

Do not take it if

Fluorometholone ophthalmic suspension 0.1% 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.
Fluorometholone ophthalmic suspension 0.1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

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 fluorometholone ophthalmic suspension 0.1% 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

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.
General The initial prescription and renewal of the medication order beyond 20 milliliters of fluorometholone ophthalmic suspension 0.1% should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use.
Fungal cultures should be taken when appropriate.
If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS ).
Information for Patients If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.
Carcinogenesis, M utagenesis, I mpairment of F ertility No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.
Pregnancy Teratogenic effects Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose.
Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
Pediatric Use Safety and effectiveness in infants below the age of two years have not been established.
Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
General The initial prescription and renewal of the medication order beyond 20 milliliters of fluorometholone ophthalmic suspension 0.1% should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use.
Fungal cultures should be taken when appropriate.
If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS ).

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Teratogenic effects 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.
It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
Systemically-administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
Because of the potential for serious adverse reactions in nursing infants from fluorometholone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

Safety and effectiveness in infants below the age of two years have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Quoted from the official label, section “Geriatric Use”.

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 fluorometholone suspension.
Other adverse events reported with the use of fluorometholone include:
allergic reactions; foreign body sensation; erythema of eyelid; eyelid edema/eye swelling; eye discharge; eye pain; eye pruritus; lacrimation increased; rash; taste perversion; visual disturbance (blurry vision); and visual field defect.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.
This product is sterile when packaged.
To prevent contamination, care should be taken to
avoid touching the bottle tip to eyelids or to any other surface.
The use of this bottle by more than one person may spread infection.
Keep bottle tightly closed when not in use.
Keep out of the reach of children.
The preservative in fluorometholone ophthalmic suspension, benzalkonium chloride, may be absorbed by soft contact lenses.
Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling fluorometholone ophthalmic suspension to insert soft contact lenses.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

Fluorometholone ophthalmic suspension, USP 0.1% is supplied sterile in opaque white LDPE plastic bottles with white high impact polystyrene (HIPS) caps as follows:
5 mL in 10 mL bottle NDC 60758-880-05 10 mL in 15 mL bottle NDC 60758-880-10 15 mL in 15 mL bottle NDC 60758-880-15 Pacific Pharma Storage:
Store at 2°-25°C (36°-77°F); protect from freezing.
Store in an upright position.
Revised : 12/20 23 For more information, call 1-800-678-1605 Distributed for: AbbVie Inc.
North Chicago, IL 60064 © 2023 AbbVie.
All rights reserved.
PACIFIC PHARMA and its design are trademarks of Allergan, Inc., an AbbVie company.
V2.0USPI880

Quoted from the official label, section “How Supplied”.

How to store it

Store at 2°-25°C (36°-77°F); protect from freezing.
Store in an upright position.
Revised : 12/20 23 For more information, call 1-800-678-1605 Distributed for: AbbVie Inc.
North Chicago, IL 60064 © 2023 AbbVie.
All rights reserved.
PACIFIC PHARMA and its design are trademarks of Allergan, Inc., an AbbVie company.
V2.0USPI880

Quoted from the official label, section “Storage and Handling”.

What is in it

Fluorometholone ophthalmic suspension, USP 0.1% is a sterile topical anti-inflammatory agent for ophthalmic use.
Chemical Name Fluorometholone:
9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione.
Contains Active: fluorometholone 0.1%.
Preservative: benzalkonium chloride 0.004%.
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.
Fluorometholone suspension is formulated with a pH from 6.2 to 7.5.
It has an osmolality range of 290-350 mOsm/kg.
Structural Formula f luorometholone Structural Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (6)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 6 of 6

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (2)

Details

Made by	Pacific Pharma, Inc.
Active substance	Fluorometholone
Used in	Hormones, such as thyroid and steroids
Strength	1 mg/mL
Form	Solution/ Drops
Route	Ophthalmic
Packs	1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER · 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
NDC	60758-880

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Solution/ Drops1 products
- 1 mg/mL
Suspension/ Drops1 products
- 1 mg/mL

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Fluorometholone1 mg/mLPrescription onlySuspension/ Drops Sandoz Inc · Fluorometholone Fluorometholone Ophthalmic Suspension1 mg/mLPrescription onlySuspension/ Drops Amneal Pharmaceuticals LLC · Fluorometholone Fml1 mg/mLPrescription onlySuspension/ Drops Allergan, Inc. · Fluorometholone Fml Forte2.5 mg/mLPrescription onlySuspension/ Drops Allergan, Inc. · Fluorometholone

See every product with Fluorometholone