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Fluorometholone

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FML

Fluorometholone Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

FML (fluorometholone) Ophthalmic Suspension is used to treat eye swelling caused by infections, injury, surgery, or other conditions. It is a steroid. Common side effects include increased sensitivity to light, or mild stinging, burning, itching, or irritation in your eyes.

Instill one drop of FML into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage may be increased to one application every four hours. Tell your doctor if you are also taking an oral steroid medication such as prednisone, methylprednisolone, hydrocortisone, and others. Other drugs may interact with FML ophthalmic. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, FML should be used only if prescribed. It may be harmful to a fetus. It is unknown if FML ophthalmic passes into breast milk or if it could harm a nursing baby. Consult your doctor before breast-feeding.

Our FML (fluorometholone) Ophthalmic Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Fluorometholone in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • pain behind your eyes, sudden vision changes, severe headache;
  • sudden eye irritation;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights; or
  • signs of new eye infection, such as swelling, draining, or crusting of your eyes.

Less serious side effects may include:

  • increased sensitivity to light; or
  • mild stinging, burning, itching, or irritation in your eyes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Fluorometholone (Fluorometholone Ophthalmic Suspension, USP 0.1% Sterile) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Fluorometholone FDA Prescribing Information: Side Effects
(Adverse Reactions)

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® 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.

Read the entire FDA prescribing information for Fluorometholone (Fluorometholone Ophthalmic Suspension, USP 0.1% Sterile) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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