FML Forte Liquifilm Side Effects

Generic name: fluorometholone ophthalmic

Note: This document contains side effect information about fluorometholone ophthalmic. Some of the dosage forms listed on this page may not apply to the brand name FML Forte Liquifilm.

Some side effects of FML Forte Liquifilm may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fluorometholone ophthalmic: ophthalmic ointment, ophthalmic suspension

Get emergency medical help if you have any of these signs of an allergic reaction while taking fluorometholone ophthalmic (the active ingredient contained in FML Forte Liquifilm) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fluorometholone ophthalmic and call your doctor at once if you have:

• worsening or no improvement in your symptoms after 48 hours of use;

• pain behind your eyes, sudden vision changes, severe headache;

• sudden eye irritation;

• severe burning, redness, or irritation of your eyes;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights; or

• signs of new eye infection, such as pain, itching, swelling, draining, or crusting of your eyes.

In rare cases, steroid medicine used in the eyes can be absorbed into the blood stream, which may cause steroid side effects throughout the body. Tell your doctor if you develop any of the following symptoms of steroid absorption:

• thinning skin, easy bruising,;

• headaches, back aches, weakness, confusion;

• weight gain, roundness in your face;

• increased acne or facial hair;

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist); or

• menstrual problems (in women), impotence or loss of interest in sex (in men).

Common side effects may include:

• mild stinging, burning, itching, or irritation in your eyes;

• feeling like something is in your eye;

• red or puffy eyelids;

• watery eyes;

• increased sensitivity to light;

• altered sense of taste; or

• mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to fluorometholone ophthalmic: compounding powder, ophthalmic ointment, ophthalmic suspension

Ocular

Frequency not reported: Elevation of intraocular pressure (IOP), development of glaucoma with optic nerve damage, posterior subcapsular cataract formation, perforation of the globe, transient burning and stinging upon instillation, ocular irritation, foreign body sensation, erythema of eyelid, eyelid edema/eye swelling, eye discharge, eye pain, eye pruritus, increased lacrimation, visual disturbance (blurry vision), visual field defect

Corticosteroid-containing preparations have caused acute anterior uveitis, keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation, ptosis.

Immunologic

Frequency not reported: Development of secondary ocular infection (bacterial, fungal and viral)

Gastrointestinal

Frequency not reported: Taste perversion

Endocrine

Frequency not reported: Systemic Hypercorticoidism

Dermatologic

Frequency not reported: Rash, delayed wound healing

Hypersensitivity

Frequency not reported: Allergic reactions

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