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FML-S Side Effects

Generic name: fluorometholone / sulfacetamide sodium ophthalmic

Note: This document contains side effect information about fluorometholone / sulfacetamide sodium ophthalmic. Some dosage forms listed on this page may not apply to the brand name FML-S.

Applies to fluorometholone/sulfacetamide sodium ophthalmic: ophthalmic suspension.


Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

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 / sulfacetamide sodium ophthalmic: ophthalmic suspension.


Ocular side effects associated with the fluorometholone component have included burning and stinging upon instillation, ocular irritation, visual disturbances, elevation of intraocular pressure with possible development of glaucoma, visual field defects, posterior subcapsular cataract formation, delayed wound healing, and optic nerve damage. Corticosteroid containing preparations have also been reported to cause acute anterior uveitis, perforation of the globe, keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation, and ptosis.

Local irritation, stinging, and burning have been reported with the use of sodium sulfacetamide.[Ref]


Fluorometholone ophthalmic has caused the development of secondary ocular infections.[Ref]


Hypersensitivity reactions to sodium sulfacetamide have been reported rarely. A case of Stevens Johnson syndrome has been reported in a patient who had previously experienced a bullous drug reaction to an orally administered sulfonamide. A case of local hypersensitivity which progressed to a fatal syndrome resembling systemic lupus erythematosus has also been reported.[Ref]


Gastrointestinal side effects have included taste perversion.[Ref]


Endocrine side effects have included rare cases of systemic hypercorticoidism after the use of topical steroids.[Ref]


1. "Product Information. FML S.O.P. (fluorometholone ophthalmic)." Allergan Inc

2. "Product Information. Sodium Sulamyd (sulfacetamide sodium ophthalmic)." Schering Corporation

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.