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FML-S Side Effects

Generic Name: fluorometholone / sulfacetamide sodium ophthalmic

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

For the Consumer

Applies to fluorometholone / sulfacetamide sodium ophthalmic: ophthalmic suspension

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; taste changes; temporary burning or stinging.

Seek medical attention right away if any of these SEVERE side effects occur while taking fluorometholone / sulfacetamide sodium ophthalmic:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; continuing blurred vision; discharge from eyes; eye pain, itching, redness, swelling, irritation, or sores not present when you began using fluorometholone/sulfacetamide suspension; fever, chills, or sore throat; red, swollen, or blistered skin; unusual tiredness or weakness; yellowing of the eyes or skin.

For Healthcare Professionals

Applies to fluorometholone / sulfacetamide sodium ophthalmic: ophthalmic suspension

Ocular

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]

Immunologic

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

Hypersensitivity

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

Gastrointestinal side effects have included taste perversion.[Ref]

Endocrine

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

References

1. "Product Information. Sulamyd Ophthalmic Solution (sodium sulfacetamide ophthalmic)." Schering Corporation, Kenilworth, NJ.

2. "Product Information. FML Ophthalmic Suspension (fluoromethalone ophthalmic)." Allergan Inc, Irvine, CA.

Not all side effects for FML-S may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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