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U.S. Department of Health and Human Services

Safety

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FML (fluorometholone) Ophthalmic Suspension, Ointment, and FML Forte (fluorometholone) ophthalmic suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2013

Summary View

 

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.

 

ADVERSE REACTIONS

  • ...rare occurrences of systemic hypercorticoidism after use of topical dermatologic steroids applied to the skin.
  • 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.