Fluocinolone ophthalmic Side Effects
Some side effects of fluocinolone ophthalmic 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 fluocinolone ophthalmic: ophthalmic implant
Side effects include:
Cataracts, increased IOP, ocular pain, and surgical complications (e.g., cataract fragments in the eye, injury, mechanical complications, migration or expulsion of implant; wound complications or wound dehiscence) reported in 50–90% of patients.
Reduced visual acuity, conjunctival hemorrhage or hyperemia, glaucoma, blurred vision, abnormal sensation in the eye, ocular irritation or inflammation, hypotony, pruritus, vitreous floaters or hemorrhage, ptosis, maculopathy, eyelid edema, increased tearing, and dry eye reported in 10–35% of patients.
Headache was most frequent systemic effect.
For Healthcare Professionals
Applies to fluocinolone ophthalmic: intraocular implant
Clinical trials have reported nearly all phakic eyes may develop cataracts and require cataract surgery within an average of 2 years following intravitreal implantation of fluocinolone.
Based on clinical trials, the manufacturer reports within 3 years post implantation, approximately 77% of patients will require IOP lowering medications to control intraocular pressure and 37% of patients will require filtering procedures to control intraocular pressure.
Ocular side effects associated with fluocinolone intravitreal implant have frequently included cataract, increased intraocular pressure, procedural complication, and eye pain reported in 50% to 90% of patients. Procedural complications have included cataract fragments in the eye postoperatively, implant expulsion, injury, mechanical complication of implant, migration of implant, postoperative complications, postoperative wound complications, and wound dehiscence. Reduced visual acuity, conjunctival hemorrhage, conjunctival hyperemia, glaucoma, blurred vision, abnormal sensation in the eye, eye irritation, hypotony, pruritus, vitreous floaters, maculopathy, vitreous hemorrhage, ptosis, eye inflammation, eyelid edema, increased tearing, and dry eye have been reported in 10% to 35% of patients. Macular edema, visual disturbance, eye discharge, conjunctival edema/chemosis, photophobia, blepharitis, corneal edema, photopsia, retinal hemorrhage, choroidal detachment, vitreous opacities, and eye swelling have been reported in 5% to 9% of patients.
Ocular side effects associated with ophthalmic administration of corticosteroids have included elevated intraocular pressure, glaucoma, optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing, ocular infection, and perforation of the globe (around area of thinning sclera).
Prolonged use of corticosteroids may result in elevated IOP and/or glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision.
Other side effects have included headache in 31% of patients. Influenza, limb pain, back pain, and pain have also been reported.
Respiratory side effects have included nasopharyngitis, sinusitis, cough, and upper respiratory tract infection.
Musculoskeletal side effects have included arthralgia.
Nervous system side effects have included dizziness.
Gastrointestinal side effects have included nausea and vomiting.
Dermatologic side effects have included rash.
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