Note: This document contains side effect information about fluocinolone ophthalmic. Some dosage forms listed on this page may not apply to the brand name Iluvien.

Applies to fluocinolone ophthalmic: intraocular implant.

Serious side effects of Iluvien

Along with its needed effects, fluocinolone ophthalmic (the active ingredient contained in Iluvien) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking fluocinolone ophthalmic:

More common

• Blindness
• bloody eye
• blurred vision
• burning, dry, or itching eyes
• change in color vision
• decreased vision
• difficulty seeing at night
• discharge or excessive tearing
• increased sensitivity of the eyes to sunlight
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• seeing flashes or sparks of light
• seeing floating spots before the eyes, or a veil or curtain appearing across part of vision

Other side effects of Iluvien

Some side effects of fluocinolone ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Feeling of having something in the eye

For Healthcare Professionals

Applies to fluocinolone ophthalmic: intravitreal implant.

General

The most frequently reported side effects were cataract operation, cataract, and increased intraocular pressure.^[Ref]

Ocular

Very common (10% or more): Cataract (82%), cataract operation (up to 80%), increased intraocular pressure (up to 34%), myodesopsia (21%), eye pain (15%), conjunctival hemorrhage (13%)

Common (1% to 10%): Glaucoma, vitreous hemorrhage, conjunctival hemorrhage, blurred vision, reduced visual acuity, vitreous floaters, trabeculectomy, vitrectomy, trabeculoplasty, eye irritation, conjunctivitis, corneal edema, foreign body sensation in eyes, ocular hyperemia, ocular discomfort, photophobia, anterior chamber cell, blepharitis, choroidal detachment, diplopia, hyphema

Uncommon (0.1% to 1%): Endophthalmitis, retinal vascular occlusion, optic nerve disorder, maculopathy, optic atrophy, conjunctival ulcer, iris neovascularization, retinal exudates, vitreous degeneration, vitreous detachment, posterior capsule opacification, iris adhesion, sclera thinning, eye discharge, eye pruritus, removal of extruded implant from sclera^[Ref]

Other

Uncommon (0.1% to 1%): Extrusion of implant, implant in line of sight, procedural complication, procedural pain, device dislocation^[Ref]

Respiratory

Common (1% to 10%): Pneumonia, nasopharyngitis, sinusitis, upper respiratory tract infection, influenza, cough^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, limb pain^[Ref]

Nervous system

Very common (10% or more): Headache (33%)

Common (1% to 10%): Dizziness^[Ref]

Gastrointestinal

Common (1% to 10%): Vomiting, nausea^[Ref]

Dermatologic

Common (1% to 10%): Rash^[Ref]

Hematologic

Very common (10% or more): Anemia (11%)^[Ref]

Renal

Common (1% to 10%): Renal failure^[Ref]