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

Applies to dexamethasone ophthalmic: intraocular implant, intraocular suspension. Other dosage forms:

• ophthalmic insert extended release, ophthalmic solution, ophthalmic suspension

Serious side effects of Dexycu

Along with its needed effects, dexamethasone ophthalmic (the active ingredient contained in Dexycu) 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 dexamethasone ophthalmic:

More common

• Bloody eye
• blurred vision
• change in vision
• eye pain
• loss of vision
• redness of the white part of the eye or inside of the eyelid
• sensitivity of the eye to light
• swelling of the eye
• tearing
• throbbing pain

Less common

• Blindness
• decreased vision
• gradual loss of vision
• headache
• itching of the eyelid
• nausea
• seeing a veil or curtain across part of your vision
• seeing flashes or sparks of light
• seeing floating spots before the eyes
• vomiting

Other side effects of Dexycu

Some side effects of dexamethasone 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

• Difficulty seeing at night
• dry eye
• feeling of having something in the eye

For Healthcare Professionals

Applies to dexamethasone ophthalmic: intraocular implant, intraocular suspension, ophthalmic insert, ophthalmic ointment, ophthalmic solution, ophthalmic suspension.

General

The most commonly reported side effects were cataract, elevation of intraocular pressure, and conjunctival hemorrhage.^[Ref]

Ocular

Very common (10% or more): Cataract (up to 68%), elevation of intraocular pressure (28%), conjunctival hemorrhage (22%)

Common (1% to 10%): Eye pain, conjunctival hyperemia, ocular hypertension, reduced visual acuity, conjunctivitis, vitreous floaters, conjunctival edema, dry eye, vitreous detachment, vitreous opacities, retinal aneurysm, foreign body sensation, corneal erosion, keratitis, anterior chamber inflammation, retinal tear, eyelid ptosis, vitreous detachment, keratoconjunctivitis sicca, corneal staining, photophobia, blurred vision, eye pruritus, increased lacrimation

Rare (less than 0.1%): Burning, stinging

Frequency not reported: Glaucoma with optic nerve damage, visual acuity and visual field defects, subcapsular cataract formation, secondary ocular infection and perforation of the globe

Postmarketing experience: Complication of device insertion (implant misplacement), device dislocation with or without corneal edema, endophthalmitis, hypotony of the eye (associated with vitreous leakage due to injection), retinal detachment^[Ref]

Cardiovascular

Very common (10% or more): Hypertension (13%)^[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Dysgeusia, migraine

Frequency not reported: Dizziness^[Ref]

Respiratory

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

Endocrine

Cushing's syndrome and adrenal suppression may occur at doses higher than recommended in predisposed patients including children and those on CYP P450 3A4 inhibitors.

Postmarketing reports: Cushing's syndrome, adrenal suppression