Ozurdex Side Effects
Please note - some side effects for Ozurdex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Ozurdex Side Effects - for the Professional
Ozurdex
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
The following information is based on the combined clinical trial results from 3 initial, randomized, 6-month, sham-controlled studies (2 for retinal vein occlusion and 1 for posterior segment uveitis):
| MedDRA Term |
Ozurdex® N=497 (%) |
Sham N=498 (%) |
| Intraocular pressure increased | 125 (25%) | 10 (2%) |
| Conjunctival hemorrhage | 108 (22%) | 79 (16%) |
| Eye pain | 40 (8%) | 26 (5%) |
| Conjunctival hyperemia | 33 (7%) | 27 (5%) |
| Ocular hypertension | 23 (5%) | 3 (1%) |
| Cataract | 24 (5%) | 10 (2%) |
| Vitreous detachment | 12 (2%) | 8 (2%) |
| Headache | 19 (4%) | 12 (2%) |
Increased IOP with Ozurdex® peaked at approximately week 8. During the initial treatment period, 1% (3/421) of the patients who received Ozurdex® required surgical procedures for management of elevated IOP.
Following a second injection of Ozurdex® in cases where a second injection was indicated, the overall incidence of cataracts was higher after 1 year.
TopSide Effects by Body System - for Healthcare Professionals
Ocular
Ocular side effects have included elevation of intraocular pressure with possible development of glaucoma, visual acuity and visual field defects, subcapsular cataract formation, optic nerve damage, secondary ocular infection and perforation of the globe. Less frequent side effects of dexamethasone ophthalmic include burning and stinging upon instillation.
Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis, keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation, and ptosis.
More Ozurdex resources
- Ozurdex Prescribing Information (FDA)
- Ozurdex Consumer Overview
- Ozurdex Advanced Consumer (Micromedex) - Includes Dosage Information
- Dexasol Drops MedFacts Consumer Leaflet (Wolters Kluwer)
- Maxidex Prescribing Information (FDA)
- Maxidex eent Monograph (AHFS DI)
- Maxidex Suspension MedFacts Consumer Leaflet (Wolters Kluwer)
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