Ozurdex
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Ozurdex
Ozurdex Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Ozurdex in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- blurred vision, eye pain, or seeing halos around lights;
- eye redness, increased sensitivity of your eyes to light; or
- vision changes.
Less serious side effects may include blurred vision.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Ozurdex (Dexamethasone Intravitreal Implant) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ozurdex FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
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):
Adverse Reactions Reported by Greater than 2% of Patients
in the First Six Months
| 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.
Postmarketing Experience
The following reactions have been identified during post-marketing use of OZURDEX® in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to OZURDEX®, or a combination of these factors, include: complication of device insertion (implant misplacement), device dislocation with or without corneal edema, endophthalmitis, and hypotony of the eye (associated with vitreous leakage due to injection).
Read the entire FDA prescribing information for Ozurdex (Dexamethasone Intravitreal Implant) »
Additional Ozurdex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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