April 27, 2017
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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 including OZURDEX® 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.

Retinal Vein Occlusion and Posterior Segment Uveitis

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):

Table 1: Adverse Reactions Reported by Greater than 2% of Patients

N=497 (%)
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.

Diabetic Macular Edema

The following information is based on the combined clinical trial results from 2 randomized, 3­year, sham-controlled studies in patients with diabetic macular edema. Discontinuation rates due to the adverse reactions listed in Table 2 were 3% in the OZURDEX® group and 1% in the Sham group. The most common ocular (study eye) and non-ocular adverse reactions are shown in Tables 2 and 3:

Table 2: Ocular Adverse Reactions Reported by ≥ 1% of Patients and Non-ocular Adverse Reactions Reported by ≥ 5% of Patients

N=324 (%)
N=328 (%)
Cataract1 166/2432 (68%) 49/230 (21%)
Conjunctival hemorrhage 73 (23%) 44 (13%)
Visual acuity reduced 28 (9%) 13 (4%)
Conjunctivitis 19 (6%) 8 (2%)
Vitreous floaters 16 (5%) 6 (2%)
Conjunctival edema 15 (5%) 4 (1%)
Dry eye 15 (5%) 7 (2%)
Vitreous detachment 14 (4%) 8 (2%)
Vitreous opacities 11 (3%) 3 (1%)
Retinal aneurysm 10 (3%) 5 (2%)
Foreign body sensation 7 (2%) 4 (1%)
Corneal erosion 7 (2%) 3 (1%)
Keratitis 6 (2%) 3 (1%)
Anterior Chamber Inflammation 6 (2%) 0 (0%)
Retinal tear 5 (2%) 2 (1%)
Eyelid ptosis 5 (2%) 2 (1%)
Hypertension 41 (13%) 21 (6%)
Bronchitis 15 (5%) 8 (2%)
1Includes cataract, cataract nuclear, cataract subcapsular, lenticular opacities in patients who were phakic at baseline. Among these patients, 61% of OZURDEX® subjects vs. 8% of sham-controlled subjects underwent cataract surgery.
2243 of the 324 OZURDEX® subjects were phakic at baseline; 230 of 328 sham-controlled subjects were phakic at baseline.

Increased Intraocular Pressure

Table 3: Summary of Elevated Intraocular Pressure (IOP) Related Adverse Reactions

IOP Treatment: N (%)
IOP elevation ≥ 10 mm Hg from Baseline at any visit 91 (28%) 13 (4%)
≥ 30 mm Hg IOP at any visit 50 (15%) 5 (2%)
Any IOP lowering medication 136 (42%) 32 (10%)
Any surgical intervention for elevated IOP * 4 (1.2%) 1 (0.3%)
* OZURDEX® : 1 surgical trabeculectomy for steroid-induced IOP increase, 1 surgical trabeculectomy for iris neovascularization,
1 laser iridotomy, 1 surgical iridectomy
Sham: 1 laser iridotomy

The increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned to baseline between treatment cycles (at the end of the 6 month period) shown below:

Figure 1: Mean IOP during the study

Mean IOP during the study - Illustration

Cataracts and Cataract Surgery

At baseline, 243 of the 324 OZURDEX® subjects were phakic; 230 of 328 sham-controlled subjects were phakic. The incidence of cataract development in patients who had a phakic study eye was higher in the OZURDEX® group (68%) compared with Sham (21%). The median time of cataract being reported as an adverse event was approximately 15 months in the OZURDEX® group and 12 months in the Sham group. Among these patients, 61% of OZURDEX® subjects vs. 8% of sham-controlled subjects underwent cataract surgery, generally between Month 18 and Month 39 (Median Month 21 for OZURDEX® group and 20 for Sham) of the studies.

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, hypotony of the eye (associated with vitreous leakage due to injection), and retinal detachment.

Read the Ozurdex (dexamethasone intravitreal implant) Side Effects Center for a complete guide to possible side effects


No information provided.

Read the Ozurdex Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/20/2017

Side Effects

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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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