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Ozurdex

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Ozurdex

Ozurdex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Ozurdex (dexamethasone) Intravitreal Implant is a steroid injected into the eye to treat swelling that may occur when there is a blockage of certain blood vessels in your eyes, and it is also used to treat non-infectious uveitis affecting the posterior segment of the eye. Common side effects include blurred vision.

Ozurdex intravitreal implant is injected into your eye by a doctor in a clinical setting. Ozurdex may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Ozurdex should be used only if prescribed. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is unknown if Ozurdex implant passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Ozurdex (dexamethasone) Intravitreal Implant Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 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

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.

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

MedDRA Term OZURDEX®
N=324 (%)
Sham
N=328 (%)
Ocular
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%)
Non-ocular
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 (%)
OZURDEX®
N=324
Sham
N=328
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 entire FDA prescribing information for Ozurdex (Dexamethasone Intravitreal Implant) »

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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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