OZURDEX: 50 Adverse Event Reports & Safety Profile
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50
Total FAERS Reports
0
Deaths Reported
1
Hospitalizations
50
As Primary/Secondary Suspect
1
Disabilities
First Report: 20110410 · Latest Report: 20140227
What Are the Most Common OZURDEX Side Effects?
#1 Most Reported
Complication of device insertion
14 reports (28.0%)
#2 Most Reported
Visual acuity reduced
8 reports (16.0%)
#3 Most Reported
Device dislocation
7 reports (14.0%)
All OZURDEX Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Complication of device insertion | 14 | 28.0% | 0 | 0 |
| Visual acuity reduced | 8 | 16.0% | 0 | 0 |
| Cataract | 7 | 14.0% | 0 | 0 |
| Device dislocation | 7 | 14.0% | 0 | 0 |
| Off label use | 6 | 12.0% | 0 | 0 |
| Corneal oedema | 5 | 10.0% | 0 | 0 |
| Endophthalmitis | 5 | 10.0% | 0 | 1 |
| Intraocular pressure increased | 5 | 10.0% | 0 | 0 |
Who Reports OZURDEX Side Effects? Age & Gender Data
Average age: 58.8 years. Most reports from: US. View detailed demographics →
Is OZURDEX Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 2 | 0 | 0 |
| 2012 | 3 | 0 | 0 |
| 2013 | 9 | 0 | 0 |
| 2014 | 3 | 0 | 0 |
What Is OZURDEX Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 18 |
| Macular oedema | 11 |
| Retinal vein occlusion | 11 |
| Uveitis | 7 |
Official FDA Label for OZURDEX
Official prescribing information from the FDA-approved drug label.