Ozurdexdexamethasone
According to the FDA label: OZURDEX is a corticosteroid indicated for: The treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) ( 1.1 ) The treatment of non-infectious uveitis affecting the posterior segment of the eye ( 1.2 ) The treatment of diabetic macular edema ( 1.3 ) 1.1 Retinal Vein Occlusion OZURDEX ® (dexamethasone intravitreal implant) is indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal…
288,979 adverse event reports submitted to the FDA (1999–2026)
Top Reported Adverse Events
The most frequently reported events in association with Ozurdex in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Off Label Use 22,050 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Fatigue 16,873 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 16,751 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Plasma Cell Myeloma 13,930 reports
A cancer of certain white blood cells in the bone marrow, also called multiple myeloma. It often appears in reports as a condition being treated.
Full definition in the glossary →Nausea 13,686 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 13,464 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Death 13,213 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Drug Ineffective 12,745 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Neutropenia 11,377 reports
A low level of neutrophils, a type of white blood cell that fights infection.
Full definition in the glossary →Pyrexia 10,770 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Thrombocytopenia 10,421 reports
A low level of platelets, the blood cells that help with clotting.
Full definition in the glossary →Dyspnoea 10,066 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Anaemia 8,876 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →Febrile Neutropenia 8,841 reports
A fever occurring together with a low level of neutrophils, a type of infection-fighting white blood cell. It is taken seriously because infection is harder to fight when these cells are low.
Full definition in the glossary →Vomiting 8,631 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 131,185 |
| Female | 123,512 |
| Unknown | 1,724 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 14,173 |
| 18-34 | 10,165 |
| 35-49 | 20,950 |
| 50-64 | 58,317 |
| 65-74 | 56,566 |
| 75+ | 39,333 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Ozurdex. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 154,252 |
| Hospitalization | 111,052 |
| Death | 46,958 |
| Non-Serious | 45,179 |
| Life-Threatening | 21,250 |
| Disability | 5,810 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Ozurdex. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1999 | 1 |
| 2003 | 1 |
| 2004 | 1,562 |
| 2005 | 2,134 |
| 2006 | 1,097 |
| 2007 | 875 |
| 2008 | 1,306 |
| 2009 | 1,926 |
| 2010 | 3,594 |
| 2011 | 5,456 |
| 2012 | 6,777 |
| 2013 | 6,788 |
| 2014 | 8,419 |
| 2015 | 17,458 |
| 2016 | 15,932 |
| 2017 | 17,974 |
| 2018 | 23,448 |
| 2019 | 23,466 |
| 2020 | 25,388 |
| 2021 | 29,147 |
| 2022 | 27,444 |
| 2023 | 24,369 |
| 2024 | 21,690 |
| 2025 | 18,640 |
| 2026 (partial) | 4,087 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Ozurdex
In FDA adverse event reports that mention Ozurdex, these medications appeared most often in the same report.
- Lenalidomide (94,660 reports)
- Bortezomib (49,745 reports)
- Cyclophosphamide (36,307 reports)
- Cyclophosphamide For (36,307 reports)
- Aspirin (35,084 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026