ArticleBMC pharmacology & toxicology2025
Assessment the real-world safety of intravitreal dexamethasone implant (Ozurdex): novel insights from a comprehensive pharmacovigilance analysis utilizing the FAERS database.
Article in BMC pharmacology & toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Exploring the role of oxidative stress in retinal vein occlusion: an updated and comprehensive review on the pathophysiology and treatment perspectives.International ophthalmology · 2025Pooled it
- Review
- Photopolymerizable Imidazolium Methacrylate Networks for Controlled Dexamethasone Release: Potential Application in Uveitis Therapy.ACS omega · 2026Article
- Sustained Intraocular Pressure Control After iStent InfiniteJournal of clinical medicine · 2026Article
- Real-world landscape of drug-related ocular injuries: a retrospective pharmacovigilance study.Frontiers in pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
objectiveThe intravitreal dexamethasone implant (Dex) is widely used for various ocular conditions, including diabetic macular edema (DME), retinal vein occlusion (RVO), and non-infectious uveitis. Despite its efficacy, concerns remain regarding its safety profile. This study aims to analyze the adverse events (AEs) associated with Dex reported in the FDA Adverse Event Reporting System (FAERS) database from 2010 to 2024.
methodsData were extracted from FAERS, focusing on cases where Dex was the primary suspect drug. The dataset was processed to eliminate duplicates and incomplete entries. Disproportionality analysis, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR), was used to detect safety signals. AEs were categorized by system organ class (SOC) and preferred term (PT).
resultsA total of 1,588 adverse event reports (AERs) were analyzed, revealing a significant upward trend. The Eye disorders was the most commonly reported SOC, with strong disproportionality signals (ROR: 45.11; PRR: 23.71). Key AEs identified at the PT level included Corneal decompensation, Choroidal hematoma, and Posterior capsule rupture, which were not listed on the drug label. Considering the reported numbers, the Endophthalmitis was the most common AE. Additionally, a significant proportion of AEs were observed within the first seven days post-administration, emphasizing the need for monitoring.
conclusionWhile Dex remains an effective treatment option for ocular conditions, its use is associated with significant risks, particularly regarding unexpected and severe complications such as corneal decompensation. Continuous pharmacovigilance and detailed patient monitoring are essential to mitigate these risks. Future studies should focus on prospective designs and comprehensive clinical data to better understand the safety profile of Dex.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.