ArticlePloS one2025
Safety of lifitegrast: A real-world pharmacovigilance study based on FAERS.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- Possible Association Between Concomitant Use of SSRIs with NSAIDs and an Increased Risk of Adverse Events Among People with Depressive Disorders: Data Mining of FDA Adverse Event Reporting System.Pharmaceuticals (Basel, Switzerland) · 2025Article
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
No grant is acknowledged in the PubMed record.
Abstract
To comprehensively assess the safety of Lifitegrast, a drug for dry eye disease, we conducted a comprehensive analysis of adverse event (AE) reports from the FDA Adverse Event Reporting System (FAERS). This retrospective study examined all AE reports submitted between Q3 2016 and Q2 2024, employing disproportionality analysis to identify safety signals associated with Lifitegrast. Out of a total of 13,326,934 AE reports indexed in the FAERS database, 12,393 listed Lifitegrast as the primary suspect drug. A total of 230 ocular AE signals were identified, with 104 of these AEs being detected by different analysis algorithms. Among these signals, 71 AEs were documented in the product insert of Lifitegrast, including but not limited to eye irritation, eye pain and eye swelling. AEs not mentioned in the drug labeling were identified, such as glaucoma and cataracts.AEs associated with Lifitegrast are more commonly observed in male patients and those aged over 65 years.The insights derived from this FAERS database analysis are significant for optimizing the use of Lifitegrast while minimizing potential side effects, thereby enhancing the safety of its clinical application.
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Registered trials
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