ArticlePloS one2025
Remimazolam's clinical application and safety: A signal detection analysis based on FAERS data and literature support.
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 6 papers.
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
6 citing papers in PubMed.
- Obesity Reduces the Median Effective Dose of Remimazolam in Aged 6-18 Pediatric Patients for Procedural Sedation.Drug design, development and therapy · 2026Trial
- Remimazolam-Induced Anaphylaxis After Spinal Anesthesia: A Case Report and Literature Review.Journal of clinical medicine · 2026Article
- Local Urticarial Reaction Above the Site of an Intravenous Cannula: Possible Allergy to Remimazolam in a Fourteen-Year-Old Adolescent.Journal of medical cases · 2026Article
- Advantages of Remimazolam in Pediatric Anesthesia: A Narrative Review.Children (Basel, Switzerland) · 2026Review
- Real-world safety profile of givinostat: an early post-marketing pharmacovigilance study based on the FAERS database.Frontiers in pharmacology · 2026Article
- Flumazenil reversal of remimazolam-induced sedation: a narrative review of safety, pharmacokinetics, and clinical considerations.Frontiers in medicine · 2026Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This study aimed to evaluate the adverse event profile of remimazolam, a novel ultra-short-acting benzodiazepine, with a focus on its safety in the respiratory, cardiovascular, and immune systems across diverse patient populations. We analyzed adverse event reports from the FAERS database over a defined period, performing signal detection using the proportional reporting ratio (PRR) and the reporting odds ratio (ROR), and contextualized the findings with a concurrent literature review. Remimazolam demonstrated a strong signal for hypoventilation. In the cardiovascular system, it was associated with serious adverse events, including cardiac and cardiorespiratory arrest, particularly in high-risk patients. Furthermore, we detected significant signals for severe hypersensitivity reactions, such as anaphylactic shock and laryngeal edema, while signals in other systems were less pronounced but remained clinically significant. Given that the study population was predominantly elderly, and considering the serious nature of the identified signals, its potential for adverse events necessitates vigilant monitoring. Future research should focus on clarifying risks within specific high-risk groups to establish optimized safety protocols.
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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.