ArticleFrontiers in pharmacology2025
Integrated pharmacovigilance of fentanyl: multinational analysis reveals novel safety signals and demographic-specific risk profiles.
Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
2 citing papers in PubMed.
- Safety signals for drug-related respiratory depression: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS).Journal of thoracic disease · 2026Article
- Safety profile of entrectinib in NSCLC: Multi-source pharmacovigilance analysis using FAERS and JADER.PloS one · 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
No grant is acknowledged in the PubMed record.
Abstract
Background: This study aimed to characterize the comprehensive safety profile of fentanyl, including emerging and demographic-specific risks, by analyzing international pharmacovigilance data. Methods: We conducted a retrospective analysis of fentanyl-associated adverse drug events (ADEs) from the FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report database (JADER) (2004-2025). Data integration was followed by rigorous cleaning, standardization using MedDRA v27.0, and multi-method disproportionality analysis (ROR, PRR, BCPNN, MGPS). Sensitivity analyses and time-to-onset modeling were performed to evaluate temporal risk dynamics. Results: Among 76,903 reports, 396 significant signals were detected in FAERS and 95 in JADER. FAERS emphasized behavioral and device-related events (e.g., drug abuse [ROR = 31.3], administration errors [ROR = 71.08]), while JADER captured acute physiological events (e.g., respiratory depression [ROR = 57.41], neonatal respiratory failure [ROR = 212.77]). Novel signals included Kounis syndrome, application site injuries, and neonatal withdrawal. Gender disparities showed higher risks of administration errors and application site reactions in females, and misuse and overdose in males. Most events (51%) occurred within 1 month of treatment initiation. Conclusion: Fentanyl's risk profile varies significantly across regions and demographics, influenced by reporting biases and clinical use patterns. These findings advocate for global harmonization of surveillance practices and targeted risk mitigation strategies.
Indexed as
Identifiers
What OpenQuestion holds
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 OpenQuestion graph.