ArticleJournal of pain research2025
Real-World Pharmacovigilance Analysis of Adverse Events Associated with Liposomal Bupivacaine and Bupivacaine.
Article in Journal of pain research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 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.
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Who cites it
4 citing papers in PubMed.
- Analgesic Efficacy of Continuous Bupivacaine Infusion versus Liposomal Bupivacaine in Parasacral Ischial Plane Block After Total Knee Arthroplasty: An Open-Label, Randomized, Controlled, Non-Inferiority Study.Drug design, development and therapy · 2026Trial
- Deviations from recommended use of liposomal bupivacaine: a real-world pharmacovigilance study using the FAERS database.Frontiers in medicine · 2026Article
- Comments on "Substitution of liposomal bupivacaine for lidocaine reduces incidence of injection-emergent adverse events after intraarticular therapies for knee osteoarthritis: a prospective cohort study".International journal of surgery (London, England) · 2026Article
- Rethinking the Boundaries of Local Anesthetic Systemic Toxicity in the Era of Sustained-Release Formulations.Journal of pain research · 2026Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: Liposomal bupivacaine, a novel formulation of bupivacaine, is increasingly employed for the long-lasting pain relief. The primary goal of this study was to conduct a thorough safety evaluation of liposomal bupivacaine and bupivacaine. Patients and Methods: This study analyzed adverse events (AEs) associated with liposomal bupivacaine and bupivacaine using the FDA Adverse Event Reporting System (FAERS) database from Q1 2004 to Q2 2024. Reports were screened for signal detection, focusing on the onset time and disproportionality analysis to identify positive safety signals. We evaluated the AEs associated with liposomal bupivacaine and bupivacaine. Then, we further categorized them according to the Important Medical Event Terms List (IME list). Results: The analysis revealed 8,023 AE reports in total. Liposomal bupivacaine had 58 positive safety signals, 24 of which were off-label and listed in the IME list. These signals were primarily associated with cardiac (eg, cardiogenic shock), gastrointestinal (eg, paralytic ileus), and neurological disorders. Bupivacaine generated 107 safety signals, with 49 being off-label but also on the IME list. These signals mainly affected the fetus (eg, fetal bradycardia), respiratory system (eg, respiratory depression), and nervous system (eg, neurotoxicity). Conclusion: This study identified unexpected AEs associated with liposomal bupivacaine and bupivacaine. Physicians must exercise particular caution when administering liposomal bupivacaine due to its associated risks. Monitoring for delayed analgesia-related AEs may enhance the safe use of this medication for pain management.
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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 OpenQuestion graph.