ArticleEuropean journal of clinical pharmacology2025
Post-market safety profile and suicide/self-injury risk signals of dextromethorphan/bupropion: a real-world pharmacovigilance study.
Article in European journal of clinical pharmacology, 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.
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Who cites it
1 citing paper in PubMed.
- Post-market safety profile and suicide risk signals of vortioxetine: a real-world pharmacovigilance study.Frontiers in pharmacology · 2026Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
backgroundDextromethorphan/bupropion (D/B) is an innovative pharmacological treatment for major depressive disorder. Nevertheless, the current evidence regarding the safety profile of D/B is predominantly derived from clinical trials, thus hindering the timely updating of adverse event (AE) data for this medication. Therefore, this study conducted data mining and analysis of AE signals (especially for suicide/self-injury) associated with D/B using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
methodsThis study used the disproportionality method to systematically evaluate the associations between D/B and potential AEs and compared these AEs with AEs related to bupropion and esketamine by using data from the FAERS collected between the third quarter of 2022 and the second quarter of 2024.
resultsA total of 2451 AE reports identifying D/B as the "primary suspect" were collected. From these reports, 81 preferred terms and 24 system organ classifications were identified, with a predominant focus on psychiatric disorders (22.07%) and nervous system disorders (18.77%). These AEs were mostly found in individuals aged 18-44 years. The median time to onset for D/B-related AEs was determined to be 2 days. Nearly 20 novel AEs identified during the labelling process were detected, such as a sensation of inebriation and panic attacks. Importantly, the risk signals for suicide/self-injury associated with D/B were significantly lower than those associated with bupropion and esketamine. However, these signals cannot be ignored in view of their serious consequences.
conclusionPsychiatric and nervous system disorders, such as suicidal/self-injurious behaviours, require careful monitoring in clinical applications. It is imperative to conduct traditional pharmacoepidemiological research to evaluate whether D/B is linked to an increased risk of dissociative disorders in the future. Moreover, health care professionals should remain vigilant for AE signals not listed in package inserts.
Indexed as
Identifiers
40263132What Socratic 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 Socratic graph.