ArticleBMC pharmacology & toxicology2025
A pharmacovigilance study of olanzapine/samidorphan based on FDA Adverse Event Reporting System (FAERS).
Article in BMC pharmacology & toxicology, 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
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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
2 citing papers in PubMed.
- Reporting patterns of adverse drug withdrawal events using individual case safety reports in the FAERS and Eudravigilance databases.Exploratory research in clinical and social pharmacy · 2026Article
- Samidorphan sadness: does the addition of samidorphan to olanzapine have prodepressive effects?International clinical psychopharmacology · 2026Article
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
objectsThe olanzapine/samidorphan (OLZ/SAM) combination is being regarded as a new strategy to combat weight gain induced by olanzapine (OLZ), and its safety is of significant concern. Specifically, as samidorphan is an opioid receptor-related drug, issues related to its potential for dependence and withdrawal symptoms deserve attention. This study aims to provide a comprehensive analysis of adverse events (AEs) associated with the OLZ/SAM.
methodsThis study is a pharmacovigilance study based on the analysis of reports from the FDA Adverse Event Reporting System (FAERS) utilizing the Openvigil online analysis platform for the period from January 1, 2023, to June 30, 2024. Signal results were reported as Reporting Odds Ratios (ROR) along with 95% confidence intervals. A binary logistic regression model was used to analyze the association between the OLZ/SAM and specific AEs.
resultsThis study included 86 reports of AEs associated with the OLZ/SAM and 4,678 reports related to OLZ. In terms of frequency of OLZ/SAM-related AEs, off-label use (N = 12) and drug withdrawal syndrome (N = 11) were reported most frequently. Among various system organ classes, the highest frequency of AEs was observed in neurological disorders (SOC) (N = 23). We identified 15 signals associated with the OLZ/SAM. The results of the stepwise regression analysis indicated that in all models, the OLZ/SAM was significantly associated with drug withdrawal syndrome when compared to OLZ (p < 0.01).
conclusionThe long-term safety of the OLZ/SAM warrants attention, particularly concerning drug withdrawal syndrome.
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Registered trials
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