Oral versus extended-release injectable naltrexone emetic event reporting in opioid-exposed FAERS: a PAMORA-referenced analysis

Oral versus extended-release injectable naltrexone emetic event reporting in opioid-exposed FAERS: a PAMORA-referenced analysis | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 20 February 2026 V1 Latest version Share on Oral versus extended-release injectable naltrexone emetic event reporting in opioid-exposed FAERS: a PAMORA-referenced analysis Authors : Liyao Huang and Xuhui Zhou 0000-0002-5423-8861 [email protected] Authors Info & Affiliations https://doi.org/10.22541/au.177156371.13770902/v1 89 views 46 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Purpose: To compare nausea/vomiting reporting signals for oral naltrexone versus extended-release injectable naltrexone (XR-NTX; Vivitrol) and benchmark against peripherally acting μ-opioid receptor antagonists (PAMORAs). Methods: Retrospective disproportionality analysis of FAERS reports accessed via openFDA. The reporting universe was opioid-exposed reports in the primary window (March 24, 2018–October 30, 2025). Primary-suspect exposures were oral naltrexone, XR-NTX, and PAMORAs. Outcomes were MedDRA preferred terms for nausea and vomiting. Reporting odds ratios (RORs) with 95% CIs were estimated, and repeated in a serious outcome subset (hospitalization or death) and a historical window (2004–2024). Results: The opioid-exposed universe comprised 620,921 reports (primary-suspect totals: oral naltrexone n=330; XR-NTX n=1,067; PAMORAs n=2,818). Across all reports, oral naltrexone showed the strongest emetic signals (nausea ROR 4.09, 95% CI 3.09–5.41; vomiting ROR 4.00, 2.91–5.50), XR-NTX was intermediate (nausea ROR 1.68, 1.35–2.08; vomiting ROR 2.05, 1.63–2.59), and PAMORAs were modest (nausea ROR 1.66, 1.45–1.90; vomiting ROR 1.37, 1.16–1.63). Patterns were directionally consistent in the serious outcome subset and in the historical reference window. Conclusions: In an opioid-exposed FAERS universe, oral naltrexone exhibited substantially stronger nausea/vomiting disproportionality than XR-NTX, while PAMORAs provided a comparatively modest reference profile. This divergence suggests peripheral μ-receptor antagonism alone is unlikely to fully explain formulation-related emetic reporting differences, supporting a role for formulation-dependent pharmacokinetics or non-peripheral contributors. Supplementary Material File (pds-26-0155-file001.docx) Download 45.84 KB Information & Authors Information Version history V1 Version 1 20 February 2026 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords faers naltrexone nausea openfda pamora vomiting Authors Affiliations Liyao Huang Hunan University of Chinese Medicine View all articles by this author Xuhui Zhou 0000-0002-5423-8861 [email protected] Hunan University of Chinese Medicine View all articles by this author Metrics & Citations Metrics Article Usage 89 views 46 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Liyao Huang, Xuhui Zhou. Oral versus extended-release injectable naltrexone emetic event reporting in opioid-exposed FAERS: a PAMORA-referenced analysis. Authorea . 20 February 2026. DOI: https://doi.org/10.22541/au.177156371.13770902/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . 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