Comparative Analysis of Neuropsychiatric Adverse Reactions Associated with Remdesivir and Nirmatrelvir/Ritonavir in COVID-19 Treatment: Insights from EudraVigilance Data

DOI record: { "DOI": "10.3390/jcm14061886", "ISSN": [ "2077-0383" ], "URL": "http://dx.doi.org/10.3390/jcm14061886", "abstract": "<jats:p>Remdesivir (RDV) and nirmatrelvir/ritonavir (NMVr) are among the most widely used antivirals in the treatment of COVID-19, aiming to reduce disease severity and progression. Adverse neuropsychiatric effects, such as anxiety, sleep disturbances, and movement disorders, have emerged as significant concerns associated with these treatments. To better understand the safety profiles of RDV and NMVr, this study performs a pharmacovigilance analysis of individual case safety reports (ICSRs) from the EudraVigilance (EV) database. Objectives: This study evaluates the risk of neuropsychiatric adverse events associated with RDV and NMVr. Comparisons with other antiviral drugs, including darunavir, sofosbuvir, ribavirin, tenofovir, ritonavir, and sotrovimab, are also performed to develop a comprehensive understanding of the safety profiles. Methods: A retrospective analysis of ICSRs submitted to EV until 7 July 2024, with data extraction on 12 July 2024, was conducted. Demographic characteristics (age, sex, geographic region, and reporter type) and case severity were included in the descriptive analysis. Disproportionality analysis using reporting odds ratio (ROR) and 95% confidence intervals (CI) was performed to compare adverse drug reaction (ADRs) frequencies across 27 system organ classes (SOCs), with emphasis on “Nervous system disorders” and “Psychiatric disorders. Results: The total number of ICSRs was significantly higher for NMVr (n = 8078) compared to RDV (n = 3934). Nervous system disorders accounted for 3.07% of the total RDV reports and for 17.31% of NMVr reports, while psychiatric disorders represented 0.92% of the total ADRs reported for RDV (n = 60) and 3.61% for NMVr (n = 672). On the other hand, RDV showed a significantly lower frequency of reporting headache compared to NMVr (ROR: 0.1057; 95% CI: 0.0676–0.1653). Conclusions: NMVr presents a higher risk of neuropsychiatric ADRs than RDV, underscoring the need for enhanced monitoring, particularly in patients with preexisting central nervous system (CNS) conditions. These findings contribute to optimizing antiviral safety and informing clinical decision making.</jats:p>", "alternative-id": [ "jcm14061886" ], "author": [ { "affiliation": [ { "name": "Department of Toxicology, Drug Industry, Management and Legislation, Faculty of Pharmacy, “Victor Babeș” University of Medicine and Pharmacy, 2nd Eftimie Murgu Square, 300041 Timișoara, Romania" }, { "name": "Preclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, Romania" } ], "family": "Pacnejer", "given": "Aliteia-Maria", "sequence": "first" }, { "ORCID": "https://orcid.org/0000-0002-3002-7656", "affiliation": [ { "name": "Department of ENT, “Victor Babeș” University of Medicine and Pharmacy, Eftimie Murgu Square No. 2, 300041 Timișoara, Romania" } ], "authenticated-orcid": false, "family": "Negru", "given": "Mihaela Cristina", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0001-9801-0060", "affiliation": [ { "name": "Preclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, Romania" } ], "authenticated-orcid": false, "family": "Arseniu", "given": "Anca Maria", "sequence": "additional" }, { "affiliation": [ { "name": "Discipline of Pharmaceutical Chemistry, Faculty of Pharmacy, “Victor Babeș” University of Medicine and Pharmacy, 2nd Eftimie Murgu Square, 300041 Timișoara, Romania" } ], "family": "Trandafirescu", "given": "Cristina", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Pulmonology, Center for Research and Innovation in Personalized Medicine of Respiratory Diseases, “Victor Babeș” University of Medicine and Pharmacy, 300041 Timișoara, Romania" } ], "family": "Oancea", "given": "Cristian", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0003-3167-9864", "affiliation": [ { "name": "Preclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, Romania" } ], "authenticated-orcid": false, "family": "Gligor", "given": "Felicia Gabriela", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0003-2730-8729", "affiliation": [ { "name": "Preclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, Romania" } ], "authenticated-orcid": false, "family": "Morgovan", "given": "Claudiu", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0003-1540-641X", "affiliation": [ { "name": "Preclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, Romania" } ], "authenticated-orcid": false, "family": "Butuca", "given": "Anca", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Toxicology, Drug Industry, Management and Legislation, Faculty of Pharmacy, “Victor Babeș” University of Medicine and Pharmacy, 2nd Eftimie Murgu Square, 300041 Timișoara, Romania" }, { "name": "Research Center for Pharmaco-Toxicological Evaluations, Faculty of Pharmacy, “Victor Babeș” University of Medicine and Pharmacy, Eftimie Murgu Square No. 2, 300041 Timișoara, Romania" } ], "family": "Dehelean", "given": "Cristina Adriana", "sequence": "additional" } ], "container-title": "Journal of Clinical Medicine", "container-title-short": "JCM", "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2025, 3, 11 ] ], "date-time": "2025-03-11T12:59:52Z", "timestamp": 1741697992000 }, "deposited": { "date-parts": [ [ 2025, 3, 12 ] ], "date-time": "2025-03-12T17:35:19Z", "timestamp": 1741800919000 }, "funder": [ { "name": "Victor Babes University of Medicine and Pharmacy Timișoara" } ], "indexed": { "date-parts": [ [ 2025, 3, 13 ] ], "date-time": "2025-03-13T04:21:34Z", "timestamp": 1741839694182, "version": "3.38.0" }, "is-referenced-by-count": 0, "issue": "6", "issued": { "date-parts": [ [ 2025, 3, 11 ] ] }, "journal-issue": { "issue": "6", "published-online": { "date-parts": [ [ 2025, 3 ] ] } }, "language": "en", "license": [ { "URL": 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