Radzuan Muhammad Ikhwan Syahmi Mohamad, Karuppannan Mahmathi
Department of Pharmacy Practice and Clinical Pharmacy, Faculty of Pharmacy, Universiti Teknologi MARA (UiTM) Selangor Branch, 42300 Bandar Puncak Alam, Selangor, Malaysia.
Curr Drug Saf. 2025;20(4):479-489. doi: 10.2174/0115748863334598241203073907.
The COVID-19 pandemic has called for the rapid development and use of antiviral drugs to effectively control the disease. Nirmatrelvir/Ritonavir (Paxlovid), Molnupiravir, and Remdesivir have been pivotal in therapeutic approaches, although they raise concerns regarding adverse drug reactions (ADRs).
This study aimed to thoroughly assess the ADRs associated with these drugs by utilizing the Adverse Event Reporting System (FAERS) database of the Food and Drug Administration (FDA).
ADR reports for Paxlovid, Molnupiravir, and Remdesivir throughout the period of January 2022 to May 2023 were extracted and classified according to the severity, type of reaction, and demographic variables. Reporting Odds Ratios (RORs) with 95% confidence intervals were calculated to evaluate the relationship between antiviral medications and various ADRs.
The study established notable correlations between Paxlovid and the recurrence of the disease (40.08%) and dysgeusia (16.29%). Molnupiravir was linked to gastrointestinal (16.73%) and skin reactions (9.47%), while Remdesivir had impairments in the liver (25.21%) and kidneys (13.34%). ADRs were more commonly observed in female patients treated with Paxlovid (57.95%) and Molnupiravir (49.40%), whereas Remdesivir ADRs were mostly reported in males (58.56%). Paxlovid and Remdesivir ADRs were frequently reported in adults between the ages of 18 and 64 (46.01% and 45.01%), while Molnupiravir ADRs were more common in older individuals aged 65 to 85 (40.38%).
This thorough assessment emphasizes the importance of careful surveillance and control of ADRs linked to COVID-19 antiviral therapies. It is essential to customize treatments by considering specific patient histories, particularly for pre-existing diseases.
新冠疫情促使人们迅速研发和使用抗病毒药物以有效控制该疾病。奈玛特韦/利托那韦（帕罗韦德）、莫努匹韦和瑞德西韦在治疗方法中发挥了关键作用，尽管它们引发了对药物不良反应（ADR）的担忧。
本研究旨在通过利用美国食品药品监督管理局（FDA）的不良事件报告系统（FAERS）数据库，全面评估与这些药物相关的ADR。
提取2022年1月至2023年5月期间帕罗韦德、莫努匹韦和瑞德西韦的ADR报告，并根据严重程度、反应类型和人口统计学变量进行分类。计算报告比值比（ROR）及95%置信区间，以评估抗病毒药物与各种ADR之间的关系。
该研究确定了帕罗韦德与疾病复发（40.08%）和味觉障碍（16.29%）之间存在显著相关性。莫努匹韦与胃肠道反应（16.73%）和皮肤反应（9.47%）有关，而瑞德西韦则导致肝脏（25.21%）和肾脏损害（13.34%）。接受帕罗韦德（57.95%）和莫努匹韦（49.40%）治疗的女性患者中更常观察到ADR，而瑞德西韦的ADR大多报告于男性（58.56%）。帕罗韦德和瑞德西韦的ADR在18至64岁的成年人中报告频繁（46.01%和45.01%），而莫努匹韦的ADR在65至85岁的老年人中更为常见（40.38%）。
这一全面评估强调了仔细监测和控制与新冠抗病毒治疗相关的ADR的重要性。考虑患者的具体病史，特别是既往疾病史，进行个性化治疗至关重要。
