Abstract：
UNASSIGNED: We aimed to examine the common adverse drug reactions (ADRs) of metoclopramide, FDA-approved for treating many gastrointestinal conditions including gastroparesis, and prucalopride, FDA-approved for treating chronic idiopathic constipation but used off-label for other gastrointestinal conditions including gastroparesis.
UNASSIGNED: The FDA Adverse Event Reporting System (FAERS) was analyzed from January 2013 to December 2023. ADR reports regarding use of only metoclopramide or prucalopride were analyzed following exclusion of reports indicating use for treatment of non-gastrointestinal conditions.
UNASSIGNED: Analysis of 1,085 reports on metoclopramide revealed tardive dyskinesia (n = 393, 36.2%) and dystonia (n = 170, 15.7%) among the most reported ADRs in addition to QTc prolongation (n = 16, 1.5%) with progression to Torsade de pointes (n = 5, 0.5%) and triggering of pheochromocytoma crisis (n = 24, 2.2%). Analysis of 865 reports on prucalopride revealed headache (n = 120, 13.9%), diarrhea (n = 116, 13.4%), and abdominal pain (n = 100, 11.6%) as the most common ADRs with 22 reports (2.5%) of dystonia with the use of prucalopride.
UNASSIGNED: This FAERS database analysis shows post-marketing reports of ADRs from metoclopramide most frequently include tardive dyskinesia, dystonia, and tremor in addition to potentially fatal arrhythmias such as Torsade de pointes. Consumers of prucalopride may also be at risk of dystonia and other ADRs.
UNASSIGNED: The FDA Adverse Event Reporting System (FAERS) was analyzed from January 2013 to December 2023. ADR reports regarding use of only metoclopramide or prucalopride were analyzed following exclusion of reports indicating use for treatment of non-gastrointestinal conditions.
UNASSIGNED: Analysis of 1,085 reports on metoclopramide revealed tardive dyskinesia (n = 393, 36.2%) and dystonia (n = 170, 15.7%) among the most reported ADRs in addition to QTc prolongation (n = 16, 1.5%) with progression to Torsade de pointes (n = 5, 0.5%) and triggering of pheochromocytoma crisis (n = 24, 2.2%). Analysis of 865 reports on prucalopride revealed headache (n = 120, 13.9%), diarrhea (n = 116, 13.4%), and abdominal pain (n = 100, 11.6%) as the most common ADRs with 22 reports (2.5%) of dystonia with the use of prucalopride.
UNASSIGNED: This FAERS database analysis shows post-marketing reports of ADRs from metoclopramide most frequently include tardive dyskinesia, dystonia, and tremor in addition to potentially fatal arrhythmias such as Torsade de pointes. Consumers of prucalopride may also be at risk of dystonia and other ADRs.
摘要：
■我们旨在检查甲氧氯普胺的常见不良反应（ADR），FDA批准用于治疗许多胃肠道疾病，包括胃轻瘫，还有普鲁卡必利,FDA批准用于治疗慢性特发性便秘，但用于其他胃肠道疾病，包括胃轻瘫。
■FDA不良事件报告系统（FAERS）于2013年1月至2023年12月进行了分析。在排除表明用于治疗非胃肠道疾病的报告后，分析了仅使用甲氧氯普胺或普鲁卡必利的ADR报告。
■对1,085份甲氧氯普胺报告的分析显示，除了QTc延长（n=16，1.5％）和嗜铬细胞瘤发作（n=5，0.5％）和触发嗜铬细胞瘤（2.2％），迟发性运动障碍（n=393，36.2％）和肌张力障碍（n=170，15.7％）。对865份普罗必利报告的分析显示头痛（n=120，13.9％），腹泻（n=116，13.4%），和腹痛（n=100，11.6％）是最常见的ADR，其中22例（2.5％）使用普鲁卡必利时出现肌张力障碍。
■此FAERS数据库分析显示，来自甲氧氯普胺的ADR上市后报告最常见的包括迟发性运动障碍，肌张力障碍,和震颤以及潜在致命的心律失常，如尖端扭转。普鲁卡必利的消费者也可能有肌张力障碍和其他不良反应的风险。
■FDA不良事件报告系统（FAERS）于2013年1月至2023年12月进行了分析。在排除表明用于治疗非胃肠道疾病的报告后，分析了仅使用甲氧氯普胺或普鲁卡必利的ADR报告。
■对1,085份甲氧氯普胺报告的分析显示，除了QTc延长（n=16，1.5％）和嗜铬细胞瘤发作（n=5，0.5％）和触发嗜铬细胞瘤（2.2％），迟发性运动障碍（n=393，36.2％）和肌张力障碍（n=170，15.7％）。对865份普罗必利报告的分析显示头痛（n=120，13.9％），腹泻（n=116，13.4%），和腹痛（n=100，11.6％）是最常见的ADR，其中22例（2.5％）使用普鲁卡必利时出现肌张力障碍。
■此FAERS数据库分析显示，来自甲氧氯普胺的ADR上市后报告最常见的包括迟发性运动障碍，肌张力障碍,和震颤以及潜在致命的心律失常，如尖端扭转。普鲁卡必利的消费者也可能有肌张力障碍和其他不良反应的风险。
