Abstract：
UNASSIGNED: Atogepant, an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist, is being investigated for the treatment of migraine.
UNASSIGNED: We collected data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Four algorithms (ROR, PRR, BCPNN, and EBGM) were used as measures to detect signals of atogepant-associated adverse events (AEs) in real-world data.
UNASSIGNED: Of the 3,552,072 reports, 2876 expressly stated the use of atogepant. Women accounted for the majority of adverse events (AEs), with a notable age concentration of 45-65 years. The percentage of reported adverse events was the highest in the United States. Significant system organ categories (SOC) included nervous system disorders, gastrointestinal disorders, nervous system disorders, surgical and medical procedures, ear and labyrinth disorders. Notably, preferred terms (PTs) related to atogepant include migraine, constipation, nausea, vertigo, somnolence, decreased appetite, dizziness and fatigue. Unexpected adverse events such as abnormal dreams, self-injurious ideation, brain fog, tension headache, nightmare, brain neoplasm, feeling abnormal, euphoric mood, hyperacusis and post concussion syndrome were also identified.
UNASSIGNED: The present investigation has detected new and unexpected signals of atogepant-related adverse drug reactions (ADRs). In order to confirm these solve safety issues that were previously overlooked, more research is necessary.
UNASSIGNED: We collected data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Four algorithms (ROR, PRR, BCPNN, and EBGM) were used as measures to detect signals of atogepant-associated adverse events (AEs) in real-world data.
UNASSIGNED: Of the 3,552,072 reports, 2876 expressly stated the use of atogepant. Women accounted for the majority of adverse events (AEs), with a notable age concentration of 45-65 years. The percentage of reported adverse events was the highest in the United States. Significant system organ categories (SOC) included nervous system disorders, gastrointestinal disorders, nervous system disorders, surgical and medical procedures, ear and labyrinth disorders. Notably, preferred terms (PTs) related to atogepant include migraine, constipation, nausea, vertigo, somnolence, decreased appetite, dizziness and fatigue. Unexpected adverse events such as abnormal dreams, self-injurious ideation, brain fog, tension headache, nightmare, brain neoplasm, feeling abnormal, euphoric mood, hyperacusis and post concussion syndrome were also identified.
UNASSIGNED: The present investigation has detected new and unexpected signals of atogepant-related adverse drug reactions (ADRs). In order to confirm these solve safety issues that were previously overlooked, more research is necessary.
摘要：
■Atogepant,口服给药，小分子,降钙素基因相关肽（CGRP）受体拮抗剂，正在研究偏头痛的治疗方法。
■我们从美国食品和药物管理局不良事件报告系统（FAERS）数据库收集数据。四种算法(ROR，PRR,BCPNN,和EBGM）被用作检测真实世界数据中与不良事件（AE）相关的信号的量度。
■在3,552,072份报告中，2876明确指出使用atogepant。女性占不良事件（AE）的大多数，显着年龄集中在45-65岁。报告的不良事件百分比在美国最高。重要的系统器官类别（SOC）包括神经系统疾病，胃肠道疾病，神经系统疾病,手术和医疗程序，耳朵和迷宫障碍。值得注意的是,与atogepant相关的首选术语（PT）包括偏头痛，便秘,恶心,眩晕,嗜睡,食欲下降,头晕和疲劳。意外的不良事件，如异常的梦，自我伤害的想法，脑雾,紧张性头痛,噩梦,脑肿瘤,感觉异常，欣快的心情,还发现了高音和脑震荡后综合征。
■本调查发现了新的和意外的与抗药物相关的药物不良反应（ADR）信号。为了确认这些解决了以前被忽视的安全问题，更多的研究是必要的。
■我们从美国食品和药物管理局不良事件报告系统（FAERS）数据库收集数据。四种算法(ROR，PRR,BCPNN,和EBGM）被用作检测真实世界数据中与不良事件（AE）相关的信号的量度。
■在3,552,072份报告中，2876明确指出使用atogepant。女性占不良事件（AE）的大多数，显着年龄集中在45-65岁。报告的不良事件百分比在美国最高。重要的系统器官类别（SOC）包括神经系统疾病，胃肠道疾病，神经系统疾病,手术和医疗程序，耳朵和迷宫障碍。值得注意的是,与atogepant相关的首选术语（PT）包括偏头痛，便秘,恶心,眩晕,嗜睡,食欲下降,头晕和疲劳。意外的不良事件，如异常的梦，自我伤害的想法，脑雾,紧张性头痛,噩梦,脑肿瘤,感觉异常，欣快的心情,还发现了高音和脑震荡后综合征。
■本调查发现了新的和意外的与抗药物相关的药物不良反应（ADR）信号。为了确认这些解决了以前被忽视的安全问题，更多的研究是必要的。
