Full
Outline
This study aims to utilize the FAERS database to identify and evaluate the adverse event signals of zuranolone after its market launch in the real world, so as to provide real-world evidence for its safe clinical application.
Collect the reports from the FAERS database for the fourth quarter of 2023 to the third quarter of 2025. Data is stored in MySQL, Medical Dictionary for Regulatory Activities (MedDRA) version 28.0 standardizes and systematically classifies adverse event terms, and Python is used for data cleaning and analysis. The Proportional Reporting Ratio (PRR) method and Bayesian Confidence Propagation Neural Network (BCPNN) method are used simultaneously to detect signals, thereby improving the accuracy of positive signals.
There were a total of 883 reports where zuranolone was identified as the primary suspected drug. 70 positive signals were identified, involving 7 system organ classes (SOCs). The SOC with the highest number of positive signals was psychiatric disorders, followed by neurological disorders. The number of positive signals for these two categories accounted for 80% of the total positive signals. The top three adverse events in terms of signal intensity were neonatal drowsiness, perinatal depression, and intoxication.
The adverse drug events (ADEs) of zuranolone mainly include mental disorders and neurological diseases. It may aggravate depressive symptoms and even induce suicidal behavior; during medication, it may impair the ability to operate precision instruments; it is necessary to strengthen the warning about infant exposure to zuranolone.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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