Potential Adverse Events of Fluoxetine: A Real-world Study Based on FAERS Database.

Objective: This study aimed to mine and analyze adverse event signals of fluoxetine using the FAERS database.

Methods: This study focused on suspected drug adverse reaction reports from the first quarter of 2004 to the second quarter of 2023, with fluoxetine as the primary suspected drug. Four signal mining and analysis methods were employed to comprehensively assess adverse event signals.

Results: A total of 19,932,732 reports were collected, of which 22,884 were primarily suspected of fluoxetine. Through analysis, 862 PT signals involving 27 SOCs were identified. Among the reported patients, female patients (58.81%) reported a higher proportion than males (26.84%), and the age group of 18 to 45 held the largest percentage. Adverse event signal strength related to pregnancy and neonatal conditions was notable, including Foetal exposure during pregnancy, Exposure during pregnancy, and neonatal health-related adverse events showed higher signal strength, such as Atrial septal defect, Premature baby, Ventricular septal defect, and Maternal drugs affecting the fetus.

Conclusion: Although Fluoxetine has been extensively approved and applied, its use in pregnant and planning-to-conceive women should be approached with caution.