ArticleRevista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)2025
Potential adverse events of fluoxetine: a real-world study based on the FAERS database.
Article in Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- Comprehensive Analysis of Ozanimod-Related Adverse Events Based on the FAERS Database.World journal of oncology · 2026Article
- Comprehensive analysis of etrasimod-related adverse events based on the FDA Adverse Event Reporting System database.Indian journal of pharmacology · 2026Article
- Bridging Literature and Real-World Evidence: External Evaluation and Development of Fluoxetine Population Pharmacokinetics Model.Pharmaceutics · 2025Article
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
objectiveThis study aimed to mine and analyze adverse event signals of fluoxetine using the U.S. Food and Drug Administration's Adverse Event Reporting System database.
methodsThis study focused on suspected adverse drug reaction reports between the first quarter of 2004 and the second quarter of 2023 in which fluoxetine was the primary suspected drug. Four signal mining and analysis methods were employed to comprehensively assess adverse event signals.
resultsA total of 19,932,732 reports were collected, of which 22,884 primarily suspected fluoxetine. Through analysis, 862 signs involving 27 system organ classes were identified. More adverse events were reported by female patients (58.81%) than male patients (26.84%), with the largest percentage being in the 18-45 year age group. The signal strength of adverse events related to pregnancy and neonatal conditions was notable, including fetal exposure during pregnancy, exposure during pregnancy, and neonatal health-related adverse events, such as atrial septal defect, premature baby, ventricular septal defect, and maternal drugs affecting the fetus.
conclusionsAlthough fluoxetine has been extensively approved and applied, its use in women who are pregnant or planning to conceive should be approached with caution.
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