Pharmacovigilance Review of Fluoxetine: Safety Profile, Adverse Drug Reactions, and Risk-Minimization Strategies

Author(s)	Bhakti Prakash Jadhav, Umme Roman Shaikh
Country	India
Abstract	Fluoxetine is a widely used selective serotonin reuptake inhibitor (SSRI) prescribed for depression, obsessive–compulsive disorder, anxiety disorders, and other psychiatric conditions. Due to its long-term and global use, continuous pharmacovigilance is essential to identify, evaluate, and prevent adverse drug reactions that may occur during therapy. This review highlights the safety profile of Fluoxetine, commonly reported and rare adverse drug reactions, post-marketing safety data, and approaches for improving monitoring and patient safety. The goal is to enhance understanding of Fluoxetine’s benefit–risk balance and support safer clinical use.
Keywords	Fluoxetine, Pharmacovigilance, Selective Serotonin Reuptake Inhibitor, Adverse Drug Reactions, Drug Safety, Post-Marketing Surveillance, Serotonin Syndrome, Risk Minimization.
Field	Medical / Pharmacy
Published In	Volume 7, Issue 6, November-December 2025
Published On	2025-11-27
DOI	https://doi.org/10.36948/ijfmr.2025.v07i06.62144
Short DOI	https://doi.org/hbdsms

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