Cited by 181Treatment of Major DepressionAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesMental Health Treatment and Access

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Side-Effect Profile of Fluoxetine in Comparison with Other SSRIs, Tricyclic and Newer Antidepressants: A Meta-Analysis of Clinical Trial Data

Brambilla, P., Cipriani, A., Hotopf, M., Barbui, C.·2005·Pharmacopsychiatry

DOI 10.1055/s-2005-837806

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Abstract

BACKGROUND: In the last ten years, SSRIs have increasingly replaced TCAs as comparators of newer antidepressants (ADs), because of their better tolerability profile. In particular, fluoxetine has become a reference drug for the treatment of depression, but the occurrence of individual side effects in depressed subjects treated with fluoxetine and each comparator AD have not been systematically investigated. METHODS: This meta-analysis investigated the frequency of side effects induced by fluoxetine or alternative ADs and compared the occurrence of individual side effects in depressed subjects. All randomised clinical trials (RCTs) comparing fluoxetine with any other AD drug in patients with major depression were located by searching the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Controlled Trials Register. Two reviewers independently extracted information. RESULTS: Significantly less percentage of patients treated with fluoxetine experienced any side effects in comparison with TCAs (50.9 % vs 60.3 %, 29 RCTs; RR = 0.84, p = 0.003), but not in comparison with other SSRIs (59.4 % vs 59.3 %, 15 RCTs; RR = 1.00, p = 0.902). In addition, fluoxetine was better tolerated in comparison with TCAs and related ADs (RR 0.61, 95 % CI 0.52, 0.71), but not in comparison with other SSRIs. Regard to individual side effects, activating (insomnia, agitation, tremor and anxiety) and gastrointestinal adverse events (nausea, vomiting, diarrhoea, weight loss and anorexia) were significantly more frequent in fluoxetine-treated patients, whereas cholinergic side effects were significantly less frequent. CONCLUSIONS: Fluoxetine compared to other ADs had more activating and gastrointestinal adverse effects, which often require additional pharmacotherapy or other managements strategies, leading to discontinuation and non-compliance and increasing the costs. This information is relevant to base on evidence the prescription of ADs in everyday clinical practice.

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Authors: Brambilla, P., Cipriani, A., Hotopf, M., & Barbui, C.
Affiliations: University of Udine (IT)
University of Verona (IT)
King's College London (GB)
ORCID: Brambilla, P.
Cipriani, A.
Hotopf, M.
Barbui, C.
Venue: Pharmacopsychiatry
Publisher: Georg Thieme Verlag KG
Published: 2005-03
Volume: 38
Issue: 2
Pages: 69-77
ISSN: 0176-3679 (ISSN-L)
1439-0795
DOI: 10.1055/s-2005-837806
OpenAlex: W2061936774
Cited by: 181
References: 0
Citations by year: 2026: 2 · 2025: 8 · 2024: 7 · 2023: 8 · 2022: 11 · 2021: 13 · 2020: 13 · 2019: 7 · 2018: 2 · 2017: 10 · 2016: 11 · 2015: 9 · 2014: 16 · 2013: 11 · 2012: 5
FWCI: 1.08
Type: journal article
Language: de
Open access: closed
Locations: Pharmacopsychiatry (publishedVersion)
PubMed (publishedVersion)
Research Portal (King's College London) (submittedVersion)
Topics: Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
Health Sciences › Medicine › Psychiatry and Mental health › Mental Health Treatment and Access
Keywords: fluoxetine, selective serotonin reuptake inhibitors, tricyclic antidepressants, newer antidepressants, major depressive disorder, adverse drug reactions, tolerability, insomnia, gastrointestinal adverse effects, cholinergic side effects, treatment discontinuation, medication non-adherence
MeSH terms: Antidepressive Agents, Tricyclic, Major Depressive Disorder, Drug Tolerance, Fluoxetine, Humans, Randomized Controlled Trials as Topic, Selective Serotonin Reuptake Inhibitors, Gastrointestinal Tract

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Side-Effect Profile of Fluoxetine in Comparison with Other SSRIs, Tricyclic and Newer Antidepressants: A Meta-Analysis of Clinical Trial Data

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