Substance / Medication

Fluoxetine

Overview

Active Ingredient
fluoxetine
RxNorm CUI
4493

Indications

Fluoxetine tablets are indicated for the treatment of: [see Clinical Studies (14.1)]. Major Depressive Disorder (MDD). The efficacy of fluoxetine tablets in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine tablets was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.2)]. Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The ef

Labeler: Strides Pharma Science LimitedUpdated: 2025-12-16T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

[see Warnings and Precautions (5.1)] Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over ag

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Research Evidence

Published studies and systematic reviews

Sort:
The loss of efficacy of fluoxetine in pediatric depression: explanations, lack of acknowledgment, and implications for other treatments.
Plöderl Martin, Lyus Richard, Horowitz Mark A et al. · J Clin Epidemiol · 2026
PMID: 41548966Meta-Analysis
Oral side effects of fluoxetine in patients with depressive disorder: A systematic review.
Sarrión Pérez M-G, Jiménez Y, Bagán L et al. · Med Oral Patol Oral Cir Bucal · 2025
PMID: 39954277Meta-AnalysisFull text (PMC)
Gene expression signatures of response to fluoxetine treatment: systematic review and meta-analyses.
Cooper David G, Cowden J Paige, Vo Patrick M et al. · Mol Psychiatry · 2025
PMID: 40676137Meta-AnalysisFull text (PMC)
Can fluoxetine influence orthodontic tooth movement? A systematic review and meta-analysis of studies on animal models.
Javed Fawad, Ahmed Zain Uddin, Rossouw P Emile et al. · Int Orthod · 2025
PMID: 39672088Meta-Analysis
The effect of Fluoxetine on lipid profiles in overweight or obese Individuals: A systematic review and meta-analysis of randomized controlled trials.
Liu Dawei, Guo Ting, Peng Qiuju et al. · Diabetes Res Clin Pract · 2025
PMID: 39978642Meta-Analysis
Emerging Therapeutic Potential of Fluoxetine on Cognitive Decline in Alzheimer's Disease: Systematic Review.
Bougea Anastasia, Angelopoulou Efthalia, Vasilopoulos Efthimios et al. · Int J Mol Sci · 2024
PMID: 38928248Meta-AnalysisFull text (PMC)
Evaluating non-monotonic dose-response relationships in ecotoxicological risk assessment: A case study based on a systematic review of data on fluoxetine.
van der Most Merel A, Rietjens Ivonne M C M, van den Brink Nico W · Chemosphere · 2024
PMID: 38986776Meta-Analysis
Individual patient data meta-analysis of the effects of fluoxetine on functional outcomes after acute stroke.
Mead Gillian, Graham Catriona, Lundström Erik et al. · Int J Stroke · 2024
PMID: 38497332Meta-AnalysisFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Fluoxetine (substance)
SNOMED CT
372767007
UMLS CUI
C0016365
RxNorm CUI
4493
Labeler
Strides Pharma Science Limited

Clinical Data

This intervention maps to 3 entities in the Healos knowledge graph.

3
Conditions
0
Biomarkers
0
Specialists
0
Symptoms

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.

Fluoxetine — Conditions, Biomarkers & Specialists | Healos | Ltrl