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Fluoxetine

Felicium, Fluctine, Fluoxetin, Flux · ATC code N06AB03

Also known as: Fluoxetin, Fluoksetin · Brand names: Felicium, Fluctine, Flux, Fluxomed, Mutan, Depreks, Fulsac, Loksetin, Prozac, Psenac, Soulzac, Zedprex

Key facts
Active substance
Fluoxetine
Drug class
Selective serotonin reuptake inhibitor
ATC code
N06AB03
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

• 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 age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)].

• In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1)].
• Fluoxetine is not approved for use in children less than 7 years of age [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax.

Key facts

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI). Per the US prescribing information, it treats depression, OCD, bulimia nervosa and panic disorder, and with olanzapine bipolar and treatment-resistant depression.

What it is used for

  • Acute and maintenance treatment of major depressive disorder
  • Acute and maintenance treatment of obsessive compulsive disorder
  • Binge-eating and vomiting behaviors in moderate to severe bulimia nervosa
  • Acute treatment of panic disorder
  • With olanzapine: depressive episodes of bipolar I disorder and treatment-resistant depression

Dosing

  • Depression, adults: 20 mg/day in the morning; may increase after several weeks, maximum 80 mg/day.
  • Depression, children and adolescents: 10 or 20 mg/day; after 1 week at 10 mg/day increase to 20 mg/day.
  • OCD: 20 mg/day; recommended range 20 to 60 mg/day, maximum 80 mg/day.
  • Bulimia: 60 mg/day in the morning, titrated over several days if needed.
  • Panic disorder: 10 mg/day, increasing to 20 mg/day after one week.
  • Hepatic impairment: lower or less frequent dosage.

Contraindications

  • MAOIs for psychiatric disorders with fluoxetine or within 5 weeks of stopping it; fluoxetine within 14 days of stopping an MAOI
  • Starting fluoxetine in patients treated with linezolid or intravenous methylene blue
  • Pimozide or thioridazine

Important warnings

  • Boxed warning: increased risk of suicidal thoughts and behavior in children, adolescents and young adults; monitor all patients closely
  • Serotonin syndrome
  • QT prolongation and ventricular arrhythmia
  • Increased risk of bleeding, hyponatremia, seizures, angle-closure glaucoma
  • Activation of mania/hypomania; screen for bipolar disorder before starting

Side effects

  • Common: nausea, insomnia, nervousness, anxiety, somnolence
  • Diarrhea, anorexia, dry mouth, tremor, asthenia
  • Sexual dysfunction, discontinuation reactions, allergic reactions and rash

Interactions

  • MAOIs: risk of serotonin syndrome; contraindicated
  • Pimozide and thioridazine: raised levels via CYP2D6 inhibition and QT prolongation
  • Tricyclic antidepressants: dose may need reduction and level monitoring
  • Other serotonergic and CNS-acting drugs: caution

Pregnancy and breastfeeding

  • SSRI exposure, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage.

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Patient information (US)

Patient information (US) →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • FeliciumStada Arzneimittel Gmbh · 1 register entry
  • FluctineEli Lilly Ges. M.B.H · 1 register entry
  • Fluoxetin1a Pharma Gmbh, Genericon Pharma Gesellschaft M.B.H., +pharma Arzneimittel Gmbh, Viatris Limited, Stada Arzneimittel Ag, G.L. Pharma Gmbh · 7 register entries
  • FluxHexal Pharma Gmbh · 1 register entry
  • FluxomedS.Med Handelsgmbh · 1 register entry
  • MutanG.L. Pharma Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Fluoxetin1 A Pharma Gmbh, Neuraxpharm Arzneimittel Gmbh, Micro Labs Gmbh, Ratiopharm Gmbh, Vitabalans Oy, Hexal Ag, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Viatris Germany Gmbh, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 14 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • DepreksABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • FulsacBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • LoksetinNOBEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • ProzacLİLLY İLAÇ TİC. LTD. ŞTİ. · 2 register entries
  • PsenacBEYMED İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • SoulzacARGİS İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • ZedprexADEKA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 27 more European countries
Belgium
Fluoxetin Ab, Fluoxetine Eg, Fluoxetine Viatris, Fluoxone Divule, Prozac
Bulgaria
Бифлокс
Croatia
Portal
Cyprus
Fluoxetine Aurobindo, Fluoxetine Aviral, Fluoxetine Kleva, Fluxil, Magrilan, Meropan, Plazeron
Czechia
Deprex, Fluoxetin Pharmconsul, Fluoxetine Vitabalans, Fluzak, Magrilan
Denmark
Fluoxetin Hexal, Fluoxetin Orifarm, Fluoxetin ”mylan”, Fluoxetine Orion, Fluoxetine Vitabalans
Estonia
Fluoxetine Vitabalans, Flux
Finland
Fluoxetine Vitabalans, Seromex, Seronil
France
Fluoxetine Accord, Fluoxetine Almus, Fluoxetine Arrow, Fluoxetine Biogaran, Fluoxetine Cristers, Fluoxetine Eg, Fluoxetine Evolugen, Fluoxetine Microlabs, Fluoxetine Sandoz, Fluoxetine Sans Sucre Biogaran, Fluoxetine Teva, Fluoxetine Viatris, Fluoxetine Zentiva, Fluoxetine Zydus, Prozac
Greece
Dagrilan, Flonital, Fokeston, Ladose, Ladosole, Sofelin, Stephadilat-S, Zinovat
Hungary
Floxet, Fluoxetin Zentiva, Fluoxetine Vitabalans
Iceland
Fluoxetin Viatris, Fluoxetin Wh, Fluoxetine Vitabalans, Fontex
Ireland
Fluoxetine Activase Pharmaceuticals, Fluoxetine Brillpharma (Ireland), Fluoxetine Syri Pharma, Fluzac, Prozac, Prozamel
Italy
Fluoxeren, Fluoxetina Accord, Fluoxetina Almus, Fluoxetina Doc Generici, Fluoxetina Eg, Fluoxetina Fidia, Fluoxetina Generics, Fluoxetina Mylan Generics, Fluoxetina Ratiopharm, Fluoxetina Sandoz Gmbh, Xeredien
Latvia
Fluoxetine Vitabalans, Flux
Lithuania
Fluoxetine Vitabalans, Flux, Magrilan
Luxembourg
Fluoxetin Ratiopharm, Fluoxetine Eg, Fluoxetine Viatris, Fluoxone Divule
Malta
Fluoxetine Accord Healthcare, Fluoxetine Activase Pharmaceuticals, Fluoxetine Aurobindo Pharma (Malta), Fluoxetine Normon, Fluxil, Magrilan
Netherlands
Fluoxetine Amdipharm, Fluoxetine Aurobindo, Fluoxetine Cf, Fluoxetine Pch, Fluoxetine Prolepha, Fluoxetine Sandoz, Fluoxetine Viatris, Prozac
Norway
Fluoxetin Ratiopharm, Fluoxetin Sandoz, Fluoxetin Viatris, Fluoxetine Orion, Fluoxetine Vitabalans
Poland
Andepin, Bioxetin, Fluoksetyna Egis, Fluoxetin Polpharma, Fluoxetine Aurovitas, Fluoxetine Vitabalans, Fluxemed, Seronil
Portugal
Digassim, Fluoxetina Alter, Fluoxetina Aurovitas, Fluoxetina Azevedos, Fluoxetina Basi, Fluoxetina Bluepharma, Fluoxetina Ciclum, Fluoxetina Farmoz, Fluoxetina Generis, Fluoxetina Germed, Fluoxetina Gp, Fluoxetina Mylan, Fluoxetina Nodepe, Fluoxetina Odipe, Fluoxetina Pharmakern, Fluoxetina Ratiopharm, Fluoxetina Tecnigen, Fluoxetina Teva, Fluoxetina Tolife, Fluoxetina Wynn, Fluoxetina Zentiva, Prozac, Psipax, Tuneluz
Romania
Fluoxetină Arena, Fluoxin
Slovakia
Fluoxetine Vitabalans, Magrilan
Slovenia
Fluoksetin Vitabalans, Fodiss
Spain
Fluoxetina Almus, Fluoxetina Aurovitas, Fluoxetina Benel, Fluoxetina Cinfa, Fluoxetina Dermogen, Fluoxetina Kern Pharma, Fluoxetina Normon, Fluoxetina Pharma Combix, Fluoxetina Pharmavic, Fluoxetina Stada, Fluoxetina Tarbis, Fluoxetina Teva-Ratiopharm, Fluoxetina Teva-Rimafar, Fluoxetina Viatris, Fluoxetina Vir, Luramon
Sweden
Fluoxetin Orifarm, Fluoxetin Ratiopharm, Fluoxetin Sandoz, Fluoxetin Stada, Fluoxetin Teva, Fluoxetin Viatris, Fluoxetine Accord, Fluoxetine Orion, Fluoxetine Vitabalans, Fontecare, Fontex

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. FLUOXETINE (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.) – Prescribing Information, 2026-08-11. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6f4e4e9f-9ded-452f-b3ef-ab6aa9c72952
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC N06AB.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.