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vortioxetine

Brintellix · ATC code N06AX26

Also known as: Vortioxetin · Brand names: Brintellix, Bremisolan, Jilordi, Vortioxetin G.L. Pharma, Vorilix, Vortioxetin Aristo, Vortioxetin Elpen, Vortioxetin Stada, Fonksera, Serenvi, Sordena

Key facts
Active substance
vortioxetine
Drug class
Antidepressant
ATC code
N06AX26
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Brintellix 5 mg film-coated tablets / Brintellix 10 mg film-coated tablets / Brintellix 15 mg film-coated tablets · Brintellix 20 mg/ml oral drops, solution
Marketing authorisation holder
H. Lundbeck A/S
Information as of
2026-10-27

Key facts

Vortioxetine is a multimodal antidepressant acting on the serotonin system. It is used to treat major depressive episodes in adults.

What it is used for

  • Major depressive episodes in adults

Dosing

  • Adults under 65: starting and recommended dose 10 mg once daily; 5 mg to 20 mg once daily depending on response
  • Aged 65 and older: start at 5 mg once daily; caution with doses above 10 mg
  • Continue for at least 6 months after symptoms resolve
  • Strong CYP2D6 inhibitors (e.g. bupropion, quinidine, fluoxetine, paroxetine): a lower dose may be considered; broad CYP inducers: dose adjustment may be considered
  • No dose adjustment in renal or hepatic impairment; with or without food; gradual reduction may be considered when stopping

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Concomitant nonselective MAO inhibitors or selective MAO-A inhibitors

Important warnings

  • Suicidal thoughts and clinical worsening, especially early in treatment; close monitoring
  • Not for children and adolescents (efficacy not shown; more suicidal ideation in adolescents)
  • Serotonin syndrome
  • Hyponatraemia, especially in the elderly, liver cirrhosis or with sodium-lowering medicines
  • Bleeding; mydriasis with possible acute narrow angle glaucoma

Side effects

  • Very common: nausea
  • Common: abnormal dreams, dizziness, diarrhoea, constipation, vomiting, dyspepsia, pruritus, hyperhidrosis
  • Frequency not known: serotonin syndrome, hyponatraemia, haemorrhage, hyperprolactinaemia

Interactions

  • Irreversible non-selective MAOIs: contraindicated; at least 14 days between stopping one and starting the other
  • Strong CYP2D6 inhibitors increase vortioxetine exposure
  • Broad CYP inducers (e.g. rifampicin, carbamazepine, phenytoin) may decrease exposure

Pregnancy and breastfeeding

  • Limited data; newborns may show adaptation problems after late-pregnancy exposure to serotonergic medicines
  • Excreted in small amounts in breast milk; a risk to the breastfed child cannot be excluded

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 →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

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.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • BremisolanG.L. Pharma Gmbh · 2 register entries
  • JilordiPharmapath Sa · 1 register entry
  • Vortioxetin G.L. PharmaG.L. Pharma Gmbh · 1 register entry

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

Germany

  • VorilixKrka, D.D., Novo Mesto · 1 register entry
  • Vortioxetin AristoAristo Pharma Gmbh (Art 57) · 1 register entry
  • Vortioxetin ElpenElpen Pharmaceutical Co. Inc. · 1 register entry
  • Vortioxetin StadaStada Arzneimittel Ag · 1 register entry
  • VortioxetineAdalvo Limited · 1 register entry

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

Turkey

  • FonkseraLUNDBECK İLAÇ TİC. LTD. ŞTİ. · 8 register entries
  • SerenviSANTA FARMA İLAÇ SAN. A.Ş. · 9 register entries
  • SordenaEİP ECZACIBAŞI İLAÇ PAZARLAMA A.Ş · 7 register entries

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

Brand names in 26 more European countries
Belgium
Vortioxetine Hcs
Bulgaria
Вареста, Ирсамла
Croatia
Tirtox, Varesta, Vortioksetin Stada, Vortioksetin Viatris Pharma, Vortioksetinbromid Stada D.O.O.
Cyprus
Etiena, Tirtox, Vortioxetine Tad
Czechia
Avortaxo, Banavin, Irsamla, Varesta, Vortioxetin Viatris, Vortioxetine Zentiva, Yapnep
Denmark
Broxeltia, Detrevaqia, Devofaroz, Jilordi, Seliora, Ternizyl, Tixadip, Vortioxetin Pharmapath, Vortioxetine Krka, Vortioxetine Orion, Vortioxetine Viatris, Vortioxetine Zentiva, Xerivoniq, Xifuqonia, Zaloqonia, Ziventri
Estonia
Varesta, Vortioxetine Orion, Vortioxetine Zentiva
Finland
Systalkin, Vortioxetine Krka, Vortioxetine Orion, Vortioxetine Stada, Vortioxetine Viatris
France
Vortioxetine Biogaran, Vortioxetine Eg Labo, Vortioxetine Hcs, Vortioxetine Viatris, Vortioxetine Zentiva, Vortioxétine Biogaran
Greece
Broxeltia, Detrevaqia, Etiena, Tirtox, Varesta, Vortioxetin Pharmapath, Vortioxetine Ariti, Vortioxetine Pharmapath, Vortioxetine Pharmazac, Vortioxetine Viatris, Vortioxetine Win Medica, Xirtov
Hungary
Avortaxo, Banavin, Bremisolan, Etiena, Irsamla, Varesta, Vortioxetin Elpen, Vortioxetine Zentiva, Yapnep
Iceland
Brintellix, Vortioxetine Krka, Vortioxetine Viatris
Ireland
Vortioxetine Clonmel, Vortioxetine Krka
Italy
Vortioxetina Eg, Vortioxetina Krka, Vortioxetina Viatris
Latvia
Irsamla, Quelarbo, Varesta, Vortioxetine G.L. Pharma, Vortioxetine Orion, Vortioxetine Unifarma, Vortioxetine Zentiva
Lithuania
Irsamla, Varesta, Vortioxetine G.L. Pharma, Vortioxetine Orion, Vortioxetine Zentiva
Malta
Devofaroz, Ternizyl, Tixadip, Xerivoniq, Ziventri
Netherlands
Qerrassa, Vortioxetine Amarox, Vortioxetine Hcs, Vortioxetine Viatris
Norway
Brintellix, Seliora, Vortioxetine
Poland
Abrix, Anubes, Avortaxo, Banavin, Irsamla, Varesta, Vortioxetine Aristo, Vortioxetine Stada, Vortioxetine Viatris Pharma
Portugal
Vortioxetina Anova, Vortioxetina Aristo, Vortioxetina Farmoz, Vortioxetina Krka, Vortioxetina Mylan, Vortioxetina Pharmakern, Vortioxetina Pharmazac, Vortioxetina Stada, Vortioxetina Tad, Vortioxetina Tecnigen, Xirtov
Romania
Irsamla, Varesta
Slovakia
Avortaxo, Banavin, Irsamla, Varesta, Vortioxetín Stada
Slovenia
Banavin, Irsamla, Varesta, Vorilix, Vortioksetin Kern Pharma, Vortioksetin Krka D.D., Vortioksetin Stada, Vortioxetine
Spain
Vortioxetina Alembic, Vortioxetina Aristo, Vortioxetina Cinfa, Vortioxetina Kern Pharma, Vortioxetina Krka, Vortioxetina Stada, Vortioxetina Tarbis, Vortioxetina Tecnigen, Vortioxetina Viatris, Zaloqonia
Sweden
Seliora, Vortioxetin Amarox, Vortioxetine Krka, Vortioxetine Orion, Vortioxetine Stada, Vortioxetine Viatris, Vortioxetine Zentiva

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

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Sources

  1. European Medicines Agency. Brintellix – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/brintellix-epar-product-information_en.pdf
  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 N06AX.

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

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.