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Vortioxetine

AEMPS

Multimodal antidepressant

ATC code: N06AX26

Updated · Methodology

Indications

A

Major depressive disorder

First line

First-line for major depressive disorder in adults per 2024 and the Spanish SEP 2024 alongside other modern antidepressants (SSRIs, SNRIs). Dose 5–20 mg once daily. Particularly suitable in patients with cognitive complaints in depression and in those with marked SSRI sexual dysfunction. The Cipriani 2018 meta-analysis showed efficacy comparable to other antidepressants with better tolerability (5.2% dropout for adverse effects vs 7.7% with SSRIs).

Sources

  1. AEMPS: Ficha técnica de Vortioxetina (2024)
  2. The Lancet: Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis (2018)
  3. Cochrane Database of Systematic Reviews: Vortioxetine for depression in adults (2017)

ICD-10: F32.9 · ICD-11: 6A70.Z

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Memory and concentration enhancement

Not recommended

Vortioxetine is an antidepressant with a multimodal mechanism of action. It is prescribed for major depression ( 2022 and NG222 guidelines). The manufacturer promotes vortioxetine as a drug for improving cognitive function in patients with depression, and this idea has spilled over into marketing for healthy adults seeking better concentration. There are no clinical studies in people without depression, and the label does not mention cognitive improvement in non-depressed patients. The drug carries standard antidepressant risks: pronounced nausea (especially in the first weeks), sexual dysfunction, discontinuation syndrome, and increased suicide risk in young adults (FDA boxed warning). If vortioxetine was prescribed for concentration improvement or brain function outside a depression indication, consider seeking a second opinion.

Sources

  1. AEMPS: Ficha técnica de Vortioxetina (2024)
  2. Cochrane: Ginkgo biloba for cognitive impairment and dementia (2009)
How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Serotonin reuptake inhibition combined with 5-HT1A agonism, partial 5-HT1B agonism, and 5-HT3, 5-HT1D, and 5-HT7 antagonism. Multimodal action gives antidepressant effect with added cognitive improvement (attention, information processing) in depressed patients. Compared with SSRIs, less sexual dysfunction and fewer GI side effects. CYP2D6-metabolized, half-life 66 hours.

Safety

Boxed warning

FDA boxed warning: antidepressants increase suicidal ideation and behavior risk in children, adolescents, and young adults under 24 during the first weeks. Careful mental status monitoring is needed.

Contraindications

  • Vortioxetine hypersensitivity
  • Concurrent MAO inhibitors or within 14 days of stopping
  • Pregnancy and lactation
  • Age under 18

Serious adverse effects

  • Serotonin syndrome with other serotonergic drugs
  • Hyponatremia (SIADH) in older adults
  • Bleeding with concomitant antiplatelets or anticoagulants
  • Suicidal thoughts (especially early therapy)
  • Manic episode in bipolar patients

Common adverse effects

  • Nausea (most common)
  • Headache
  • Constipation or diarrhea
  • Dry mouth
  • Dizziness
  • Abnormal dreams

Pregnancy: can you take Vortioxetine?

Limited pregnancy data. T3 use linked to neonatal adaptation syndrome. Sertraline is preferred in pregnant patients with depression.

Breastfeeding: can you take Vortioxetine?

Limited data. Not recommended during lactation.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take once daily, with or without food. Effect on depressive symptoms develops over 2–4 weeks; on cognitive symptoms, 6–8 weeks. The 66-hour half-life makes withdrawal mild – no marked discontinuation symptoms after a single missed dose. CYP2D6 poor metabolizers (~7% of Caucasians) get a 10 mg cap. Strong CYP2D6 inhibitors (bupropion, fluoxetine, paroxetine) require halving the dose.
Label mentions65 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • CriticalIMAOclass named in the label
    «Uso concomitante con inhibidores no selectivos de la monoaminooxidasa (IMAOs) o inhibidores selectivos de la MAO-A (ver sección 4.5).»

    AEMPS, section 4.3 · Open on CIMA

  • CriticalLinezolid
    «CONTRAINDICATIONS: The use of MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX is contraindicated because of an increased risk of…»

    FDA, section 4 · Open on DailyMed

  • CriticalMAO inhibitorsclass named in the label
    «CONTRAINDICATIONS: The use of MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX is contraindicated because of an increased risk of…»

    FDA, section 4 · Open on DailyMed

  • CriticalMoclobemide
    «Inhibidor de la MAO-A reversible y selectivo (moclobemida): La combinación de vortioxetina con un inhibidor de la MAO-A reversible y selectivo, como la moclobemida, está contraindicada (ver sección…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateAcetylsalicylic acid
    «Anticoagulantes y antiagregantes plaquetarios: No se observaron efectos significativos, en comparación con placebo, en los valores de INR, protrombina o concentraciones plasmáticas de warfarina R y…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateAINEclass named in the label
    «Anticoagulantes y antiagregantes plaquetarios: No se observaron efectos significativos, en comparación con placebo, en los valores de INR, protrombina o concentraciones plasmáticas de warfarina R y…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateantiagregantesclass named in the label
    «Anticoagulantes y antiagregantes plaquetarios: No se observaron efectos significativos, en comparación con placebo, en los valores de INR, protrombina o concentraciones plasmáticas de warfarina R y…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateanticoagulantesclass named in the label
    «Anticoagulantes y antiagregantes plaquetarios: No se observaron efectos significativos, en comparación con placebo, en los valores de INR, protrombina o concentraciones plasmáticas de warfarina R y…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateanticoagulantsclass named in the label
    «Drugs Having Clinically Important Interactions with TRINTELLIX: Intervention Inform patients of the increased risk of bleeding associated with the concomitant use of TRINTELLIX and antiplatelet…»

    FDA, section 7 · Open on DailyMed

  • Moderateantidepresivos tricíclicosclass named in the label
    «Medicamentos que disminuyen el umbral convulsivo: Los antidepresivos con efecto serotoninérgico pueden disminuir el umbral convulsivo. Se recomienda precaución cuando se utilicen de manera simultánea…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateantiplateletsclass named in the label
    «Drugs Having Clinically Important Interactions with TRINTELLIX: Intervention Inform patients of the increased risk of bleeding associated with the concomitant use of TRINTELLIX and antiplatelet…»

    FDA, section 7 · Open on DailyMed

  • Moderateantipsicóticosclass named in the label
    «Medicamentos que disminuyen el umbral convulsivo: Los antidepresivos con efecto serotoninérgico pueden disminuir el umbral convulsivo. Se recomienda precaución cuando se utilicen de manera simultánea…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateBupropion
    «Medicamentos que disminuyen el umbral convulsivo: Los antidepresivos con efecto serotoninérgico pueden disminuir el umbral convulsivo. Se recomienda precaución cuando se utilicen de manera simultánea…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateCarbamazepine
    «Inductores del citocromo P450: Al administrar conjuntamente una dosis única de 20 mg de vortioxetina tras recibir durante 10 días 600 mg/día de rifampicina (un inductor de amplio espectro de las…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateCYP2D6 inhibitorsclass named in the label
    «Drugs Having Clinically Important Interactions with TRINTELLIX: Intervention Reduce TRINTELLIX dose by half when a strong CYP2D6 inhibitor is coadministered [see Dosage and Administration (2.5) ] .»

    FDA, section 7 · Open on DailyMed

  • ModerateISRSclass named in the label
    «Medicamentos que disminuyen el umbral convulsivo: Los antidepresivos con efecto serotoninérgico pueden disminuir el umbral convulsivo. Se recomienda precaución cuando se utilicen de manera simultánea…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateLithium
    «Litio y triptófano: No se observó un efecto clínico relevante durante la exposición en estado estacionario a litio tras la administra ción conjunta de dosis múltiples de vortioxetina en sujetos…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateopioidesclass named in the label
    «Síndrome Serotoninérgico (SS) o Síndrome Neuroléptico Maligno (SNM): La administración de vortioxetina puede dar lugar al Síndrome Serotoninérgico (SS) o al Síndrome Neuroléptico Maligno (SNM)…»

    AEMPS, section 4.4 · Open on CIMA

  • ModeratePhenytoin
    «Inductores del citocromo P450: Al administrar conjuntamente una dosis única de 20 mg de vortioxetina tras recibir durante 10 días 600 mg/día de rifampicina (un inductor de amplio espectro de las…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateRasagiline
    «Inhibidores de la MAO-B irreversibles y selectivos (selegilina, rasagilina): Si bien con los inhibidores de la MAO-B selectivos se prevé un riesgo menor de síndrome serotoninérgico que con los…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateRifampicin
    «Inductores del citocromo P450: Al administrar conjuntamente una dosis única de 20 mg de vortioxetina tras recibir durante 10 días 600 mg/día de rifampicina (un inductor de amplio espectro de las…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateSelegiline
    «Inhibidores de la MAO-B irreversibles y selectivos (selegilina, rasagilina): Si bien con los inhibidores de la MAO-B selectivos se prevé un riesgo menor de síndrome serotoninérgico que con los…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateserotonergic drugsclass named in the label
    «Drugs Having Clinically Important Interactions with TRINTELLIX: Intervention Monitor for symptoms of serotonin syndrome when TRINTELLIX is used concomitantly with other drugs that may affect the…»

    FDA, section 7 · Open on DailyMed

  • ModerateTramadol
    «Medicamentos que disminuyen el umbral convulsivo: Los antidepresivos con efecto serotoninérgico pueden disminuir el umbral convulsivo. Se recomienda precaución cuando se utilicen de manera simultánea…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatetriptanesclass named in the label
    «Síndrome Serotoninérgico (SS) o Síndrome Neuroléptico Maligno (SNM): La administración de vortioxetina puede dar lugar al Síndrome Serotoninérgico (SS) o al Síndrome Neuroléptico Maligno (SNM)…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateWarfarin
    «Anticoagulantes y antiagregantes plaquetarios: No se observaron efectos significativos, en comparación con placebo, en los valores de INR, protrombina o concentraciones plasmáticas de warfarina R y…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateWarfarin
    «Drugs Having Clinically Important Interactions with TRINTELLIX: Intervention Inform patients of the increased risk of bleeding associated with the concomitant use of TRINTELLIX and antiplatelet…»

    FDA, section 7 · Open on DailyMed

  • MinorFluconazole
    «Inhibidores de la CYP3A4, la CYP2C9 y la CYP2C19: Al co-administrar vortioxetina tras 6 días de ketoconazol 400 mg/día (un inhibidor de la CYP3A4/5 y la glucoproteína P) o tras 6 días de fluconazol…»

    AEMPS, section 4.5 · Open on CIMA

  • Minorinhibidores del CYP3A4class named in the label
    «Inhibidores de la CYP3A4, la CYP2C9 y la CYP2C19: Al co-administrar vortioxetina tras 6 días de ketoconazol 400 mg/día (un inhibidor de la CYP3A4/5 y la glucoproteína P) o tras 6 días de fluconazol…»

    AEMPS, section 4.5 · Open on CIMA

  • MinorKetoconazole
    «Inhibidores de la CYP3A4, la CYP2C9 y la CYP2C19: Al co-administrar vortioxetina tras 6 días de ketoconazol 400 mg/día (un inhibidor de la CYP3A4/5 y la glucoproteína P) o tras 6 días de fluconazol…»

    AEMPS, section 4.5 · Open on CIMA

  • Amiodarone
    «Interacciones en metabolizadores pobres de la CYP2D6: La administración conjunta de inhibidores potentes de la CYP3A4 (como el itraconazol, voriconazol, claritromicina, telitromicina, nefazodona…»

    AEMPS, section 4.5 · Open on CIMA

  • anticonceptivos hormonalesclass named in the label
    «Sustratos del citocromo P450: No se observaron interacciones farmacodinámicas. No se observó deterioro significativo de la función cognitiva respecto a placebo con vortioxetina tras la administración…»

    AEMPS, section 4.5 · Open on CIMA

  • Bupropion
    «Drugs Having Clinically Important Interactions with TRINTELLIX: Examples bupropion, fluoxetine, paroxetine, quinidine»

    FDA, section 7 · Open on DailyMed

  • Caffeine
    «Sustratos del citocromo P450: Tras la administración de dosis múltiples de vortioxetina, no se observó un efecto inhibidor en sujetos sanos sobre las isoenzimas del citocromo P450 CYP2C19 (omeprazol…»

    AEMPS, section 4.5 · Open on CIMA

  • Carbamazepine
    «Drugs Having Clinically Important Interactions with TRINTELLIX: Examples rifampin, carbamazepine, phenytoin»

    FDA, section 7 · Open on DailyMed

  • Clarithromycin
    «Interacciones en metabolizadores pobres de la CYP2D6: La administración conjunta de inhibidores potentes de la CYP3A4 (como el itraconazol, voriconazol, claritromicina, telitromicina, nefazodona…»

    AEMPS, section 4.5 · Open on CIMA

  • Clopidogrel
    «Drugs Having Clinically Important Interactions with TRINTELLIX: Examples aspirin, clopidogrel, heparin, warfarin»

    FDA, section 7 · Open on DailyMed

  • Dextromethorphan
    «Sustratos del citocromo P450: Tras la administración de dosis múltiples de vortioxetina, no se observó un efecto inhibidor en sujetos sanos sobre las isoenzimas del citocromo P450 CYP2C19 (omeprazol…»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • CriticalTranylcypromine
    «medicamentos con una marcada inhibición de la recaptación de serotonina, como todos los inhibidores selectivos de la recaptación de serotonina, clomipramina, venlafaxina, duloxetina, milnaciprán…»

    AEMPS, section 4.3 · Open on CIMA

  • CriticalTranylcypromine
    «Combination with Certain Drugs: Antidepressants including but not limited to: Other monoamine oxidase inhibitors (MAOIs) Selective serotonin reuptake inhibitors (SSRIs) and serotonin and…»

    FDA, section 4 · Open on DailyMed

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Frequently asked

What is Vortioxetine used for?

Vortioxetine is evaluated for the following indications with varying evidence strength: Major depressive disorder (evidence tier A), Memory and concentration enhancement (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Vortioxetine?

Common side effects of Vortioxetine (≥ 1 in 100): Nausea (most common), Headache, Constipation or diarrhea, Dry mouth, Dizziness, Abnormal dreams. See the Safety section for uncommon and serious reactions.

Is Vortioxetine safe during pregnancy?

Limited pregnancy data. T3 use linked to neonatal adaptation syndrome. Sertraline is preferred in pregnant patients with depression.

Is Vortioxetine compatible with breastfeeding?

Limited data. Not recommended during lactation.

Who should not take Vortioxetine?

Vortioxetine is contraindicated in: Vortioxetine hypersensitivity; Concurrent MAO inhibitors or within 14 days of stopping; Pregnancy and lactation; Age under 18. Full list in the Safety section.

Does Vortioxetine carry an FDA boxed warning?

FDA boxed warning: antidepressants increase suicidal ideation and behavior risk in children, adolescents, and young adults under 24 during the first weeks. Careful mental status monitoring is needed.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

5-hydroxytryptophan (5-HTP), Agomelatine, Amitriptyline, Atomoxetine, Citalopram, Ginkgo biloba extract, Mirtazapine, Piracetam + cinnarizine