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Vortioxetine

Vortioxetine is an antidepressant used to treat major depressive disorder (MDD) in adults.

Brand names TrintellixBrintellix
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 6, 2026
Vortioxetine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Vortioxetine (Trintellix) is a once-daily antidepressant for adults with major depressive disorder that blocks serotonin reuptake (reabsorption) and acts on several other serotonin receptors; on the U.S. market since about 2013, it is usually tried after a first-choice antidepressant such as sertraline falls short. Most people tolerate it fairly well, and nausea is what they notice most, often easing after the first couple of weeks. Its boxed warning covers suicidal thoughts and behaviors in people 24 and under, so watch for worsening mood or new suicidal thoughts at any age, especially early on and after dose changes.

Clinical pearls

  • Never combine it with MAOIs such as phenelzine, and check triptans, opioids, lithium or St. John's Wort for serotonin syndrome risk.
  • Bupropion, fluoxetine and paroxetine raise vortioxetine levels, so the vortioxetine dose is cut in half when they are combined.
  • Aspirin, NSAIDs like ibuprofen, clopidogrel and warfarin add bleeding risk, and warfarin users need extra INR (clotting test) checks.
  • It can cause a false positive on urine drug tests for methadone, so mention it before any drug screening.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Antidepressants like vortioxetine can increase suicidal thoughts and behaviors in children, teens, and young adults (24 and under). This was seen in short-term studies, and the risk was highest in people with MDD.

Everyone starting an antidepressant should be watched closely for worsening depression or new suicidal thoughts or behaviors. Contact your prescriber right away if you notice these changes. Trintellix is not approved for children.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2013
Companies listing it with the FDA3
FDA label last updatedFeb 17, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Vortioxetine, written from its FDA label.

What Vortioxetine is used for

▾

Vortioxetine is an antidepressant with one supported use:

  • Trintellix (oral tablet) treats major depressive disorder (MDD) in adults.

How Vortioxetine works

▾

Vortioxetine is thought to ease depression by increasing serotonin activity in the brain. It blocks serotonin reuptake, so more serotonin stays available.

It also acts on other serotonin receptors, including 5-HT3 and 5-HT1A. How much these actions add to its effect has not been established.

Vortioxetine dosage

▾

Trintellix is a tablet taken by mouth once a day, with or without food. Your prescriber typically starts you on one dose and may raise it as tolerated. A lower dose may be used if you have trouble with higher ones.

  • It can be stopped abruptly, but at higher doses your prescriber may lower the dose for a week first.
  • Your dose may change if you take certain other medicines or are a known CYP2D6 poor metabolizer.

Follow your prescriber's directions and the label.

Dosing details from the FDA-approved label

From the Vortioxetine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • General recommended dosage (starting dose and titration)
    • Starting dose 10 mg administered orally once daily without regard to meals
    • Then increased to 20 mg/day, as tolerated
    • Efficacy and safety of doses above 20 mg/day have not been evaluated in controlled clinical trials
  • Patients who do not tolerate higher doses
    • Dose decrease down to 5 mg/day may be considered
  • Discontinuing treatment (patients on 15 mg/day or 20 mg/day)
    • Decrease dose to 10 mg/day for one week before full discontinuation
    • TRINTELLIX can be abruptly discontinued, but transient adverse reactions such as headache and muscle tension occurred after abrupt discontinuation of 15 mg/day or 20 mg/day
  • Known CYP2D6 poor metabolizers
    • Maximum recommended dose is 10 mg/day
    • Maximum: 10 mg/day
  • Patients taking a strong CYP2D6 inhibitor (e.g., bupropion, fluoxetine, paroxetine, quinidine)
    • Reduce the dose of TRINTELLIX by one-half
    • Increase to the original level when the CYP2D6 inhibitor is discontinued
  • Patients taking strong CYP inducers (e.g., rifampin, carbamazepine, phenytoin)
    • Consider increasing the dose when coadministered for greater than 14 days
    • Reduce to the original level within 14 days when the inducer is discontinued
    • Maximum: Should not exceed three times the original dose
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • The recommended starting dose is 10 mg administered orally once daily without regard to meals ( 2.1 ). • The dose should then be increased to 20 mg/day, as tolerated ( 2.1 ). • Consider 5 mg/day for patients who do not tolerate higher doses ( 2.1 ). • TRINTELLIX can be discontinued abruptly. However, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for one week prior to full discontinuation if possible ( 2.3 ). • The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers ( 2.5 ). 2.1 Recommended Dosage The recommended starting dose is 10 mg administered orally once daily without regard to meals. Dosage should then be increased to 20 mg/day, as tolerated. The efficacy and safety of doses above 20 mg/day have not been evaluated in controlled clinical trials. A dose decrease down to 5 mg/day may be considered for patients who do not tolerate higher doses [see Clinical Studies (14) ] . 2.2 Screen for Bipolar Disorder Prior to Starting TRINTELLIX Prior to initiating treatment with TRINTELLIX or another antidepressant, screen patients for personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.4) ] . 2.3 Discontinuing Treatment Although TRINTELLIX can be abruptly discontinued, in placebo-controlled trials patients experienced transient adverse reactions such as headache and muscle tension following abrupt discontinuation of TRINTELLIX 15 mg/day or 20 mg/day. It is recommended that the dose be decreased to 10 mg/day for one week before full discontinuation of TRINTELLIX 15 mg/day or 20 mg/day [see Warnings and Precautions (5.5) and Adverse Reactions (6) ] . 2.4 Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days must elapse between discontinuation of a MAOI intended to treat psychiatric disorders and initiation of therapy with TRINTELLIX to avoid the risk of Serotonin Syndrome [see Warnings and Precautions (5.2) ] . Conversely, at least 21 days must elapse after stopping TRINTELLIX before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4) ] . 2.5 Use of TRINTELLIX in Known CYP2D6 Poor Metabolizers or in Patients Taking Strong CYP2D6 Inhibitors The maximum recommended dose of TRINTELLIX is 10 mg/day in known CYP2D6 poor metabolizers.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Vortioxetine side effects

▾

The most common side effects in studies were stomach-related.

Common side effects

  • Nausea (the most common one)
  • Constipation
  • Vomiting
  • Diarrhea
  • Dry mouth
  • Dizziness
  • Gas (flatulence)

When to get medical help

  • Call your doctor right away if you have new or worsening depression, suicidal thoughts, or unusual changes in behavior.
  • Get help for signs of serotonin syndrome (a dangerous buildup of serotonin), especially if you take other serotonin-affecting drugs.
  • Tell your doctor about unusual bleeding or bruising, especially if you take aspirin, NSAIDs, blood thinners or antiplatelet drugs.
  • Get help for signs of an allergic reaction, such as hives, swelling, or trouble breathing (anaphylaxis, angioedema, urticaria).
  • Report symptoms of mania or hypomania (unusually high energy or elevated mood).
  • Seek care for low sodium (hyponatremia) symptoms, or for eye problems from angle closure glaucoma.
  • Tell your doctor about sexual side effects.

Get medical help for suicidal thoughts, signs of serotonin syndrome, unusual bleeding, allergic reactions, or manic symptoms.

Vortioxetine warnings and precautions

▾
  • Suicidal thoughts and behaviors: boxed warning, highest risk in children, teens, and young adults. Watch closely for worsening mood.
  • Serotonin syndrome: can happen alone but is more likely with other serotonin-affecting drugs.
  • Bleeding: higher risk with aspirin, NSAIDs, antiplatelets, and warfarin.
  • Mania/hypomania: you should be screened for bipolar disorder first.
  • Angle closure glaucoma: can occur in people with untreated narrow angles in the eye.
  • Hyponatremia: low sodium, which can be tied to SIADH.
  • Sexual dysfunction: may occur.

Vortioxetine interactions

▾

Several medicines can change how vortioxetine works or raise its risks.

  • MAOIs, linezolid, and IV methylene blue: contraindicated due to serotonin syndrome risk.
  • Other serotonin-affecting drugs (SSRIs, SNRIs, triptans, opioids, lithium, buspirone, St. John's Wort): raise serotonin syndrome risk.
  • Bupropion, fluoxetine, paroxetine, quinidine: raise vortioxetine levels, so the dose is halved.
  • Rifampin, carbamazepine, phenytoin: lower vortioxetine levels, so a dose increase may be considered.
  • Aspirin, clopidogrel, heparin, warfarin: may increase bleeding risk.
  • Alcohol: a single-dose study showed vortioxetine did not add to alcohol's effect on mental and motor skills.

Interactions listed in the FDA-approved label

From the Vortioxetine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Monoamine Oxidase Inhibitors (MAOIs) (e.g., selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue): Concomitant use of SSRIs and SNRIs including TRINTELLIX with MAOIs increases the risk of serotonin syndrome. Contraindicated with an MAOI intended to treat psychiatric disorders or within 21 days of stopping TRINTELLIX; within 14 days of stopping an MAOI intended to treat psychiatric disorders; and in a patient being treated with linezolid or intravenous methylene blue.
  • Other serotonergic drugs (other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, St. John's Wort): Concomitant use increases the risk of serotonin syndrome. Monitor for symptoms of serotonin syndrome; if it occurs, consider discontinuation of TRINTELLIX and/or the concomitant serotonergic drugs.
  • Strong CYP2D6 inhibitors (bupropion, fluoxetine, paroxetine, quinidine): Concomitant use increases plasma concentrations of vortioxetine. Reduce TRINTELLIX dose by half when a strong CYP2D6 inhibitor is coadministered.
  • Strong CYP inducers (rifampin, carbamazepine, phenytoin): Concomitant use decreases plasma concentrations of vortioxetine. Consider increasing the TRINTELLIX dose; the maximum dose is not recommended to exceed three times the original dose.
  • Drugs that interfere with hemostasis (antiplatelet agents and anticoagulants: aspirin, clopidogrel, heparin, warfarin): Concomitant use may potentiate the risk of bleeding. Inform patients of the increased bleeding risk; for patients taking warfarin, carefully monitor the INR; monitor carefully when TRINTELLIX is initiated or discontinued.
  • Drugs highly bound to plasma protein (e.g., warfarin): May increase free concentrations of TRINTELLIX or other tightly-bound drugs in plasma. Monitor for adverse reactions and reduce dosage of TRINTELLIX or other protein bound drugs as warranted.
  • Lithium and diazepam (other CNS active agents): No clinically relevant effect on steady-state lithium exposure; multiple doses of TRINTELLIX did not affect the pharmacokinetics or pharmacodynamics of diazepam.
  • Alcohol: A single dose of 20 or 40 mg TRINTELLIX did not increase the impairment of mental and motor skills caused by a single dose of alcohol 0.6 g/kg.
  • Methadone urine enzyme immunoassays: False positive results in urine enzyme immunoassays for methadone have been reported in patients who have taken vortioxetine. Consider an alternative analytical technique (e.g., chromatographic methods) to confirm positive methadone urine drug screen results.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Strong inhibitors of CYP2D6: Reduce TRINTELLIX dose by half when coadministered ( 2.5 , 7.1 ). • Strong CYP Inducers: Consider dose increase of TRINTELLIX dose when coadministered for more than 14 days. The maximum recommended dose should not exceed 3 times the original dose ( 2.6 , 7.1 ). 7.1 Drugs Having Clinically Important Interactions with TRINTELLIX Table 4: Clinically Important Drug Interactions with TRINTELLIX Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of SSRIs and SNRIs including TRINTELLIX with MAOIs increases the risk of serotonin syndrome. Intervention Concomitant use of TRINTELLIX is contraindicated: • With an MAOI intended to treat psychiatric disorders or within 21 days of stopping treatment with TRINTELLIX. • Within 14 days of stopping an MAOI intended to treat psychiatric disorders. • In a patient who is being treated with linezolid or intravenous methylene blue. [see Dosage and Administration (2.4) , Contraindications (4) , Warnings and Precautions (5.2) ] Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact Concomitant use of TRINTELLIX with other serotonergic drugs increases the risk of serotonin syndrome. Intervention Monitor for symptoms of serotonin syndrome when TRINTELLIX is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of TRINTELLIX and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2) ] . Examples Other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort Strong Inhibitors of CYP2D6 Clinical Impact Concomitant use of TRINTELLIX with strong CYP2D6 inhibitors increases plasma concentrations of vortioxetine.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿100 supplements and herbs with documented Vortioxetine interactions, ranked by severity Check Vortioxetine against a supplement or herb →

Before taking Vortioxetine

▾
  • Do not use if allergic to vortioxetine or any ingredient.
  • Do not use with MAOIs, linezolid, or IV methylene blue as described above.
  • Tell your doctor about any personal or family history of bipolar disorder, mania, or hypomania.
  • Not approved for children or teens.
  • Pregnancy: late-pregnancy use may cause newborn complications, and use in the month before delivery may raise postpartum bleeding risk. Do not stop without talking to your doctor, since untreated depression also carries risks.
  • Breastfeeding: no human milk data. Discuss the benefits and risks with your doctor.
  • Older adults: no age-based dose change is recommended.

Vortioxetine overdose

▾

In reports, overdoses caused nausea, vomiting, dizziness, diarrhea, stomach discomfort, itching, sleepiness, and flushing. Serotonin syndrome and a seizure were reported at very high doses. No specific antidote is known. Call Poison Help at 1-800-222-1222 for guidance.

What Vortioxetine does in the body

▾

Vortioxetine binds strongly to the serotonin transporter and selectively blocks serotonin reuptake. It also acts on several serotonin receptors, as an antagonist at some and an agonist at 5-HT1A. In a driving study in healthy people, it did not impair driving performance. In a heart study, it did not show a meaningful effect on the QTc interval (a heart rhythm measure).

How your body processes Vortioxetine

▾

After a dose, blood levels peak in about 7 to 11 hours. Food does not affect absorption. The half-life is about 66 hours, and steady levels build within about two weeks. The liver breaks it down, mainly through CYP2D6, into an inactive metabolite, and it leaves the body mostly through urine and feces as metabolites. CYP2D6 poor metabolizers have about twice the usual drug levels.

How to store Vortioxetine

▾

Store at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

100

Supplements & herbs that interact with Vortioxetine

100 supplements and herbal products have documented interactions with Vortioxetine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 2
  • Moderate · 73
  • Minor · 25
ACTIVATED CHARCOAL Major LITHIUM Major 1,3-DMAA Moderate 5-HTP Moderate ACACIA RIGIDULA Moderate ACETYL-L-CARNITINE Moderate ACTIVE HEXOSE CORRELATED COMPOUND (AHCC) Moderate AYAHUASCA Moderate +92 more
Every supplement checked against Vortioxetine — ranked by severity The full interaction hub: 2 major · 73 moderate · 25 minor · every one linked to its full report. Check Vortioxetine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Vortioxetine has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

SODIUM Moderate Depletion
See the full Vortioxetine nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Vortioxetine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Vortioxetine — the kind of thing our pharmacy team would talk through with you at the counter.

What is vortioxetine for?

▾
Vortioxetine, sold as Trintellix, treats major depressive disorder in adults. It is not approved for children or teens.

How should I take it?

▾
Take one tablet by mouth once a day, with or without food. Your prescriber may adjust your dose over time, so follow their directions. If you want to stop, talk to them first, since higher doses are usually stepped down for a week.

What side effects should I expect?

▾
Nausea is the most common, and it was the top reason people stopped it in studies. Constipation, vomiting, diarrhea, dry mouth, and dizziness can also happen. Let your doctor know if they bother you or don't go away.

When should I call my doctor right away?

▾
Call if you have new or worsening depression, suicidal thoughts, or unusual mood or behavior changes. Also call for unusual bleeding, signs of serotonin syndrome, a rash or swelling that may be an allergic reaction, or eye problems.

Can I take it with my other medicines?

▾
Not always. It must never be combined with MAOIs, linezolid, or IV methylene blue. Tell me about every medicine and supplement you take, especially other antidepressants, St. John's Wort, aspirin, NSAIDs, or warfarin.

Is it safe in pregnancy?

▾
Talk to your doctor before making any change. Use late in pregnancy may cause problems in newborns, but stopping an antidepressant can also bring on a depression relapse. Your doctor can help you weigh both.

Is Vortioxetine available over the counter?

▾
No. Vortioxetine is a prescription medicine: every Vortioxetine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Vortioxetine first available?

▾
The earliest FDA record we hold for Vortioxetine is from 2013: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Vortioxetine was first used.

Who makes Vortioxetine?

▾
3 companies currently list Vortioxetine products in the FDA's NDC Directory, including Takeda Pharmaceuticals America, Inc., Cardinal Health 107, LLC, Remedyrepack Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Vortioxetine on HelloPharmacist

📊Vortioxetine supplement interactions100 checked — ranked by severity 🌿Drug & Supplement CheckerVortioxetine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Vortioxetine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Vortioxetine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Vortioxetine forms and strengths (how it comes)

Vortioxetine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Vortioxetine inactive ingredients by manufacturer.

Tablet

By mouth
Brands Trintellix
How this form is used
What it may be used for
  • Trintellix is used to treat major depressive disorder (MDD) in adults.
Important instructions
  • Trintellix is taken by mouth once daily, with or without food.
  • Trintellix is not approved for use in children or teens.
Available strengths 3 strengths
5 mg 10 mg 20 mg
20 FDA-listed product records ⓘ

Vortioxetine on the U.S. market: products, makers and brands

How Vortioxetine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

3 companies list 7 Vortioxetine product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2013. Brand names on the directory include Trintellix, Brintellix; the rest are generics.

1
Dose forms ⓘ
3
Labelers (makers, repackagers, distributors)
1
Brand names
7
FDA-listed product records ⓘ
2013
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (13) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Takeda Pharmaceuticals America, Inc.43%
Cardinal Health 107, LLC29%
Remedyrepack Inc.29%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Vortioxetine is used (Medicaid data)

A general measure of how commonly Vortioxetine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Vortioxetine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

354,075
Medicaid prescriptions filled (Q1–Q4 2025)
$195.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Vortioxetine prescribed? Of the 1,601 medications we measure, Vortioxetine ranks #303 by Medicaid prescriptions — more than 81% of them.

Where Vortioxetine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #303 of 1,601
#298 Enalapril 361,404 Rx #299 Desmopressin 357,369 Rx #300 Aripiprazole Injection 354,838 Rx #301 Emtricitabine and Teno... 354,223 Rx #302 Emtricitabine / Tenofo... 354,223 Rx #303 Vortioxetine 354,075 Rx #304 Azelastine Ophthalmic 347,051 Rx #305 Brexpiprazole 344,798 Rx #306 OnabotulinumtoxinA Inj... 343,452 Rx #307 Diphenhydramine Inject... 342,553 Rx #308 Nitroglycerin Spray 340,741 Rx

Utilization by Vortioxetine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 20 mg oral tablet is the most-dispensed Vortioxetine product — about 49% of these Medicaid prescriptions.

vortioxetine 20 MG Oral Tablet Most dispensed

172,971 Medicaid prescriptions (Q1–Q4 2025) 49% of Vortioxetine prescriptions shown $96.1M gross reimbursement (before rebates) ≈ $556 per prescription (gross)

Summed across the 1 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1439810

vortioxetine 10 MG Oral Tablet

131,197 Medicaid prescriptions (Q1–Q4 2025) 37% of Vortioxetine prescriptions shown $72M gross reimbursement (before rebates) ≈ $549 per prescription (gross)

Summed across the 1 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1439808

vortioxetine 5 MG Oral Tablet

49,907 Medicaid prescriptions (Q1–Q4 2025) 14% of Vortioxetine prescriptions shown $27.4M gross reimbursement (before rebates) ≈ $549 per prescription (gross)

Summed across the 1 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1439812

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Vortioxetine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 28 listed Vortioxetine NDCs with Medicaid activity.

Compare Vortioxetine products

A representative set of FDA-listed product records for Vortioxetine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
10 mg Oral Cardinal Health 107, LLC NDA View NDC →
20 mg Oral Cardinal Health 107, LLC NDA View NDC →
5 mg Oral Remedyrepack Inc. NDA View NDC →
10 mg Oral Remedyrepack Inc. NDA View NDC →
5 mg Oral Takeda Pharmaceuticals America, Inc. NDA View NDC →
10 mg Oral Takeda Pharmaceuticals America, Inc. NDA View NDC →
20 mg Oral Takeda Pharmaceuticals America, Inc. NDA View NDC →

Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Vortioxetine NDCs →

Vortioxetine side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Vortioxetine — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Vortioxetine are nausea, fatigue, headache; about 48% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

16,915
Reports mentioning it
48%
Reported as serious
12
Distinct effects shown
Most reported effects
Nausea
2,259
Fatigue
1,212
Headache
1,066
Anxiety
1,039
Vomiting
1,020
Suicidal Ideation
942
Insomnia
925
Dizziness
890
Diarrhoea
837
Pruritus
785
Age groups
Adult · 1,283Elderly · 608Neonate · 9Adolescent · 8Child · 5Infant · 1

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Vortioxetine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Vortioxetine FDA approval history

How Vortioxetine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Vortioxetine was first approved by the FDA in 2013 (Brand: TRINTELLIX · Takeda Pharms Usa). It remains available in U.S. pharmacies today.

2013
Brand approved
Brand: TRINTELLIX · Takeda Pharms Usa
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Vortioxetine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Vortioxetine recalls since July 2021.

✅No Vortioxetine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Vortioxetine RxCUI 1455099 1 dose form · 4 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 1439807 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 1439812 10 MG RxCUI 1439808 15 MG RxCUI 1439840 20 MG RxCUI 1439810

Look up RxCUI 1455099 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Vortioxetine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 5 mg $17.20 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Vortioxetine brand names

Vortioxetine is sold under 2 brand names in the FDA directory — Trintellix, Brintellix. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Trintellix Brintellix

Who makes Vortioxetine: manufacturers and labelers

3 companies list Vortioxetine products with the FDA. By number of product records, the largest are Takeda Pharmaceuticals America, Inc., Cardinal Health 107, LLC, Remedyrepack Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Takeda Pharmaceuticals America, Inc. 3 Cardinal Health 107, LLC 2 Remedyrepack Inc. 2

Vortioxetine drug class (RxNorm)

Vortioxetine belongs to the Other antidepressants class.

Drug family (ATC) Other antidepressants

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Vortioxetine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 17, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Vortioxetine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Vortioxetine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
4
Finished products in the current FDA directory
7
Companies listing them (makers, repackagers, distributors)
3
FDA labeler codes behind them ⓘ
3
Linked representative label ⓘ
Cardinal Health 107, LLC
Linked label effective
Feb 17, 2026
Composite sections available
24
Linked SPL Set ID
cb1e9df4-dd74-4073-9d78-bb55593dd000
Linked SPL Document ID
7b53e0ea-8161-474c-b623-734841128a9a
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Cardinal Health 107, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →