Prescription medicine
Vortioxetine Brand names: Trintellix
Vortioxetine (Trintellix) is a prescription medicine with an FDA approval on record since 2013. No generic is listed; pharmacies paid $17.20 per Trintellix 10 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the vortioxetine FDA label on DailyMed (effective March 5, 2025, Takeda Pharmaceuticals America, Inc.); the NDA 204447 record on Drugs@FDA; every vortioxetine label on DailyMed.
Highlights of the record
FDA label of March 5, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SUICIDAL THOUGHTS AND BEHAVIORS.
Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ]. TRINTELLIX is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in pediatric and young adult patients taking antidepressants. Closely monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). TRINTELLIX is not approved for use in pediatric patients ( 8.4 ).
Used for
From the label: indications and usageTRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.
Forms and strengths
- 5 mg
- 10 mg
- 20 mg
Film-coated tablet.
On the market
- Earliest approval on file
- September 30, 2013 Trintellix, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- September 21, 2032 Trintellix tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $17.20 per tablet Trintellix 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 16,915 through July 30, 2026
What is vortioxetine used for?
From the label: indications and usageTRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults. TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults ( 1 , 14 ).
Conditions named in the indications of vortioxetine's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Trintellix), Takeda Pharmaceuticals America, Inc., effective March 5, 2025 (SPL set 1a5b68e2-14d0-419d-9ec6-1ca97145e838), via openFDA; the full label on DailyMed
What does the patient leaflet for vortioxetine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TRINTELLIX?TRINTELLIX can cause serious side effects, including: Increased risk of suicidal thoughts and actions. TRINTELLIX and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. TRINTELLIX is not for use in children. Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, of if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency help right away if you have any of the following symptoms, especially if they are new, worse, or worry you: attempts to commit suicide thoughts about suicide or dying feeling agitated, restless, angry or irritable other unusual changes in behavior or mood acting on dangerous impulses new or worse depression trouble sleeping acting aggressive or violent new or worse anxiety or panic attacks an increase in activity or talking more than what is normal for you
From the patient leaflet: How should I store TRINTELLIX?Store TRINTELLIX at room temperature between 68°F to 77°F (20°C to 25°C). Keep TRINTELLIX and all medicines out of the reach of children.
Source: FDA drug label (Trintellix), Takeda Pharmaceuticals America, Inc., effective March 5, 2025 (SPL set 1a5b68e2-14d0-419d-9ec6-1ca97145e838), via openFDA; the full label on DailyMed
Is there a generic for vortioxetine (Trintellix)?
No generic vortioxetine is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 6 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 10 patents for Trintellix tablets: the compound patent runs to June 30, 2031 (pediatric exclusivity to December 30, 2031), and the last listed entry to September 21, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for vortioxetine (Trintellix)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $17.20 per Trintellix 10 mg tablet, up 5% from $16.41 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Trintellix 5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Trintellix 10 mg tablet | Brand | $17.20 per tablet | $515.92 | +5% |
| Trintellix 20 mg tablet | Brand | $17.20 per tablet | $515.99 | +5% |
| Trintellix 5 mg tablet | Brand | $17.20 per tablet | $515.90 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the vortioxetine label say about other medicines?
The vortioxetine label names 25 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name vortioxetine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | Examples aspirin, clopidogrel, heparin, warfarin Drugs Highly Bound to Plasma Protein Clinical Impact TRINTELLIX is highly bound to plasma protein. The concomitant use of TRINTELLIX with another drug that is highly bound to plasma protein may increase free concentrations of TRINTELLIX or other tightly-bound drugs in … |
| Bupropion | drug interactions | Examples; bupropion, fluoxetine, paroxetine, quinidine |
| Buspirone | drug interactions | 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. … |
| Carbamazepine | drug interactions | Examples; rifampin, carbamazepine, phenytoin |
| Clopidogrel | drug interactions | Examples aspirin, clopidogrel, heparin, warfarin Drugs Highly Bound to Plasma Protein Clinical Impact TRINTELLIX is highly bound to plasma protein. The concomitant use of TRINTELLIX with another drug that is highly bound to plasma protein may increase free concentrations of TRINTELLIX or other tightly-bound drugs in … |
| Diazepam | drug interactions | … doses of TRINTELLIX did not affect the pharmacokinetics or pharmacodynamics (composite cognitive score) of diazepam [see Clinical Pharmacology (12.3) ]. A clinical study has shown that TRINTELLIX (single dose of 20 or 40 mg) did not increase the impairment of mental and motor skills caused by alcohol (single dose of … |
| Fentanyl | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, meperidine, methadone, buspirone, amphetamines, and St. … |
| Fluoxetine | drug interactions | Examples; bupropion, fluoxetine, paroxetine, quinidine |
| Heparin | drug interactions | Examples aspirin, clopidogrel, heparin, warfarin Drugs Highly Bound to Plasma Protein Clinical Impact TRINTELLIX is highly bound to plasma protein. The concomitant use of TRINTELLIX with another drug that is highly bound to plasma protein may increase free concentrations of TRINTELLIX or other tightly-bound drugs in … |
| Isocarboxazid | drug interactions | 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 … |
| Linezolid | contraindications | Starting TRINTELLIX in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2) ]. |
| Lithium | drug interactions | 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. … |
| Meperidine | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, meperidine, methadone, buspirone, amphetamines, and St. … |
| Methadone | drug interactions | … change in INR was observed [see Drug Interactions (7.1), Clinical Pharmacology (12.3) ]. Immunoassays for Methadone False positive results in urine enzyme immunoassays for methadone have been reported in patients who have taken vortioxetine. … |
Every other medicine the vortioxetine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Methylene blue | contraindications | Starting TRINTELLIX in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see … |
| Paroxetine | drug interactions | Examples; bupropion, fluoxetine, paroxetine, quinidine |
| Phenelzine | drug interactions | … Precautions (5.2) ] Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact Concomitant use of TRINTELLIX with other … |
| Phenytoin | drug interactions | Examples; rifampin, carbamazepine, phenytoin |
| Quinidine | drug interactions | Examples; bupropion, fluoxetine, paroxetine, quinidine |
| Rifampin | drug interactions | Examples; rifampin, carbamazepine, phenytoin |
| Salicylic acid | drug interactions | … effect on platelet aggregation or pharmacokinetics of aspirin and salicylic acid [see Clinical Pharmacology (12.3) ]. Patients receiving other drugs that interfere with hemostasis should be carefully … |
| Selegiline | drug interactions | … (2.4), Contraindications (4), Warnings and Precautions (5.2) ] Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact … |
| Tramadol | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, meperidine, methadone, buspirone … |
| Tranylcypromine | drug interactions | … Contraindications (4), Warnings and Precautions (5.2) ] Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact Concomitant … |
| Warfarin | drug interactions | … TRINTELLIX and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see, ]. |
Source: FDA drug label (Trintellix), Takeda Pharmaceuticals America, Inc., effective March 5, 2025 (SPL set 1a5b68e2-14d0-419d-9ec6-1ca97145e838), via openFDA; the full label on DailyMed
What do FAERS reports show for vortioxetine?
The FDA Adverse Event Reporting System holds 16,915 reports that list vortioxetine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,001 are coded as a death and 2,858 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as vortioxetine?
30 other medicines are given the same way (oral) and in the same FDA class as vortioxetine or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Bupropion | Depression | 73 labelers | $0.0785 per tablet 150 mg tablet | No current entry |
| Venlafaxine | Depression | 62 labelers | $0.0799 per capsule 75 mg capsule | No current entry |
| Aripiprazole | Depression | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Fluoxetine | Depression | 59 labelers | $0.0519 per capsule 40 mg capsule | No current entry |
| Sertraline | Depression | 48 labelers | $0.0507 per tablet 100 mg tablet | No current entry |
| Amitriptyline | Depression | 36 labelers | $0.03 per tablet 10 mg tablet | No current entry |
| Duloxetine | Depression | 45 labelers | $0.102 per capsule 30 mg capsule | No current entry |
| Doxepin | Depression | 48 labelers | $0.0779 per capsule 10 mg capsule | No current entry |
Every medicine labeled for the same conditions as vortioxetine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to vortioxetine
- 30 medicines for the same use
- Vortioxetine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other