What this pack is
TRINTELLIX is the brand name in this record; vortioxetine is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
TRINTELLIXGeneric namevortioxetine
How this medicine works
The current label says the complete antidepressant mechanism of vortioxetine is not fully understood. Its activity is thought to involve inhibition of the serotonin transporter (5-HT reuptake) and modulation of several 5-HT receptors. This multimodal pharmacology does not predict individual suitability, superiority to another antidepressant, strength choice or safe combination with another serotonergic medicine.
Read source: United States ↗Current regulatory record · reviewed 2026-08-30More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- TRINTELLIX
- Generic name
- vortioxetine
- Dosage-form class
- Dosage form and presentation as documented in the linked primary label
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
3 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. DailyMed public label (SPL v18; updated 5 Mar and published 11 Mar 2025)
Vortioxetine 5 mg per tablet; 30-tablet bottle
- Product code
- NDC 64764-720-30
- Form and route
- TRINTELLIX vortioxetine oral film-coated tablet · oral; exact tablet-identity field, with no personal-use or splitting inference from appearance
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- vortioxetine (supplied as vortioxetine hydrobromide)
- 5 mglabelled vortioxetine amount per tablet; not an individual's tablet count, frequency, splitting, stopping or switching instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- pink · almond-shaped, biconvex, film-coated tablet; unscored · imprint 5 / TLUnscored in this labelled presentation
United States label · Current U.S. DailyMed public label (SPL v18; updated 5 Mar and published 11 Mar 2025)
Vortioxetine 10 mg per tablet; 30-tablet bottle
- Product code
- NDC 64764-730-30
- Form and route
- TRINTELLIX vortioxetine oral film-coated tablet · oral; exact tablet-identity field, with no personal-use or splitting inference from appearance
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- vortioxetine (supplied as vortioxetine hydrobromide)
- 10 mglabelled vortioxetine amount per tablet; not an individual's tablet count, frequency, splitting, stopping or switching instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- yellow · almond-shaped, biconvex, film-coated tablet; unscored · imprint 10 / TLUnscored in this labelled presentation
United States label · Current U.S. DailyMed public label (SPL v18; updated 5 Mar and published 11 Mar 2025)
Vortioxetine 20 mg per tablet; 30-tablet bottle
- Product code
- NDC 64764-750-30
- Form and route
- TRINTELLIX vortioxetine oral film-coated tablet · oral; exact tablet-identity field, with no personal-use or splitting inference from appearance
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- vortioxetine (supplied as vortioxetine hydrobromide)
- 20 mglabelled vortioxetine amount per tablet; not an individual's tablet count, frequency, splitting, stopping or switching instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- red · almond-shaped, biconvex, film-coated tablet; unscored · imprint 20 / TLUnscored in this labelled presentation
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
TRINTELLIX label reading: separate vortioxetine, BRINTELLIX and BRILINTA first
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
U.S. TRINTELLIX and EU BRINTELLIX can identify vortioxetine products, but their markets, strengths and dosage forms differ. BRILINTA is the antiplatelet medicine ticagrelor. Check the full name, mg per tablet, dosage form, market and actual pack together rather than the first few letters.
- U.S. 5, 10 and 20 mg are labelled vortioxetine amounts per tablet, not tablets per dose or doses per day. The EU also lists a 15 mg tablet and 20 mg/mL oral drops. Mg per tablet and mg per mL are different units and must not be self-converted or substituted by colour.
- Do not confuse TRINTELLIX/BRINTELLIX with BRILINTA. BRILINTA contains ticagrelor and is an antiplatelet medicine. If a list, prescription or pack name is unclear, stop guessing from the name and have a pharmacist or prescriber check the actual packaging.
- MAOIs, linezolid, intravenous methylene blue and other serotonergic antidepressants, tramadol, lithium, buspirone, amphetamines, tryptophan or St John's wort are priority serotonin-syndrome checks. Fever with agitation, tremor, muscle rigidity, diarrhoea, altered awareness or seizures requires immediate local emergency support.
- Aspirin, NSAID pain medicines, warfarin, antiplatelets or other anticoagulants may add bleeding risk. Older adults, people taking diuretics or those who are volume depleted also need priority review for hyponatraemia. New severe bleeding, marked weakness, headache, confusion, unsteady gait, falls, seizures or altered awareness needs timely medical assessment.
- Strong CYP2D6 inhibitors such as bupropion, fluoxetine, paroxetine or quinidine and strong enzyme inducers such as rifampin, carbamazepine or phenytoin may affect professional management. A CYP2D6 label statement does not mean everyone needs whole-genome screening, and the site does not generate an individual dose-change or stopping/switching plan from genes, age or a medicine name.
- Feeling better, unwell, nauseated, missing a dose, fearing an adverse effect or noticing sexual problems is not a reason to abruptly self-stop, alternate days, add another antidepressant or substitute leftovers. Thoughts of self-harm/suicide, marked behavioural change, a severe allergy-like reaction or another acute serious concern requires immediate local emergency or crisis support.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-30
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 1
- European Union / European Economic Area · 1
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. TRINTELLIX vortioxetine oral-tablet public label and Medication Guide (SPL v18; updated 5 Mar 2025) ↗Current regulatory record · reviewed 2026-08-30
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- EMA · European Union / European Economic Area · Regulatory product record or EU product information · 2026-08-30EMA: current BRINTELLIX 5/10/15/20 mg tablet and 20 mg/mL oral-drop product information (updated 19 Jan 2026) ↗Current regulatory record · reviewed 2026-08-30
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about TRINTELLIX (vortioxetine). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
TRINTELLIX is the brand in this record and vortioxetine is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary label) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. TRINTELLIX vortioxetine oral-tablet public label and Medication Guide (SPL v18; updated 5 Mar 2025) ↗Current regulatory record · reviewed 2026-08-30
- EMA: current BRINTELLIX 5/10/15/20 mg tablet and 20 mg/mL oral-drop product information (updated 19 Jan 2026) ↗Current regulatory record · reviewed 2026-08-30
HOW IT WORKS · NOT A TREATMENT PLAN
How vortioxetine works: serotonin-transporter and receptor activity without a fully established therapeutic mechanism
- Mechanism is a clue for pharmacology and interaction review, not a tool to self-diagnose depression, choose a medicine, increase a dose or stop treatment from symptoms. Prior response, other conditions, the full medicine list, age, liver/kidney status and professional assessment may all affect an individual decision.
- Shared antidepressant use, serotonergic activity or similar names do not permit milligram conversion, rotation or combination of TRINTELLIX with CELEXA, LEXAPRO, ZOLOFT, PROZAC, PAXIL, CYMBALTA, EFFEXOR or another product.
- Originator and generic products can share an active ingredient and regulatory equivalence basis while excipients, appearance and exact packaging may differ. Any substitution must use the current target-market approval and prescription, not colour, imprint, a shared ingredient or mechanism to decide which pack is better.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): current U.S. TRINTELLIX vortioxetine oral-tablet public label and Medication Guide (SPL v18; updated 5 Mar 2025) ↗Current regulatory record · reviewed 2026-08-30
- FDA Drugs@FDA: TRINTELLIX / BRINTELLIX (vortioxetine) NDA 204447 application and label record ↗Current regulatory record · reviewed 2026-08-30
- FDA: BRINTELLIX (vortioxetine) NDA 204447 original approval letter (30 Sep 2013) ↗reviewed 2026-08-30
- FDA: vortioxetine NDA 204447 clinical review (Takeda; 5/10/15/20 mg development and original application record) ↗reviewed 2026-08-30
- FDA AEMS: BRINTELLIX/BRILINTA name-confusion signal and the 2016 TRINTELLIX rename safety record ↗reviewed 2026-08-30
- EMA: BRINTELLIX (vortioxetine) EPAR and current EU product-information access ↗Current regulatory record · reviewed 2026-08-30
- EMA: current BRINTELLIX 5/10/15/20 mg tablet and 20 mg/mL oral-drop product information (updated 19 Jan 2026) ↗Current regulatory record · reviewed 2026-08-30
SOURCE-TRACEABLE ARCHIVE
TRINTELLIXvortioxetine
This page includes an exact current U.S. public-label package panel for TRINTELLIX, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Initial U.S. NDA 204447 approval
The FDA approval letter records BRINTELLIX (vortioxetine) 5, 10, 15 and 20 mg tablets for adult major depressive disorder. This is initial application history and does not turn historical 15 mg into a current displayed U.S. pack.
FDA: BRINTELLIX (vortioxetine) NDA 204447 original approval letter (30 Sep 2013) ↗EU BRINTELLIX marketing authorisation
The EMA EPAR records the EU authorisation and H. Lundbeck A/S as holder. Current product information lists 5, 10, 15 and 20 mg tablets and 20 mg/mL oral drops.
EMA: BRINTELLIX (vortioxetine) EPAR and current EU product-information access ↗U.S. brand changed from BRINTELLIX to TRINTELLIX
The FDA safety record says the change was intended to reduce prescribing and dispensing confusion with the antiplatelet medicine BRILINTA (ticagrelor). The date identifies a regulatory safety action and does not mean an individual should change medicine or market pack.
FDA AEMS: BRINTELLIX/BRILINTA name-confusion signal and the 2016 TRINTELLIX rename safety record ↗Current U.S. DailyMed SPL v18 updated
The current brand label displays 5, 10 and 20 mg 30-tablet bottle panels and a Medication Guide. A label does not establish local stock, purchase availability or individual suitability.
DailyMed (NLM): current U.S. TRINTELLIX vortioxetine oral-tablet public label and Medication Guide (SPL v18; updated 5 Mar 2025) ↗
MARKET SCOPE
Market-record boundary
United States
Current TRINTELLIX brand label, Medication Guide, NDA record and three exact 30-tablet bottles linkedOnly official display panels are entered as product presentations. Other 7-, 90- and 500-tablet label NDCs remain available in the source label, but no package image is invented without a separate display panel.
European Union
BRINTELLIX EPAR and current 5/10/15/20 mg tablets plus 20 mg/mL oral-drops information linkedEU product information lists several pack quantities. This page first establishes market and dosage-form boundaries and does not infer that an EU pack is a Mainland-China or U.S. pack or convert drops into tablet counts.
Mainland China, Japan and other markets
Current market records not yet establishedThe alias “心达悦” is retained only as a search clue. Without a current first-party record in this review, no local approval, pack, holder, supply, originator/generic relationship or interchangeability is inferred.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Are BRINTELLIX, TRINTELLIX and BRILINTA the same medicine?
No. TRINTELLIX is the current U.S. vortioxetine brand name, while the EU still uses BRINTELLIX. BRILINTA is the antiplatelet medicine ticagrelor. Check the full name, generic, market and actual pack rather than similar spelling.
The current U.S. panels do not show 15 mg. Can I assemble it from 5 mg and 10 mg myself?
Do not arrange that from arithmetic or the EU 15 mg product. Current U.S. display panels, EU product information and an individual prescription are different layers. The treating professional must review any tablet combination, strength change or cross-market substitution.
The label mentions CYP2D6. Does everyone need whole-genome screening first?
The label does not make whole-genome screening a universal prerequisite. A usual first step is to give the prescriber the exact pack, prescription and non-prescription medicines, supplements, prior response and relevant history. A professional should explain whether a specific genetic test is relevant.
Can TRINTELLIX be alternated by day with another antidepressant?
Do not self-alternate, combine or abruptly stop. Shared serotonergic activity does not permit rotation, and discontinuation effects, serotonin syndrome and interactions require prescriber management using the full medicine list.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.