Prescription medication · Serotonin Modulator
vortioxetine
Also sold as Trintellix. Trintellix is used to treat major depressive disorder (MDD) in adults.
Data updated 2026-05-15
- 16,243
- FDA reportsModerately reported
- 18
- InteractionsSeveral interactions
- $15.65
- Brand price (NADAC)
What the data shows
vortioxetine (Trintellix) is a prescription Serotonin Modulator, reported at a middle-of-the-pack volume (16,243 FDA reports), with 18 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
vortioxetine (Trintellix) is a prescription Serotonin Modulator. Trintellix is used to treat major depressive disorder (MDD) in adults.
Trintellix is a medicine used to treat major depressive disorder (MDD) in adults. It helps to improve mood and reduce symptoms of depression.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$15.65/unit
Generic Available
No
TAKEDA PHARMS USA
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Trintellix is used to treat major depressive disorder (MDD) in adults.
Common side effects
Nausea, Constipation, Vomiting
Key warnings
Antidepressants may increase the risk of suicidal thoughts and behaviors in young adults.
The sections below are summarized in plain English from vortioxetine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Trintellix affects the levels of certain chemicals in the brain. These chemicals, like serotonin, help regulate mood. By changing the balance of these chemicals, Trintellix can help improve symptoms of depression.
How to Take It
Take Trintellix once a day by mouth, with or without food. The usual starting dose is 10 mg per day. Your doctor may increase your dose to 20 mg per day, or decrease it to 5 mg per day, depending on how you respond to the medicine. If you are taking 15 mg or 20 mg per day, talk to your doctor before stopping, as they may want you to lower the dose to 10mg for a week before stopping completely.
This is a plain-language summary of vortioxetine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. Taking Trintellix in the last 3 months of pregnancy may cause problems in the newborn. There is a pregnancy registry to monitor outcomes in women exposed to antidepressants during pregnancy. You can register by calling 1-844-405-6185.
This is a plain-language summary of vortioxetine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of vortioxetine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Trintellix at room temperature, between 59°F and 86°F.
Side Effects (from patient reports)
Based on 16,243 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for vortioxetine, by number of reports
- Feeling sick to your stomach
Feeling sick to your stomach
2,185 reports
- Feeling very tired
Feeling very tired
1,179 reports
- Pain in your head
Pain in your head
1,027 reports
- Feeling worried or nervous
Feeling worried or nervous
996 reports
- Throwing up
Throwing up
989 reports
- Trouble sleeping
Trouble sleeping
901 reports
- Thoughts of killing yourself
Thoughts of killing yourself
898 reports
- Feeling like you are spinning 858
Feeling like you are spinning
858 reports
- Loose, watery stools 795
Loose, watery stools
795 reports
- Weakness 770
Weakness
770 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for vortioxetine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where vortioxetine sits
vortioxetine has more FDA adverse-event reports than 51% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is vortioxetine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 16,243 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2012–2025.
Total Reports
16,243
Reports Mentioning Death
958
5.9% of reports — not proof of cause
Hospitalization Reports
2,691
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | NAUSEA | 2,185 |
| 2 | FATIGUE | 1,179 |
| 4 | HEADACHE | 1,027 |
| 5 | ANXIETY | 996 |
| 6 | VOMITING | 989 |
| 7 | INSOMNIA | 901 |
| 8 | SUICIDAL IDEATION | 898 |
| 10 | DIZZINESS | 858 |
| 11 | DIARRHOEA | 795 |
| 12 | ASTHENIA | 770 |
| 13 | PRURITUS | 766 |
| 14 | DEPRESSION | 723 |
| 15 | FEELING ABNORMAL | 661 |
| 16 | WEIGHT INCREASED | 579 |
| 17 | FALL | 538 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Antidepressants may increase the risk of suicidal thoughts and behaviors in young adults. Your doctor will monitor you closely for worsening depression or suicidal thoughts, especially when you first start taking Trintellix or when your dose is changed. Trintellix is not approved for use in children.
Known Drug Interactions
Examples rifampin, carbamazepine, phenytoin Drugs that Interfere with Hemostasis (antiplatelets agents and anticoagulants) Clinical Impact Concomitant use of TRINTELLIX with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding.
Mechanism: Taking these medications together can interfere with how your blood clots, which increases your risk of bleeding.
What to do: Tell your doctor if you notice any unusual bruising or bleeding while taking these drugs.
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.
Mechanism: Both of these drugs increase the amount of a chemical called serotonin in your brain, and having too much can be dangerous.
What to do: Do not take these medications together because it can cause a dangerous condition called serotonin syndrome.
Examples rifampin, carbamazepine, phenytoin Drugs that Interfere with Hemostasis (antiplatelets agents and anticoagulants) Clinical Impact Concomitant use of TRINTELLIX with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding.
Mechanism: Taking these drugs together can interfere with how your blood clots. This increases your risk of experiencing bleeding problems.
What to do: Your doctor should monitor you closely for signs of bleeding or bruising. They may need to adjust your medication doses.
[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.
Mechanism: Both drugs increase the level of a brain chemical called serotonin. Having too much serotonin can cause a dangerous condition called serotonin syndrome.
What to do: Do not take these drugs together. Your doctor will likely have you wait at least 14 days between stopping one and starting the other.
[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.
Mechanism: These medications both raise serotonin levels in your body. Combining them can lead to a serious reaction known as serotonin syndrome.
What to do: This combination should be avoided. Talk to your doctor about the safe amount of time to wait when switching between these medications.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I stop taking Trintellix suddenly?
What should I do if I experience side effects?
Can I drink alcohol while taking Trintellix?
Will Trintellix interact with other medications I am taking?
How long does it take for Trintellix to start working?
What if I have a history of bipolar disorder?
Can Trintellix cause angle closure glaucoma?
What happens if I take too much Trintellix?
Can Trintellix cause sexual dysfunction?
What if I am taking a strong CYP2D6 inhibitor?
What are the common side effects of vortioxetine?
Does vortioxetine interact with other medications?
What drug class is vortioxetine?
Is vortioxetine safe during pregnancy?
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amitriptyline
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for vortioxetine
The FDA label for vortioxetine (sold under brand names such as Trintellix) classifies it as a prescription-only medication in the Serotonin Modulator class. Trintellix is used to treat major depressive disorder (MDD) in adults. Official labeling lists 3 commonly reported side effects, including Nausea, Constipation, Vomiting.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 16,243 voluntary reports. The database also lists 18 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: March 5, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages