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vortioxetine

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Brand names: Trintellix

Serotonin Modulator Rx

Trintellix is a medicine used to treat major depressive disorder (MDD) in adults. It helps to improve mood and reduce symptoms of depression.

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.

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.

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.

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.

Storage

Store Trintellix at room temperature, between 59°F and 86°F.

Side Effects (from patient reports)

Based on 10,977 FDA adverse event reports.

Feeling sick to your stomach
2,185
Feeling very tired
1,179
The medicine is not working
1,063
Pain in your head
1,027
Feeling worried or nervous
996
Throwing up
989
Trouble sleeping
901
Thoughts of killing yourself
898
Using the medicine for something it is not approved for
881
Feeling like you are spinning
858

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

Death-Related Reports

958

Hospitalization Reports

2,691

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 9,914 (70%)
Male 4,284 (30%)

Age Distribution

0–17 940
18–44 3,158
45–64 2,988
65–74 1,049
75+ 548

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 NAUSEA 2,185
2 FATIGUE 1,179
3 DRUG INEFFECTIVE 1,063
4 HEADACHE 1,027
5 ANXIETY 996
6 VOMITING 989
7 INSOMNIA 901
8 SUICIDAL IDEATION 898
9 OFF LABEL USE 881
10 DIZZINESS 858
11 DIARRHOEA 795
12 ASTHENIA 770
13 PRURITUS 766
14 DEPRESSION 723
15 FEELING ABNORMAL 661

Reactions in Death Reports

COMPLETED SUICIDE 275
DEATH 234
HAEMORRHAGIC STROKE 225
TACHYCARDIA 224
FALL 222
CARDIO-RESPIRATORY ARREST 221
ALTERED STATE OF CONSCIOUSNESS 212
OCULAR DISCOMFORT 212
SEPSIS 212
HAEMATEMESIS 210

Reactions in Hospitalization Reports

DRUG INEFFECTIVE 295
NAUSEA 259
SUICIDAL IDEATION 245
DEPRESSION 243
OFF LABEL USE 219
HOSPITALISATION 213
SUICIDE ATTEMPT 198
CONDITION AGGRAVATED 179
DRUG INTERACTION 168
FALL 165

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.

moderate linezolid

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.

moderate rifampin

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.

moderate phenelzine

[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.

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Common Questions

Can I stop taking Trintellix suddenly?
You can stop Trintellix suddenly, but if you are taking 15 mg or 20 mg per day, it is recommended that the dose be decreased to 10 mg/day for one week before stopping completely.
What should I do if I experience side effects?
Tell your doctor about any side effects you experience while taking Trintellix.
Can I drink alcohol while taking Trintellix?
Ask your doctor if it is safe to drink alcohol while taking Trintellix.
Will Trintellix interact with other medications I am taking?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How long does it take for Trintellix to start working?
It may take several weeks for you to feel the full effects of Trintellix.
What if I have a history of bipolar disorder?
Tell your doctor if you have a personal or family history of bipolar disorder.
Can Trintellix cause angle closure glaucoma?
Yes, angle closure glaucoma has occurred in patients with untreated narrow angles treated with antidepressants.
What happens if I take too much Trintellix?
Call your doctor or go to the nearest hospital emergency room right away.
Can Trintellix cause sexual dysfunction?
Yes, Trintellix may cause symptoms of sexual dysfunction.
What if I am taking a strong CYP2D6 inhibitor?
The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers. Reduce the dose of TRINTELLIX by one-half when patients are receiving a CYP2D6 strong inhibitor.
What are the common side effects of vortioxetine?
The most commonly reported side effects of vortioxetine include Nausea, Constipation, Vomiting. Based on 10,977 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does vortioxetine interact with other medications?
Yes, vortioxetine has 18 known drug interactions. Notable interactions include carbamazepine, linezolid, rifampin. Always inform your doctor about all medications you are taking.
What drug class is vortioxetine?
vortioxetine belongs to the Serotonin Modulator drug class. It requires a prescription (Rx). Trintellix is used to treat major depressive disorder (MDD) in adults.
Is vortioxetine safe during pregnancy?
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. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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 10,977 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

All federal data sources used on this page