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.
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
- Nausea
Nausea
2,185 reports
- Fatigue
Fatigue
1,179 reports
- Headache
Headache
1,027 reports
- Anxiety
Anxiety
996 reports
- Vomiting
Vomiting
989 reports
- Insomnia
Insomnia
901 reports
- Suicidal Ideation
Suicidal Ideation
898 reports
- Dizziness 858
Dizziness
858 reports
- Diarrhoea 795
Diarrhoea
795 reports
- Asthenia 770
Asthenia
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) 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.
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.
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.
[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.
[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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for vortioxetine?
Related Medications in Serotonin Modulator
Other drugs grouped near vortioxetine - same-class peers and common alternatives.
acamprosate
Campral
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alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
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amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
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amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
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aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for vortioxetine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 16,243.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 5.90%.
- ergocalciferol Δ 0.00 pts · 366,491 reports · Vitamin D2 Supplement 5.90%death share
- dicyclomine Δ 0.01 pts · 13,367 reports · Anticholinergic / Antispasmodic 5.91%death share
- chlorthalidone Δ 0.05 pts · 11,035 reports · Thiazide-Like Diuretic 5.94%death share
- ezetimibe Δ 0.05 pts · 70,203 reports · Cholesterol Absorption Inhibitor 5.84%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: March 5, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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