What the label lists and what reports show
Vortioxetine side effects
Vortioxetine's FDA label: “Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were: nausea, constipation and vomiting ( 6 ).” FAERS holds 16,915 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (2,259 reports).
- 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 FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TRINTELLIX?TRINTELLIX may cause serious side effects, including: See, " What is the most important information I should know about TRINTELLIX? " Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take TRINTELLIX with certain other medicines. See, " Do not take TRINTELLIX if you ". Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome: agitation seeing or hearing things that are not real (hallucinations) confusion coma fast heart-beat changes in blood pressure dizziness sweating flushing high body temperature (hyperthermia) shaking (tremors), stiff muscles, or muscle twitching loss of coordination seizures nausea, vomiting, diarrhea Increased risk of bleeding. […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were: nausea, constipation and vomiting ( 6 ).
Table 2: Adverse Reactions Occurring in ≥2% of Patients Treated with Any TRINTELLIX Dose and at Least 2% Greater Than the Incidence in Placebo-Treated Patients
| System Organ Class Preferred Term | TRINTELLIX 5 mg/day N=1013 % | TRINTELLIX 10 mg/day N=699 % | TRINTELLIX 15 mg/day N=449 % | TRINTELLIX 20 mg/day N=455 % | Placebo N=1621 % |
|---|---|---|---|---|---|
| Nausea | 21 | 26 | 32 | 32 | 9 |
| Diarrhea | 7 | 7 | 10 | 7 | 6 |
| Dry mouth | 7 | 7 | 6 | 8 | 6 |
| Constipation | 3 | 5 | 6 | 6 | 3 |
| Vomiting | 3 | 5 | 6 | 6 | 1 |
| Flatulence | 1 | 3 | 2 | 1 | 1 |
| Dizziness | 6 | 6 | 8 | 9 | 6 |
| Abnormal dreams | <1 | <1 | 2 | 3 | 1 |
| Pruritus includes pruritus generalized | 1 | 2 | 3 | 3 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity [see Contraindications (4) ] Clinical Worsening and Suicide Risk [see Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Increased Risk of Bleeding [see Warnings and Precautions (5.3) ] Activation of Mania/Hypomania [see Warnings and Precautions (5.4) ] Discontinuation Syndrome [see Warnings and Precautions (5.5) ] Angle Closure Glaucoma [see Warnings and Precautions (5.6) ] Hyponatremia [see Warnings and Precautions (5.7) ] Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were: nausea, constipation and vomiting ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Source: FDA drug label, 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?
16,915 reports list vortioxetine among the medicines taken, 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. Of the 20 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Vortioxetine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions