The vortioxetine label: nausea in about a third at higher doses, and no benefit found in children
Trintellix is approved for adult depression. On its label, nausea hit 21 to 32 percent on the drug against 9 percent on placebo. Two US trials of 5 mg failed, and two pediatric trials found no benefit over placebo.
Reasonable evidence with real limitations. how we score evidence
Caveat on this rating: Label efficacy rests on short placebo-controlled trials, with two failed 5 mg US trials and two negative pediatric trials stated on the label itself.
The FDA-approved label for vortioxetine (Trintellix), read for what its own trials show in both directions.
Significant findings
TRINTELLIX "is indicated for the treatment of major depressive disorder (MDD) in adults." It carries the class boxed warning on suicidal thoughts and behaviors in young people. The recommended start is 10 mg a day, increased to 20 mg as tolerated, with 5 mg for those who cannot tolerate more.
Nausea is the main side effect. In the pooled 6 to 8 week placebo-controlled trials, nausea was reported by 21, 26, 32 and 32 percent at 5, 10, 15 and 20 mg, against 9 percent on placebo, and it "was the most common adverse reaction reported as a reason for discontinuation." Stopping for any adverse reaction ran 5 to 8 percent against 4 percent on placebo. Warnings cover serotonin syndrome (5.2), bleeding risk with aspirin, NSAIDs or anticoagulants (5.3), activation of mania (5.4), hyponatremia (5.7) and sexual dysfunction (5.8). Because spontaneous reports undercount sexual side effects, the trials measured them prospectively with the Arizona Sexual Experiences Scale.
On efficacy, "Two studies of the 5 mg dose in the U.S. (not represented in Table 5) failed to show effectiveness." In children: two 8 week trials, 540 patients aged 7 to 11 and 616 aged 12 to 17, and "TRINTELLIX was not superior to placebo in either study."
The other direction
The label states efficacy in adults from six 6 to 8 week placebo-controlled studies, including one in the elderly, and one maintenance study; in each of the acute studies, at least one dose beat placebo. On stopping, it says the drug "can be abruptly discontinued", though it recommends stepping 15 or 20 mg down to 10 mg for a week first because headache and muscle tension followed abrupt stops in trials.
What this does not show
It does not compare vortioxetine with other antidepressants, and it is not a reason to start, stop or switch.
Worth asking
If nausea is the problem, does the dose or timing change it, and what would we try before switching?
Source
TRINTELLIX (vortioxetine) tablets: FDA-approved prescribing information, Boxed Warning, Dosage 2.1 and 2.3, Warnings 5.1 to 5.8, Adverse Reactions 6.1, Pediatric Use 8.4, Clinical Studies 14 — Takeda Pharmaceuticals America, Inc.; US Food and Drug Administration (2025)
Regulator or national health body
How this was scored
- Study design
- Regulatory safety determination
- Funding
- Industry funded
- Published in
- Regulator or national health body
- Sample size
- not recorded
- Preregistered
- not recorded
- Conflicts disclosed
- not recorded
- Independent of proponent
- not recorded
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published October 21, 2026.
Questions
How strong is the evidence behind this?
veisund rates this source "moderate evidence". Reasonable evidence with real limitations. It scores 57 out of 100 on our published rubric. One caveat travels with that badge: Label efficacy rests on short placebo-controlled trials, with two failed 5 mg US trials and two negative pediatric trials stated on the label itself. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
TRINTELLIX (vortioxetine) tablets: FDA-approved prescribing information, Boxed Warning, Dosage 2.1 and 2.3, Warnings 5.1 to 5.8, Adverse Reactions 6.1, Pediatric Use 8.4, Clinical Studies 14 — Takeda Pharmaceuticals America, Inc.; US Food and Drug Administration (2025). Published in: Regulator or national health body. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Regulatory safety determination. Funding: Industry funded. Independence from the proponent is not recorded. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is vortioxetine (Trintellix, Brintellix), trintellix FDA approved?
Yes — this medication carries FDA approval. Approval is always for a specific indication, not for every use it is prescribed for.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.