TRINTELLIX® (vortioxetine) is indicated for the treatment of Major Depressive Disorder (MDD) in adults.

Safety Data

How the safety profile fits in the story

Established safety profile: Safety of TRINTELLIX was evaluated in more than 5800 adult patients across multiple clinical studies1

Common adverse reactions occurring in ≥2% of patients treated with TRINTELLIX and at least 2% greater than the incidence in placebo-treated patients in 6- to 8-week trials*1

Common Adverse Reactions (6- to 8-Week Studies) Table

*Based on the rates for 5-, 10-, 15-, and 20-mg doses.1
Includes pruritus generalized.1

Quote: "My doctor was clear about what to expect when I started TRINTELLIX."

Discontinuation rates

Discontinuation rates due to adverse reactions in pooled 6- to 8-week clinical studies1

Discontinuation Rates (6- to 8-Week Studies) Table
  • Nausea was the most common adverse reaction reported as a reason for discontinuation1


  • The most common adverse reaction
  • Frequency was dose-related
  • Typically found to have been mild or moderate in intensity
  • Most commonly occurred in the first week of treatment, with 15% to 20% of patients experiencing nausea after 1 to 2 days of treatment
  • Approximately 10% of patients taking TRINTELLIX 10 mg/day to 20 mg/day still had nausea at the end of the 6- to 8-week placebo-controlled studies
  • Median duration was 2 weeks

No significant effect on body weight in 6 short-term MDD studies and 1 long‑term MDD study1

Change in weight in randomized, double-blind, placebo-controlled studies10,11

Effect on body weight in randomized, double-blind, placebo-controlled studies table

No statistical analyses were conducted with regard to weight change in the US-based long-term study (Study 10); weight increase was a reported adverse reaction in the TRINTELLIX 20 mg group (≥5%).

Short-term: TRINTELLIX 5 mg/day to 20 mg/day had no significant effect on body weight as measured by the mean change from baseline in 6- to 8-week placebo‑controlled studies1

Long-term: In the 6-month, double-blind,
placebo-controlled phase of the non-US long-term study (Study 9) in patients who had responded to TRINTELLIX during the initial 12-week, open-label phase, there was no significant effect on body weight between TRINTELLIX and placebo-treated patients1

Some reports of weight gain have been received since product approval1

Is TESD a part of your patients' stories?

Switching from SSRIs to TRINTELLIX resulted in statistically superior improvement in TESD vs escitalopram in MDD patients1,13

Head-to-head study results showed TRINTELLIX lessened SSRI-induced sexual side effects for adult MDD patients more than escitalopram.1,13

Mean change from baseline in CSFQ-14 total score1,13


At Week 8, improvement in SSRI-induced sexual dysfunction in MDD patients switched to TRINTELLIX was superior to improvement in patients who switched to escitalopram.1

  • Clinically meaningful improvement considered to be 2- to 3-point increase in CSFQ-14 total score1
  • Assesses 3 phases of the sexual response cycle (desire, arousal, and orgasm)1,13
  • Results based on 8-week, head-to-head, randomized, double-blind study comparing TRINTELLIX (n=217) with escitalopram (n=207) in patients with well-treated MDD experiencing SSRI-induced sexual dysfunction as measured by CSFQ-141,13
  • Patients switched from citalopram, paroxetine, or sertraline to either TRINTELLIX or escitalopram (both groups started on 10 mg once daily, then increased to 20 mg at Week 1, followed by flexible dosing)1,13

Antidepressant efficacy was not lost when patients switched to TRINTELLIX or escitalopram1,13

Mean change from baseline in MADRS total score13

TRINTELLIX and escitalopram maintained antidepressant efficacy chart
  • Common adverse events (incidence ≥5% for TRINTELLIX) were nausea (25.0%, 5.4%), headache (9.4%, 7.7%), dizziness (8.0%, 5.0%), and pruritus, generalized (5.8%, 0%) for TRINTELLIX and escitalopram, respectively.13  Three patients experienced a total of 5 SAEs in the TRINTELLIX group and 1 patient in the escitalopram group reported 1 SAE. There was 1 case of suicidal behavior in the TRINTELLIX group but no attempted or completed suicides. Twenty patients (8.9%) in the TRINTELLIX group and 14 (6.3%) in the escitalopram group withdrew because of an AE
  • In clinical studies, TESD was both voluntarily and prospectively assessed in patients taking TRINTELLIX1
  • Warning and Precaution for Sexual Dysfunction: Use of serotonergic antidepressants, including TRINTELLIX, may cause symptoms of sexual dysfunction. In male patients, serotonergic antidepressant use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, use may result in decreased libido and delayed or absent orgasm1

Abbrevations: CSFQ-14, Changes in Sexual Functioning Questionnaire; SAE, serious adverse event; SSRI, selective serotonin reuptake inhibitor; TESD, treatment-emergent sexual dysfunction.

Quote: "I finally had the TALK with my doctor. Sexual side effects from my SSRI medication kept getting in the way."

Adverse sexual reactions were voluntarily and prospectively assessed1

  • Voluntary reports of adverse sexual reactions are known to be underreported1

Voluntary reports with TRINTELLIX were ≤5% in 6- to 8-week placebo-controlled studies*1

Voluntarily reported adverse sexual reactions table

*Voluntarily reported adverse reactions related to sexual dysfunction were captured as individual event terms and aggregated to report overall incidence.1

Prospectively assessed rates of adverse sexual reactions1

  • Separate, self-rated questionnaire was provided to patients during clinical studies

Incidence of adverse sexual reactions using ASEX in patients without sexual dysfunction at baseline in 7 placebo-controlled studies†1

Prospectively assessed adverse sexual reactions bar graph

Incidence based on the number of subjects with sexual dysfunction during the study/number of subjects without sexual dysfunction at baseline (approximately 1/3 of the population across all study groups).1 Sexual dysfunction was defined as a subject scoring any of the following on the ASEX scale at 2 consecutive visits during the study: total score ≥19; any single item ≥5; or 3 or more items each with a score of ≥4.

Abbrevation: ASEX, Arizona Sexual Experiences Scale.


Changes in sexual functioning questionnaire short form (CSFQ-14)1

The CSFQ-14 is a validated scale that measures sexual functioning, including the 3 phases of the sexual response cycle:

  • Desire
  • Arousal
  • Orgasm


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  1. Trintellix (vortioxetine) prescribing information. Takeda Pharmaceuticals.
  2. Alvarez E, Perez V, Dragheim M, Loft H, Artigas F. A double-blind, randomized, placebo-controlled, active reference study of LuAA21004 in patients with Major Depressive Disorder. Int J Neuropsychopharmacol. 2012;15(5):589-600.
  3. Henigsberg N, Mahableshwarkar AR, Jacobsen P, Chen Y, Thase ME. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with Major Depressive Disorder. J Clin Psychiatry. 2012;73(7):953-959.
  4. Boulenger J-P, Loft H, Olsen CK. Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with Major Depressive Disorder. Int Clin Psychopharmacol. 2014;29(3):138-149.
  5. Mahableshwarkar AR, Jacobsen P, Chen Y, Serenko M, Trivedi MH. A randomized, double-blind, duloxetine‑referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD. Psychopharmacology (Berl). 2015;232(12):2061-2070.
  6. Jacobsen P, Mahableshwarkar AR, Serenko M, Chan S, Trivedi MH. A randomized, double-blind, placebo-controlled study of the efficacy and safety of vortioxetine 10 mg and 20 mg in adults with Major Depressive Disorder. J Clin Psychiatry. 2015;76(5):575-582.
  7. Katona C, Hansen T, Olsen CK. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with Major Depressive Disorder. Int Clin Psychopharmacol. 2012;27(4):215-223.
  8. McIntyre RS, Lophaven S, Olsen CK. A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults. Int J Neuropsychopharmacol. 2014;17(10):1557-1567.
  9. Mahableshwarkar AR, Zajecka J, Jacobson W, Chen Y, Keefe RSE. A randomized, placebo-controlled, active-reference, double-blind, flexible-dose study of the efficacy of vortioxetine on cognitive function in Major Depressive Disorder. Neuropsychopharmacology. 2015;40(8):2025-2037.
  10. Data on file. Takeda Pharmaceuticals.
  11. Data on file. Lundbeck.
  12. Boulenger J-P, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with Major Depressive Disorder. J Psychopharmacol. 2012;26(11):1408-1416.
  13. Jacobsen PL, Mahableshwarkar AR, Chen Y, Chrones L, Clayton AH. Effect of vortioxetine vs. escitalopram on sexual functioning in adults with well‑treated Major Depressive Disorder experiencing SSRI-induced sexual dysfunction. J Sex Med. 2015;12(10):2036-2048.
  14. Kambeitz JP, Howes OD. The serotonin transporter in depression: Meta-analysis of in vivo and post mortem findings and implications for understanding and treating depression. J Affect Disord. 2015;186:358-366.
  15. American Psychiatric Association. Depressive disorders. In: Diagnostic and Statistical Manual of Mental Disorders. 5th edition (DSM-5®). Arlington, VA: American Psychiatric Association; 2013:155-188.
  16. ICD-10-CM Tabular list of diseases and injuries. Centers for Medicare & Medicaid Services. Published 2022. Accessed August 19, 2022.