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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

VORTIOXETINE: 2,446 Adverse Event Reports & Safety Profile

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2,446
Total FAERS Reports
566 (23.1%)
Deaths Reported
809
Hospitalizations
2,446
As Primary/Secondary Suspect
65
Life-Threatening
70
Disabilities
None
Status

FDA Application: 211024 ·

First Report: 19560520 · Latest Report: 20250829

What Are the Most Common VORTIOXETINE Side Effects?

#1 Most Reported
Suicidal ideation
319 reports (13.0%)
#2 Most Reported
Nausea
264 reports (10.8%)
#3 Most Reported
Drug ineffective
245 reports (10.0%)

All VORTIOXETINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Suicidal ideation 319 13.0% 9 86
Nausea 264 10.8% 107 51
Drug ineffective 245 10.0% 10 119
Dizziness 218 8.9% 149 19
Insomnia 211 8.6% 146 11
Fall 206 8.4% 152 26
Headache 193 7.9% 130 17
Pruritus 189 7.7% 150 11
Tachycardia 182 7.4% 163 10
Diarrhoea 181 7.4% 149 9
Completed suicide 170 7.0% 170 40
Somnolence 170 7.0% 129 9
Arthralgia 168 6.9% 149 10
Fatigue 168 6.9% 128 5
Haemorrhagic stroke 167 6.8% 166 0
Dyspnoea 166 6.8% 149 10
Malaise 165 6.8% 121 14
Vomiting 165 6.8% 103 22
Ocular discomfort 164 6.7% 155 0
Altered state of consciousness 160 6.5% 153 3

Who Reports VORTIOXETINE Side Effects? Age & Gender Data

Gender: 64.4% female, 35.6% male. Average age: 49.7 years. Most reports from: US. View detailed demographics →

Is VORTIOXETINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 2 0 2
2012 1 0 1
2013 1 0 1
2014 9 2 2
2015 47 14 15
2016 39 7 14
2017 56 13 25
2018 72 15 23
2019 91 7 42
2020 86 5 32
2021 74 14 31
2022 68 12 29
2023 42 20 11
2024 42 15 22
2025 26 4 8

View full timeline →

What Is VORTIOXETINE Used For?

IndicationReports
Product used for unknown indication 1,402
Depression 439
Major depression 308
Anxiety 88
Bipolar disorder 35
Suicide attempt 20
Antidepressant therapy 15
Generalised anxiety disorder 9
Delusion 8
Depressed mood 8

VORTIOXETINE vs Alternatives: Which Is Safer?

VORTIOXETINE vs VORTIOXETINE HYDROBROMIDE VORTIOXETINE vs VOSORITIDE VORTIOXETINE vs VOTRIENT VORTIOXETINE vs VOXELOTOR VORTIOXETINE vs VUTRISIRAN VORTIOXETINE vs VX-950 VORTIOXETINE vs VYVANSE VORTIOXETINE vs WARFARIN VORTIOXETINE vs WATER VORTIOXETINE vs WELLBUTRIN

Official FDA Label for VORTIOXETINE

Official prescribing information from the FDA-approved drug label.