MID-VOLUME · SEX-BALANCED
vortioxetine Side Effects
vortioxetine (also sold as Trintellix) sits MID-VOLUME #259 of 524 by FAERS report count. Lead signal: SEX-BALANCED - 70% of sex-coded reports are female (9,914 F / 4,284 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 16,243
- FAERS reports
FDA Adverse Event Reporting System extract for vortioxetine. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-MID. How figures are compiled.
vortioxetine reporting skew - 70% of sex-coded reports are female (9,914 F / 4,284 M). Volume band MID-VOLUME #259 of 524 by FAERS report count; caseload WATCHLIST.
Mid-book FAERS page for vortioxetine (Trintellix) (16,243 reports). Signature SEX-BALANCED. Dominant age band on file: 18-44. Educational reference only.
Counts from the openFDA FAERS extract (2012–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
NAUSEA leads 2,185 of 16,243 reports
Who reports · age peak 18-44 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 18-44 (3,158 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (958 reports, 5.9%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 275 |
| DEATH | 234 |
| HAEMORRHAGIC STROKE | 225 |
| TACHYCARDIA | 224 |
| FALL | 222 |
| CARDIO-RESPIRATORY ARREST | 221 |
| ALTERED STATE OF CONSCIOUSNESS | 212 |
| OCULAR DISCOMFORT | 212 |
| SEPSIS | 212 |
| HAEMATEMESIS | 210 |
| DIARRHOEA | 209 |
| PRURITUS | 209 |
| AMAUROSIS FUGAX | 208 |
| DYSPNOEA | 208 |
| EYE PAIN | 207 |
| ARTHRALGIA | 206 |
| ASCITES | 206 |
| DIZZINESS | 206 |
| HEAD DISCOMFORT | 206 |
| INSOMNIA | 206 |
Reactions in Hospitalization Reports
Hospitalization mid-share (2,691, 16.6%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| NAUSEA | 259 |
| SUICIDAL IDEATION | 245 |
| DEPRESSION | 243 |
| HOSPITALISATION | 213 |
| SUICIDE ATTEMPT | 198 |
| CONDITION AGGRAVATED | 179 |
| DRUG INTERACTION | 168 |
| FALL | 165 |
| VOMITING | 160 |
| ANXIETY | 143 |
| SEROTONIN SYNDROME | 143 |
| HEADACHE | 123 |
| FATIGUE | 119 |
| DIZZINESS | 118 |
| PAIN | 117 |
| DIARRHOEA | 95 |
| PNEUMONIA | 92 |
| ARTHRALGIA | 89 |
How to read vortioxetine FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-MID)
FAERS holds 16,243 voluntary reports linked to vortioxetine (Trintellix), 2012-2025. Death is listed on 958 (5.9%). Hospitalization appears on 2,691 (16.6%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-MID as signal-detection rates next to 70% of sex-coded reports are female (9,914 F / 4,284 M).
Read with vortioxetine
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 16,238 FAERS cases (Δ 5 lighter vs vortioxetine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 16,231 FAERS cases (Δ 12 lighter vs vortioxetine); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 16,403 FAERS cases (Δ 160 heavier vs vortioxetine); DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 16,062 FAERS cases (Δ 181 lighter vs vortioxetine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 56.2 pp vs vortioxetine's DEATH-HEAVY): CASELOAD · HOSP-MID.
vortioxetine stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.