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Vortioxetine Side Effects

The most commonly reported side effects of vortioxetine include nausea, fatigue, and headache, based on 16,624 FDA adverse event reports from 2013 to 2025. 6.8% of reports found the drug to be ineffective.

Vortioxetine side effects

Percentages show how often each reaction appears relative to total reports for vortioxetine.

1
Nausea13.6%2,254
2
Fatigue7.3%1,219
3
Drug Ineffective6.8%1,128
4
Headache6.6%1,091
5
Anxiety6.4%1,061
6
Vomiting6.0%1,000
7
Off Label Use5.7%954
8
Suicidal Ideation5.5%918
9
Insomnia5.5%914
10
Dizziness5.5%913
11
Diarrhoea5.1%846
12
Asthenia4.7%783
13
Pruritus4.7%780
14
Depression4.5%745
15
Feeling Abnormal4.0%666

These are voluntary reports and do not establish that vortioxetine caused these reactions.

Report severity

48.5%Serious8,059 reports
17.1%Hospitalizations2,844 reports
6.0%Fatal992 reports

Seriousness is determined by the reporter, not by OpenClaim.

Vortioxetine drug interactions

Other drugs that appear in adverse event reports alongside vortioxetine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Venlafaxine3.8%632
2
Escitalopram-oxalate3.6%596
3
Mirtazapine3.2%533
4
Sodium-oxybate3.1%520
5
Brexpiprazole3.1%512
6
Fluoxetine-hydrochloride2.9%476
7
Bupropion2.8%472
8
Quetiapine-fumarate2.8%458
9
Pregabalin2.7%444
10
Acetaminophen2.6%425
11
Adalimumab2.4%402
12
Sertraline-hydrochloride2.4%400
13
Atorvastatin-calcium2.1%343
14
Omeprazole2.1%341
15
Donepezil-hydrochloride2.0%336

Taken alongside

1
Levothyroxine-sodium6.6%1,103
2
Ergocalciferol6.5%1,085
3
Acetaminophen6.1%1,020
4
Clonazepam6.0%991
5
Bupropion5.7%940
6
Gabapentin5.6%928
7
Omeprazole4.8%793
8
Alprazolam4.7%787
9
Trazodone-hydrochloride4.6%766
10
Atorvastatin-calcium4.6%758
11
Albuterol4.4%733
12
Aspirin4.0%671
13
Lamotrigine3.8%633
14
Lorazepam3.7%615
15
Fluticasone3.5%590

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports vortioxetine side effects

61.0% of vortioxetine adverse event reports involve female patients and 26.4% involve male patients. The largest age group is adult at 76%. These figures reflect who reports side effects, not underlying risk.

Sex

Female61.0%
Male26.4%
Unknown12.6%

Age group

< 20.2%
2–110.2%
12–171.1%
18–6476.2%
65+22.3%

What is vortioxetine used for

Conditions and purposes for which patients were taking vortioxetine when the adverse event was reported.

Abdominal PainAdjustment DisorderAdjustment Disorder With Depressed MoodAdjustment Disorder With Mixed Anxiety And Depressed MoodAdjuvant TherapyAffective DisorderAgitated DepressionAgitationAmnesiaAngerAnhedoniaAntidepressant Drug ClearanceAntidepressant Drug LevelAntidepressant TherapyAnxiety

Showing 15 of 265 indications

Vortioxetine brand names and reporting trend

Vortioxetine is sold under the brand name Vortioxetine Hydrobromide.

Brand names

Vortioxetine Hydrobromide4,855

Quarterly reports (20132025)

20132016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking vortioxetine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.