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vilazodone Side Effects

Also known as: Viibryd

Analysis of 9,764 adverse event reports submitted to the FDA from 2009 to 2025.

Total Reports

9,764

Death-Related

328

3.4% of reports

Hospitalizations

1,195

12.2% of reports

Top Indication

Depression

Most Reported Adverse Reactions

OFF LABEL USE
1,111
DIARRHOEA
808
NAUSEA
808
ANXIETY
662
INSOMNIA
634
DRUG INEFFECTIVE
610
HEADACHE
565
DEPRESSION
522
DIZZINESS
508
FATIGUE
491
SUICIDAL IDEATION
436
FEELING ABNORMAL
421
WEIGHT INCREASED
307
PARAESTHESIA
303
VOMITING
287
TREMOR
281
SOMNOLENCE
278
PAIN
269
PRURITUS
238
AGITATION
215

Who Reports Side Effects

Gender Distribution

Female 6,520 (72%)
Male 2,551 (28%)
Unknown 43

Age Distribution

0-17 384 (7%)
18-44 1,888 (34%)
45-64 2,351 (43%)
65-74 635 (12%)
75+ 259 (5%)

Reporting Trend by Year

2009 2025

Reactions in Death Reports

Top reactions reported in 328 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
COMPLETED SUICIDE 174
DEATH 77
TOXICITY TO VARIOUS AGENTS 38
CARDIO-RESPIRATORY ARREST 22
CARDIAC ARREST 15
OVERDOSE 15
SUSPECTED SUICIDE 13
RESPIRATORY ARREST 10
OFF LABEL USE 9
ACUTE KIDNEY INJURY 8
GUN SHOT WOUND 8
INTENTIONAL OVERDOSE 8
FATIGUE 7
HYPERTHERMIA 6
HYPOTENSION 6
NAUSEA 6
PNEUMONIA 6
PULMONARY OEDEMA 6
RENAL FAILURE 6
BRADYCARDIA 5

Reactions in Hospitalization Reports

Top reactions in 1,195 reports where hospitalization was an outcome.

Reaction Reports
NAUSEA 90
ANXIETY 86
DEPRESSION 79
SEROTONIN SYNDROME 79
SUICIDAL IDEATION 74
FALL 73
HEADACHE 73
VOMITING 68
FATIGUE 64
PAIN 61
DIARRHOEA 60
DRUG INEFFECTIVE 60
OFF LABEL USE 58
DIZZINESS 53
SUICIDE ATTEMPT 52
DYSPNOEA 48
ASTHENIA 46
OVERDOSE 46
TREMOR 43
HOSPITALISATION 42

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What the FAERS Data Reveals About vilazodone Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 9,764 voluntary reports linked to vilazodone and its brand equivalents (Viibryd), spanning 2009 through 2025. Of those, 328 (3.4%) listed death as an outcome and 1,195 (12.2%) involved hospitalization. The most common indication reported alongside adverse events was Depression.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 72% were female and 28% male; age distribution skews toward 45-64, with 2,351 reports in that bracket. The single most reported reaction is off label use with 1,111 submissions, followed by diarrhoea and nausea.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.