Vilazodone side effects: what 9,167 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Vilazodone Hydrochloride (Vilazodone Hydrochloride)
Who reports
9,167 reports · 39% serious · 185 with death outcome · 72% female
Used for
Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults . Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. ( 1 )
What it is
Vilazodone hydrochloride tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT 1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1 H -indol-3-yl)butyl]-1-piperazinyl]-, hydrochloride (1:1).
Boxed warning
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] .
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 962 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Sleep paralysis | 62 | 101.1 78.5–130.3ROR 101.8 · χ² 5,787 / p <1e-300 | 94.1 EB05 76.0 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=24 | no trial data cached |
| Hypnagogic hallucination | 10 | 78.0 41.6–146.6ROR 78.1 · χ² 663 / p 2e-146 | 66.3 EB05 38.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Electric shock sensation | 25 | 21.4 14.5–31.8ROR 21.5 · χ² 463 / p 6e-103 | 20.9 EB05 14.9 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=11 | no trial data cached |
| Pre-existing condition improved | 53 | 19.4 14.8–25.4ROR 19.5 · χ² 897 / p 2e-197 | 19.1 EB05 15.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Sleep terror | 32 | 17.5 12.4–24.8ROR 17.6 · χ² 478 / p 2e-106 | 17.2 EB05 12.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Violence-related symptom | 11 | 16.2 9.0–29.4ROR 16.3 · χ² 141 / p 7e-33 | 14.8 EB05 7.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Tachyphrenia | 24 | 15.9 10.7–23.8ROR 16.0 · χ² 319 / p 1e-71 | 15.5 EB05 10.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=8 · 77% consumer | no trial data cached |
| Anorgasmia | 17 | 14.4 8.9–23.1ROR 14.4 · χ² 197 / p 4e-45 | 13.5 EB05 8.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=4 | no trial data cached |
| Hypomania | 21 | 13.1 8.5–20.1ROR 13.1 · χ² 221 / p 2e-50 | 12.3 EB05 8.0 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious n=11 | no trial data cached |
| Mania | 93 | 13.0 10.6–15.9ROR 13.1 · χ² 1,014 / p 8e-223 | 12.8 EB05 10.7 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.4 | no trial data cached |
| Abnormal dreams | 156 | 12.9 11.0–15.1ROR 13.1 · χ² 1,693 / p <1e-300 | 12.8 EB05 11.2 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.9 | no trial data cached |
| Drug titration error | 14 | 12.4 7.4–21.0ROR 12.4 · χ² 135 / p 1e-31 | 11.1 EB05 6.4 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product administration interrupted | 41 | 12.3 9.0–16.7ROR 12.3 · χ² 412 / p 8e-92 | 11.9 EB05 9.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=38 | no trial data cached |
| Serotonin syndrome | 100 | 12.0 9.9–14.6ROR 12.1 · χ² 994 / p 2e-218 | 11.8 EB05 10.0 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 17.2 | no trial data cached |
| Gambling disorder | 14 | 11.8 7.0–20.0ROR 11.9 · χ² 128 / p 6e-30 | 10.4 EB05 6.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Dissociation | 37 | 11.3 8.2–15.6ROR 11.3 · χ² 335 / p 5e-75 | 10.8 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Crying | 173 | 10.9 9.4–12.6ROR 11.1 · χ² 1,540 / p <1e-300 | 10.8 EB05 9.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 · 77% consumer | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 415 | 10.4 9.5–11.4ROR 10.8 · χ² 3,514 / p <1e-300 | 10.3 EB05 9.5 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 14.9 | no trial data cached |
| Nightmare | 157 | 10.4 8.9–12.1ROR 10.5 · χ² 1,316 / p 2e-288 | 10.2 EB05 8.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Anger | 149 | 10.1 8.6–11.8ROR 10.2 · χ² 1,205 / p 2e-264 | 9.9 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Sexual dysfunction | 51 | 10.0 7.6–13.2ROR 10.1 · χ² 404 / p 4e-90 | 9.6 EB05 7.5 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.9 · ♀ 21% (drug 72%) | no trial data cached |
| Post-traumatic stress disorder | 28 | 9.6 6.6–13.9ROR 9.6 · χ² 206 / p 6e-47 | 8.8 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Panic attack | 142 | 8.9 7.6–10.5ROR 9.1 · χ² 990 / p 1e-217 | 8.8 EB05 7.6 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 · 75% consumer | no trial data cached |
| Muscle twitching | 89 | 8.8 7.2–10.9ROR 8.9 · χ² 609 / p 1e-134 | 8.6 EB05 7.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Suicidal behaviour | 16 | 8.8 5.4–14.3ROR 8.8 · χ² 102 / p 2e-24 | 7.5 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Hangover | 13 | 8.4 4.9–14.5ROR 8.4 · χ² 78 / p 6e-19 | 6.9 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Feeling jittery | 69 | 8.3 6.5–10.5ROR 8.3 · χ² 434 / p 1e-96 | 8.0 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=20 · 71% consumer | no trial data cached |
| Drug screen false positive | 10 | 8.2 4.4–15.3ROR 8.2 · χ² 56 / p 4e-14 | 6.4 EB05 3.6 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Obsessive-compulsive disorder | 28 | 8.0 5.5–11.5ROR 8.0 · χ² 163 / p 1e-37 | 7.2 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Impulsive behaviour | 13 | 7.9 4.6–13.7ROR 7.9 · χ² 72 / p 1e-17 | 6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Snoring | 13 | 7.9 4.6–13.6ROR 7.9 · χ² 71 / p 1e-17 | 6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Loss of employment | 10 | 7.5 4.0–14.0ROR 7.5 · χ² 50 / p 7e-13 | 5.9 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Tearfulness | 14 | 7.4 4.4–12.5ROR 7.4 · χ² 71 / p 2e-17 | 6.2 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Bruxism | 17 | 7.2 4.5–11.6ROR 7.2 · χ² 85 / p 2e-20 | 6.2 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Logorrhoea | 11 | 7.1 4.0–12.9ROR 7.2 · χ² 52 / p 3e-13 | 5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Ocular discomfort | 33 | 7.0 5.0–9.8ROR 7.0 · χ² 162 / p 2e-37 | 6.4 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=31 | no trial data cached |
| Screaming | 19 | 6.8 4.3–10.7ROR 6.8 · χ² 88 / p 3e-21 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Mydriasis | 37 | 6.6 4.8–9.1ROR 6.6 · χ² 170 / p 3e-39 | 6.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · ♀ 95% (drug 72%) · 73% consumer | no trial data cached |
| Somnambulism | 19 | 6.6 4.2–10.4ROR 6.6 · χ² 85 / p 2e-20 | 5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Restless legs syndrome | 52 | 6.5 5.0–8.6ROR 6.6 · χ² 238 / p 4e-54 | 6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 · 80% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 1,090 | 2.9 2.7–3.0ROR 3.1 · χ² 1,386 / p <1e-300 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 1.4 · 82% consumer | no trial data cached |
| Diarrhoea (diarrhea) | 781 | 2.8 2.6–3.0ROR 2.9 · χ² 914 / p 3e-201 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 · 73% consumer | no trial data cached |
| Nausea | 780 | 2.3 2.1–2.4ROR 2.4 · χ² 569 / p 5e-126 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 · 72% consumer | no trial data cached |
| Anxiety | 634 | 5.1 4.7–5.5ROR 5.4 · χ² 2,104 / p <1e-300 | 5.1 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
| Insomnia (trouble sleeping) | 617 | 5.3 4.9–5.7ROR 5.6 · χ² 2,170 / p <1e-300 | 5.3 EB05 4.9 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · 80% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 562 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.284 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.2 · 77% consumer | no trial data cached |
| Headache | 542 | 2.0 1.8–2.1ROR 2.0 · χ² 270 / p 6e-61 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.2 · 73% consumer | no trial data cached |
| Depression | 490 | 4.9 4.5–5.4ROR 5.1 · χ² 1,536 / p <1e-300 | 4.9 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.7 | no trial data cached |
| Dizziness | 483 | 2.2 2.0–2.4ROR 2.3 · χ² 330 / p 5e-74 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Fatigue (tiredness) | 457 | 1.3 1.2–1.5ROR 1.4 · χ² 42 / p 5e-11 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.6 · 76% consumer | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 415 | 10.4 9.5–11.4ROR 10.8 · χ² 3,514 / p <1e-300 | 10.3 EB05 9.5 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 14.9 | no trial data cached |
| Feeling abnormal | 401 | 3.8 3.5–4.2ROR 3.9 · χ² 839 / p 9e-185 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 77% consumer | no trial data cached |
| Weight increased (weight gain) | 298 | 3.1 2.7–3.4ROR 3.1 · χ² 415 / p 1e-92 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 · 73% consumer | no trial data cached |
| Paraesthesia (tingling/numbness) | 295 | 4.3 3.8–4.8ROR 4.4 · χ² 743 / p 5e-164 | 4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Vomiting | 273 | 1.3 1.2–1.5ROR 1.3 · χ² 23 / p 9e-7 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Pre-existing condition improved — n=53, PRR 19.4
- Sleep terror — n=32, PRR 17.5
- Tachyphrenia — n=24, PRR 15.9
- Dissociation — n=37, PRR 11.3
- Crying — n=173, PRR 10.9
- Nightmare — n=157, PRR 10.4
- Anger — n=149, PRR 10.1
- Post-traumatic stress disorder — n=28, PRR 9.6
- Muscle twitching — n=89, PRR 8.8
- Feeling jittery — n=69, PRR 8.3
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Vilazodone?
In FDA FAERS, the most frequently co-reported reaction terms for Vilazodone are diarrhoea, nausea, anxiety, insomnia, headache, depression. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Vilazodone have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] .
Do FAERS signals prove that Vilazodone causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 3a4745a0-de23-4b40-923e-0d7dfe6b8634, effective 20240522; matched on
openfda.generic_name.exact:"VILAZODONE HYDROCHLORIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,002 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.