What the label lists and what reports show
Vilazodone side effects
Vilazodone's FDA label: “Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo): diarrhea, nausea, vomiting, and insomnia.” FAERS holds 9,170 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (781 reports).
- Generic listed
- Boxed warning
Check it at the source: the vilazodone FDA label on DailyMed (effective May 22, 2024, Teva Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of vilazodone hydrochloride tablets?Vilazodone hydrochloride tablets may cause serious side effects, including: See, “What is the most important information I should know about vilazodone hydrochloride tablets?” Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome can happen when vilazodone hydrochloride tablets are taken with certain other medicines. […]
Source: FDA drug label, Teva Pharmaceuticals, Inc., effective May 22, 2024 (SPL set 3a4745a0-de23-4b40-923e-0d7dfe6b8634), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥5% and at least twice the rate of placebo): diarrhea, nausea, vomiting, and insomnia.
Table 2: Common Adverse Reactions Occurring in ≥2% of Vilazodone Hydrochloride-treated Patients and Greater than the Rate of Placebo-Treated Patients
| System Organ Class Preferred Term | Placebo N=967 | Vilazodone Hydrochloride 20 mg/day N=288 | Vilazodone Hydrochloride 40 mg/day N=978 |
|---|---|---|---|
| Diarrhea | 10% | 26% | 29% |
| Nausea | 7% | 22% | 24% |
| Dry mouth | 5% | 8% | 7% |
| Vomiting | 2% | 4% | 5% |
| Abdominal pain 1 | 3% | 7% | 4% |
| Dyspepsia | 2% | 2% | 3% |
| Flatulence | 1% | 3% | 3% |
| Gastroenteritis | 1% | 1% | 2% |
| Abdominal distension | 1% | 2% | 1% |
| Headache 2 | 14% | 15% | 14% |
| Dizziness | 5% | 6% | 8% |
| Somnolence | 2% | 4% | 5% |
| Paresthesia | 1% | 1% | 2% |
| Insomnia | 2% | 7% | 6% |
| Abnormal dreams | 2% | 2% | 3% |
| Restlessness 3 | 1% | 2% | 3% |
| Fatigue | 3% | 4% | 3% |
| Palpitations | <1% | 1% | 2% |
| Increased appetite | 1% | 1% | 3% |
| Arthralgia | 1% | 2% | 1% |
| Increased weight | 1% | 1% | 2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( 5.1 )]. Serotonin Syndrome [see Warnings and Precautions ( 5.2 )]. Increased Risk of Bleeding [see Warnings and Precautions ( 5.3 )]. Activation of Mania or Hypomania [see Warnings and Precautions ( 5.4 )]. Discontinuation Syndrome [see Warnings and Precautions ( 5.5 )]. Seizures [see Warnings and Precautions ( 5.6 )]. Angle-Closure Glaucoma [see Warnings and Precautions ( 5.7 )]. Hyponatremia [see Warnings and Precautions ( 5.8 )]. Sexual Dysfunction [see Warnings and Precautions ( 5.9 )]. Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo): diarrhea, nausea, vomiting, and insomnia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions and varying lengths of time, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice. …
Source: FDA drug label, Teva Pharmaceuticals, Inc., effective May 22, 2024 (SPL set 3a4745a0-de23-4b40-923e-0d7dfe6b8634), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,170 reports list vilazodone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 185 are coded as a death and 1,012 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 15 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Vilazodone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions