From the Guidelines
Vilazodone is associated with a range of side effects, including gastrointestinal issues, sexual dysfunction, and increased risk of serotonin syndrome, which patients should be aware of before starting treatment. The most commonly reported adverse events with vilazodone include nausea, diarrhea, vomiting, insomnia, dizziness, dry mouth, and sexual dysfunction (decreased libido, delayed ejaculation, or difficulty achieving orgasm) 1. These side effects are similar to those of other second-generation antidepressants, with some differences in the incidence of specific adverse events. For example, venlafaxine has a higher incidence of nausea and vomiting than other SSRIs, while sertraline has a higher rate of diarrhea than some other antidepressants 1.
Common Side Effects
- Nausea and vomiting, which are the most common reasons for discontinuation in efficacy studies
- Diarrhea
- Insomnia
- Dizziness
- Dry mouth
- Sexual dysfunction, including decreased libido, delayed ejaculation, or difficulty achieving orgasm
- Headaches
- Fatigue
- Increased sweating
Serious but Less Common Side Effects
- Serotonin syndrome, characterized by confusion, rapid heart rate, high blood pressure, dilated pupils, and muscle rigidity
- Increased risk of bleeding, especially when combined with NSAIDs or blood thinners
- Hyponatremia, or low sodium levels
- Increased suicidal thoughts, particularly in young adults and adolescents during the first few weeks of treatment
It is essential to monitor patients for these side effects and adjust treatment as needed to minimize their impact on quality of life. Additionally, vilazodone should be tapered slowly when discontinuing to avoid withdrawal symptoms like irritability, anxiety, dizziness, and headaches 1.
From the FDA Drug Label
The most commonly observed adverse reactions in vilazodone hydrochloride-treated patients with major depressive disorder (MDD) in placebo-controlled studies (incidence ≥ 5% and at least twice the rate of placebo) were diarrhea, nausea, vomiting, and insomnia Table 2 shows the incidence of common adverse reactions occurring in ≥ 2% of vilazodone hydrochloride-treated patients and greater than the rate of placebo-treated patients in MDD Studies. Table 3 displays the most common sexual adverse reactions in the placebo-controlled MDD studies The common side effects of Vilazodone include:
- Gastrointestinal disorders:
- Diarrhea
- Nausea
- Vomiting
- Dry mouth
- Abdominal pain
- Nervous system disorders:
- Headache
- Dizziness
- Somnolence
- Psychiatric disorders:
- Insomnia
- Abnormal dreams
- Sexual adverse reactions:
- Abnormal orgasm
- Erectile dysfunction
- Libido decreased
- Ejaculation disorder 2
From the Research
Vilazodone Side Effects
- The most common side effects of vilazodone are diarrhea, nausea, and headache 3.
- Vilazodone has a relatively benign tolerability profile, with gastrointestinal side effects similar to those of selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), but possibly with a lower incidence of sexual side effects and weight gain 4.
- A meta-review of 78 adverse effects of psychotropic medications, including vilazodone, found that nausea/vomiting and discontinuation due to adverse event were most frequently associated with antidepressants 5.
- Vilazodone has not been studied in pediatric patients or well studied in patients older than 65, which may limit the understanding of its side effects in these populations 3.
- The safety profile of vilazodone is considered to be safer than some other antidepressants, such as venlafaxine, but the available literature is not as comprehensive as for some other medications 5.