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Vilazodone Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 23, 2022.

Summary

Commonly reported side effects of vilazodone include: diarrhea and nausea. Other side effects include: dizziness, insomnia, and abnormal dreams. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to vilazodone: oral tablets

Warning

    Suicidality
  • Antidepressants increased risk of suicidal thinking and behavior (suicidality) compared with placebo in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.1 12 14 Vilazodone is not approved for use in pediatric patients.1 (See Pediatric Use under Cautions.)

  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.1 12 14

  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.1 12 14 15

  • Appropriately monitor and closely observe all patients who are started on vilazodone therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.1 12 14 15 (See Worsening of Depression and Suicidality Risk under Cautions.)

Side effects include:

Diarrhea, nausea, vomiting, insomnia.

For Healthcare Professionals

Applies to vilazodone: oral kit, oral tablet

General

The most commonly observed side effects were: diarrhea, nausea, headache, and dry mouth.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 29%), nausea (up to 24%)

Common (1% to 10%): Abdominal distension, abdominal pain, pain, dry mouth, dyspepsia, flatulence, gastroenteritis, vomiting

Frequency not reported: Abdominal discomfort, acute pancreatitis, upper abdominal pain[Ref]

Nervous system

Very common (10% or more): Headache (up to 15%)

Common (1% to 10%): Dizziness, paresthesia, sedation, somnolence, tremor

Uncommon (0.1% to 1%): Migraine, serotonin syndrome

Frequency not reported: Akathisia, paresthesia/electric shock sensation, restless legs syndrome, sensory disturbances

Postmarketing reports: Sleep paralysis[Ref]

Psychiatric

Common (1% to 10%): Abnormal dreams, abnormal orgasm, decreased libido, insomnia, restlessness

Uncommon (0.1% to 1%): Activation of mania/hypomania, panic attack

Frequency not reported: Agitation, anorgasmia, anxiety, clinical worsening, confusion, discontinuation symptoms, dysphoric mood, emotional lability, lethargy, seizures, suicide risk

Postmarketing reports: Irritability, hallucinations, suicide attempt, suicidal ideation[Ref]

Metabolic

Common (1% to 10%): Increased appetite, increased weight

Frequency not reported: Hyponatremia[Ref]

Genitourinary

Common (1% to 10%): Ejaculation disorder, erectile dysfunction[Ref]

Cardiovascular

Common (1% to 10%): Palpitations

Uncommon (0.1% to 1%): Ventricular extrasystoles[Ref]

Other

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Tinnitus[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision, dry eye

Rare (0.01% to 0.1%): Cataracts[Ref]

Dermatologic

Uncommon (0.1% to 1%): Hyperhidrosis, night sweats

Postmarketing reports: Drug eruption, generalized rash, rash, urticaria[Ref]

Hematologic

Frequency not reported: Abnormal Bleeding[Ref]

Frequently asked questions

References

1. "Product Information. Viibryd (vilazodone)." Trovis Pharmaceuticals LLC (2011):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.