Summary
Commonly reported side effects of vilazodone include: diarrhea and nausea. Other side effects include: dizziness, insomnia, and abnormal dreams. Continue reading for a comprehensive list of adverse effects.
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]
