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Vilazodone Side Effects

For the Consumer

Applies to vilazodone: oral tablet

Along with its needed effects, vilazodone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking vilazodone:

Less common
  • Actions that are out of control
  • anxiety
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • extra heartbeat
  • fast, irregular, pounding, or racing heartbeat or pulse
  • irritability
  • shakiness in the legs, arms, hands, or feet
  • sweating
  • talking, feeling, and acting with excitement
  • trembling or shaking of the hands or feet

Some side effects of vilazodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Diarrhea
  • dizziness
  • dry mouth
  • nausea
  • trouble sleeping
Less common
  • Abdominal or stomach pain
  • abnormal dreams
  • aching or discomfort in the lower legs or sensation of crawling in the legs
  • acid or sour stomach
  • belching
  • blindness
  • bloated or full feeling
  • blurred vision
  • change in taste
  • decreased interest in sexual intercourse
  • decreased vision
  • difficulty with moving
  • drowsiness
  • dry eyes
  • excess air or gas in the stomach or intestines
  • feeling jittery
  • headache, severe and throbbing
  • heartburn
  • inability to have or keep an erection
  • increased or decreased appetite
  • increased sweating
  • indigestion
  • loss in sexual ability, desire, drive, or performance
  • loss of appetite
  • loss of taste
  • muscle pain or stiffness
  • night sweats
  • not able to have an orgasm
  • pain in the joints
  • passing gas
  • relaxed and calm
  • restlessness
  • sleepiness or unusual drowsiness
  • stomach discomfort or upset
  • unusual tiredness or weakness
  • vomiting
  • weakness
Incidence not known
  • Eye pain

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]

References

1. "Product Information. Viibryd (vilazodone)." Trovis Pharmaceuticals LLC, New Haven, CT.

Some side effects of vilazodone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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