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Vraylar - What are some of the important warnings?

Medically reviewed by Judith Stewart, BPharm. Last updated on Feb 16, 2021.

Official Answer

by Drugs.com

Vraylar (cariprazine) is an oral, once daily atypical antipsychotic medication that is used to treat schizophrenia and bipolar disorder. Vraylar may cause serious side effects including the increased risk of death in elderly people with dementia related psychosis. It may also increase the risk of suicidal thoughts or actions in children and young adults.

What is Vraylar used for?

  • Vraylar is approved for the treatment of schizophrenia in adults.
  • Vraylar is also approved for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder and for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults.

Warnings include:

  • Increased risk of death and cerebrovascular adverse reactions (e.g. stroke, transient ischemic attack) in older adults with dementia-related psychosis
  • Increased risk of suicidal thoughts or actions in children and young adults.

Patients and caregivers should look out for the onset of suicidal thoughts and behaviors, especially early during treatment, and when the dosage is adjusted up or down. Any new or sudden changes in mood, behaviors, thoughts, or feelings should be reported to the patient's healthcare provider right away.

Symptoms of concern include:

  • thoughts about suicide or dying
  • new or worse depression
  • feeling very agitated or restless
  • trouble sleeping (insomnia)
  • acting aggressive, being angry, or violent
  • an extreme increase in activity and talking (mania)
  • attempts to commit suicide
  • new or worse anxiety
  • panic attacks
  • new or worse irritability
  • acting on dangerous impulses
  • other unusual changes in behavior or mood

Other warnings and precautions for Vraylar include:

  • neuroleptic malignant syndrome
  • tardive dyskinesia
  • metabolic changes like high blood sugar, diabetes, weight gain and elevated lipids like cholesterol, LDL, and HDL
  • leukopenia, neutropenia, and agranulocytosis
  • orthostatic hypotension which may lead to fainting and falls
  • seizures
  • potential for cognitive and motor impairment
  • body temperature dysregulation
  • dysphagia

Common side effects reported in schizophrenia patients include extrapyramidal symptoms and akathisia.

Common side effects reported in bipolar mania patients include extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness.

Common side effects reported in bipolar depression patients include nausea, akathisia, restlessness, and extrapyramidal symptoms.

References
  • Food and Drug Administration. VRAYLAR Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204370s006lbl.pdf [Accessed February 16, 2021]

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