SIDE EFFECTS OF LATUDA

Ask your doctor about possible side effects with LATUDA

Understanding the possible side effects of LATUDA is an important part of taking your medication. Knowing as much as you can about LATUDA can help you and your doctor make informed decisions and may help you stick to your treatment plan.

The side effects shown below are NOT a complete list. Please see additional Important Safety Information for a more comprehensive list.

Be aware of any possible side effects and work with your doctor to help manage them. Speak up if your medicine is not working or if you have any side effects. If you are starting to experience worsening of symptoms, don't be afraid to reach out and call your doctor.

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death compared to patients receiving placebo (sugar pill). LATUDA is not approved for the treatment of patients with dementia-related psychosis.

Antidepressant medicines may increase suicidal thoughts or behaviors in some children, teenagers, and young adults within the first few months of treatment. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. LATUDA is not approved for use in pediatric patients with depression.

Most common side effects with LATUDA

In clinical studies the most common side effects with LATUDA included:

Adults

  • sleepiness or drowsiness
  • restlessness or feeling like you need to move around (akathisia)
  • difficulty moving, slow movements, muscle stiffness, or tremor
  • nausea

Adolescents

  • sleepiness or drowsiness
  • nausea
  • restlessness and feeling like you need to move around (akathisia)
  • difficulty moving, slow movements, muscle stiffness, or tremor
  • runny nose/nasal inflammation
  • vomiting

This is not a complete list of side effects. Please see the Important Safety Information, including Boxed Warnings, below and on the following page, for a more complete list. Tell your health care provider if you experience any side effects while taking LATUDA.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

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