IMPORTANT SAFETY INFORMATION

  • XENAZINE can cause serious side effects, including:

    • depression
    • suicidal thoughts
    • suicidal actions

  • You should not start taking XENAZINE if you are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts.

  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings, or worsening depression. This is especially important when XENAZINE is started and when the dose is changed.

  • Do not take XENAZINE if you have liver problems or are taking monoamine oxidase inhibitors (MAOIs), reserpine, deutetrabenazine or valbenazine. Ask your doctor or pharmacist if you are not sure. You must wait at least 20 days after stopping reserpine before starting XENAZINE.
  • Tell your doctor if you have breast cancer or a history of breast cancer, have heart disease or an irregular heartbeat, are pregnant or plan to become pregnant, or are breastfeeding.
  • Tell your doctor about all the medicines you take. Using XENAZINE with certain other medicines may cause serious side effects. Do not start any new medicines while taking XENAZINE without talking to your doctor first.
  • Take XENAZINE exactly as prescribed by your doctor. The dose of XENAZINE should be increased slowly over several weeks to find a dose that is best for you. Do not stop taking XENAZINE without talking to your doctor first. Tell your doctor if you stop taking XENAZINE for more than 5 days. Do not take another dose until you talk to your doctor. If your doctor thinks you need to take more than 50 mg of XENAZINE each day, you will need to have a blood test to see if a higher dose is safe for you. Your doctor should evaluate your need for XENAZINE on an ongoing basis.
  • Neuroleptic Malignant Syndrome (NMS) is a potentially fatal side effect reported with XENAZINE. Call your doctor right away and go to the nearest emergency room if you develop these signs and symptoms that do not have another obvious cause: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, or increased sweating. Your doctor should stop XENAZINE immediately if NMS is diagnosed.
  • XENAZINE can also cause other serious side effects, including: Parkinsonism (slight shaking, body stiffness, trouble moving, or keeping your balance), restlessness (feeling of a strong urge to move called akathisia), irregular heartbeat, and dizziness due to blood pressure changes when you change position (orthostatic hypotension). Change positions slowly from lying down to sitting up and from sitting up to standing when taking XENAZINE. Tell your doctor right away if you get dizzy or faint while taking XENAZINE.
  • The risk of side effects, such as, Parkinsonism, NMS, and restlessness (akathisia), may be increased when using XENAZINE with other drugs (e.g., dopamine antagonists or antipsychotics).
  • Sleepiness (sedation) is a common side effect of XENAZINE. Do not drive a car or operate dangerous machinery until you know how XENAZINE affects you. Drinking alcohol and taking other drugs may increase any sleepiness caused by XENAZINE.
  • The most commonly reported side effects in studies with XENAZINE were sleepiness (sedation), trouble sleeping, depression, tiredness (fatigue), anxiety, restlessness, agitation, and nausea.

For more information, please see the Medication Guideand full Prescribing Information, including Boxed Warning for depression and suicidality, or go to www.XenazineUSA.com.

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

IMPORTANT SAFETY INFORMATION

  • XENAZINE can cause serious side effects, including:

    • depression
    • suicidal thoughts
    • suicidal actions

  • You should not start taking XENAZINE if you are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts.

  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings, or worsening depression. This is especially important when XENAZINE is started and when the dose is changed.

  • Do not take XENAZINE if you have liver problems or are taking monoamine oxidase inhibitors (MAOIs), reserpine, deutetrabenazine or valbenazine. Ask your doctor or pharmacist if you are not sure. You must wait at least 20 days after stopping reserpine before starting XENAZINE.
  • Tell your doctor if you have breast cancer or a history of breast cancer, have heart disease or an irregular heartbeat, are pregnant or plan to become pregnant, or are breastfeeding.
  • Tell your doctor about all the medicines you take. Using XENAZINE with certain other medicines may cause serious side effects. Do not start any new medicines while taking XENAZINE without talking to your doctor first.
  • Take XENAZINE exactly as prescribed by your doctor. The dose of XENAZINE should be increased slowly over several weeks to find a dose that is best for you. Do not stop taking XENAZINE without talking to your doctor first. Tell your doctor if you stop taking XENAZINE for more than 5 days. Do not take another dose until you talk to your doctor. If your doctor thinks you need to take more than 50 mg of XENAZINE each day, you will need to have a blood test to see if a higher dose is safe for you. Your doctor should evaluate your need for XENAZINE on an ongoing basis.
  • Neuroleptic Malignant Syndrome (NMS) is a potentially fatal side effect reported with XENAZINE. Call your doctor right away and go to the nearest emergency room if you develop these signs and symptoms that do not have another obvious cause: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, or increased sweating. Your doctor should stop XENAZINE immediately if NMS is diagnosed.
  • XENAZINE can also cause other serious side effects, including: Parkinsonism (slight shaking, body stiffness, trouble moving, or keeping your balance), restlessness (feeling of a strong urge to move called akathisia), irregular heartbeat, and dizziness due to blood pressure changes when you change position (orthostatic hypotension). Change positions slowly from lying down to sitting up and from sitting up to standing when taking XENAZINE. Tell your doctor right away if you get dizzy or faint while taking XENAZINE.
  • The risk of side effects, such as, Parkinsonism, NMS, and restlessness (akathisia), may be increased when using XENAZINE with other drugs (e.g., dopamine antagonists or antipsychotics).
  • Sleepiness (sedation) is a common side effect of XENAZINE. Do not drive a car or operate dangerous machinery until you know how XENAZINE affects you. Drinking alcohol and taking other drugs may increase any sleepiness caused by XENAZINE.
  • The most commonly reported side effects in studies with XENAZINE were sleepiness (sedation), trouble sleeping, depression, tiredness (fatigue), anxiety, restlessness, agitation, and nausea.

For more information, please see the Medication Guideand full Prescribing Information, including Boxed Warning for depression and suicidality, or go to www.XenazineUSA.com.

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