Common side effects
from the clinical study*

In the clinical study, the most common side effects of AUSTEDO® (deutetrabenazine) tablets included:

Sleepiness (sedation)
Diarrhea
Dry mouth
Tiredness

2% of people taking AUSTEDO dropped out of the study due to side effects

*Once-daily AUSTEDO XR® contains the same active ingredient as twice-daily AUSTEDO. Data on this page is based on twice-daily dosing.

Discuss your symptoms with your healthcare provider

Use this guide when you discuss your Huntington’s disease (HD) chorea symptoms with your healthcare provider to help determine if AUSTEDO XR is appropriate for you.

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These are not all the possible side effects of AUSTEDO/AUSTEDO XR. Tell your healthcare provider if you have any side effects that bother you or that do not go away.

AUSTEDO XR/AUSTEDO can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Do not start taking AUSTEDO XR/AUSTEDO if you are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using AUSTEDO XR/AUSTEDO with certain other medicines may cause side effects. Do not start any new medicines while taking AUSTEDO XR/AUSTEDO without talking to your healthcare provider first.

In the clinical study, AUSTEDO provided significant and meaningful control of HD chorea with demonstrated safety and tolerability. AUSTEDO/AUSTEDO XR does not cure the cause of the uncontrollable movements and it does not treat the other symptoms of HD, such as problems with thinking or emotions.

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AUSTEDO XR^® (deutetrabenazine) extended-release tablets and AUSTEDO^® (deutetrabenazine) tablets are prescription medicines that are used to treat:

the involuntary movements (chorea) of Huntington’s disease. AUSTEDO XR and AUSTEDO do not cure the cause of the involuntary movements, and it does not treat other symptoms of Huntington’s disease, such as problems with thinking or emotions.
movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

It is not known if AUSTEDO XR and AUSTEDO are safe and effective in children.

AUSTEDO XR^® and AUSTEDO^® can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Do not start taking AUSTEDO XR or AUSTEDO 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. This is especially important when AUSTEDO XR or AUSTEDO is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of suicide.

Do not take AUSTEDO XR or AUSTEDO if you:

have Huntington’s disease and are depressed or have thoughts of suicide.
have liver problems.
are taking reserpine. Do not take medicines that contain reserpine with AUSTEDO XR or AUSTEDO. If your healthcare provider plans to switch you from taking reserpine to AUSTEDO XR or AUSTEDO, you must wait at least 20 days after your last dose of reserpine before you start taking AUSTEDO XR or AUSTEDO.
are taking a monoamine oxidase inhibitor (MAOI) medicine. Do not take an MAOI within 14 days after you stop taking AUSTEDO XR or AUSTEDO. Do not start AUSTEDO XR or AUSTEDO if you stopped taking an MAOI in the last 14 days. Ask your healthcare provider or pharmacist if you are not sure.
are taking tetrabenazine. If your healthcare provider plans to switch you from tetrabenazine to AUSTEDO XR or AUSTEDO, take your first dose of AUSTEDO XR or AUSTEDO on the day after your last dose of tetrabenazine.
are taking valbenazine.

Other possible serious side effects include:

Irregular heartbeat (QT prolongation). AUSTEDO XR and AUSTEDO increases your chance of having certain changes in the electrical activity in your heart. These changes can lead to a dangerous abnormal heartbeat. Taking AUSTEDO XR or AUSTEDO with certain medicines may increase this chance.
Neuroleptic Malignant Syndrome. Call your healthcare provider 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.
Restlessness. You may get a condition where you feel a strong urge to move. This is called akathisia.
Parkinsonism. Symptoms include: slight shaking, body stiffness, trouble moving, trouble keeping your balance, or falls.

Sleepiness (sedation) is a common side effect of AUSTEDO XR and AUSTEDO. While taking AUSTEDO XR or AUSTEDO, do not drive a car or operate dangerous machinery until you know how AUSTEDO XR or AUSTEDO affects you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking AUSTEDO XR or AUSTEDO may increase any sleepiness caused by AUSTEDO XR and AUSTEDO.

The most common side effects of AUSTEDO in people with Huntington’s disease include sleepiness (sedation), diarrhea, tiredness, and dry mouth.

The most common side effects of AUSTEDO in people with tardive dyskinesia include inflammation of the nose and throat (nasopharyngitis) and problems sleeping (insomnia).

The most common side effects of AUSTEDO XR are expected to be similar to AUSTEDO in people with Huntington’s disease or tardive dyskinesia.

These are not all the possible side effects of AUSTEDO XR or AUSTEDO. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying Medication Guide.

Common side effects from the clinical study*

In the clinical study, the most common side effects of AUSTEDO® (deutetrabenazine) tablets included:

Discuss your symptoms with your healthcare provider

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Common side effects
from the clinical study*