Austedo XR is used in adults to treat involuntary muscle movements (chorea) caused by Huntington's disease. This medicine is not a cure for Huntington's disease and will not treat other symptoms of this condition.

Austedo XR is also used in adults to treat symptoms of tardive dyskinesia, a nervous system disorder. Tardive dyskinesia causes repetitive uncontrolled muscle movements, usually in the face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement).

Austedo XR is not a permanent cure for involuntary movement disorders.

Austedo XR may also be used for purposes not listed in this medication guide.

Some people have thoughts about suicide while taking Austedo XR. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

If you are switching from a similar medicine called tetrabenazine, take your first dose of deutetrabenazine one day after your last dose of tetrabenazine.

Austedo XR is usually taken 1 or 2 times per day with or without food and a whole glass of water.

Swallow the tablet whole and do not crush, chew, or break it. Tell your doctor if you have trouble swallowing the tablet whole.

You may need medical tests to check your heart function using an electrocardiograph or ECG (sometimes called an EKG).

Do not stop the medicine without your doctor's advice. If you stop taking Austedo XR for longer than 1 week, do not start taking it again without your doctor's advice.

Store at room temperature away from moisture and heat. Keep the medicine in the original container, along with the packet or canister of moisture-absorbing preservative.

You should not use Austedo XR if you are allergic to it, or if you have:

• untreated or uncontrolled depression;

• thoughts about suicide or hurting yourself;

• if you have recently taken tetrabenazine or valbenazine; or

• liver disease.

Do not use Austedo XR if you have taken reserpine in the past 20 days, or if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Tell your doctor if you have or have ever had:

• depression, anxiety, nervousness, or agitation;

• mental illness or psychosis;

• suicidal thoughts or actions;

• breast cancer;

• a heart rhythm disorder;

• long QT syndrome (in you or a family member);

• an electrolyte imbalance (such as low blood levels of potassium or magnesium); or

• liver disease.

People with Huntington's disease may have a higher risk of depression and suicidal thoughts or behaviors. Taking Austedo XR may further increase this risk. However, the benefits of taking Austedo XR (improvement in daily living) may outweigh any suicidal risks.

Taking Austedo XR may cause symptoms similar to Parkinson's disease (resting tremor, stiff muscles, slow movements, difficulty maintaining balance and walking). Ask your doctor about your risk.

Your doctor will need to check your progress on a regular basis. Your family or caregivers should also watch for sudden changes in your behavior.

Tell your doctor if you are pregnant or breastfeeding.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include involuntary muscle movements, tremors, rapid eye movements, nausea, vomiting, diarrhea, flushing, sweating, severe drowsiness, confusion, hallucinations, or feeling light-headed.

Avoid driving or hazardous activity until you know how Austedo XR will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Drinking alcohol with this medicine can cause side effects.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people have thoughts about suicide while taking Austedo XR. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Some side effects may actually be signs that your Huntington's disease is progressing. Your doctor will need to check your progress on a regular basis.

Austedo XR may cause serious side effects. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• severe restlessness or agitation;

• tremors, shaking;

• muscle stiffness;

• problems with balance or coordination; or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects of Austedo XR may include:

• drowsiness;

• tiredness;

• dry mouth;

• runny or stuffy nose, sore throat;

• sleep problems (insomnia); or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Austedo XR can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using Austedo XR with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can affect Austedo XR. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.