Deutetrabenazine

Generic name: deutetrabenazine [ DOO-tet-ra-BEN-a-zeen ]
Brand names: Austedo, Austedo XR
Dosage forms: Austedo tablets , (6 mg, 9 mg, 12 mg), Austedo XR tablets (6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, and 48 mg)
Drug class: VMAT2 inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Feb 5, 2025.

What is deutetrabenazine?

Deutetrabenazine (Austedo and Austedo XR) are used to treat involuntary movement disorders in tardive dyskinesia (TD) and Huntington's disease (Huntington's chorea) to help reduce the severity of symptoms and improve quality of life.

Deutetrabenazine works by changing the activity of natural chemical messengers (dopamine, serotonin, norepinephrine, and histamine) between nerve cells which helps control involuntary muscle movements.  Deutetrabenazine does this by blocking a protein called VMAT2 which is responsible amount of chemical messengers in the nerve terminals. 

Deutetrabenazine drug class is VMAT2 inhibitors (vesicular monoamine transporter 2 inhibitor). 

Deutetrabenazine brand name is Austedo and Austedo XR (extended-release tablet). Austedo XR is taken once daily and Austedo tablets are taken twice daily.

What is tardive dyskinesia (TD) and Huntington’s disease chorea

Tardive dyskinesia is a nervous system disorder that causes repetitive, uncontrolled muscle movements, usually in the face (chewing, lip smacking, frowning, tongue movement, blinking, or eye movement). Tardive dyskinesia can develop due to using certain medicines.

Huntington's disease chorea is sudden involuntary movements usually of the arms, legs, face, and tongue. It is an inherited disease that causes the progressive breakdown of nerve cells in the brain. Deutetrabenazine is not a cure for Huntington's disease and will not treat other symptoms of this condition.

Deutetrabenazeine FDA approval

Deutetrabenazine FDA approval for treatment of chorea associated with Huntington’s disease was granted on April 3, 2017, based on positive results from deutetrabenazine clinical trials, the Phase III randomized, placebo-controlled study called First-HD. Total Maximal Chorea Scores were averaged over the maintenance period (week 9 to week 12).

Total Maximal Chorea Scores were improved by: 

• 4.4 units for deutetrabenazine patients 
• 1.9 units for placebo patients.

Deutetrabenazine FDA approval for the treatment of tardive dyskinesia in adults was received on August 30, 2017, after positive results from deutetrabenazine clinical trials AIM-TD and ARM-TD, two Phase III randomized, double-blind, placebo-controlled, parallel-group studies. In the clinical trial, ARM-TD tardive dyskinesia severity was measured using the change in Abnormal Involuntary Movement Scale (AIMS) from baseline levels to levels at Week 12.

The AIMS total score was improved by: 

• 3.0 units for patients taking deutetrabenazine (statistically significant improvement)
• 1.6 units in the placebo group
• treatment effect of -1.4 units. 

How does deutetrabenazine work?

Deutetrabenazine mechanism of action is a VMAT2 inhibitor that blocks VMAT2 protein, which reduces the amount of neurotransmitter available in the nerve terminals and, therefore, reduces unwanted body movements. 

Body movement or motor function is controlled in the brain by nerve cells (neurons) that speak to each other by passing chemical messengers (neurotransmitters) from one nerve cell to another nerve cell.

In movement disorders such as Huntington’s disease and tardive dyskinesia there can be a problem with this system and by lowering the amount of chemical messengers between the nerve cells you relieve the uncontrolled movements.

The protein called VMAT2 controls how much neurotransmitter is stored in the nerve cell and how much is absorbed. The VMAT2 inhibitors block VMAT2, so there is a lower amount of neurotransmitter available, so improves the unwanted body movements.

What is the cost of Deutetrabenazine?

The cost of deutetrabenazine varies depending on your insurance plan and which pharmacy you use. Refer to our Austedo price guide or Austedo XR price guide pages for more information about the cost of this medicine.

Deutetrabenazine Copay Card or Coupon

You may pay as little as $0 out-of-pocket if you qualify for the Deutetrabenazine (Austedo brand) copay card. The Austedo Coupon or Copay Card helps you save money on prescriptions for this medicine. 

Who is eligible for the Deutetrabenazine Coupon or Copay Card?

You are eligible for the Austedo Copay Card if you have commercial or private insurance, a valid prescription, and are a resident of the United States and United States territories. 

You are not eligible for an Austedo Copay Card if you are enrolled in Medicare, Medigap, Medicaid, VA, DOD, TRICARE, Puerto Rico Government Health Insurance Plan, and Medicare-eligible patients enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees.

How can I apply for the Deutetrabenazine Copay Card?

You can apply for the deutetrabenazine Copay Card or Coupon (Austedo brand) online; there is a link on the Austedo Price Guide page. 

Check the terms and conditions for the Austedo Savings Card online.

Deutetrabenazine side effects

Common deutetrabenazine side effects

Common deutetrabenazine side effects when used for Huntington’s disease may include:

• Drowsiness (11%)
• Tiredness (9%)
• Dry mouth (9%)
• Urinary tract infection (7%)
• Anxiety (4%)
• Sleep problems or insomnia (7%)
• Diarrhea (9%)
• Constipation (4%)
• Confusion(4%)

The side effects that affected 4% or more of patients using deutetrabenazine for Huntington’s disease in clinical trial Study 1.

Common deutetrabenazine side effects when used for tardive dyskinesia may include:

• Nasopharyngitis (4%)
• Sleep problems or insomnia (4%)
• Depression/ Dysthymic disorder (2%)
• Agitation/Restlessness/Akathisia (2%)

The side effects that affected 4% or more of patients using deutetrabenazine for tardive dyskinesia in clinical trials Study 1 and Study 2.

Serious deutetrabenazine side effects

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

Some people have thoughts about suicide while taking deutetrabenazine. 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.

Deutetrabenazine 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.

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 the FDA at 1-800-FDA-1088.

Related/similar drugs

Warnings

QTc Prolongation

This medicine may prolong the QT interval, but the degree of QT prolongation is not clinically significant when administered within the recommended dosage range. Deutetrabenazine should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias associated with prolonged QT interval.

Certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including:

• slow heart rate (bradycardia),
• low potassium levels (hypokalemia),
• low magnesium blood levels (hypomagnesemia),
• having a congenital prolongation of the QT interval, and
• concomitant use of other drugs that prolong the QTc interval.

Depression and Suicide

Some people have thoughts about suicide while takingdeutetrabenazine; stay alert to changes in your mood, feelings, thoughts, or behaviors. Tell your doctor right away if you have any sudden changes in mood or behavior or thoughts about suicide.

You should not use deutetrabenazine if you have Huntington’s disease and you have untreated or uncontrolled depression or if you have thoughts about suicide.

Other medicines

Do not use deutetrabenazineif you have taken reserpine (Serpalan, Renese-R) in the past 20 days, or if you have used an MAO inhibitor (isocarboxazid, linezolid, rasagiline, selegiline, and others) in the past 14 days. See Interactions section for more interactions with this medicine.

Before taking this medicine

You should not use deutetrabenazine 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 deutetrabenazine 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, anger, 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 deutetrabenazine may further increase this risk. However, the benefits of taking deutetrabenazine (improvement in daily living) may outweigh any suicidal risks.

Taking deutetrabenazine 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.

How should I take deutetrabenazine?

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 on the day after your last dose of tetrabenazine.

You may take deutetrabenazine with or without food and with a whole glass of water.

Deutetrabenazine tablets are taken twice daily with food. Swallow whole. Do not chew, crush, or break tablets. Take Austedo's total daily dosage of 12 mg or above in two divided doses.

Deutetrabenazine XR tablets are taken once daily with or without food. Swallow whole. Do not chew, crush, or break tablets. The XR tablets are made with a shell that is not absorbed or melted in the body. Part of this shell may appear in your stool. This is normal and will not make the medicine less effective.

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

Some tablets are made with a shell that is not absorbed or melted in the body. Part of this shell may appear in your stool. This is normal and will not make the medicine less effective.

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

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

Deutetrabenazine dosing information

Deutetrabenazine dosing information (Austedo Brand)

Initial Dose: 6 mg twice daily (12 mg per day).
Dose titration: May increase dose in increments of 6 mg/day at weekly intervals, based on reduction of chorea or tardive dyskinesia, and tolerability up to a maximum of 48 mg/day in divided doses.
Maximum Dose: 48 mg/day in divided doses.
Important Administration Instructions:

• Take Austedo with food
• Swallow whole. Do not chew, crush, or break tablets
• Take Austedo total daily dosages of 12 mg or above in two divided doses.

Austedo XR dosing information

Initial Dose: 12 mg once daily (12 mg per day).
Dose titration: May increase dose in increments of 6 mg/day at weekly intervals, based on reduction of chorea or tardive dyskinesia, and tolerability up to a maximum of 48 mg/day.
Maximum Dose: 48 mg/day
Important Administration Instructions:

• Take XR tablets with or without food
• Swallow whole. Do not chew, crush, or break tablets.
• Take Austedo XR once daily.

Switching Between Austedo and Austedo XR

When switching between Austedo tablets (twice daily) and Austedo XR extended-release tablets (once daily), switch to the same total daily dosage.

Dose modifications

Dose modification is required for Strong CYP2D6 Inhibitors and in Poor CYP2D6 Metabolizers.

Discontinuation and Interruption of Treatment

Treatment with this medicine can be discontinued without tapering. Following treatment interruption of greater than one week, this therapy should be re-titrated when resumed. For treatment interruption of less than one week, treatment can be resumed at the previous maintenance dose without titration.

Austedo is avialable as:

• Austedo tablets are available as 6 mg, 9 mg, and 12 mg.
• Austedo XR (extended-release tablet) is available as 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, and 48 mg.

What happens if I miss a dose?

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.

What happens if I overdose?

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.

What should I avoid while taking deutetrabenazine?

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

Drinking alcohol with this medicine can cause side effects.

What other drugs will affect deutetrabenazine?

QT Prolongation This medicine may prolong the QT interval and should not be used with medicines that prolong the QTc interval. Talk to your healthcare provider about other medicines you take, or if you start taking new medicines.

Reserpine. Do not take deutetrabenazine if you are taking reserpine. If your healthcare provider plans to switch you from taking reserpine to this medicine you must wait at least 20 days after your last dose of reserpine before you start taking deutetrabenazine.

Monoamine oxidase inhibitor (MAOI) medicine. Do not take an MAOI within 14 days after you stop taking deutetrabenazine. Do not start this medicine if you stopped taking an MAOI (isocarboxazid, linezolid, rasagiline, selegiline, and others) in the last 14 days. Ask your healthcare provider or pharmacist if you are not sure.

Tetrabenazine. Deutetrabenazine is contraindicated in patients currently taking tetrabenazine. If your healthcare provider plans to switch you from tetrabenazine to deutetrabenazine take your first dose of deutetrabenazine on the day after your last dose of tetrabenazine.

Valbenazine. Deutetrabenazine is contraindicated in patients currently taking valbenazine.

Neuroleptic Drugs The risk of parkinsonism, Neuroleptic Malignant Syndrome (NMS), and being unable to remain still (akathisia) may be increased by using this medicine with dopamine antagonists or antipsychotics. Talk to your healthcare provider about other medicines you take, or if you start taking new medicines.

Alcohol or Other Sedating Drugs Using alcohol or other sedating drugs may have additive effects and make sedation and sleepiness worse.

Strong CYP2D6 inhibitors. A dose reduction in deutetrabenazine may be necessary when adding a strong CYP2D6 inhibitor in patients maintained on a stable dose of deutetrabenazine. Using strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion) has been shown to increase deutetrabenazine effectiveness. If you are using strong CYP2D6 inhibitors, the maximum recommended dose of deutetrabenazine is 36 mg per day.

This list is not complete, and many other drugs can interact with deutetrabenazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Click the link below to check for interactions with this medicine.

Deutetrabenazine Package Insert

Review the Austedo Package Insert (PI) for more detailed information about this medicine. The Austedo PI contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Austedo Prescribing Information or FDA label.

Storage

• Store tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the bottle tightly closed to protect tablets from light and moisture.
• Do not throw away the desiccant canister in the bottle until the last dose has been taken.

Ingredients

Active ingredient: deutetrabenazine.
Inactive ingredients:

Austedo: ammonium hydroxide, black iron oxide, n-butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&C blue #2 lake. The 6 mg tablets also contain FD&C red #40 lake. The 12 mg tablets also contain FD&C yellow #6 lake.

Austedo XR: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&C red #40 lake.

The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extended-release tablets also contain FD&C yellow #6 lake.

The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&C blue #2 lake. The 18 mg extended-release tablets also contain carmine

Company

AUSTEDO is made for Teva Neuroscience, Inc. Parsippany, NJ 07054 

Popular FAQ

More FAQ

• Austedo vs Ingrezza: How do they compare?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer