Prescription medicine
Deutetrabenazine Brand names: Austedo
Deutetrabenazine (Austedo) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $249.32 per unit (Austedo XR titr(12-18-24-30 mg)) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the deutetrabenazine FDA label on DailyMed (effective February 28, 2025, Teva Neuroscience, Inc.); the NDA 208082 record on Drugs@FDA; every deutetrabenazine label on DailyMed.
Highlights of the record
FDA label of February 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE AUSTEDO.
XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDO XR or AUSTEDO must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington’s disease. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageAUSTEDO XR ® and AUSTEDO ® are indicated in adults for the treatment of: chorea associated with Huntington’s disease [see Clinical Studies ( 14.1 )] tardive dyskinesia [see Clinical Studies ( 14.2 )] AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease ( 1 ) Tardive dyskinesia
Forms and strengths
- 6 mg
- 9 mg
- 12 mg
- 18 mg
- 24 mg
- 30 mg
- 36 mg
- 42 mg
- 48 mg
Film-coated extended-release tablet; coated tablet; kit.
On the market
- Earliest approval on file
- April 3, 2017 Austedo, Teva Branded Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first December 26, 2024; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 10, 2041 Austedo XR tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $249.32 per unit Austedo XR titr(12-18-24-30 mg)
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 7,234 through July 30, 2026
What is deutetrabenazine used for?
From the label: indications and usageAUSTEDO XR ® and AUSTEDO ® are indicated in adults for the treatment of: chorea associated with Huntington’s disease [see Clinical Studies ( 14.1 )] tardive dyskinesia [see Clinical Studies ( 14.2 )] AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease ( 1 ) Tardive dyskinesia
Source: FDA drug label (Austedo), Teva Neuroscience, Inc., effective February 28, 2025 (SPL set 7ea3c60a-45c7-44cc-afc2-d87fa53993c0), via openFDA; the full label on DailyMed
What does the patient leaflet for deutetrabenazine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about AUSTEDO XR and AUSTEDO?AUSTEDO XR and AUSTEDO can cause serious side effects in people with Huntington’s disease, including: depression suicidal thoughts suicidal actions Do not start taking AUSTEDO XR or AUSTEDO if you have Huntington’s disease and 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 or have any of the following symptoms, especially if they are new, worse, or worry you: feel sad or have crying spells lose interest in seeing your friends or doing things you used to enjoy sleep a lot more or a lot less than usual feel unimportant feel guilty feel hopeless or helpless feel more irritable, angry, or aggressive than usual feel more or less hungry than usual or notice a big change in your body weight have trouble paying attention feel tired or sleepy all the time have thoughts about hurting yourself or ending your life
From the patient leaflet: What should I avoid while taking AUSTEDO XR or AUSTEDO?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.
From the patient leaflet: How should I store AUSTEDO XR and AUSTEDO?Store AUSTEDO XR and AUSTEDO tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed to protect AUSTEDO XR and AUSTEDO from light and moisture. Do not throw away the desiccant canister in the bottle until the last dose of AUSTEDO XR or AUSTEDO is taken. Keep AUSTEDO XR and AUSTEDO and all medicines out of the reach of children.
Source: FDA drug label (Austedo), Teva Neuroscience, Inc., effective February 28, 2025 (SPL set 7ea3c60a-45c7-44cc-afc2-d87fa53993c0), via openFDA; the full label on DailyMed
Is there a generic for deutetrabenazine (Austedo)?
The FDA approved the first generic deutetrabenazine on December 26, 2024. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 13 patents for Austedo XR tablets: the compound patent runs to September 18, 2033 (pediatric exclusivity to March 18, 2034), and the last listed entry to June 10, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2024 first generic approved
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for deutetrabenazine (Austedo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $249.32 per unit (Austedo XR titr(12-18-24-30 mg)), up 6% from $236.41 on November 19, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Austedo XR titr(12-18-24-30 mg) (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Austedo 12 mg tablet | Brand | $125.03 per tablet | $3,750.89 | +5% |
| Austedo 6 mg tablet | Brand | $83.20 per tablet | $2,496.00 | +5% |
| Austedo 9 mg tablet | Brand | $93.97 per tablet | $2,819.12 | +5% |
| Austedo XR 12 mg tablet | Brand | $166.76 per tablet | $5,002.94 | +5% |
| Austedo XR 18 mg tablet | Brand | $251.16 per tablet | $7,534.82 | +6% |
| Austedo XR 24 mg tablet | Brand | $250.63 per tablet | $7,518.94 | +5% |
| Austedo XR 30 mg tablet | Brand | $332.34 per tablet | $9,970.20 | +5% |
| Austedo XR 36 mg tablet | Brand | $416.76 per tablet | $12,502.68 | +5% |
| Austedo XR 42 mg tablet | Brand | $498.13 per tablet | $14,944.05 | +6% |
| Austedo XR 48 mg tablet | Brand | $500.84 per tablet | $15,025.31 | +6% |
| Austedo XR 6 mg tablet | Brand | $83.03 per tablet | $2,491.03 | +4% |
| Austedo XR titr(12-18-24-30 mg) | Brand | $249.32 per unit | n/a | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the deutetrabenazine label say about other medicines?
The deutetrabenazine label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name deutetrabenazine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bupropion | drug interactions | Concomitant use of strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion) has been shown to increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. |
| Fluoxetine | drug interactions | Concomitant use of strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion) has been shown to increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. |
| Paroxetine | drug interactions | Concomitant use of strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion) has been shown to increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. |
| Quinidine | drug interactions | Concomitant use of strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion) has been shown to increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. |
| Tetrabenazine | contraindications | Taking tetrabenazine or valbenazine [see Drug Interactions ( 7.6 )]. |
| Valbenazine | contraindications | Taking tetrabenazine or valbenazine [see Drug Interactions ( 7.6 )]. |
Source: FDA drug label (Austedo), Teva Neuroscience, Inc., effective February 28, 2025 (SPL set 7ea3c60a-45c7-44cc-afc2-d87fa53993c0), via openFDA; the full label on DailyMed
What do FAERS reports show for deutetrabenazine?
The FDA Adverse Event Reporting System holds 7,234 reports that list deutetrabenazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 581 are coded as a death and 937 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Alternatives to deutetrabenazine
- medicines labeled for the same conditions
- Deutetrabenazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other