Prescription medication · VMAT2 Inhibitor
deutetrabenazine
Also sold as Austedo. Austedo and Austedo XR are used to treat chorea (uncontrollable movements) caused by Huntington's disease.
Data updated 2026-05-15
- 6,445
- FDA reportsLightly reported
- 7
- InteractionsFew interactions
- $116.80
- Brand price (NADAC)
What the data shows
deutetrabenazine (Austedo) is a prescription VMAT2 Inhibitor, reported less often than most tracked drugs (6,445 FDA reports), with 7 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
deutetrabenazine (Austedo) is a prescription VMAT2 Inhibitor. Austedo and Austedo XR are used to treat chorea (uncontrollable movements) caused by Huntington's disease.
Austedo and Austedo XR help control movements in adults with Huntington's disease or tardive dyskinesia. It works by changing the levels of certain chemicals in the brain.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$116.80/unit
Generic Available
No
TEVA
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Austedo and Austedo XR are used to treat chorea (uncontrollable movements) caused by Huntington's disease.
Common side effects
Feeling sleepy, Diarrhea, Dry mouth
Key warnings
Austedo and Austedo XR can increase the risk of depression and suicidal thoughts in people with Huntington's disease.
The sections below are summarized in plain English from deutetrabenazine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Austedo and Austedo XR affect a protein in the brain called VMAT2. This protein helps move certain chemicals like dopamine. By blocking VMAT2, Austedo and Austedo XR help regulate these chemicals, which reduces unwanted movements.
How to Take It
Your doctor will tell you how much Austedo or Austedo XR to take. The starting dose is usually 12 mg per day. Your doctor may increase the dose by 6 mg each week, up to 48 mg per day. Take Austedo XR once a day, with or without food. Take Austedo with food, and if your daily dose is 12 mg or higher, divide it into two doses.
This is a plain-language summary of deutetrabenazine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if Austedo or Austedo XR will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if Austedo or Austedo XR passes into breast milk. Talk to your doctor about the best way to feed your baby if you are taking this medicine.
This is a plain-language summary of deutetrabenazine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose of Austedo XR, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses at once to make up for the missed dose.
This is a plain-language summary of deutetrabenazine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Austedo and Austedo XR at room temperature, away from light and moisture.
Side Effects (from patient reports)
Based on 6,445 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for deutetrabenazine, by number of reports
- Feeling sad or hopeless
Feeling sad or hopeless
463 reports
- Involuntary movements
Involuntary movements
403 reports
- Death
Death
402 reports
- Shaking
Shaking
330 reports
- Sleepiness
Sleepiness
305 reports
- Tiredness
Tiredness
290 reports
- Thoughts of suicide
Thoughts of suicide
287 reports
- Trouble sleeping
Trouble sleeping
281 reports
- Falling down
Falling down
262 reports
- Involuntary, repetitive movements
Involuntary, repetitive movements
221 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for deutetrabenazine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where deutetrabenazine sits
deutetrabenazine has more FDA adverse-event reports than 29% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is deutetrabenazine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 6,445 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2016–2025.
Total Reports
6,445
Reports Mentioning Death
464
7.2% of reports — not proof of cause
Hospitalization Reports
802
Top Indication
Tardive Dyskinesia
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | DEPRESSION | 463 |
| 3 | DYSKINESIA | 403 |
| 4 | DEATH | 402 |
| 5 | TREMOR | 330 |
| 7 | SOMNOLENCE | 305 |
| 8 | FATIGUE | 290 |
| 9 | SUICIDAL IDEATION | 287 |
| 10 | INSOMNIA | 281 |
| 12 | FALL | 262 |
| 14 | TARDIVE DYSKINESIA | 221 |
| 15 | DIZZINESS | 210 |
| 16 | ANXIETY | 189 |
| 17 | FEELING ABNORMAL | 167 |
| 18 | CONFUSIONAL STATE | 139 |
| 19 | LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES | 139 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Austedo and Austedo XR can increase the risk of depression and suicidal thoughts in people with Huntington's disease. If you have Huntington's disease, your doctor will monitor you closely for any changes in your mood or behavior. Tell your doctor right away if you feel depressed or have thoughts of harming yourself. You should not take Austedo or Austedo XR if you are suicidal or have untreated depression.
Known Drug Interactions
7.6 Concomitant Tetrabenazine or Valbenazine AUSTEDO XR and AUSTEDO are contraindicated in patients currently taking tetrabenazine or valbenazine.
Mechanism: These two medicines work in the same way, and taking them at the same time can cause the drug effects to become too strong and unsafe.
What to do: Do not take these two medications together; your doctor will have you stop one before starting the other.
7.7 Concomitant Deutetrabenazine or Valbenazine Tetrabenazine is contraindicated in patients currently taking deutetrabenazine or valbenazine.
Mechanism: These two drugs are very similar and work in the same way to treat movement disorders. Taking them together can lead to an overdose of the same medicine type and cause severe side effects.
What to do: You must not take these two medications at the same time. Talk to your doctor about which single treatment is right for you.
7.4 Neuroleptic Drugs The risk of parkinsonism, NMS, and akathisia may be increased by concomitant use of AUSTEDO XR or AUSTEDO with dopamine antagonists or antipsychotics.
Mechanism: This drug lowers the amount of dopamine available in the brain. Taking it with other drugs that affect dopamine can increase the risk of serious movement-related side effects like stiffness or restlessness.
What to do: Your doctor will watch you closely for any new or worsening movement problems. They may need to adjust your treatment plan if you use both.
Prescribers should wait for chorea or dyskinesia to reemerge before administering AUSTEDO XR or AUSTEDO to help reduce the risk of overdosage and major depletion of serotonin and norepinephrine in the central nervous system.
Mechanism: This medication can lower the levels of norepinephrine in your brain. Taking it when levels are already low could cause a severe and dangerous drop in this important chemical.
What to do: Your doctor will wait for your symptoms to return before starting this medication to ensure your chemical levels are safe.
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.
Mechanism: Bupropion slows down the liver enzyme that clears deutetrabenazine from your body, causing the drug to build up.
What to do: Your doctor may need to reduce your dose of deutetrabenazine to prevent it from reaching unsafe levels.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I stop taking Austedo or Austedo XR suddenly?
Can I drink alcohol while taking Austedo or Austedo XR?
What should I tell my doctor before taking Austedo or Austedo XR?
Can Austedo or Austedo XR affect my ability to drive?
How long does it take for Austedo or Austedo XR to start working?
What if I take too much Austedo or Austedo XR?
Can I take other medications with Austedo or Austedo XR?
Will Austedo or Austedo XR cure my condition?
How often will I see my doctor while taking Austedo or Austedo XR?
What are the common side effects of deutetrabenazine?
Does deutetrabenazine interact with other medications?
What drug class is deutetrabenazine?
Is deutetrabenazine safe during pregnancy?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for deutetrabenazine
The FDA label for deutetrabenazine (sold under brand names such as Austedo) classifies it as a prescription-only medication in the VMAT2 Inhibitor class. Austedo and Austedo XR are used to treat chorea (uncontrollable movements) caused by Huntington's disease. Official labeling lists 6 commonly reported side effects, including Feeling sleepy, Diarrhea, Dry mouth.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 6,445 voluntary reports. The database also lists 7 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: February 28, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages