Prescription medication · VMAT2 Inhibitor

deutetrabenazine

Name: deutetrabenazine - FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

Also sold as Austedo. Austedo and Austedo XR are used to treat chorea (uncontrollable movements) caused by Huntington's disease.

Compiled by PlainMeds, Drug Information Editorial Process

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

TEVA

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

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.

Side Effects (from patient reports)

Based on 6,445 FDA adverse event reports.

Depression

463
Dyskinesia

403
Death

402
Tremor

330
Somnolence

305
Fatigue

290
Suicidal Ideation

287
Insomnia

281
Fall

262
Tardive Dyskinesia

221

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.

fewest reports most reports

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

Female 3,878 (68%)

Male 1,851 (32%)

Age Distribution

0–17 46

18–44 487

45–64 1,505

65–74 1,201

75+ 622

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

DEATH 400

COMPLETED SUICIDE 19

FALL 7

PNEUMONIA 7

DISEASE PROGRESSION 6

HOSPITALISATION 6

TOXICITY TO VARIOUS AGENTS 6

HOSPICE CARE 5

INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 5

CARDIAC ARREST 4

Reactions in Hospitalization Reports

HOSPITALISATION 113

FALL 82

DEPRESSION 59

TREMOR 48

SUICIDAL IDEATION 40

CONFUSIONAL STATE 39

DIZZINESS 35

PNEUMONIA 35

URINARY TRACT INFECTION 33

TARDIVE DYSKINESIA 31

Source: 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

major valbenazine

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.

major tetrabenazine

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.

moderate dopamine

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.

moderate norepinephrine

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.

minor bupropion

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.

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This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I stop taking Austedo or Austedo XR suddenly?

Talk to your doctor before stopping Austedo or Austedo XR. Stopping suddenly may cause your symptoms to worsen.

Can I drink alcohol while taking Austedo or Austedo XR?

Drinking alcohol while taking Austedo or Austedo XR may make you feel more sleepy.

What should I tell my doctor before taking Austedo or Austedo XR?

Tell your doctor about all of your medical conditions, including if you have depression, liver problems, or heart problems.

Can Austedo or Austedo XR affect my ability to drive?

Austedo or Austedo XR may cause sleepiness, which can affect your ability to drive or operate machinery.

How long does it take for Austedo or Austedo XR to start working?

It may take a few weeks for you to notice the full effects of Austedo or Austedo XR.

What if I take too much Austedo or Austedo XR?

Call your doctor or go to the nearest emergency room right away.

Can I take other medications with Austedo or Austedo XR?

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Will Austedo or Austedo XR cure my condition?

Austedo or Austedo XR can help manage your symptoms, but it will not cure your condition.

How often will I see my doctor while taking Austedo or Austedo XR?

Your doctor will want to see you regularly to monitor your condition and adjust your dose as needed.

What are the common side effects of deutetrabenazine?

The registry lists Feeling sleepy, Diarrhea, Dry mouth, Feeling tired, Runny nose among the most-reported FAERS reaction terms for deutetrabenazine. The compiled record contains 6,445 FDA adverse-event reports. These counts are not an individual symptom assessment.

Does deutetrabenazine interact with other medications?

The registry has 7 documented interaction rows for deutetrabenazine. Notable source-record pairings include valbenazine, tetrabenazine, dopamine. These rows are not a complete medication review.

What drug class is deutetrabenazine?

deutetrabenazine belongs to the VMAT2 Inhibitor drug class. It requires a prescription (Rx). Austedo and Austedo XR are used to treat chorea (uncontrollable movements) caused by Huntington's disease.

What pregnancy or breastfeeding source fields are listed for deutetrabenazine?

The FDA label for deutetrabenazine contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

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