Deutetrabenazine
Deutetrabenazine is a VMAT2 inhibitor used in adults to treat chorea (involuntary, jerky movements) from Huntington’s disease and tardive dyskinesia (uncontrolled muscle movements).
Built from the FDA-approved label, dated Feb 28, 2025 · How this page is built
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Deutetrabenazine can increase the risk of depression and suicidal thoughts and behavior in people with Huntington’s disease.
Your doctor will weigh this risk against the need to treat your chorea. People with a history of depression or suicide attempts or thoughts need extra caution. It must not be used if you are suicidal or have untreated or inadequately treated depression.
You, your caregivers and your family should watch for new or worsening depression, suicidal thoughts, or unusual behavior changes. Report them to your doctor promptly.
⚡ Quick answers about Deutetrabenazine
What is deutetrabenazine for?
It treats involuntary movements in adults. That means chorea from Huntington’s disease and tardive dyskinesia. Both Austedo and Austedo XR are approved for these.
See it in the FAQ →How should I take it?
Swallow the tablet whole, without chewing, crushing or breaking it. Austedo XR is taken once a day, with or without food. Austedo is taken with food, and at higher total daily doses it’s split into two doses.
Read the full answer →What side effects should I expect?
The most common ones are sleepiness, fatigue, diarrhea and dry mouth. Some people also have trouble sleeping or catch more colds. Don’t drive until you know how it affects you.
See it in the FAQ →What should I call my doctor about right away?
Call about any new or worse depression, suicidal thoughts, or unusual behavior changes.
Read the full answer →🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →📖 Deutetrabenazine: Patient Information Guide
A plain-language walkthrough of Deutetrabenazine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Deutetrabenazine is used for
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Deutetrabenazine is a VMAT2 inhibitor used in adults for these conditions:
- Chorea associated with Huntington’s disease (Austedo XR and Austedo)
- Tardive dyskinesia (Austedo XR and Austedo)
How Deutetrabenazine works
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Deutetrabenazine is broken down in the liver into active products that block VMAT2. This transporter loads brain chemicals like dopamine into storage packets in nerve endings. Blocking it lowers the stores of these chemicals.
The exact way this eases chorea and tardive dyskinesia is not known.
How Deutetrabenazine is taken (dosage)
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Austedo XR is an extended-release tablet taken once a day, with or without food. Austedo is a regular tablet taken with food, split into two doses a day at higher total daily doses.
- Swallow tablets whole. Do not chew, crush or break them.
- Your prescriber raises the dose slowly, about weekly, based on symptom control and tolerability.
- You can stop it without tapering. If you stop for more than a week, the dose is built up again when you restart. After a break of less than a week, you can usually resume your previous dose.
Follow your prescriber’s directions and the label.
Dosing details from the FDA-approved label
From the Deutetrabenazine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
Administer AUSTEDO total daily dosages of 12 mg or above in two divided doses.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION AUSTEDO XR AUSTEDO Recommended Starting Dosage 12 mg once daily (12 mg per day) 6 mg twice daily (12 mg per day) Titrate at weekly intervals by 6 mg per day based on reduction of chorea or tardive dyskinesia, and tolerability, up to a maximum recommended daily dosage of 48 mg ( 2.1 ) Administer AUSTEDO XR with or without food in once-daily doses ( 2.1 ) Administer AUSTEDO with food and administer total daily dosages of 12 mg or above in two divided doses ( 2.1 ) Swallow tablets whole; do not chew, crush, or break ( 2.1 ) If switching patients from tetrabenazine, discontinue tetrabenazine and initiate AUSTEDO XR or AUSTEDO the following day. See full prescribing information for recommended conversion table ( 2.2 ) Maximum recommended dosage of AUSTEDO XR or AUSTEDO in poor CYP2D6 metabolizers is 36 mg per day ( 2.4 , 8.7 ) 2.1 Dosing Information The dose of AUSTEDO XR and AUSTEDO is determined individually for each patient based on reduction of chorea or tardive dyskinesia and tolerability. Table 1 displays the recommended dosage and important administration instructions of AUSTEDO XR and AUSTEDO when first prescribed to patients who are not being switched from tetrabenazine (a related VMAT2 inhibitor). Table 1: Recommended Dosage and Important Administration Instructions for AUSTEDO XR and AUSTEDO AUSTEDO XR extended-release tablet AUSTEDO tablet Recommended Starting Dosage 12 mg once daily (12 mg per day) 6 mg twice daily (12 mg per day) Recommended Dose Titration The dosage of AUSTEDO XR or AUSTEDO may be increased at weekly intervals in increments of 6 mg per day based on reduction of chorea or tardive dyskinesia, and tolerability, up to a maximum recommended daily dosage of 48 mg [see Clinical Trials ( 14.1 , 14.2 )] . Important Administration Instructions Administer AUSTEDO XR with or without food [see Clinical Pharmacology ( 12.3 )] . Swallow AUSTEDO XR whole. Do not chew, crush, or break tablets. Administer AUSTEDO XR once daily. Administer AUSTEDO with food [see Clinical Pharmacology ( 12.3 )] . Swallow AUSTEDO whole. Do not chew, crush, or break tablets. Administer AUSTEDO total daily dosages of 12 mg or above in two divided doses. 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.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Deutetrabenazine side effects in detail
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Common side effects
- Sleepiness (somnolence)
- Fatigue
- Diarrhea
- Dry mouth
- Common cold symptoms (nasopharyngitis)
- Trouble sleeping (insomnia)
- Urinary tract infection
- Anxiety
When to get medical help
- Call your doctor right away if you notice new or worsening depression, suicidal thoughts, or unusual changes in behavior.
- Get help if you develop fever, stiff muscles, confusion, a fast or irregular pulse, unstable blood pressure, or heavy sweating. These can be signs of neuroleptic malignant syndrome, which can be fatal.
- Tell your doctor if you feel restless or agitated or can’t sit still. These can be signs of akathisia, and your dose may need to be lowered.
- Report parkinsonism signs such as slowed movement, walking problems or falls, stiffness, or new or worse tremor. These most often appeared within the first two weeks of starting or raising the dose.
- Report fainting, a racing or irregular heartbeat, or dizziness, especially if you have a heart rhythm problem.
- Tell your doctor about symptoms that could come from high prolactin, such as missed periods, milk discharge from the breasts, breast enlargement in men, or impotence.
The most common side effects seen in studies were:
- Sleepiness
- Fatigue
- Diarrhea
- Dry mouth
- Common cold symptoms (nasopharyngitis)
- Trouble sleeping
Call your doctor promptly about mood changes, suicidal thoughts, restlessness, movement or walking problems, or fever with stiff muscles and confusion.
Deutetrabenazine warnings and precautions
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- Depression and suicidality in people with Huntington’s disease (boxed warning).
- Sleepiness: avoid driving until you know how it affects you.
- QT prolongation: avoid in congenital long QT syndrome or a history of arrhythmias.
- Neuroleptic malignant syndrome: a rare, potentially fatal reaction. Stop the drug if it occurs.
- Akathisia and parkinsonism: the dose may need to be reduced or stopped.
- High prolactin: a concern in particular if you have had breast cancer.
- Melanin binding: the drug can build up in tissues like the eye. Long-term effects are unknown.
- In Huntington’s disease, the drug may worsen mood, thinking, rigidity and function, so your need for it is reviewed periodically.
Deutetrabenazine interactions: what it interacts with
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Several medicines can clash with deutetrabenazine:
- Reserpine: never together. Wait at least 20 days after stopping it.
- MAOIs: never together or within 14 days of stopping one.
- Tetrabenazine or valbenazine: never together, since they are related drugs.
- Strong CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine, bupropion): they raise active drug levels about 3-fold, so the dose is capped.
- Alcohol or sedating drugs: they add to sleepiness.
- Antipsychotics or dopamine blockers: they may raise the risk of parkinsonism, NMS and akathisia.
Interactions listed in the FDA-approved label
From the Deutetrabenazine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
Concomitant use of strong CYP2D6 inhibitors: Maximum recommended dose of AUSTEDO XR or AUSTEDO is 36 mg per day ( 2.3 , 7.1 ) Alcohol or other sedating drugs: May have additive sedation and somnolence ( 7.5 ) 7.1 Strong CYP2D6 Inhibitors A reduction in AUSTEDO XR or AUSTEDO dose may be necessary when adding a strong CYP2D6 inhibitor in patients maintained on a stable dose of AUSTEDO XR or AUSTEDO. Concomitant use of…
Read the label’s full interactions text
7 DRUG INTERACTIONS Concomitant use of strong CYP2D6 inhibitors: Maximum recommended dose of AUSTEDO XR or AUSTEDO is 36 mg per day ( 2.3 , 7.1 ) Alcohol or other sedating drugs: May have additive sedation and somnolence ( 7.5 ) 7.1 Strong CYP2D6 Inhibitors A reduction in AUSTEDO XR or AUSTEDO dose may be necessary when adding a strong CYP2D6 inhibitor in patients maintained on a stable dose of AUSTEDO XR or AUSTEDO. 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. The daily dose of AUSTEDO XR or AUSTEDO should not exceed 36 mg per day in patients taking strong CYP2D6 inhibitors [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 )]. 7.2 Reserpine Reserpine binds irreversibly to VMAT2 and the duration of its effect is several days. 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. At least 20 days should elapse after stopping reserpine before starting AUSTEDO XR or AUSTEDO. AUSTEDO XR and AUSTEDO should not be used concomitantly with reserpine [see Contraindications ( 4 )] . 7.3 Monoamine Oxidase Inhibitors (MAOIs) AUSTEDO XR and AUSTEDO are contraindicated in patients taking MAOIs. AUSTEDO XR and AUSTEDO should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI [see Contraindications ( 4 )] . 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. 7.5 Alcohol or Other Sedating Drugs Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence [see Warnings and Precautions ( 5.7 )].
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Deutetrabenazine
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- Not for people with Huntington’s disease who are suicidal or have untreated or inadequately treated depression.
- Not for people with liver impairment.
- Use caution with a history of depression or suicide attempts or thoughts.
- Avoid with congenital long QT syndrome or a history of arrhythmias.
- Tell your doctor if you have had breast cancer.
- Pregnancy: animal data suggest it may cause fetal harm, and human data are inadequate.
- Breastfeeding: there are no data on milk transfer or effects on the infant.
- Children: safety and effectiveness are not established.
- Poor CYP2D6 metabolizers have a lower maximum daily dose.
Deutetrabenazine overdose: if you take too much
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Overdose data for deutetrabenazine itself are limited. With the related drug tetrabenazine, overdoses caused muscle spasms, nausea, vomiting, sweating, sedation, low blood pressure, confusion, diarrhea, hallucinations and tremor. Care is supportive, with monitoring of heart rhythm and vital signs. Contact a poison control center if an overdose happens.
Pharmacodynamics: what Deutetrabenazine does in the body
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At the maximum recommended dose, deutetrabenazine does not prolong the QT interval to a clinically relevant extent. In animal studies, the drug or its breakdown products bind to melanin-containing tissues like the eye and skin. They were still detectable in eye and fur 35 days after a single dose.
Pharmacokinetics: how your body processes Deutetrabenazine
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At least 80% of the drug is absorbed after you swallow it. The liver quickly converts it to active breakdown products, which peak in the blood in about 3 to 4 hours with Austedo. Austedo XR peaks in about 3 hours and then holds a plateau that supports once-daily dosing.
Food does not change how much of the drug is absorbed. With Austedo tablets, food raises the peak level by about 50%. The active products have half-lives of roughly 7.5 to 12 hours, are cleared mainly by the CYP2D6 enzyme, and leave mostly through the urine.
How to store Deutetrabenazine
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Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Protect from light and moisture. Dispense in original containers or in tight containers as defined in USP.
📄 Written from Deutetrabenazine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Deutetrabenazine
148 supplements and herbal products have documented interactions with Deutetrabenazine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 13
- Moderate · 114
- Minor · 21
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Deutetrabenazine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Deutetrabenazine — the kind of thing our pharmacy team would talk through with you at the counter.
What is deutetrabenazine for?
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How should I take it?
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What side effects should I expect?
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What should I call my doctor about right away?
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Can I take it with my other medicines?
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Is it safe in pregnancy?
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Is Deutetrabenazine available over the counter?
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When was Deutetrabenazine first available?
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Who makes Deutetrabenazine?
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💬 Answers drafted from Deutetrabenazine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Deutetrabenazine on HelloPharmacist
💊 Deutetrabenazine forms and strengths (how it comes)
Deutetrabenazine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Extended-release tablet
How this form is used
- Austedo XR is used in adults for chorea associated with Huntington’s disease.
- Austedo XR is used in adults for tardive dyskinesia.
- Austedo XR is taken once daily, with or without food.
- Swallow Austedo XR whole. Do not chew, crush or break the tablets.
- If switching between Austedo and Austedo XR, your prescriber uses the same total daily dose.
Tablet
How this form is used
- Austedo is used in adults for chorea associated with Huntington’s disease.
- Austedo is used in adults for tardive dyskinesia.
- Take Austedo with food.
- Austedo total daily doses of 12 mg or more are split into two doses a day.
- Swallow Austedo whole. Do not chew, crush or break the tablets.
📊 Deutetrabenazine on the U.S. market: products, makers and brands
How Deutetrabenazine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
10 companies list 39 Deutetrabenazine product records with the FDA, mostly as extended-release tablet, tablet; the earliest marketing or approval year on record is 2017. Brand names on the directory include Austedo Xr, Austedo; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (10) · Kit (9) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Deutetrabenazine is used (Medicaid data)
A general measure of how commonly Deutetrabenazine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Deutetrabenazine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Deutetrabenazine prescribed? Of the 1,599 medications we measure, Deutetrabenazine ranks #601 by Medicaid prescriptions — more than 62% of them.
Utilization by Deutetrabenazine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
deutetrabenazine 12 MG Oral Tablet Most dispensed
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1876910
deutetrabenazine 6 MG Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1876918
24 HR deutetrabenazine 24 MG Extended Release Oral Tablet
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2630150
deutetrabenazine 9 MG Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1876922
24 HR deutetrabenazine 36 MG Extended Release Oral Tablet
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2683288
24 HR deutetrabenazine 12 MG Extended Release Oral Tablet
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2630144
24 HR deutetrabenazine 30 MG Extended Release Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2683282
24 HR deutetrabenazine 48 MG Extended Release Oral Tablet
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2683300
24 HR deutetrabenazine 6 MG Extended Release Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2630155
24 HR deutetrabenazine 42 MG Extended Release Oral Tablet
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2683294
24 HR deutetrabenazine 18 MG Extended Release Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2686153
Other Deutetrabenazine products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 20 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Deutetrabenazine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 12 of 41 listed Deutetrabenazine NDCs with Medicaid activity.
🔍 Compare Deutetrabenazine products
A representative set of FDA-listed product records for Deutetrabenazine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Extended-release tablet | ||||
| 6 mg | Oral | Teva Neuroscience, Inc. × 2 listings | NDA | View NDC → |
| 12 mg | Oral | Teva Neuroscience, Inc. × 2 listings | NDA | View NDC → |
| 18 mg | Oral | Teva Neuroscience, Inc. | NDA | View NDC → |
| 24 mg | Oral | Teva Neuroscience, Inc. × 2 listings | NDA | View NDC → |
| 30 mg | Oral | Teva Neuroscience, Inc. | NDA | View NDC → |
| 36 mg | Oral | Teva Neuroscience, Inc. | NDA | View NDC → |
| 42 mg | Oral | Teva Neuroscience, Inc. | NDA | View NDC → |
| 48 mg | Oral | Teva Neuroscience, Inc. | NDA | View NDC → |
| 💊Tablet | ||||
| 6 mg | Oral | Teva Neuroscience, Inc. × 3 listings | NDA | View NDC → |
| 9 mg | Oral | Teva Neuroscience, Inc. × 3 listings | NDA | View NDC → |
| 12 mg | Oral | Teva Neuroscience, Inc. × 3 listings | NDA | View NDC → |
| 💊Kits | ||||
| — | — | Teva Neuroscience, Inc. × 9 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 50 kg/50 kg | — | Aurobindo Pharma Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Farmhispania S.A. × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Hetero Drugs Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Lupin Manufacturing Solutions Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Maithri Drugs Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Life Sciences Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Neuland Laboratories Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Rolabo Outsourcing S.L. | BULK INGREDIENT | View NDC → |
| 100 kg/100 kg | — | Sicor S.r.l. | BULK INGREDIENT | View NDC → |
Showing 39 of 39 products — FDA National Drug Code Directory. See every product, package size and price: browse all 39 Deutetrabenazine NDCs →
📈 Deutetrabenazine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Deutetrabenazine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Deutetrabenazine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Deutetrabenazine FDA approval history
How Deutetrabenazine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Deutetrabenazine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1876905 2 dose forms · 11 strengths
-
Dose form (SCDF) Extended Release Oral Tablet RxCUI 2630143In current FDA listingsClinical drug / strength (SCD) 24 HR deutetrabenazine 12 MGRxCUI 263014424 HR deutetrabenazine 18 MGRxCUI 268615324 HR deutetrabenazine 24 MGRxCUI 263015024 HR deutetrabenazine 30 MGRxCUI 268328224 HR deutetrabenazine 36 MGRxCUI 268328824 HR deutetrabenazine 42 MGRxCUI 268329424 HR deutetrabenazine 48 MGRxCUI 268330024 HR deutetrabenazine 6 MGRxCUI 2630155 -
Dose form (SCDF) Oral Tablet RxCUI 1876909In current FDA listings
Look up RxCUI 1876905 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Deutetrabenazine supply and shortage status
Whether Deutetrabenazine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Deutetrabenazine brand names
Deutetrabenazine is sold under 2 brand names in the FDA directory — Austedo Xr, Austedo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
🏭 Who makes Deutetrabenazine: manufacturers and labelers
10 companies list Deutetrabenazine products with the FDA. By number of product records, the largest are Teva Neuroscience, Inc., Farmhispania S.A., Aurobindo Pharma Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Deutetrabenazine drug class (RxNorm)
Deutetrabenazine belongs to the Other nervous system drugs class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Deutetrabenazine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Teva Neuroscience, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.