Austedo (deutetrabenazine) is a brand-name prescription medication. As with other drugs, Austedo can cause side effects. The Food and Drug Administration (FDA) has approved it to treat:

Here are some fast facts about Austedo:

  • Active ingredient: deutetrabenazine
  • Drug class: vesicular monoamine transporter 2 (VMAT2) inhibitor
  • Drug form: oral tablet
  • FDA approval year: 2017

Read on to learn about potential common, mild, and serious side effects of Austedo. For a general overview of the drug, including details about its uses, see this article.

Austedo can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Austedo in clinical trials. These side effects can vary depending on the condition the drug is being used to treat.

More common side effects in people taking Austedo for chorea include:

More common side effects in people taking Austedo for tardive dyskinesia include:

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Austedo. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Austedo’s prescribing information.

Mild side effects that have been reported in people taking Austedo for chorea include:

Mild side effects that have been reported in people taking Austedo for tardive dyskinesia include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Austedo and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.

Austedo may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more details, you can refer to Austedo’s prescribing information.

If you develop serious side effects while taking Austedo, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

* Austedo has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA).
† An allergic reaction is possible after using Austedo. However, it’s not clear whether this side effect occurred in clinical trials.
‡ To learn more, see “Side effect specifics” below.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Click here for more links and local resources.

Austedo may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Does Austedo cause weight gain?

No, weight gain wasn’t a side effect that people taking Austedo reported in clinical trials. However, the drug can cause changes in mood, including depression.* In some cases, mood changes may lead to changes in body weight, including weight gain.

Children given Austedo had increased body weight in clinical trials. However, the drug is not approved for use in children at this time.

If you notice weight gain during your treatment with Austedo, talk with your doctor. They can help determine the cause and suggest ways to manage your weight.

* Austedo has a boxed warning for the increased risk of suicidal thoughts and behaviors and depression in people with Huntington’s disease. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see “Side effect specifics” below.

Should I expect any Austedo side effects after stopping treatment?

No, you shouldn’t experience any side effects from stopping treatment with Austedo. However, stopping treatment may worsen your condition. So if you stop taking Austedo, you may notice the symptoms of chorea or tardive dyskinesia return.

It’s important that you do not stop Austedo treatment without first consulting your doctor. They can help determine the best way for you to stop taking the drug. Your doctor may also recommend different medications for your condition.

Learn more about some of the side effects that Austedo may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Austedo.

Increased risk of suicidal thoughts and behaviors and depression in people with Huntington’s disease

It’s possible for Austedo to increase the risk of suicidal thoughts and behaviors and depression in people with Huntington’s disease. In fact, Austedo has a boxed warning for this risk. A boxed warning is the most serious warning from the FDA. The purpose of a boxed warning is to alert patients and prescribers about the risks of taking a medication.

In clinical trials of people taking Austedo, there was a small risk of thoughts of suicide as well as depression. If you’re taking this medication, it’s important that you’re aware of the symptoms of depression. These may include:

  • loss of interest in activities you used to enjoy
  • sadness or hopelessness
  • sleepiness
  • feeling irritable or angry
  • trouble paying attention
  • thoughts of self-harm

What you can do

If you notice changes in your mood, including suicidal thoughts or behaviors, or depression, talk with your doctor right away. They may advise that you stop treatment with Austedo. In some cases, they may recommend treatment for your changes in mood.

You should also tell your family, friends, and caregivers about the risks of suicidal thoughts and behaviors and depression with Austedo. If they notice any changes in your mood, you should see your doctor right away.

Sleepiness

Sleepiness was one of the most common side effects reported by people taking Austedo for chorea in clinical trials.

What you can do

Because of the risk of sleepiness, driving and operating machinery is not recommended when you first start taking Austedo. Be sure to wait until you know how the drug affects you.

If you experience sleepiness during your treatment with Austedo, talk with your doctor. They can help determine how to treat this side effect.

Anxiety

Anxiety may occur during treatment with Austedo. In clinical trials, the medication caused anxiety in people taking the drug for chorea associated with Huntington’s disease. Keep in mind that this side effect was not one of the most common side effects reported.

Symptoms of anxiety can include:

  • trouble concentrating
  • feeling irritable
  • trouble sleeping
  • feelings of worry that you can’t manage
  • feeling restless

What you can do

While taking Austedo, be sure to tell your doctor right away if you notice any mood changes, including anxiety. They can help determine how to manage it and the best ways to ease your symptoms. In cases of severe anxiety, your doctor may recommend that you stop Austedo treatment and switch to a different medication.

Insomnia

It’s possible to experience insomnia during treatment with Austedo. Insomnia refers to trouble falling asleep or staying asleep.

Insomnia was reported in people taking Austedo for either tardive dyskinesia or chorea related to Huntington’s disease. In fact, insomnia was one of the most common side effects reported by people taking the drug for tardive dyskinesia.

What you can do

If you have trouble falling asleep or staying asleep during your treatment with Austedo, talk with your doctor or pharmacist. They may be able to recommend ways to help treat your insomnia.

Allergic reaction

As with most drugs, Austedo can cause an allergic reaction in some people. However, it’s not clear whether this side effect occurred in clinical trials.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Austedo. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

It’s important to tell your doctor about any medical conditions that you have before you start taking Austedo. They can help determine whether this medication may be safe for you.

Boxed warning: Increased risk of suicidal thoughts and behaviors and depression in people with Huntington’s disease

This drug has a boxed warning for the increased risk of suicidal thoughts and behaviors and depression in people with Huntington’s disease. This is a serious warning from the Food and Drug Administration (FDA). For details, see “Side effect specifics” above.

Other precautions

Be sure to talk with your doctor about your health history before you take Austedo. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Mood conditions. Tell your doctor about any mood problems that you have. These can include anxiety, depression, anger, or a history of suicidal thoughts or behaviors. Austedo may cause changes in mood, which can worsen these conditions. If you have a mood problem, your doctor may monitor you more often for changes in your mood. In some cases, they may recommend a treatment other than Austedo.

Liver problems. If you have any liver problems, tell your doctor before taking Austedo. It’s possible for people with certain liver conditions to be exposed to too much Austedo. This can increase your risk of side effects from the drug. Your doctor can help determine whether Austedo is right for you if you have certain liver conditions. In some cases, they may recommend a different treatment option.

Certain heart rhythm problems. If you have an irregular heart rhythm or long QT syndrome, tell your doctor before taking Austedo. This drug can cause long QT syndrome. If you already have this condition or a condition affecting your heart rhythm, taking Austedo may worsen it. Your doctor can help determine whether Austedo is safe for you.

Allergic reaction. If you’ve had an allergic reaction to Austedo or any of its ingredients, your doctor will likely not prescribe the drug. Ask them about other medications that may be better options for you.

Low levels of potassium or magnesium. Low levels of potassium or magnesium in your blood may cause changes in heart rhythm. Austedo may also cause such changes. If you have low potassium or magnesium levels, taking the drug could increase the risk of a heart problem called long QT syndrome. Your doctor will likely treat the low levels before you start taking Austedo.

Alcohol with Austedo

Drinking alcohol is not recommended while taking Austedo. Both alcohol and Austedo can cause sleepiness. A combination of alcohol and Austedo may further increase your risk of this side effect. (For more information about sleepiness, see “Side effect specifics” above.)

If you have questions about alcohol and Austedo, talk with your doctor.

Pregnancy and breastfeeding while taking Austedo

It’s not known whether it’s safe to take Austedo during pregnancy or while you’re breastfeeding.

At this time, there hasn’t been enough research to determine:

  • whether Austedo is safe to take during pregnancy
  • what effects the drug may have on a developing fetus

In animal studies, there was an increased risk of pregnancy loss when the animal was given Austedo during pregnancy. However, animal studies don’t always indicate what may happen in humans.

It’s also not known whether Austedo passes into breast milk or what effects the drug may have on a developing baby.

If you’re pregnant or planning to become pregnant, talk with your doctor before taking Austedo. You should also talk with them if you’re breastfeeding or considering it. Your doctor can help determine whether Austedo is a safe treatment option for you.

You may experience side effects while taking Austedo. Although most side effects from this drug are mild, serious side effects may also occur. Be sure to talk with your doctor if you develop serious side effects.

If you’d like to learn more about Austedo, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

  • More information about Austedo. For details about other aspects of Austedo, refer to this article.
  • Drug comparison. Learn how Austedo compares with Ingrezza and Xenazine, which are prescribed for similar uses.
  • Dosage. For information about the dosage of Austedo, view this article.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.