Qelbree (viloxazine) is a brand-name extended-release oral capsule that’s prescribed for attention deficit hyperactivity disorder (ADHD). As with other drugs, Qelbree can cause side effects, such as headache and sleeping problems.

With Qelbree extended-release capsules, the active drug releases into your body over time.

Qelbree belongs to a drug class called selective norepinephrine reuptake inhibitors. The drug isn’t available in a generic version.

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

Qelbree can cause certain side effects, some 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 Qelbree in clinical trials:

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

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

Mild side effects that have been reported with Qelbree 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 and reviews side effects of the medication. If you develop a side effect while taking Qelbree and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see the “Side effect specifics” section below.
† An allergic reaction is possible after taking Qelbree. However, this side effect wasn’t reported in clinical trials. To learn more, see the “Side effect specifics” section below.

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

If you develop serious side effects while taking Qelbree, 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:

* An allergic reaction is possible after taking Qelbree. However, this side effect wasn’t reported in clinical trials. To learn more, see the “Side effect specifics” section below.
† Qelbree has a boxed warning for this side effect. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effect specifics” section below.

The side effects of Qelbree in children are generally the same as those in adults. However, certain side effects were more common in children than adults in clinical trials of Qelbree. For example, drowsiness and lethargy were much more common in children than adults. But adults were more likely than children to have sleeping problems,* such as insomnia.

Children may also experience changes in weight while taking Qelbree. This may be due to a decreased appetite,* another possible side effect of the drug. Appetite loss can lead to weight loss or not gaining weight at the same rate as children taking a placebo. Your child’s doctor will monitor your child’s weight during Qelbree treatment. This is to make sure they’re maintaining a weight that’s healthy for them.

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

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

Will side effects of Qelbree go away?

Many side effects of Qelbree will go away in a few days or weeks. However, it’s possible that they’ll last longer or become bothersome or severe. In clinical trials, some people stopped taking Qelbree due to side effects, such as decreased appetite* and headache.

If you have side effects that aren’t going away, let your doctor know. They may be able to suggest ways to manage them.

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

How do side effects of Qelbree compare to those seen with Adderall?

Qelbree and Adderall share some common side effects. Both drugs treat attention deficit hyperactivity disorder (ADHD), but they belong to different drug classes. This means they work differently in the body and can cause different side effects. Qelbree belongs to a class of drugs called selective norepinephrine reuptake inhibitors. Adderall belongs to a class of drugs called stimulants.

Some of the side effects they have in common include:

Unlike Qelbree, Adderall may cause slowed growth in children and weight loss. Also, Adderall is a controlled substance with the risk of misuse and dependence.† To learn more about Adderall’s side effects, view this article.

Your doctor or pharmacist can tell you more about how side effects of Qelbree and Adderall compare.

* For more information about this mild side effect of Qelbree, see the “Side effect specifics” section below.
† With misuse, a drug is taken in a way other than how it’s prescribed. With dependence, your body needs the drug to function as usual.

Will I experience certain side effects when first starting Qelbree?

Yes, certain side effects are more likely when first starting Qelbree. For example, suicidal thoughts or behaviors* may be seen when starting Qelbree or with dose changes. However, as your body gets used to the medication, many side effects go away. It can take several days or weeks for your body to adjust.

If side effects aren’t going away, be sure to tell your doctor. They can recommend ways to ease the side effect. They can also determine whether you should continue taking Qelbree.

* Qelbree has a boxed warning for this side effect. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effect specifics” section below.

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

Risk of suicidal thoughts and behaviors

Qelbree has a boxed warning for the risk of suicidal thoughts and behaviors. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). The purpose of a boxed warning is to alert doctors and patients about the risks of taking a medication.

In clinical trials, suicidal thoughts and behaviors were not common. When they did occur, they were reported in both adults and children who took Qelbree.

Signs of this side effect can include:

The risk of suicidal thoughts may be higher at the beginning of treatment and after dosage increases. It can also be higher in people with a mental health condition.

What you can do

Due to this risk, your doctor will monitor you for the signs listed above. Also, before starting Qelbree, tell your doctor if you or a family member has ever had a mental health condition. Ask your doctor whether Qelbree is the right treatment choice for you.

Let your doctor know right away if you, or someone else, notice any of the warning signs listed above. Your doctor may have you stop taking Qelbree. They can also recommend a different treatment option.

If you’d like to learn more about this boxed warning, talk with your doctor.

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.

Find more links and local resources.

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Decreased appetite

Decreased appetite was a common side effect in people who took Qelbree in clinical trials. Qelbree can make some people not want to eat because they don’t feel hungry.

What you can do

In some cases, a lack of appetite will be short term and temporary. It’ll improve as your body gets used to Qelbree. It isn’t clear whether Qelbree causes decreased appetite and weight loss long term.

If you’re having problems with your appetite, let your doctor know. They can suggest ways to manage it. You can also read this article about how to increase your appetite.

Sleeping problems

Qelbree may cause insomnia and drowsiness. Sleeping problems were common in the drug’s clinical trials.

Insomnia can mean trouble falling asleep, staying asleep, or waking up too early. People also reported lower sleep quality while taking Qelbree.

These sleep problems led to a small number of adults stopping Qelbree treatment. Also, some children stopped Qelbree treatment due to drowsiness.

What you can do

Sleep problems may be temporary and go away as your body adjusts to Qelbree. However, be sure to tell your doctor if you continue to have sleep problems. They may decide to adjust your Qelbree dosage. For information about Qelbree dosages, see this article.

Your doctor can also recommend ways to manage sleep problems. For some tips to help you fall asleep, read this article.

Allergic reaction

As with most drugs, Qelbree can cause an allergic reaction in some people. However, this side effect wasn’t reported 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 Qelbree. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Qelbree comes with several warnings, including a boxed warning.

Boxed warning: Risk of suicidal thoughts and behaviors

This drug has a boxed warning for the risk of suicidal thoughts and behaviors. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before you take Qelbree. This drug may not be the right treatment option 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:

Allergic reaction. If you’ve ever had an allergic reaction to Qelbree or any of its ingredients, your doctor will likely not prescribe Qelbree. Ask your doctor what other medications may be better options for you.

High blood pressure or heart problems. Qelbree can increase heart rate* and blood pressure* in some people. If you have high blood pressure or a heart problem, taking Qelbree could make it worse. Due to this risk, your doctor will check your heart rate and blood pressure before starting Qelbree and during treatment. Be sure to tell your doctor about any problems with your heart or blood pressure.

Mental health conditions. Qelbree can increase the risk of suicidal thoughts and behaviors.† Having a mental health condition such as depression can increase this risk with Qelbree. For this reason, be sure to tell your doctor if you or a family member has ever had a mental health condition. Ask whether Qelbree is the right treatment option for you. If your doctor prescribes Qelbree, they’ll monitor you for changes in your thoughts or behaviors.

Monoamine oxidase inhibitor use. People who take a monoamine oxidase inhibitor (MAOI) drug, such as phenelzine (Nardil), should not take Qelbree. This is because the drug can interact with an MAOI. (For more details, see this article.) Tell your doctor about all the medications you take before starting Qelbree.

Severe kidney problems. If you have severe kidney problems, you have an increased risk of severe side effects with Qelbree. Due to this risk, talk with your doctor about your kidney function before starting Qelbree. Your doctor may need to adjust your dosage in some cases. For information about Qelbree dosages, see this article.

* Qelbree has a boxed warning about this risk. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section below.

Alcohol with Qelbree

Qelbree is known to interact with alcohol. Consuming high concentrations of alcohol* and Qelbree together may increase the risk of Qelbree side effects. These include dizziness, nausea, and headache.

If you drink alcohol, talk with your doctor about it before taking Qelbree. They may recommend limiting or avoiding alcohol during Qelbree treatment.

* High concentrations of alcohol refer to spirits such as vodka. To learn more about different alcohol concentrations, read this article.

Pregnancy and breastfeeding while taking Qelbree

It isn’t known whether Qelbree is safe to take during pregnancy or while breastfeeding.

Animal studies found that Qelbree was harmful to developing offspring. However, Qelbree clinical trials didn’t include pregnant people.

Tell your doctor right away if you become pregnant while taking Qelbree. Due to the risk of harm, your doctor will likely stop Qelbree treatment. They may be able to recommend a different treatment option for attention deficit hyperactivity disorder (ADHD).

Your doctor may also encourage you to enroll in a pregnancy registry for ADHD medications. The registry helps evaluate the effects of Qelbree in people who are exposed to the drug before knowing they are pregnant. You can learn more or sign up by calling 866-961-2388 or visiting the registry website.

If you’re planning on breastfeeding and take Qelbree, talk with your doctor. They’ll be able to advise whether you should continue taking Qelbree. They can also recommend the best way to feed your baby while taking Qelbree.

Qelbree has some common side effects that are typically mild. However, serious side effects are possible.

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

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

  • More information about Qelbree. For details about other aspects of Qelbree, refer to this article.
  • Dosage. For information about the dosage of Qelbree, view this article.
  • A look at your condition. For details about attention deficit hyperactivity disorder (ADHD), see our ADHD hub.

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.