Vraylar side effects: A detailed guide

Specifically, the Food and Drug Administration (FDA) has approved Vraylar to treat:

• schizophrenia in adults
• mixed or manic episodes in adults with bipolar I disorder
• bipolar depression in adults with bipolar I disorder
• depression in adults, when used with antidepressants

This article describes possible side effects of Vraylar. You can explore this overview article to learn more about Vraylar, including the drug’s uses, ways to save on cost, and more.

Vraylar is a brand-name medication that comes as capsules that you swallow. It isn’t available in a generic version.

Vraylar has a boxed warning. A boxed warning is the most serious warning from the FDA. For details, see the “Side effects of Vraylar in detail” section below.

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More common side effects of Vraylar

Vraylar may cause mild or serious side effects. Below are some of the more common side effects reported in people taking Vraylar. These side effects varied to some degree based on the condition being treated.

• akathisia (restlessness and trouble sitting still)
• constipation*
• extrapyramidal symptoms (drug-induced movement disorders)*
• indigestion†
• insomnia‡
• nausea and vomiting
• sleepiness

* Seen most commonly in studies of Vraylar for schizophrenia and mania
† Only common in studies of Vraylar for mania
‡ Seen most commonly in studies of Vraylar for depression or bipolar depression

Mild side effects of Vraylar

Vraylar may cause certain mild side effects. Usually, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.

Mild side effects of Vraylar that occurred in studies include:

• extrapyramidal symptoms
• akathisia
• indigestion
• nausea and vomiting
• sleepiness
• fatigue
• constipation
• insomnia

Vraylar may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.

Serious side effects of Vraylar

Vraylar may cause certain serious side effects. If you have any serious side effects from Vraylar, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.

After the FDA approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with Vraylar.

Serious side effects of Vraylar that occurred in studies include:

• tardive dyskinesia*
• seizures
• neuroleptic malignant syndrome (a rare reaction characterized by very high fever, stiff muscles, and fast heart rate)
• high blood sugar, which can lead to diabetes
• high cholesterol or high triglyceride levels
• low white blood cell count
• drop in blood pressure upon standing or sitting up, which can lead to fainting or falls
• increased risk of death in older adults with certain medical conditions*†
• suicidal thoughts and behaviors*†

* To learn more about this side effect, see the “Side effects of Vraylar in detail” section below.
† Vraylar has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA.

Suicide prevention

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

• Call the 988 Suicide and Crisis Lifeline at 988.
• Text HOME to the Crisis Text Line at 741741.
• Not in the United States? Find a helpline in your country with Befrienders Worldwide.
• Call 911 or your local emergency services number if you feel safe to do so.

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you are not in the same household, stay on the phone with them until help arrives.

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For some people, Vraylar can cause an allergic reaction.

But it’s not clear whether this side effect occurred in the drug’s studies.

In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Vraylar, your doctor may recommend taking a different medication instead.

Common questions about side effects of Vraylar

Here are answers to some common questions about side effects of Vraylar. If you have other questions, talk with your doctor or pharmacist.

How long does it take for Vraylar side effects to go away?

It depends. In most cases, mild side effects are temporary and will go away in a few days or weeks as your body gets used to the medication. However, some side effects can last for a long time after you’ve stopped the drug.

If you experience side effects from Vraylar that get worse or don’t go away, talk with your doctor.

Is weight gain a side effect of Vraylar?

Yes, weight gain is a possible side effect of Vraylar. It was more common in people taking Vraylar for schizophrenia compared to those who took it for bipolar mania, bipolar depression, or depression.

Due to this risk, your doctor will likely monitor your weight before starting Vraylar and frequently during treatment. To manage weight gain, consider eating a balanced diet and exercising regularly.

If you have concerns about weight gain with Vraylar, talk with your doctor.

Does Vraylar cause long-term side effects?

Yes, in some cases, Vraylar may cause long-term side effects. These can last for a while after you’ve stopped taking the drug.

Possible long-term side effects reported with Vraylar include:

• certain movement disorders, such as tardive dyskinesia*
• akathisia (restlessness and trouble sitting still)
• high blood sugar
• high cholesterol
• high triglycerides

Talk with your doctor to learn more about these side effects and how to manage them. Ask your doctor for more information about how long these side effects of Vraylar may last.

* To learn more about this side effect, see the “Side effects of Vraylar in detail” section below.

Side effects of Vraylar in detail

Below you’ll find details on some of the side effects of Vraylar.

Tardive dyskinesia

Tardive dyskinesia was rare in studies of people taking Vraylar. This side effect may be mild or serious.

Tardive dyskinesia is a condition that causes uncontrollable movements in your body. In some cases, these movements can become permanent. Typically, you can experience repetitive movements of your tongue, head, neck, legs, or arms. Examples of these movements include:

• frequent blinking
• smacking or puckering your lips
• sticking out your tongue
• tapping your toes

Certain factors can increase the risk of tardive dyskinesia and the chances of it becoming permanent. These include:

• being age 65 years or older
• being female* and age 65 years or older
• taking Vraylar for a long time
• taking high doses of Vraylar

Ways to manage

To lower the risk of tardive dyskinesia, your doctor will prescribe the lowest effective dose of Vraylar. And they’ll prescribe it for the shortest amount of time needed.

If you experience symptoms of tardive dyskinesia, tell your doctor. They’ll likely recommend you stop taking Vraylar.

* Sex and gender exist on spectrums. In this article, we use the term “female” to refer to a person’s sex assigned at birth.

Increased risk of death in certain older adults

Vraylar has a boxed warning for the risk of death in older adults with dementia-related psychosis. A boxed warning is the most serious warning from the FDA.

Vraylar belongs to a group of drugs called antipsychotics. Antipsychotics can increase the risk of death in older adults (ages 65 years and older) who have psychosis that’s related to dementia. (Psychosis is a loss of contact with reality. Dementia is a decline in brain function.) In studies, the causes of death varied but most were related to heart problems or an infection, such as pneumonia.

Ways to manage

Due to this risk, doctors typically won’t prescribe Vraylar for older adults with dementia-related psychosis. They can discuss other treatment options that are safer for you if you’re in this category.

Suicidal thoughts and behaviors

Vraylar also has a boxed warning for the risk of suicidal thoughts and behaviors in people ages 24 years or younger.

Young adults, adolescents, and children who take Vraylar may have an increased risk of suicidal thoughts and behaviors. The risk is highest during the first few months of starting Vraylar and when your dose is changed.

Ways to manage

You and your loved ones should report any changes in your thoughts, mood, or behavior to your healthcare professional right away. If your symptoms of depression are worsening, your doctor may have you stop taking Vraylar and switch to a safer alternative.

Warnings for Vraylar

Below are some factors you may want to discuss with your doctor before taking Vraylar.

Boxed warning

Vraylar has boxed warnings. A boxed warning is the most serious warning from the FDA. For details, see the “Side effects of Vraylar in detail” section above.

Other warnings

It may not be safe for you to take Vraylar if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether Vraylar is a safe treatment option for you.

Before taking Vraylar, tell your doctor about your health and medications you take. Things to consider include:

• history of heart problems
• history of stroke
• diabetes or high blood sugar, including a family history of these
• high blood pressure or low blood pressure
• high cholesterol or triglycerides
• history of seizures
• kidney problems
• liver problems
• low white blood cell count
• currently pregnant or planning to become pregnant
• currently breastfeeding or planning to breastfeed
• past allergic reaction to Vraylar

Vraylar and pregnancy

Vraylar should not be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. Your doctor may suggest birth control options to use during treatment with Vraylar.

Vraylar and breastfeeding

It’s not known whether Vraylar should be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.

Vraylar and alcohol

Vraylar is not known to interact with alcohol.

But drinking alcohol while taking Vraylar can increase your risk of certain side effects. These include nausea, dizziness, and sleepiness. Alcohol can also worsen symptoms of mental health conditions, such as depression or bipolar depression, which Vraylar is used to treat.

If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with Vraylar.

Disclaimer: Optum Perks 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.