All About Vraylar
Your doctor may recommend Vraylar for certain mental health conditions.
Vraylar is a prescription drug that’s used to treat:
- mixed or manic episodes in adults with bipolar I disorder
- major depressive disorder (depression) in adults*
- bipolar depression in adults with bipolar I disorder
- schizophrenia in adults
For more details about these conditions and how Vraylar is used, see the “What is Vraylar used for?” section below.
* For this use, Vraylar is taken together with an antidepressant.
Vraylar basics
Vraylar is classified as an atypical antipsychotic, which is a kind of antipsychotic drug. (A drug’s classification refers to the group of medications that it belongs to.)
Vraylar contains the active ingredient cariprazine. The drug is not available in a generic version.
Almost two-thirds of that $3.3 trillion cost – 64% – is paid for by American tax dollars, and that amount is growing. A study by the American Journal of Public Health predicts that taxpayers will shoulder 67.3% of the burden of healthcare costs by the year 2024, Physicians for a National Health Program
Vraylar comes as a capsule that you swallow.
Keep reading to learn about Vraylar’s side effects, dosage, FAQs, and more.
Like most drugs, Vraylar may cause mild or serious side effects. The lists below describe some of the more common side effects that Vraylar may cause. These lists don’t include all possible side effects. If you’d like more information about Vraylar’s side effects, see this article.
Keep in mind that side effects of a drug can depend on:
- your age
- other health conditions you have
- other medications you take
Your doctor or pharmacist can tell you more about the potential side effects of Vraylar. They can also suggest ways to help reduce side effects.
Mild side effects
Here’s a short list of some of the mild side effects that Vraylar can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Vraylar’s prescribing information.
Mild side effects of Vraylar that have been reported include:
- akathisia (feeling restless and an intense urge to move around, mainly in your legs)
- feeling sleepy or tired
- nausea and vomiting
- movements that are slow or more difficult than usual
- muscle stiffness
- tremors (repeated movements of a body part that which you can’t control)
- increased saliva (drool)
- upset stomach
- headache
- constipation
- dizziness
- weight gain*
Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.
* For more information about this side effect, see the “Side effect focus” section below.
Serious side effects
Serious side effects of Vraylar can occur, but they aren’t common. If you have serious side effects from Vraylar, call your doctor right away. But if you think you’re having a medical emergency, you should call 911 or your local emergency number.
Serious side effects of Vraylar that have been reported include:
- tardive dyskinesia (random movements of your tongue, head, neck, legs, or arms that you can’t control)
- risk of falling due to movement problems or dizziness
- seizures
- trouble swallowing
- increased risk of heatstroke or overheating due to problems regulating your body temperature
- orthostatic hypotension (a drop in blood pressure upon standing or sitting up)
- changes in your blood test results, including:
- low white blood cell count
- high cholesterol or triglyceride level
- high blood sugar level, which may lead to diabetes
- risk of suicidal thoughts and behaviors in young adults and children
- increased risk of death in older adults with psychosis related to dementia
* For more information about this side effect, see the “Side effect focus” section below.
Do Vraylar’s side effects go away?
Some side effects of Vraylar should go away with time. Others may be long term.
Keep in mind that Vraylar takes a long time to build up in your system. Because of this, certain side effects may take a while to appear and also to go away.
Short-term side effects
Certain mild side effects of Vraylar usually last a few weeks to months. Examples of these short-term side effects include nausea, upset stomach, headache, and feeling sleepy. Over time, these side effects should ease as your body gets used to the drug. Short-term side effects may return for a time if your doctor increases your dosage.
Long-term side effects
Some side effects of Vraylar are long term, but they can be managed. Your doctor will monitor you and prescribe treatments as necessary. Examples of these side effects and treatments include:
- high blood sugar levels, which may be treated with metformin (Fortamet, Glumetza), insulin, or other diabetes medications
- high cholesterol or triglyceride levels, which may be treated with statins, such as atorvastatin (Lipitor) or fibrates, such as fenofibrate (Triglide, Tricor)
Akathisia. One of the more common side effects of Vraylar is a movement disorder called akathisia. With akathisia, you feel restless and have an intense urge to move constantly, mainly in your legs. Tell your doctor if you notice this side effect, which may be short or long term. They may decrease your dosage or have you stop taking the drug.
Tardive dyskinesia. Another possible long-term side effect of Vraylar is tardive dyskinesia. It involves random movements of your tongue, head, neck, legs, or arms that you can’t control. Tardive dyskinesia is a side effect that can occur after you have taken Vraylar for a long time or after you have stopped taking the drug.
Other long-term side effects of Vraylar are possible. If you have questions about your risk of side effects from the medication, talk with your doctor.
Side effect focus
Learn more about some of the side effects that Vraylar may cause.
Boxed warnings
Vraylar has boxed warnings . A boxed warning is a serious warning from the Food and Drug Administration (FDA).
Risk of suicidal thoughts and behaviors in young adults and children. Young adults (ages 24 years and younger) and children who take antidepressants have an increased risk of suicidal thoughts and behaviors. Vraylar has effects that are similar to antidepressants, which is why it’s used to treat bipolar depression and major depressive disorder (depression).
As a result, the drug has this boxed warning. The risk of this side effect is highest for people who recently started taking Vraylar or recently had their dosage changed. It’s important to note that Vraylar is not prescribed for children.
Increased risk of death in older adults with psychosis related to dementia. Antipsychotic use is linked to an increased risk of death in older adults (ages 65 years and older) with psychosis that’s related to dementia. (Psychosis is a loss of awareness of reality. Dementia refers to problems with thinking, memory, and communication.)
Vraylar belongs to a group of drugs called antipsychotics. (Specifically, it’s an atypical antipsychotic.) These medications are known to increase the risk of death in older adults with psychosis that’s related to dementia.
Antipsychotics can also increase the risk of stroke in people with psychosis related to dementia. And in some cases, stroke can lead to death. Symptoms of stroke include:
- weakness on one side of the body, usually in the face, arm, or leg
- headache
- slurred speech
- trouble seeing or walking
What might help
If you’re age 65 years or older and have psychosis related to dementia, your doctor will likely not prescribe Vraylar. They can tell you about other treatment options that may be safer.
If you have symptoms of stroke while taking Vraylar, call 911 or your local emergency number right away.
If you’re age 24 years or younger, your doctor will monitor you very closely if they prescribe Vraylar. You, your family, your friends, and your doctor should watch for any symptoms of depression or suicidal behavior. You or your loved ones should talk with your doctor right away if you have thoughts of harming yourself.
If you have questions about whether Vraylar is safe for you, talk with your doctor.
Help is out there
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 Textline 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.
