May 11, 2022

Side Effects, Dosage, Uses, Cost & More

Like most medicines, Vraylar can cause mild to severe side effects. The lists below describe some of the more common side effects that Vraylar can cause. These lists do not include all possible side effects.

Keep in mind that the side effects of a medicine can depend on:

  • your age
  • other health problems you have
  • other medicines you are taking

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 is a short list of some of the mild side effects that Vraylar can cause. For more information about other mild side effects, talk to your doctor or pharmacist, or read the Package Leaflet for Vraylar prescribing information.

Mild side effects of Vraylar that have been reported include:

  • akathisia (sensation of restlessness and intense urge to move, mainly in the legs)
  • feeling drowsy or tired
  • nausea and vomiting
  • slow or more difficult movements than usual
  • muscle stiffness
  • shaking (repeated movements of a part of the body, which you cannot control)
  • increased saliva (drool)
  • stomach ache
  • headache
  • constipation
  • dizziness
  • weight gain*

Mild side effects of many medications can disappear within days to weeks. But if they become bothersome, talk to your doctor or pharmacist.

*For more information on this side effect, see the “Side Effects Focus” section below.

Serious side effects

Serious side effects from Vraylar can occur, but they are not common. If you have serious side effects from Vraylar, call your doctor right away. But if you think you have a medical emergency, you should call 911 or your local emergency number.

Serious side effects of Vraylar that have been reported include:

*For more information on this side effect, see the “Side Effects Focus” section below.

Do the side effects of Vraylar go away?

Some Vraylar side effects should go away over time. Others may be long term.

Keep in mind that Vraylar takes a long time to build up in your system. For this reason, some side effects may take some time to appear and disappear.

Short-term side effects. Some mild Vraylar side effects usually last a few weeks to a few months. Some examples of these short-term side effects include nausea, upset stomach, headache, and drowsiness. Over time, these side effects should subside as your body adjusts to the medication. Short-term side effects may return for a while if your doctor increases your dose.

Long term side effects. Some Vraylar side effects are long term, but they can be managed. Your doctor will monitor you and prescribe the necessary treatments. Here are some examples of these side effects and treatments:

Akathisia. One of the most common side effects of Vraylar is a movement disorder called akathisia. With akathisia, you feel restless and have an intense need to constantly move, primarily in your legs. Tell your doctor if you notice this side effect, which may be short or long term. They may lower your dose or make you stop taking the medicine.

Tardive dyskinesia. Another possible long-term side effect of Vraylar is tardive dyskinesia. It involves random movements of the tongue, head, neck, legs, or arms that you cannot control. Tardive dyskinesia is a side effect that can occur after taking Vraylar for a long time or after stopping the medicine.

Other long-term side effects of Vraylar are possible. If you have questions about your risk of side effects from the medicine, talk to your doctor.

Focus on side effects

Learn about some of the side effects Vraylar can cause.

Boxed warnings

Vraylar has framed warnings. A boxed warning is a serious warning from the Food and Drug Administration (FDA).

Risk of suicidal ideation and behavior in young adults and children. Vraylar contains a boxed warning about the risk of suicidal thoughts and behaviors in young adults (24 years and under) and children. The risk is greatest for people who have recently started taking Vraylar or whose dosage has recently been changed. It is important to note that Vraylar is not prescribed for children.

Increased risk of death in older people with dementia-related psychosis. Use of Vraylar is linked to an increased risk of death in older people (65 years and older) with dementia-related psychosis. (Psychosis is a loss of awareness of reality. Dementia refers to problems with thinking, memory, and communication.) Vraylar belongs to a group of medicines called antipsychotics. These drugs are known to increase the risk of death in older people with dementia-related psychosis.

Antipsychotics may also increase the risk of stroke in people with this dementia-related psychosis. And in some cases, a stroke can lead to death. Symptoms of a stroke include:

  • weakness on one side of the body, usually in the face, arm, or leg
  • headache
  • slurred speech
  • difficulty seeing or walking

What might help

If you’re 65 or older and have dementia-related psychosis, your doctor probably won’t prescribe Vraylar for you. They can tell you about other treatment options that might be safer.

If you have symptoms of stroke while taking Vraylar, call 911 or your local emergency number immediately.

If you are 24 or younger, your doctor will monitor you very closely if they prescribe Vraylar for you. You, your family, friends, and your doctor should watch for any symptoms of depression or suicidal behavior. You or your loved ones should talk to your doctor right away if you have thoughts of harming yourself.

If you’re wondering if Vraylar is safe for you, talk to your doctor.

SUICIDE PREVENTION

If you think someone is at immediate risk of harming themselves or another person:

  • Dial 911 or your local emergency number.
  • Stay with the person until help arrives.
  • Remove any guns, knives, drugs, or other objects that could cause damage.
  • Listen, but don’t judge, argue, threaten or yell.

If you or someone you know is considering suicide, get help from a crisis or suicide prevention hotline. Try the National Suicide Prevention Lifeline at 800-273-8255.

Weight gain

Weight gain is a possible side effect of Vraylar.

Vraylar belongs to a group of medicines called antipsychotics. These drugs are known to cause changes in your metabolism (the way your body converts calories into energy). These changes can lead to weight gain in some people.

At Vraylar studies, weight gain was more common in people taking the drug to treat schizophrenia. This was compared to people taking Vraylar to treat bipolar depression or mixed or manic episodes of bipolar I disorder.

What might help

Your doctor will monitor your weight regularly while you are taking Vraylar.

Physical activity can help you reach or maintain a weight that’s right for you. Before starting a new workout routine, talk to your doctor. This is because Vraylar can cause problems regulating body temperature. Too much exercise, especially in hot weather, can increase your risk of heatstroke or overheating while taking Vraylar.

To help prevent or limit weight gain, it is also important to have a balanced diet. This may include consuming less processed foods, sweets and fried foods. Consider talking to a Registered Dietitian to learn more about healthy eating that’s right for you.

Allergic reaction

Some people may have an allergic reaction to Vraylar. It is not known how often allergic reactions have occurred in the drug. studies.

Symptoms of a mild allergic reaction may include:

  • itchy skin
  • itching
  • rinsing (temporary warmth, redness or deepening of skin color)

A more serious allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under the skin, usually on the eyelids, lips, hands or feet. They can also include swelling of the tongue, mouth, or throat, which can lead to difficulty breathing.

Call your doctor right away if you have an allergic reaction to Vraylar. But if you think you have a medical emergency, call 911 or your local emergency number.


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