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cariprazine

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Brand names: Vraylar

Atypical Antipsychotic Rx

Vraylar is a medicine used to treat certain mental health conditions. It can help with schizophrenia, bipolar disorder, and major depressive disorder.

Drug Pricing (NADAC)

Brand Price

$46.27/unit

Generic Available

No

ABBVIE

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Vraylar can treat schizophrenia in adults and kids 13 and older.

Common side effects

Problems with muscle movement, Feeling restless, Upset stomach

Key warnings

Vraylar may increase the risk of death in older adults with dementia-related psychosis.

How It Works

Vraylar affects certain chemicals in the brain. These chemicals are called neurotransmitters. By changing the balance of these chemicals, Vraylar can help reduce symptoms of mental health conditions.

How to Take It

Take Vraylar once a day by mouth. You can take it with or without food. It's important to take Vraylar regularly as your doctor tells you. Do not change your dose without talking to your doctor.

Pregnancy & Breastfeeding

Vraylar may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. There is a pregnancy registry for women who take Vraylar during pregnancy; you can contact them at 1-866-961-2388.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.

Storage

Store Vraylar at room temperature, away from light and moisture.

Side Effects (from patient reports)

Based on 4,359 FDA adverse event reports.

Using the medicine for something it is not approved for
1,017
The medicine is not working
502
Gaining weight
441
Restlessness
395
Feeling worried or nervous
354
Problems with muscle movement that may not go away
347
Feeling sick to your stomach
331
Shaking
327
Trouble sleeping
324
Feeling tired
321

FDA Adverse Event Report Analysis

Detailed analysis of 8,574 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2011–2025.

Total Reports

8,574

Death-Related Reports

225

Hospitalization Reports

1,156

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 4,591 (67%)
Male 2,240 (33%)

Age Distribution

0–17 457
18–44 1,655
45–64 1,220
65–74 283
75+ 99

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 OFF LABEL USE 1,017
2 DRUG INEFFECTIVE 502
3 WEIGHT INCREASED 441
4 AKATHISIA 395
5 ANXIETY 354
6 TARDIVE DYSKINESIA 347
7 NAUSEA 331
8 TREMOR 327
9 INSOMNIA 324
10 FATIGUE 321
11 SUICIDAL IDEATION 300
12 DIZZINESS 268
13 DEPRESSION 266
14 SOMNOLENCE 231
15 FEELING ABNORMAL 212

Reactions in Death Reports

DEATH 95
COMPLETED SUICIDE 70
TOXICITY TO VARIOUS AGENTS 13
OFF LABEL USE 9
CARDIO-RESPIRATORY ARREST 8
FALL 6
CARDIAC ARREST 5
DRUG INEFFECTIVE 5
MYOCARDIAL INFARCTION 5
CEREBROVASCULAR ACCIDENT 4

Reactions in Hospitalization Reports

DRUG INEFFECTIVE 92
SUICIDAL IDEATION 85
DRUG INTERACTION 83
OFF LABEL USE 78
HOSPITALISATION 70
INSOMNIA 56
SUICIDE ATTEMPT 56
TREMOR 56
AKATHISIA 55
WEIGHT INCREASED 55

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Vraylar may increase the risk of death in older adults with dementia-related psychosis. Vraylar and antidepressants can increase suicidal thoughts and behaviors in children, teens, and young adults. Tell your doctor right away if you have thoughts of harming yourself.

Known Drug Interactions

Antipsychotics, Anxiolytics and Hypnotics Alprazolam a Midazolam (IV) a Aripiprazole a Quetiapine Buspirone a Cariprazine Ramelteon Diazepam a Risperidone a Haloperidol a Suvorexant Monitor for adverse reactions.

Mechanism: Itraconazole interferes with the way your body processes cariprazine. This can lead to higher levels of cariprazine in your blood than intended.

What to do: Your doctor should watch you for side effects and may need to adjust your treatment plan while you take these together.

aripiprazole, brexpiprazole, cariprazine, iloperidone, lumateperone, pimavanserin ↑ aripiprazole ↑ brexpiprazole ↑ cariprazine ↑ iloperidone ↑ lumateperone ↑ pimavanserin Dosage adjustment of aripiprazole, brexpiprazole, cariprazine, iloperidone, lumateperone, and pimavanserin is recommended.

Mechanism: This combination makes it harder for your body to get rid of cariprazine, which can cause the drug to build up to higher levels.

What to do: Your healthcare provider should adjust your cariprazine dose if you are taking both of these medications.

Common Questions

Can I drive while taking Vraylar?
Vraylar may cause sleepiness or dizziness. Be careful driving or operating machinery until you know how Vraylar affects you.
Can I drink alcohol while taking Vraylar?
Talk to your doctor about drinking alcohol while taking Vraylar. Alcohol may worsen some side effects of Vraylar.
How long does it take for Vraylar to work?
It may take several weeks to see the full effects of Vraylar. Talk to your doctor if you don't feel any better after a few weeks.
What should I do if I have side effects?
Tell your doctor about any side effects you have while taking Vraylar. They may be able to adjust your dose or recommend ways to manage the side effects.
Can I stop taking Vraylar suddenly?
Do not stop taking Vraylar without talking to your doctor. Stopping Vraylar suddenly can cause withdrawal symptoms.
Does Vraylar interact with other medications?
Yes, Vraylar can interact with other medications. Tell your doctor about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Will Vraylar cause me to gain weight?
Vraylar can cause weight gain in some people. Talk to your doctor about ways to manage your weight while taking Vraylar.
Is Vraylar addictive?
Vraylar is not considered addictive.
Can children take Vraylar?
Vraylar is approved to treat schizophrenia in children 13 years and older and bipolar mania in children 10 years and older.
What is the most important information I should know about Vraylar?
Vraylar may increase the risk of death in older adults with dementia-related psychosis and can increase suicidal thoughts and behaviors in young people. Tell your doctor about any changes in your mood or behavior.
What are the common side effects of cariprazine?
The most commonly reported side effects of cariprazine include Problems with muscle movement, Feeling restless, Upset stomach, Throwing up, Feeling sleepy. Based on 4,359 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does cariprazine interact with other medications?
Yes, cariprazine has 2 known drug interactions. Notable interactions include itraconazole, nirmatrelvir/ritonavir. Always inform your doctor about all medications you are taking.
What drug class is cariprazine?
cariprazine belongs to the Atypical Antipsychotic drug class. It requires a prescription (Rx). Vraylar can treat schizophrenia in adults and kids 13 and older.
Is cariprazine safe during pregnancy?
Vraylar may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for cariprazine

The FDA label for cariprazine (sold under brand names such as Vraylar) classifies it as a prescription-only medication in the Atypical Antipsychotic class. Vraylar can treat schizophrenia in adults and kids 13 and older. Official labeling lists 10 commonly reported side effects, including Problems with muscle movement, Feeling restless, Upset stomach.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 4,359 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: December 18, 2025

All federal data sources used on this page