Prescription medication · Atypical Antipsychotic
cariprazine
Also sold as Vraylar. Vraylar can treat schizophrenia in adults and kids 13 and older.
Data updated 2026-05-15
- 8,574
- FDA reportsLightly reported
- 2
- InteractionsFew interactions
- $46.27
- Brand price (NADAC)
What the data shows
cariprazine (Vraylar) is a prescription Atypical Antipsychotic, reported less often than most tracked drugs (8,574 FDA reports), with 2 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
cariprazine (Vraylar) is a prescription Atypical Antipsychotic. Vraylar can treat schizophrenia in adults and kids 13 and older.
Vraylar is a medicine used to treat certain mental health conditions. It can help with schizophrenia, bipolar disorder, and major depressive disorder.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from cariprazine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of cariprazine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of cariprazine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of cariprazine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Vraylar at room temperature, away from light and moisture.
Side Effects (from patient reports)
Based on 8,574 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for cariprazine, by number of reports
- Gaining weight
Gaining weight
441 reports
- Restlessness
Restlessness
395 reports
- Feeling worried or nervous
Feeling worried or nervous
354 reports
- Problems with muscle movement that may not go away
Problems with muscle movement that may not go away
347 reports
- Feeling sick to your stomach
Feeling sick to your stomach
331 reports
- Shaking
Shaking
327 reports
- Trouble sleeping
Trouble sleeping
324 reports
- Feeling tired
Feeling tired
321 reports
- Thoughts of harming yourself
Thoughts of harming yourself
300 reports
- Feeling lightheaded
Feeling lightheaded
268 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for cariprazine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where cariprazine sits
cariprazine has more FDA adverse-event reports than 36% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is cariprazine; the line is the median (50th percentile).
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
Reports Mentioning Death
225
2.6% of reports — not proof of cause
Hospitalization Reports
1,156
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 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 |
| 16 | HEADACHE | 196 |
| 17 | DRUG INTERACTION | 195 |
Reactions in Death Reports
Reactions in Hospitalization Reports
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I drive while taking Vraylar?
Can I drink alcohol while taking Vraylar?
How long does it take for Vraylar to work?
What should I do if I have side effects?
Can I stop taking Vraylar suddenly?
Does Vraylar interact with other medications?
Will Vraylar cause me to gain weight?
Is Vraylar addictive?
Can children take Vraylar?
What is the most important information I should know about Vraylar?
What are the common side effects of cariprazine?
Does cariprazine interact with other medications?
What drug class is cariprazine?
Is cariprazine safe during pregnancy?
Related Medications in Atypical Antipsychotic
Other drugs grouped near cariprazine - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
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alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with cariprazine →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
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amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
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aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 8,574 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
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages