Prescription medicine
Cariprazine Brand names: Vraylar
Cariprazine (Vraylar) is a prescription medicine with an FDA approval on record since 2015. No generic is listed; pharmacies paid $50.84 per Vraylar 1.5 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the cariprazine FDA label on DailyMed (effective December 18, 2025, Allergan, Inc.); the NDA 204370 record on Drugs@FDA; every cariprazine label on DailyMed.
Highlights of the record
FDA label of December 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED.
PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for the emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.2 )]. WARNING : INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 ) Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors.
Used for
From the label: indications and usageINDICATIONS AND USAGE VRAYLAR ® is indicated for:
Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies ( 14.1 )]
Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies ( 14.2 )]
Treatment of depressive episodes associated with bipolar I disorder (bipolar de
Forms and strengths
- 0.5 mg
- 0.75 mg
- 1.5 mg
- 3 mg
- 4.5 mg
- 6 mg
Gelatin-coated capsule; kit.
On the market
- Earliest approval on file
- September 17, 2015 Vraylar, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first September 9, 2022; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 17, 2030 Vraylar capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $50.84 per capsule Vraylar 1.5 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 9,254 through July 30, 2026
What is cariprazine used for?
From the label: indications and usageINDICATIONS AND USAGE VRAYLAR ® is indicated for:
Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies ( 14.1 )]
Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies ( 14.2 )]
Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies ( 14.3 )]
Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies ( 14.4 )] VRAYLAR is an atypical antipsychotic indicated for: Treatment of […]
Conditions named in the indications of cariprazine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Atypical Antipsychotic.
Source: FDA drug label (Vraylar), NDA204370 (Abbvie), as published by Allergan, Inc., effective December 18, 2025 (SPL set 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f), via openFDA; the full label on DailyMed
What does the patient leaflet for cariprazine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VRAYLAR?VRAYLAR may cause serious side effects, including: Increased risk of death in elderly people with dementia related psychosis. Medicines like VRAYLAR can raise the risk of death in elderly who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). VRAYLAR is not approved for the treatment of patients with dementia-related psychosis. Increased risk of suicidal thoughts and actions. VRAYLAR and antidepressant medicines increase the risk of suicidal thoughts or actions in people 24 years of age and younger especially within the first few months of treatment or when the dose is changed. ○ Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? ○ Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when VRAYLAR or the antidepressant medicine is started or when the dose is changed. ○ Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. ○ Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. […]
From the patient leaflet: What should I avoid while taking VRAYLAR?Do not drive, operate machinery, or do other dangerous activities until you know how VRAYLAR affects you. VRAYLAR may make you drowsy. Do not become too hot or dehydrated during treatment with VRAYLAR. ○ Do not exercise too much. ○ In hot weather, stay inside in a cool place if possible. ○ Stay out of the sun. ○ Do not wear too much clothing or heavy clothing. ○ Drink plenty of water.
From the patient leaflet: How should I store VRAYLAR?Store VRAYLAR at room temperature, between 68°F to 77°F (20°C to 25°C). Protect 3 mg and 4.5 mg capsules from light to help prevent potential color fading. Keep VRAYLAR and all medicines out of the reach of children.
Source: FDA drug label (Vraylar), NDA204370 (Abbvie), as published by Allergan, Inc., effective December 18, 2025 (SPL set 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f), via openFDA; the full label on DailyMed
Is there a generic for cariprazine (Vraylar)?
The FDA approved the first generic cariprazine on September 9, 2022. 3 generic applications are approved; 0 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 5 patents for Vraylar capsules: the compound patent runs to September 17, 2029 (pediatric exclusivity to March 17, 2030). A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2022 first generic approved
- 2030 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cariprazine (Vraylar)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $50.84 per Vraylar 1.5 mg capsule, up 5% from $48.53 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Vraylar 1.5 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Vraylar 0.5 mg capsule | Brand | $50.78 per capsule | $1,523.36 | n/a |
| Vraylar 0.75 mg capsule | Brand | $50.84 per capsule | $1,525.16 | n/a |
| Vraylar 1.5 mg capsule | Brand | $50.84 per capsule | $1,525.27 | +5% |
| Vraylar 3 mg capsule | Brand | $50.88 per capsule | $1,526.52 | +5% |
| Vraylar 4.5 mg capsule | Brand | $50.79 per capsule | $1,523.58 | +5% |
| Vraylar 6 mg capsule | Brand | $50.78 per capsule | $1,523.28 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the cariprazine label say about other medicines?
The cariprazine label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name cariprazine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aripiprazole | warnings and precautions | Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia -Related Psychosis In placebo-controlled trials in elderly patients with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal … |
| Olanzapine | warnings and precautions | Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia -Related Psychosis In placebo-controlled trials in elderly patients with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal … |
| Risperidone | warnings and precautions | Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia -Related Psychosis In placebo-controlled trials in elderly patients with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal … |
Other labels that name cariprazine
Source: FDA drug label (Vraylar), NDA204370 (Abbvie), as published by Allergan, Inc., effective December 18, 2025 (SPL set 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f), via openFDA; the full label on DailyMed
What do FAERS reports show for cariprazine?
The FDA Adverse Event Reporting System holds 9,254 reports that list cariprazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 244 are coded as a death and 1,289 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cariprazine?
21 other medicines are given the same way (oral) and in the same FDA class as cariprazine or labeled mainly for the same use (schizophrenia), the same class first. Schizophrenia lists all 24 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Quetiapine | Depression, Bipolar disorder, Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Aripiprazole | Depression, Bipolar disorder, Schizophrenia | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Olanzapine | Depression, Bipolar disorder, Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Risperidone | Bipolar disorder, Schizophrenia | 35 labelers | $0.0368 per tablet 0.25 mg tablet | No current entry |
| Lurasidone | Depression, Bipolar disorder, Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| Ziprasidone | Bipolar disorder, Schizophrenia | 16 labelers | $0.269 per capsule 20 mg capsule | No current entry |
| Paliperidone | Schizophrenia | 18 labelers | $0.972 per tablet 3 mg tablet | No current entry |
| Clozapine | Schizophrenia | 11 labelers | $0.610 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as cariprazine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does cariprazine compare with medicines for the same use?
4 side-by-side pages set cariprazine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to cariprazine
- 21 medicines for the same use
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Cariprazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other