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Cariprazine

Cariprazine is an atypical antipsychotic used to treat schizophrenia, manic or mixed episodes and depressive episodes associated with bipolar I disorder, and as an add-on treatment for major depressive disorder.

Brand name Vraylar
Drug class Atypical Antipsychotic
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Cariprazine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Cariprazine (Vraylar), on the market since about 2015, is a newer atypical antipsychotic for schizophrenia, bipolar I disorder (manic and depressive episodes), and, added to an antidepressant, major depressive disorder in adults. It tends to cause less weight gain and drowsiness than many in its class, but akathisia (inner restlessness, an urge to keep moving) is the side effect people notice most. Its boxed warning covers a higher risk of death in older adults with dementia-related psychosis and of suicidal thoughts in young people, so report any darkening mood early. It lingers in the body for weeks, so effects and side effects build slowly and follow-up visits matter.

Clinical pearls

  • Before starting an antifungal, antibiotic or HIV medicine, have it checked, since some raise cariprazine levels and need a lower dose.
  • Rifampin and certain seizure medicines can change cariprazine levels unpredictably, and combining them with it is not recommended.
  • Ask for blood sugar, cholesterol and weight checks before and during treatment, since it can still raise all three.
  • Stand up slowly and stay well hydrated, because it can drop blood pressure on standing and make overheating harder to handle.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Elderly patients with dementia-related psychosis who take antipsychotic drugs have a significantly higher risk of death — Vraylar is NOT approved for this use. Studies show the death rate in elderly dementia patients taking antipsychotics was roughly 1.6 to 1.7 times higher than in those taking placebo, often from heart or lung problems. If you have a loved one with dementia, speak with their doctor about safer alternatives.

Additionally, antidepressant medications — including when cariprazine is used alongside them for major depressive disorder — have been shown to increase the risk of suicidal thoughts and behaviors in children, teenagers, and young adults (under 25). All patients starting this type of treatment should be watched closely for any signs of worsening mood or new thoughts of self-harm, especially in the early weeks of treatment.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule
Earliest FDA record2015
Companies listing it with the FDA1
FDA label last updatedDec 18, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Cariprazine, written from its FDA label.

What Cariprazine is used for

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Cariprazine is an atypical antipsychotic approved for several mental health conditions. The only brand currently available is Vraylar, taken as an oral capsule.

  • Schizophrenia: Vraylar is approved for adults and teenagers aged 13 and older
  • Manic or mixed episodes associated with bipolar I disorder: Vraylar is approved for adults and children aged 10 and older
  • Depressive episodes associated with bipolar I disorder (bipolar depression): Vraylar is approved for adults only
  • Major depressive disorder (MDD) — add-on therapy: Vraylar is approved as an addition to antidepressants in adults only

How Cariprazine works

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Cariprazine is thought to work by partially activating (acting as a partial agonist at) dopamine D2 and D3 receptors and serotonin 5-HT1A receptors in the brain, while blocking (acting as an antagonist at) serotonin 5-HT2A receptors. This fine-tuning of dopamine and serotonin activity helps regulate mood, thinking, and perception. The exact mechanism behind its effectiveness is not fully known.

Cariprazine is broken down in the liver into two major active metabolites — DCAR and DDCAR — that have similar effects on the brain. DDCAR in particular builds up to high levels and lingers in the body for weeks, which is why changes in dose take time to fully show their effects.

Cariprazine dosage

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Vraylar capsules are taken once daily by mouth and can be taken with or without food. The dose is started low and increased gradually over days to weeks depending on how you respond and what condition is being treated. Because cariprazine and its active metabolites have a very long half-life, it can take several weeks for the full effect — or full side effects — of any dose change to become apparent.

  • Take it at the same time each day as directed by your prescriber
  • Do not stop or change your dose without talking to your doctor — the drug stays in your system for weeks even after stopping
  • If you take a strong or moderate CYP3A4 inhibitor drug, your Vraylar dose will need to be reduced
  • Using Vraylar alongside CYP3A4 inducer medications is not recommended

Dosing details from the FDA-approved label

From the Cariprazine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Schizophrenia in Adults
    • Starting dosage 1.5 mg orally once daily
    • Recommended range 1.5 mg to 6 mg orally once daily
    • The dosage can be increased to 3 mg on Day 2. Further dose adjustments can be made in 1.5 mg or 3 mg increments depending upon clinical response and tolerability
    • Maximum: 6 mg orally once daily
    • Taken with or without food
  • Schizophrenia in Pediatric Patients (13 to 17 years of age)
    • Starting dosage 0.5 mg orally once daily
    • Recommended range 1.5 mg to 4.5 mg orally once daily
    • Increase to 1.5 mg once daily on Day 3, may be increased to 3 mg once daily starting on Day 5, and to 4.5 mg once daily starting on Day 8
    • Maximum: 4.5 mg orally once daily
    • Taken with or without food
  • Manic or Mixed Episodes Associated with Bipolar I Disorder in Adults
    • Starting dosage 1.5 mg orally once daily
    • Increase to 3 mg once daily on Day 2. Recommended range 3 mg to 6 mg orally once daily
    • Further adjustments can be made in 1.5 mg or 3 mg increments
    • Maximum: 6 mg orally once daily
    • Taken with or without food
  • Manic or Mixed Episodes Associated with Bipolar I Disorder in Pediatric Patients (10 to 17 years of age)
    • Starting dosage 0.5 mg orally once daily
    • Recommended dosage 3 mg or 4.5 mg orally once daily
    • Increase to 1.5 mg once daily on Day 3 and to 3 mg once daily on Day 5
    • May be increased to 4.5 mg once daily starting on Day 8
    • Maximum: 4.5 mg orally once daily
    • Taken with or without food
  • Depressive Episodes Associated with Bipolar I Disorder (Bipolar Depression) in Adults
    • Starting dosage 1.5 mg orally once daily
    • Depending on clinical response and tolerability, may be increased to 3 mg orally once daily on Day 15
    • Maximum: 3 mg orally once daily
    • Recommended dose 1.5 mg or 3 mg daily
  • Adjunctive Therapy to Antidepressants for Major Depressive Disorder in Adults
    • Starting dosage 1.5 mg orally once daily
    • Depending on clinical response and tolerability, may be increased to 3 mg orally once daily on Day 15
    • Maximum: 3 mg orally once daily
    • Titration at intervals of less than 14 days resulted in a higher incidence of adverse reactions in clinical trials
  • Adults starting VRAYLAR while taking a strong CYP3A4 inhibitor
    • Schizophrenia: start at 0.5 mg orally once daily
    • Increase to 0.75 mg once daily, if needed
    • Bipolar mania, bipolar depression, adjunctive MDD: 0.5 mg orally once daily
    • Starting VRAYLAR in pediatric patients taking a strong or moderate CYP3A4 inhibitor is not recommended
  • Adults starting VRAYLAR while taking a moderate CYP3A4 inhibitor
    • Schizophrenia: start at 0.75 mg orally once daily
    • Increase to 1.5 mg daily, if needed
    • Bipolar mania, bipolar depression, adjunctive MDD: 0.75 mg orally once daily
    • Increase depends on clinical response and tolerability
  • Adult and pediatric patients on stable VRAYLAR 1.5 mg or 3 mg once daily who start a CYP3A4 inhibitor
    • Strong CYP3A4 inhibitor: 0.5 mg orally once daily
    • Moderate CYP3A4 inhibitor: 0.75 mg orally once daily
    • Dosage may need to be increased when the inhibitor is discontinued
  • Adult and pediatric patients on stable VRAYLAR 4.5 mg or 6 mg once daily who start a CYP3A4 inhibitor
    • Strong CYP3A4 inhibitor: 0.75 mg orally once daily
    • Moderate CYP3A4 inhibitor: 1.5 mg orally once daily
    • Dosage may need to be increased when the inhibitor is discontinued
Read the label’s full dosing text

2 . DOSAGE AND ADMINISTRATION Administer VRAYLAR orally once daily with or without food ( 2 ) Starting Dose Recommended Dose Schizophrenia in Adults ( 2.2 ) 1.5 mg daily 1.5 mg to 6 mg daily Schizophrenia in Pediatric Patients (13-17 years) ( 2.2 ) 0.5 mg daily 1.5 mg to 4.5 mg daily Bipolar Mania in Adults ( 2.3 ) 1.5 mg daily 3 mg to 6 mg daily Bipolar Mania in Pediatric Patients (10-17 years) ( 2.3 ) 0.5 mg daily 3 mg or 4.5 mg daily Bipolar Depression in Adults ( 2.4 ) 1.5 mg daily 1.5 mg or 3 mg daily Adjunctive therapy to antidepressants for MDD in Adults ( 2.5 ) 1.5 mg daily 1.5 mg or 3 mg daily Adults with Schizophrenia and Bipolar Mania: Maximum recommended daily dosage is 6 mg. Dosages above 6 mg daily do not confer significant benefit, but increase the risk of dose-related adverse reactions ( 2.2 , 2.3 ) Pediatric patients with Schizophrenia and Bipolar Mania: Maximum recommended daily dosage is 4.5 mg. Adults with Bipolar Depression: Maximum recommended daily dosage is 3 mg ( 2.4 ) Adjunctive therapy for treatment of MDD in Adults: Maximum recommended daily dosage is 3 mg ( 2.5 ) 2.1 General Dosing Information VRAYLAR is given orally once daily and can be taken with or without food. Because of the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks. Prescribers should monitor patients for adverse reactions and treatment response for several weeks after starting VRAYLAR and after each dosage change [see Warnings and Precautions ( 5.6 ) , Clinical Pharmacology ( 12.3 )] . 2.2 Recommended Dosage in Schizophrenia Adult Patients The starting dosage of VRAYLAR is 1.5 mg orally once daily. The recommended dosage range is 1.5 mg to 6 mg orally once daily. The dosage can be increased to 3 mg on Day 2. Depending upon clinical response and tolerability, further dose adjustments can be made in 1.5 mg or 3 mg increments. The maximum recommended dosage is 6 mg orally once daily. In short-term controlled trials, dosages above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.1 )] . Pediatric Patients (13 to 17 years of age) The starting dosage of VRAYLAR is 0.5 mg orally once daily. The recommended dosage range is 1.5 mg to 4.5 mg orally once daily.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Cariprazine side effects

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The most common side effects vary by condition being treated, but generally include:

Common side effects

  • Extrapyramidal symptoms (muscle stiffness, tremor, or movement problems)
  • Akathisia (feeling of inner restlessness or an urge to move)
  • Nausea
  • Vomiting
  • Constipation
  • Fatigue
  • Somnolence (drowsiness)
  • Dizziness
  • Akathisia — a feeling of inner restlessness or an uncontrollable need to move
  • Increased appetite and weight gain

When to get medical help

  • Call your doctor right away if you notice uncontrolled or unusual muscle movements, especially in your face or limbs — this could be tardive dyskinesia
  • Seek emergency help if you experience high fever, severe muscle stiffness, confusion, or irregular heartbeat — these may be signs of neuroleptic malignant syndrome (a rare but life-threatening reaction)
  • Tell your doctor immediately if you notice new or worsening thoughts of suicide or self-harm, especially if you are young
  • Get medical help if you feel faint, dizzy, or lightheaded when standing up — this can mean a dangerous drop in blood pressure
  • Contact your doctor if you develop signs of high blood sugar: unusual thirst, frequent urination, blurred vision, or increased hunger
  • Tell your doctor if you have a seizure while taking this medication
  • Seek care right away for difficulty swallowing (dysphagia)

Seek medical attention right away for signs of neuroleptic malignant syndrome (high fever, severe muscle stiffness, confusion) or tardive dyskinesia (involuntary, repetitive muscle movements) — both are rare but serious and require prompt care.

Cariprazine warnings and precautions

▾
  • Elderly patients with dementia-related psychosis: Antipsychotics significantly increase the risk of death in this group. Vraylar is NOT approved for dementia-related psychosis.
  • Suicidal thoughts: Antidepressant use — including Vraylar as add-on therapy for MDD — raises the risk of suicidal thinking in patients under 25. Monitor closely, especially early in treatment.
  • Tardive dyskinesia: Long-term use can cause uncontrolled muscle movements that may be permanent. Report any new involuntary movements to your doctor right away.
  • Neuroleptic malignant syndrome (NMS): A rare but life-threatening reaction involving high fever, severe muscle rigidity, and confusion. Requires emergency medical care.
  • Metabolic changes: Vraylar can raise blood sugar (potentially causing diabetes), increase cholesterol, and cause weight gain. Regular monitoring is needed.
  • Low blood pressure when standing (orthostatic hypotension): Can cause dizziness or fainting — extra care is needed if you have heart or vascular disease.
  • Late-occurring side effects: Because of cariprazine's long half-life, side effects may appear weeks after starting or changing a dose. Your doctor should monitor you for several weeks after any dose change.

Cariprazine interactions

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Cariprazine is processed primarily by a liver enzyme called CYP3A4. Medications that affect this enzyme can significantly change how much cariprazine builds up in your body:

  • Strong or moderate CYP3A4 inhibitors (e.g., certain antifungals like ketoconazole, some antibiotics like clarithromycin, HIV medications) — these slow down the breakdown of cariprazine, raising its levels and increasing the risk of side effects; your dose must be reduced
  • CYP3A4 inducers (e.g., rifampin, certain anti-seizure drugs like carbamazepine) — these speed up cariprazine's breakdown in an unpredictable way; combined use is not recommended

Interactions listed in the FDA-approved label

From the Cariprazine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong or moderate CYP3A4 inhibitors: Concomitant use increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to VRAYLAR alone. Reduce VRAYLAR dosage.
  • CYP3A4 inducers: The effect of CYP3A4 inducers on VRAYLAR exposure has not been evaluated, and the net effect is unclear. Concomitant use is not recommended.
Read the label’s full interactions text

7 DRUG INTERACTIONS Table 15 displays clinically significant drug interactions with VRAYLAR. Table 15. Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ]. Intervention: If VRAYLAR is used with a strong or moderate CYP3A4 inhibitor, reduce VRAYLAR dosage [see D osage and A dministration ( 2.6 ) ] . CYP3A4 Inducers Clinical Impact: CYP3A4 is responsible for the formation and elimination of the active metabolites of cariprazine. The effect of CYP3A4 inducers on the exposure of VRAYLAR has not been evaluated, and the net effect is unclear [see Clinical Pharmacology ( 12.3 ) ]. Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] . Strong and Moderate CYP3A4 inhibitors: Reduce VRAYLAR dosage ( 2.6 , 7 ) CYP3A4 inducers: Concomitant use is not recommended ( 2.6 , 7 )

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿145 supplements and herbs with documented Cariprazine interactions, ranked by severity Check Cariprazine against a supplement or herb →

Before taking Cariprazine

▾
  • Allergy: Do not take cariprazine if you have had a hypersensitivity reaction to it — including rash, hives, swelling of the face, tongue, or throat
  • Pregnancy: Animal studies suggest cariprazine may harm a developing fetus. The active metabolite can remain detectable for up to 12 weeks after stopping the medication. A pregnancy registry is available (1-866-961-2388). Discuss risks and benefits with your doctor.
  • Breastfeeding: It is unknown whether cariprazine passes into human breast milk. Discuss with your doctor before breastfeeding.
  • Newborns: Babies born to mothers who took antipsychotics in the third trimester may have withdrawal symptoms — including tremor, stiffness, drowsiness, and breathing difficulties. These babies need to be monitored after birth.
  • Children and teenagers: Vraylar is approved for schizophrenia in patients 13 and older, and for bipolar mania in patients 10 and older. It is not approved for bipolar depression or MDD in pediatric patients. Starting Vraylar in pediatric patients while taking a strong or moderate CYP3A4 inhibitor is not recommended.
  • Elderly patients with dementia: Vraylar is not approved for this group and carries a significantly increased risk of death.
  • Liver problems: Mild to moderate liver impairment can increase cariprazine exposure. Vraylar has not been studied in severe liver impairment.
  • History of seizures or low seizure threshold: Use with caution and inform your doctor.
  • Low white blood cell count: Tell your doctor if you have a history of leukopenia or neutropenia; blood counts may need to be monitored.

Cariprazine overdose

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In clinical trials, one case of accidental overdose (at a very high daily dose) was reported and resulted in low blood pressure and sedation; the person fully recovered the same day. There is no specific antidote for cariprazine overdose.

If you suspect an overdose, call Poison Control immediately at 1-800-222-1222 or seek emergency medical care. Close monitoring and supportive care are the standard approach.

What Cariprazine does in the body

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Cariprazine acts as a partial agonist at dopamine D3 and D2 receptors and at serotonin 5-HT1A receptors, and as an antagonist (blocker) at serotonin 5-HT2A and 5-HT2B receptors. It also binds to histamine H1 receptors. It has very little activity at muscarinic (cholinergic) receptors, which is why it tends to cause fewer of the dry mouth and constipation effects seen with older antipsychotics.

At doses up to three times the maximum recommended dose, cariprazine does not meaningfully prolong the QTc interval (an electrical measurement of the heart's rhythm), which is reassuring for heart safety.

How your body processes Cariprazine

▾

After taking a Vraylar capsule, cariprazine reaches peak blood levels in about 3 to 6 hours. Food does not significantly affect how much of the drug is absorbed. Cariprazine and its active metabolites are highly bound to proteins in the blood (91–97%) and are processed mainly by the liver enzyme CYP3A4.

One of its metabolites, DDCAR, builds up to levels roughly four times higher than cariprazine itself and has an estimated half-life of 1 to 3 weeks — meaning it takes weeks to fully clear after stopping the medication. In fact, DDCAR can still be detected up to 8 weeks after a single dose, and some patients may not reach steady-state levels even after 12 weeks of treatment. This slow buildup and long persistence mean dose changes take time to fully reflect in the body, and side effects can emerge late.

How to store Cariprazine

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Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

145

Supplements & herbs that interact with Cariprazine

145 supplements and herbal products have documented interactions with Cariprazine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 99
  • Minor · 41
ACTIVATED CHARCOAL Major GRAPEFRUIT Major INDIAN SNAKEROOT Major RAUVOLFIA VOMITORIA Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate +137 more
Every supplement checked against Cariprazine — ranked by severity The full interaction hub: 5 major · 99 moderate · 41 minor · every one linked to its full report. Check Cariprazine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Cariprazine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Cariprazine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Vraylar used for? My doctor prescribed it but didn't fully explain.

▾
Vraylar (cariprazine) is an antipsychotic medication used for a few different conditions. It can treat schizophrenia, the manic or mixed episodes of bipolar I disorder, and the depressive episodes of bipolar I disorder. It can also be added to an antidepressant if you have major depressive disorder and your antidepressant alone isn't doing enough. Which of those fits your situation depends on what your doctor prescribed it for — if you're unsure, that's a great question to ask them directly.

How long does it take for Vraylar to start working?

▾
This one requires some patience. Vraylar and its active breakdown products stay in your body for a long time, and it can take several weeks for levels to fully build up and stabilize. Some people notice improvements sooner, but it's also common for side effects to appear gradually over weeks too — not just right away. Your doctor should check in with you regularly for at least the first few weeks after you start or change your dose, so don't skip those follow-up appointments.

What side effects should I watch out for, and which ones are serious enough to call my doctor about?

▾
The most common side effects are things like restlessness or an uncomfortable urge to move (called akathisia), muscle stiffness or tremors, nausea, and drowsiness. Those are worth mentioning at your next appointment. But call your doctor right away — or go to the ER — if you develop a high fever with severe muscle stiffness and confusion (that's a rare but serious reaction called neuroleptic malignant syndrome), or if you notice uncontrolled, repetitive movements in your face or body (called tardive dyskinesia). Also reach out quickly if you feel faint when standing, have a seizure, or notice worsening depression or thoughts of self-harm.

Does it matter if I take this with or without food?

▾
No — Vraylar can be taken with or without food, whichever you prefer. A high-fat meal was studied and did not meaningfully change how much of the drug gets into your system. The most important thing is to take it at roughly the same time each day, as directed.

I'm pregnant — is it safe to take Vraylar?

▾
This is really important to discuss with your doctor before making any decisions. Animal studies showed potential harm to developing fetuses, so there is reason for caution. One thing to know is that cariprazine's active metabolite can remain in your body for up to 12 weeks after you stop taking it, so timing matters. Also, babies born to mothers who took antipsychotics in the third trimester sometimes have withdrawal symptoms after birth and need monitoring. There's a free pregnancy registry you can join to help track outcomes: call 1-866-961-2388. Your doctor can help weigh the risks of the medication against the risks of untreated illness.

Are there any medications or supplements I need to avoid while taking Vraylar?

▾
Yes — this is a big one. Vraylar is broken down by a liver enzyme called CYP3A4, so anything that strongly affects that enzyme can change how much Vraylar stays in your blood. Some common culprits include certain antifungal drugs, some antibiotics like clarithromycin, and some HIV medications — these can raise Vraylar levels and your dose would need to be lowered. On the flip side, drugs like rifampin (an antibiotic) or some anti-seizure medications can speed up Vraylar's breakdown unpredictably, so combining them is not recommended. Always tell every prescriber and pharmacist that you're taking Vraylar, including for new prescriptions or even over-the-counter supplements.

Is Cariprazine available over the counter?

▾
No. Cariprazine is a prescription medicine: every Cariprazine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Cariprazine first available?

▾
The earliest FDA record we hold for Cariprazine is from 2015: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Cariprazine was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Cariprazine on HelloPharmacist

📊Cariprazine supplement interactions145 checked — ranked by severity 🌿Drug & Supplement CheckerCariprazine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Cariprazine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Cariprazine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Cariprazine forms and strengths (how it comes)

Cariprazine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Vraylar
How this form is used
What it may be used for
  • Vraylar capsules are used to treat schizophrenia in adults and teenagers aged 13 and older
  • Vraylar capsules are used for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and children aged 10 and older
  • Vraylar capsules are used to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults
  • Vraylar capsules are used as add-on therapy with antidepressants for major depressive disorder (MDD) in adults
Important instructions
  • Vraylar capsules are taken by mouth once daily, with or without food
  • Vraylar capsules are started at a low dose and increased gradually based on your response and tolerability — follow your prescriber's schedule exactly
  • Because Vraylar stays in your body for a long time, do not change your dose or stop without talking to your doctor first
  • If you are also taking a strong or moderate CYP3A4 inhibitor medication, your Vraylar dose will need to be adjusted — your doctor will guide you
Available strengths 6 strengths
0.5 mg 0.75 mg 1.5 mg 3 mg 4.5 mg 6 mg
28 FDA-listed product records ⓘ

Cariprazine on the U.S. market: products, makers and brands

How Cariprazine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 7 Cariprazine product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2015. Brand names on the directory include Vraylar; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
7
FDA-listed product records ⓘ
2015
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (10) · Kit (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Cariprazine is used (Medicaid data)

A general measure of how commonly Cariprazine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Cariprazine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,076,596
Medicaid prescriptions filled (Q1–Q4 2025)
$1.6B gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cariprazine prescribed? Of the 1,601 medications we measure, Cariprazine ranks #170 by Medicaid prescriptions — more than 89% of them.

Where Cariprazine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #170 of 1,601
#165 Fenofibrate 1,097,185 Rx #166 Cyanocobalamin 1,095,564 Rx #167 Clobetasol Topical 1,093,267 Rx #168 Cyanocobalamin Injecti... 1,087,734 Rx #169 Nifedipine 1,079,242 Rx #170 Cariprazine 1,076,596 Rx #171 Naltrexone 1,052,053 Rx #172 Lurasidone 1,049,340 Rx #173 Paliperidone 1,015,111 Rx #174 Levocetirizine 1,014,061 Rx #175 Ethinyl Estradiol / Fe... 1,010,948 Rx

Utilization by Cariprazine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1.5 mg oral capsule is the most-dispensed Cariprazine product — about 44% of these Medicaid prescriptions.

cariprazine 1.5 MG Oral Capsule Most dispensed

473,420 Medicaid prescriptions (Q1–Q4 2025) 44% of Cariprazine prescriptions shown $698.9M gross reimbursement (before rebates) ≈ $1,476 per prescription (gross)

Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1667660

cariprazine 3 MG Oral Capsule

371,556 Medicaid prescriptions (Q1–Q4 2025) 35% of Cariprazine prescriptions shown $556.7M gross reimbursement (before rebates) ≈ $1,498 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1667668

cariprazine 4.5 MG Oral Capsule

136,464 Medicaid prescriptions (Q1–Q4 2025) 13% of Cariprazine prescriptions shown $202.5M gross reimbursement (before rebates) ≈ $1,484 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1667672

cariprazine 6 MG Oral Capsule

95,156 Medicaid prescriptions (Q1–Q4 2025) 9% of Cariprazine prescriptions shown $140.7M gross reimbursement (before rebates) ≈ $1,479 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1667676

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cariprazine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 20 listed Cariprazine NDCs with Medicaid activity.

Compare Cariprazine products

A representative set of FDA-listed product records for Cariprazine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Capsule
0.5 mg Oral Allergan, Inc. NDA View NDC →
0.75 mg Oral Allergan, Inc. NDA View NDC →
1.5 mg Oral Allergan, Inc. NDA View NDC →
3 mg Oral Allergan, Inc. NDA View NDC →
4.5 mg Oral Allergan, Inc. NDA View NDC →
6 mg Oral Allergan, Inc. NDA View NDC →
💊Kits
— Oral Allergan, Inc. NDA View NDC →

Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Cariprazine NDCs →

Cariprazine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Cariprazine recalls since July 2021.

✅No Cariprazine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Cariprazine RxCUI 1667655 1 dose form · 6 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 1667659 In current FDA listings
    Clinical drug / strength (SCD) 0.5 MG RxCUI 2729792 0.75 MG RxCUI 2729796 1.5 MG RxCUI 1667660 3 MG RxCUI 1667668 4.5 MG RxCUI 1667672 6 MG RxCUI 1667676

Look up RxCUI 1667655 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Cariprazine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule, Gelatin Coated · Oral 4.5 mg $50.79 per capsule NDC details & price history
Capsule, Gelatin Coated · Oral 0.75 mg $50.84 per capsule NDC details & price history
Capsule, Gelatin Coated · Oral 0.5 mg $50.78 per capsule NDC details & price history
Capsule, Gelatin Coated · Oral 6 mg $50.78 per capsule NDC details & price history
Capsule, Gelatin Coated · Oral 3 mg $50.88 per capsule NDC details & price history
Capsule, Gelatin Coated · Oral 1.5 mg $50.84 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Cariprazine brand names

Cariprazine is sold under one brand name in the FDA directory — Vraylar. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Vraylar

Who makes Cariprazine: manufacturers and labelers

One company lists Cariprazine products with the FDA. By number of product records, the largest are Allergan, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Allergan, Inc. 7

Cariprazine drug class (RxNorm)

Cariprazine belongs to the Atypical Antipsychotic class.

Pharmacologic class Atypical Antipsychotic
Drug family (ATC) Other antipsychotics

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Cariprazine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 18, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cariprazine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Cariprazine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
7
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Allergan, Inc.
Linked label effective
Dec 18, 2025
Composite sections available
26
Linked SPL Set ID
4b5f7c65-aa2d-452a-b3db-bc85c06ff12f
Linked SPL Document ID
db2154b0-f0c7-403c-95fd-794666e79e30
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Allergan, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →