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Vraylar

Last reviewed on RxList: 6/5/2019
Vraylar Side Effects Center

Last reviewed on RxList 6/5/2019

Vraylar (cariprazine) is an atypical antipsychotic indicated for the treatment of schizophrenia, and the acute treatment of manic or mixed episodes associated with bipolar I disorder. Common side effects of Vraylar include:

The starting dose of Vraylar is 1.5 mg once daily. Vraylar may interact with CYP3A4 inducers and inhibitors. Tell your doctor all medications and supplements you use. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Vraylar during pregnancy. Talk to your doctor about the National Pregnancy Registry for Atypical Antipsychotics. Vraylar causes extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. It is unknown if Vraylar passes into breast milk. Consult your doctor before breastfeeding.

Our Vraylar (cariprazine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see BOX WARNING and WARNINGS AND PRECAUTIONS]
  • Suicidal Thoughts and Behaviors [see BOX WARNING and WARNINGS AND PRECAUTIONS]
  • Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [see WARNINGS AND PRECAUTIONS]
  • Neuroleptic Malignant Syndrome [see WARNINGS AND PRECAUTIONS]
  • Tardive Dyskinesia [see WARNINGS AND PRECAUTIONS]
  • Late Occurring Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Metabolic Changes [see WARNINGS AND PRECAUTIONS]
  • Leukopenia, Neutropenia, and Agranulocytosis [see WARNINGS AND PRECAUTIONS]
  • Orthostatic Hypotension and Syncope [see WARNINGS AND PRECAUTIONS]
  • Falls [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Potential for Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS]
  • Body Temperature Dysregulation [see WARNINGS AND PRECAUTIONS]
  • Dysphagia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The information below is derived from an integrated clinical study database for VRAYLAR consisting of 4753 adult patients exposed to one or more doses of VRAYLAR for the treatment of schizophrenia, manic or mixed episodes associated with bipolar I disorder, and bipolar depression in placebo-controlled studies. This experience corresponds with a total experience of 940.3 patient-years. A total of 2568 VRAYLAR-treated patients had at least 6 weeks and 296 VRAYLAR-treated patients had at least 48 weeks of exposure.

Patients With Schizophrenia

The following findings are based on four placebo-controlled, 6-week schizophrenia trials with VRAYLAR doses ranging from 1.5 to 12 mg once daily. The maximum recommended dosage is 6 mg daily.

Adverse Reactions Associated with Discontinuation of Treatment

There was no single adverse reaction leading to discontinuation that occurred at a rate of ≥ 2% in VRAYLAR-treated patients and at least twice the rate of placebo.

Common Adverse Reactions (≥ 5% and at least twice the rate of placebo): extrapyramidal symptoms and akathisia.

Adverse Reactions with an incidence of ≥ 2% and greater than placebo, at any dose are shown in Table 5.

Table 5. Adverse Reactions Occurring in ≥ 2% of VRAYLAR-treated Patients and > Placebo-treated Adult Patients in 6-Week Schizophrenia Trials

System Organ Class / Preferred Term Placebo
(N= 584)
(%)
VRAYLAR*
1.5 -3 mg/day
(N=539
) (%)
4.5 -6 mg/day
(N=575)
(%)
9 -12 mg/day°
(N=203)
(%)
Cardiac Disorders
Tachycardiaa 1 2 2 3
Gastrointestinal Disorders
Abdominal painb 5 3 4 7
Constipation 5 6 7 10
Diarrheac 3 1 4 5
Dry Mouth 2 1 2 3
Dyspepsia 4 4 5 5
Nausea 5 5 7 8
Toothache 4 3 3 6
Vomiting 3 4 5 5
General Disorders/Administration Site Conditions
Fatigued 1 1 3 2
Infections and infestations
Nasopharyngitis 1 1 1 2
Urinary tract infection 1 1 <1 2
Investigations
Blood creatine phosphokinase increased 1 1 2 3
Hepatic enzyme increasede <1 1 1 2
Weight increased 1 3 2 3
Metabolism and nutrition disorders
Decreased appetite 2 1 3 2
Musculoskeletal and Connective Tissue Disorders
Arthralgia 1 2 1 2
Back pain 2 3 3 1
Pain in extremity 3 2 2 4
Nervous System Disorders
Akathisia 4 9 13 14
Extrapyramidal Symptomsf 8 15 19 20
Headacheg 13 9 11 18
Somnolenceh 5 5 8 10
Dizziness 2 3 5 5
Psychiatric Disorders
Psychiatric Disorders 4 3 5 3
Insomniai 11 12 13 11
Restlessness 3 4 6 5
Anxiety 4 6 5 3
Respiratory, thoracic and mediastinal disorders
Cough 2 1 2 4
Skin and subcutaneous disorders
Rash 1 <1 1 2
Vascular Disorders
Hypertensionj 1 2 3 6
Note: Figures rounded to the nearest integer
* Data shown by modal daily dose, defined as most frequently administered dose per patient
aTachycardia terms: heart rate increased, sinus tachycardia, tachycardia
bAbdominal pain terms: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, gastrointestinal pain
cDiarrhea terms: diarrhea, frequent bowel movements
dFatigue terms: asthenia, fatigue
eHepatic enzyme increase terms: alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased
fExtrapyramidal Symptoms terms: bradykinesia, cogwheel rigidity, drooling, dyskinesia, dystonia, extrapyramidal disorder, hypokinesia, masked facies, muscle rigidity, muscle tightness, Musculoskeletal stiffness, oculogyric crisis, oromandibular dystonia, parkinsonism, salivary hypersecretion, tardive dyskinesia, torticollis, tremor, trismus
gHeadache terms: headache, tension headache
hSomnolence terms: hypersomnia, sedation, somnolence
iInsomnia terms: initial insomnia, insomnia, middle insomnia, terminal insomnia
jHypertension terms: blood pressure diastolic increased, blood pressure increased, blood pressure systolic increased, hypertension
° The maximum recommended daily dose is 6 mg. Doses above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

Patients With Bipolar Mania

The following findings are based on three placebo-controlled, 3-week bipolar mania trials with VRAYLAR doses ranging from 3 to 12 mg once daily. The maximum recommended dosage is 6 mg daily.

Adverse Reactions Associated with Discontinuation of Treatment

The adverse reaction leading to discontinuation that occurred at a rate of ≥ 2% in VRAYLAR-treated patients and at least twice the rate of placebo was akathisia (2%). Overall, 12% of the patients who received VRAYLAR discontinued treatment due to an adverse reaction, compared with 7% of placebo-treated patients in these trials.

Common Adverse Reactions (≥ 5% and at least twice the rate of placebo): extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness.

Adverse Reactions with an incidence of ≥ 2% and greater than placebo at any dose are shown in Table 6.

Table 6. Adverse Reactions Occurring in ≥ 2% of VRAYLAR-treated Patients and > Placebo-treated Adult Patients in 3-Week Bipolar Mania Trials

System Organ Class / Preferred Term Placebo
(N= 442)
(%)
VRAYLAR*
3 -6 mg/day
(N=263)
(%)
9 -12 mg/day°
(N=360)
(%)
Cardiac Disorders
Tachycardiaa 1 2 1
Eye Disorders
Vision blurred 1 4 4
Gastrointestinal Disorders
Nausea 7 13 11
Constipation 5 6 11
Vomiting 4 10 8
Dry mouth 2 3 2
Dyspepsia 4 7 9
Abdominal painb 5 6 8
Diarrheac 5 5 6
Toothache 2 4 3
General Disorders/Administration Site Conditions
Fatigued 2 4 5
Pyrexiae 2 1 4
Investigations
Blood creatine phosphokinase increased 2 2 3
Hepatic enzymes increasedf <1 1 3
Weight increased 2 2 3
Metabolism and Nutrition Disorders
Decreased appetite 3 3 4
Musculoskeletal and Connective Tissue Disorders
Pain in extremity 2 4 2
Back pain 1 1 3
Nervous System Disorders
Akathisia 5 20 21
Extrapyramidal Symptomsg 12 26 29
Headacheh 13 14 13
Dizziness 4 7 6
Somnolencei 4 7 8
Psychiatric Disorders
Insomniaj 7 9 8
Restlessness 2 7 7
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain 2 1 3
Vascular Disorders
Hypertensionk 1 5 4
Note: Figures rounded to the nearest integer
*Data shown by modal daily dose, defined as most frequently administered dose per patient
aTachycardia terms: heart rate increased, sinus tachycardia, tachycardia
bAbdominal pain terms: abdominal discomfort, abdominal pain, abdominal pain upper, abdominal tenderness,
cDiarrhea: diarrhea, frequent bowel movements
dFatigue terms: asthenia, fatigue
ePyrexia terms: body temperature increased, pyrexia
fHepatic enzymes increased terms: alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, transaminases increased
gExtrapyramidal Symptoms terms: bradykinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, hypokinesia, muscle rigidity, muscle tightness, musculoskeletal stiffness, oromandibular dystonia, parkinsonism, salivary hypersecretion, tremor
hHeadache terms: headache, tension headache
iSomnolence terms: hypersomnia, sedation, somnolence
jInsomnia terms: initial insomnia, insomnia, middle insomnia
kHypertension terms: blood pressure diastolic increased, blood pressure increased, hypertension
° The maximum recommended daily dose is 6 mg. Doses above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

Patients With Bipolar Depression

The following findings are based on three placebo-controlled, two 6-week and one 8-week bipolar depression trials with VRAYLAR doses of 1.5 mg and 3 mg once daily.

Adverse Reactions Associated with Discontinuation of Treatment

There were no adverse reaction leading to discontinuation that occurred at a rate of ≥ 2% in VRAYLAR-treated patients and at least twice the rate of placebo. Overall, 6% of the patients who received VRAYLAR discontinued treatment due to an adverse reaction, compared with 5% of placebo-treated patients in these trials.

Common Adverse Reactions

(≥ 5% and at least twice the rate of placebo): nausea, akathisia, restlessness, and extrapyramidal symptoms.

Adverse Reactions with an incidence of ≥ 2% and greater than placebo at 1.5 mg or 3 mg doses are shown in Table 7.

Table 7. Adverse Reactions Occurring in ≥ 2% of VRAYLAR-treated Patients and > Placebo-treated Adult Patients in two 6-week trials and one 8-week trial

  Placebo
(N=468)
(%)
VRAYLAR
1.5 mg/day
(N=470)
(%)
3 mg/day
(N=469)
(%)
Restlessness 3 2 7
Akathisia 2 6 10
Extrapyramidal symptomsa 2 4 6
Dizziness 2 4 3
Somnolenceb 4 7 6
Nausea 3 7 7
Increased appetite 1 3 3
Weight increase <1 2 2
Fatiguec 2 4 3
Insomniad 7 7 10
aExtrapyramidal symptoms terms: akinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, hypokinesia, muscle tightness, musculoskeletal stiffness, myoclonus, oculogyric crisis, salivary hypersecretion, tardive dyskinesia, tremor
bSomnolence terms: hypersomnia, sedation, somnolence
cFatigue terms: asthenia, fatigue, malaise
dInsomnia terms: initial insomnia, insomnia, insomnia related to another mental condition, middle insomnia, sleep disorder terminal insomnia

Dystonia

Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. Although these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and higher doses of first-generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Extrapyramidal Symptoms (EPS) And Akathisia

In schizophrenia, bipolar mania, and bipolar depression trials, data were objectively collected using the Simpson Angus Scale (SAS) for treatment-emergent EPS (parkinsonism) (SAS total score ≤ 3 at baseline and > 3 post-baseline) and the Barnes Akathisia Rating Scale (BARS) for treatment-emergent akathisia (BARS total score ≤ 2 at baseline and > 2 post-baseline).

In 6-week schizophrenia trials, the incidence of reported events related to extrapyramidal symptoms (EPS), excluding akathisia and restlessness was 17% for VRAYLAR-treated patients versus 8% for placebo-treated patients. These events led to discontinuation in 0.3% of VRAYLAR-treated patients versus 0.2% of placebo-treated patients. The incidence of akathisia was 11% for VRAYLAR-treated patients versus 4% for placebo-treated patients. These events led to discontinuation in 0.5% of VRAYLAR-treated patients versus 0.2% of placebo-treated patients. The incidence of EPS is shown in Table 8.

Table 8. Incidence of EPS Compared to Placebo in 6-Week Schizophrenia Studies

Adverse Event Term Placebo
(N= 584)
(%)
VRAYLAR*
1.5 -3 mg/day
(N=539)
(%)
4.5 -6 mg/day
(N=575)
(%)
9-12 mg/day°
(N=203)
(%)
All EPS events 14 24 32 33
All EPS events, excluding Akathisia/Restlessness 8 15 19 20
Akathisia 4 9 13 14
Dystonia** <1 2 2 2
Parkinsonism§ 7 13 16 18
Restlessness 3 4 6 5
Musculoskeletal stiffness 1 1 3 1
Note: Figures rounded to the nearest integer
*Data shown by modal daily dose, defined as most frequently administered dose per patient
** Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, trismus, torticollis
§ Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, dyskinesia, extrapyramidal disorder, hypokinesia, masked facies, muscle rigidity, muscle tightness, parkinsonism, tremor, salivary hypersecretion
° The maximum recommended daily dose is 6 mg. Doses above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

In 3-week bipolar mania trials, the incidence of reported events related to extrapyramidal symptoms (EPS), excluding akathisia and restlessness, was 28% for VRAYLAR-treated patients versus 12% for placebo-treated patients. These events led to a discontinuation in 1% of VRAYLAR-treated patients versus 0.2% of placebo-treated patients. The incidence of akathisia was 20% for VRAYLAR-treated patients versus 5% for placebo-treated patients. These events led to discontinuation in 2% of VRAYLAR-treated patients versus 0% of placebo-treated patients. The incidence of EPS is provided in Table 9.

Table 9. Incidence of EPS Compared to Placebo in 3-Week Bipolar Mania Trials

Adverse Event Term Placebo
(N= 442)
(%)
VRAYLAR*
3 -6 mg/day
(N=263)
(%)
9 -12 mg/day°
(N=360)
(%)
All EPS events 18 41 45
All EPS events, excluding Akathisia/Restlessness 12 26 29
Akathisia 5 20 21
Dystonia** 1 5 3
Parkinsonism§ 10 21 26
Restlessness 2 7 7
Musculoskeletal stiffness 1 2 2
Note: Figures rounded to the nearest integer
*Data shown by modal daily dose, defined as most frequently administered dose per patient
** Dystonia includes adverse event terms: dystonia, oromandibular dystonia
§ Parkinsonism includes adverse event terms: bradykinesia, drooling, dyskinesia, extrapyramidal disorder, hypokinesia, muscle rigidity, muscle tightness, parkinsonism, salivary hypersecretion, tremor
° The maximum recommended daily dose is 6 mg. Doses above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

In the two 6-week and one 8-week bipolar depression trials, the incidence of reported events related to EPS, excluding akathisia and restlessness was 4% for VRAYLAR-treated patients versus 2% for placebo-treated patients. These events led to discontinuation in 0.4% of VRAYLAR-treated patients versus 0% of placebo-treated patients. The incidence of akathisia was 8% for VRAYLAR-treated patients versus 2% for placebo-treated patients. These events led to discontinuation in 1.5% of VRAYLAR-treated patients versus 0% of placebo-treated patients. The incidence of EPS is shown in Table 10.

Table 10. Incidence of EPS Compared to Placebo in two 6-Week and one 8-Week Bipolar Depression Trials

Adverse Event Term Placebo
(N=468)
(%)
VRAYLAR*
1.5 mg/day
(N=470)
(%)
3 mg/day
(N=469)
(%)
All EPS events 7 10 19
All EPS events, excluding Akathisia/Restlessness 2 4 6
Akathisia 2 6 10
Dystonia* <1 <1 <1
Parkinsonism§ 2 3 4
Restlessness 3 2 7
Musculoskeletal stiffness <1 <1 1
Tardive Dyskinesia 0 0 <1
Note: Figures rounded to the nearest integer
*Dystonia includes adverse event terms: dystonia, myoclonus, oculogyric crisis
§ Parkinsonism includes adverse event terms: akinesia, drooling, dyskinesia, extrapyramidal disorder, hypokinesia, muscle tightness, salivary hypersecretion, and tremor.

Cataracts

In the long-term uncontrolled schizophrenia (48-week) and bipolar mania (16-week) trials, the incidence of cataracts was 0.1% and 0.2%, respectively. The development of cataracts was observed in nonclinical studies [see Nonclinical Toxicology]. The possibility of lenticular changes or cataracts cannot be excluded at this time.

Vital Signs Changes

There were no clinically meaningful differences between VRAYLAR-treated patients and placebo-treated patients in mean change from baseline to endpoint in supine blood pressure parameters except for an increase in supine diastolic blood pressure in the 9 -12 mg/day VRAYLAR-treated patients with schizophrenia.

Pooled data from 6-week schizophrenia trials are shown in Table 11 and from 3-week bipolar mania trials are shown in Table 12.

Table 11. Mean Change in Blood Pressure at Endpoint in 6-Week Schizophrenia Trials

  Placebo
(N=574)
VRAYLAR*
1.5 -3 mg/day
(N=512)
4.5 -6 mg/day
(N=570)
9-12 mg/day°
(N=203)
Supine Systolic Blood Pressure (mmHg) +0.9 +0.6 +1.3 +2.1
Supine Diastolic Blood Pressure (mmHg) +0.4 +0.2 +1.6 +3.4
Data shown by modal daily dose, defined as most frequently administered dose per patient
° The maximum recommended daily dose is 6 mg. Doses above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

Table 12. Mean Change in Blood Pressure at Endpoint in 3-Week Bipolar Mania Trials

  Placebo
(N=439)
VRAYLAR*
3 -6 mg/day
(N=259)
9 – 12 mg/day°
(N=360)
Supine Systolic Blood Pressure (mmHg) -0.5 +0.8 +1.8
Supine Diastolic Blood Pressure (mmHg) +0.9 +1.5 +1.9
* Data shown by modal daily dose, defined as most frequently administered dose per patient
° The maximum recommended daily dose is 6 mg. Doses above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions.

In the two 6-week and one 8-week bipolar depression trials, there were no clinically meaningful differences between VRAYLAR-treated patients and placebo-treated patients in mean change from baseline to endpoint in supine systolic and diastolic blood pressure.

Pooled data from two 6-week and one 8-week bipolar depression trials are shown in Table 13.

Table 13. Mean Change in Blood Pressure at Endpoint in two 6-Week and one 8-Week Bipolar Depression Trials

  Placebo
(N=468)
VRAYLAR*
1.5 mg/day
(N=572)
3 mg/day
(N=426)
Supine Systolic Blood Pressure (mmHg) -0.2 0.2 -0.1
Supine Diastolic Blood Pressure (mmHg) 0.2 0.1 -0.3

Changes In Laboratory Tests

The proportions of patients with transaminase elevations of ≥3 times the upper limits of the normal reference range in 6-week schizophrenia trials ranged between 1% and 2% for VRAYLAR-treated patients, increasing with dose, and was 1% for placebo-treated patients. The proportions of patients with transaminase elevations of ≥3 times the upper limits of the normal reference range in 3-week bipolar mania trials ranged between 2% and 4% for VRAYLAR-treated patients depending on dose group administered and 2% for placebo-treated patients. The proportions of patients with transaminase elevations of ≥3 times the upper limits of the normal reference range in 6-week and 8-week bipolar depression trials ranged between 0% and 0.5% for VRAYLAR-treated patients depending on dose group administered and 0.4% for placebo-treated patients.

The proportions of patients with elevations of creatine phosphokinase (CPK) greater than 1000 U/L in 6-week schizophrenia trials ranged between 4% and 6% for VRAYLAR-treated patients, increasing with dose, and was 4% for placebo-treated patients. The proportions of patients with elevations of CPK greater than 1000 U/L in 3-week bipolar mania trials was about 4% in VRAYLAR and placebo-treated patients. The proportions of patients with elevations of CPK greater than 1000 U/L in 6-week and 8-week bipolar depression trials ranged between 0.2% and 1% for VRAYLAR-treated patients versus 0.2% for placebo-treated patients.

Other Adverse Reactions Observed During The Pre-Marketing Evaluation Of Vraylar

Adverse reactions listed below were reported by patients treated with VRAYLAR at doses of ≥ 1.5 mg once daily within the premarketing database of 3988 VRAYLAR-treated patients. The reactions listed are those that could be of clinical importance, as well as reactions that are plausibly drug-related on pharmacologic or other grounds. Reactions that appear elsewhere in the VRAYLAR label are not included.

Reactions are further categorized by organ class and listed in order of decreasing frequency, according to the following definition: those occurring in at least 1/100 patients (frequent) [only those not already listed in the tabulated results from placebo-controlled studies appear in this listing]; those occurring in 1/100 to 1/1000 patients (infrequent); and those occurring in fewer than 1/1000 patients (rare).

Gastrointestinal Disorders: Infrequent: gastroesophageal reflux disease, gastritis

Hepatobiliary Disorders: Rare: hepatitis

Metabolism and Nutrition Disorders: Frequent: decreased appetite; Infrequent: hyponatremia

Musculoskeletal and Connective Tissue Disorders: Rare: rhabdomyolysis

Nervous System Disorders: Rare: ischemic stroke

Psychiatric Disorders: Infrequent: suicide attempts, suicide ideation; Rare: completed suicide

Renal and Urinary Disorders: Infrequent: pollakiuria

Skin and Subcutaneous Tissue Disorders: Infrequent: hyperhidrosis

Postmarketing Experience

The following adverse reaction has been identified during post approval use of VRAYLAR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.

Skin and Subcutaneous Tissue Disorders – Stevens-Johnson syndrome

Read the entire FDA prescribing information for Vraylar (Cariprazine Capsules)

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© Vraylar Patient Information is supplied by Cerner Multum, Inc. and Vraylar Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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