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Vraylar Side Effects

Generic name: cariprazine

Medically reviewed by Philip Thornton, DipPharm. Last updated on Oct 9, 2023.

Note: This document contains side effect information about cariprazine. Some dosage forms listed on this page may not apply to the brand name Vraylar.

Applies to cariprazine: oral capsule.

Warning

Oral route (Capsule)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Cariprazine is not approved for the treatment of patients with dementia-related psychosis. 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. The safety and effectiveness of cariprazine have not been established in pediatric patients.

Serious side effects of Vraylar

Along with its needed effects, cariprazine (the active ingredient contained in Vraylar) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cariprazine:

More common

Less common

Rare

Incidence not known

Other side effects of Vraylar

Some side effects of cariprazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

For Healthcare Professionals

Applies to cariprazine: oral capsule.

General

The most frequently reported adverse effects were extrapyramidal symptoms, akathisia, nausea, vomiting, somnolence, and restlessness.[Ref]

Nervous system

Very common (10% or more): Extrapyramidal symptoms (up to 45%), parkinsonism (up to 26%), akathisia (up to 21%), headache (up to 18%), somnolence (up to 10%)

Common (1% to 10%): Dizziness, dystonia, other abnormal movement disorders, other extrapyramidal diseases, sedation

Uncommon (0.1% to 1%): Dysesthesia, dyskinesia, lethargy, tardive dyskinesia, vertigo

Rare (less than 0.1%): Amnesia, aphasia, convulsion, ischemic stroke, seizures

Frequency not reported: Akinesia, balance disorder, bradykinesia, cerebrovascular adverse reactions, choreoathetosis, circadian rhythm sleep disorder, cognitive impairment, cogwheel rigidity, drooling, dysarthria, extrapyramidal disorder, gait deviation, gait disturbance, glabellar reflex abnormal, grimacing, hypersomnia, hypokinesia, hyporeflexia, masked facies, motor impairment, movement disorder, neuroleptic malignant syndrome, oromandibular dystonia, psychomotor hyperactivity, restless legs syndrome, stroke, syncope, tension headache, tremor[Ref]

During 6-week schizophrenia placebo-controlled trials, 17% of patients reported extrapyramidal symptoms, excluding akathisia and restlessness in the treatment group. This led to study discontinuation in 0.3% of patients. Akathisia occurred in 11% of patients, leading to study discontinuation of 0.5%.

In 3-week bipolar mania placebo-controlled trials, 28% of patients given this drug experienced extrapyramidal symptoms, excluding akathisia and restlessness. This led to study discontinuation in 1% of patients. Akathisia occurred in 20% of patients, leading to study discontinuation of 2%.[Ref]

Gastrointestinal

Very Common (10% or more): Nausea (up to 13%), constipation (up to 11%), vomiting (up to 10%)

Common (1% to 10%): Abdominal pain, diarrhea, dry mouth, dyspepsia, toothache

Uncommon (0.1% to 1%): Gastritis, gastroesophageal reflux disease

Rare (0.01% to 0.1%): Dysphagia

Frequency not reported: Abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, frequent bowel movements, gastrointestinal pain, lip swelling, salivary hypersecretion, swallowing difficulty, tongue movement disturbance, tongue protrusion, tongue swelling[Ref]

Metabolic

Very Common (10% or more): Weight gain (up to 17%)

Common (1% to 10%): Decreased appetite, dyslipidemia, hyperglycemia, increased appetite

Uncommon (0.1% to 1%): Blood glucose abnormal, blood sodium abnormal, diabetes mellitus, hyponatremia, thirst

Frequency not reported: Metabolic changes[Ref]

Hyperglycemia/Diabetes Mellitus: In long-term, open label studies in patients with schizophrenia or bipolar disorder, 4% of patients with normal baseline hemoglobin A1c developed elevated levels (HbA1c 6.5% or higher). In short-term trials, the number of patients with shifts from normal fasting glucose (less than 100 mg/dL) to high (greater than 126 mg/dL) and borderline (100 to less than 126 mg/dL) levels were similar to placebo-treated patients.

Dyslipidemia: In the 3-week placebo controlled bipolar mania and 6-week placebo controlled schizophrenia trials, the shifts in fasting total cholesterol, LDL, HDL, and triglycerides were similar in treatment and placebo groups.

Weight gain: In the 6-week placebo controlled trial of patients with schizophrenia, a 7% weight increase or greater was observed in 8% of the patients receiving 1.5 mg to 3 mg of drug daily (n=512), 8% of patients receiving 4.5 mg to 6 mg daily (n=570), and 17% in the 9 mg to 12 mg once daily group (n=203). During a long term, uncontrolled trial in patients with schizophrenia, the mean change from baseline weight at 48 weeks was 2.5 kg.[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 13%)

Common (1% to 10%): Agitation, anxiety, restlessness, sleep disorders

Uncommon (0.1% to 1%): Delirium, depression, libido decreased/increased, suicidal behavior, suicidal ideation, suicide attempts

Rare (less than 0.1%): Completed suicide

Frequency not reported: Abnormal dreams, bradyphrenia, bruxism, dyssomnia, increased mortality in elderly patients with dementia-related psychosis, initial insomnia, middle insomnia, neonatal drug withdrawal syndrome, nightmare, somnambulism, terminal insomnia[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, blood creatine phosphokinase increased, musculoskeletal stiffness, pain in extremities

Rare (less than 0.1%): Rhabdomyolysis

Frequency not reported: Joint stiffness, muscle rigidity, muscle tightness, neck muscle spasm, nuchal rigidity, torticollis, trismus[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, tachyarrhythmia, tachycardia

Uncommon (0.1% to 1%): Bradyarrhythmia, cardiac conduction disorders, electrocardiogram QT prolonged, electrocardiogram T wave abnormal, hypotension

Frequency not reported: Blood pressure diastolic increased, blood pressure increased, blood pressure systolic increased, deep vein thrombosis, heart rate increased, orthostatic hypotension, sinus tachycardia, venous thromboembolism[Ref]

In 3 placebo-controlled trials, during a three-week period of treating bipolar mania (n=1065), there was no clinically significant difference between this drug and placebo-treated patients regarding changes from baseline to endpoint supine blood pressure parameters. There was, however, an increase in supine diastolic blood pressure in patients given 9 to 12 mg orally once a day.[Ref]

Respiratory

Common (1% to 10%): Cough, nasopharyngitis, oropharyngeal pain

Uncommon (0.1% to 1%): Hiccups

Frequency not reported: Difficulty breathing, pharyngeal edema, pulmonary embolism, throat tightness[Ref]

Other

Common (1% to 10%): Fatigue, pyrexia

Frequency not reported: Asthenia, body temperature dysregulation, body temperature increased, falls, late-occurring adverse reactions[Ref]

Ocular

Common (1% to 10%): Blurred vision

Uncommon (0.1% to 1%): Accommodation disorder, cataracts, eye irritation, intraocular pressure increased, visual acuity reduced

Rare (0.01% to 0.1%): Photophobia

Frequency not reported: Blepharospasm, oculogyric crisis[Ref]

In long term uncontrolled schizophrenia (48-week) and bipolar mania (16-week) trials, cataracts occurred in 0.1% and 0.2% of participants respectively.[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Dysuria, erectile dysfunction, pollakiuria[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Hyperhidrosis, pruritus

Frequency not reported: Face edema, face swelling, urticaria

Postmarketing reports: Stevens-Johnson syndrome[Ref]

Hepatic

Common (1% to 10%): Increase in hepatic enzymes

Uncommon (0.1% to 1%): Blood bilirubin increased

Rare (less than 0.1%): Hepatitis

Frequency not reported: ALT increased, AST increased, toxic hepatitis, transaminases increased[Ref]

Transaminase elevations 3 times the upper limit of normal or greater occurred in 1% to 2% of patients in the group treated with this drug during 6-week schizophrenia trials; the incidence increased with dose. Elevations occurred in 2% to 4% of patients during 3-week bipolar mania trials.[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, eosinophilia

Rare (0.01% to 0.1%): Neutropenia

Frequency not reported: Agranulocytosis, leukopenia[Ref]

Endocrine

Uncommon (0.1% to 1%): Blood thyroid stimulating hormone decreased

Rare (0.01% to 0.1%): Hypothyroidism[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity

Frequency not reported: Angioedema, hypersensitivity reaction[Ref]

Frequently asked questions

References

1. Product Information. Vraylar (cariprazine). Actavis Pharma, Inc. 2015.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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