Note: This document contains side effect information about cariprazine. Some of the dosage forms listed on this page may not apply to the brand name Vraylar.
Common side effects of Vraylar include: oculogyric crisis, trismus, akathisia, basal ganglia disease, bradykinesia, cogwheel rigidity, constipation, drowsiness, dyskinesia, dystonia, extrapyramidal reaction, hypersomnia, hypertonia, hypokinesia, muscle rigidity, nausea, sedated state, tardive dyskinesia, torticollis, tremor, vomiting, weight gain, and drooling. Other side effects include: asthenia, blurred vision, dizziness, dyspepsia, fatigue, hypertension, increased blood pressure, increased creatine phosphokinase in blood specimen, and restlessness. See below for a comprehensive list of adverse effects.
Applies to cariprazine: oral capsule
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.
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:
Incidence not known
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:
Applies to cariprazine: oral capsule
The most frequently reported adverse effects were extrapyramidal symptoms, akathisia, nausea, vomiting, somnolence, and restlessness.
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
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%.
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
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.
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
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
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
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
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.
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
Common (1% to 10%): Fatigue, pyrexia
Frequency not reported: Asthenia, body temperature dysregulation, body temperature increased, falls, late-occurring adverse reactions
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
In long term uncontrolled schizophrenia (48-week) and bipolar mania (16-week) trials, cataracts occurred in 0.1% and 0.2% of participants respectively.
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Dysuria, erectile dysfunction, pollakiuria
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
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
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.
Uncommon (0.1% to 1%): Anemia, eosinophilia
Rare (0.01% to 0.1%): Neutropenia
Frequency not reported: Agranulocytosis, leukopenia
Uncommon (0.1% to 1%): Blood thyroid stimulating hormone decreased
Rare (0.01% to 0.1%): Hypothyroidism
Rare (0.01% to 0.1%): Hypersensitivity
Frequency not reported: Angioedema, hypersensitivity reaction
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Vraylar