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Vraylar (cariprazine) is an antipsychotic medication that affects chemicals in the brain.
Vraylar is used to treat schizophrenia in adults.
Vraylar is also used to treat manic or mixed episodes in adults with bipolar disorder type I.
Vraylar is not approved for use in older adults with dementia-related conditions.
Vraylar may disrupt the body’s ability to reduce core body temperature. Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may cause an increase body temperature. Use this medicine with caution in these circumstances.
You should not use Vraylar if you are allergic to cariprazine.
Vraylar is not approved for use by anyone younger than 18 years old.
Cariprazine may increase the risk of death in older adults with dementia-related conditions and is not approved for this use.
To make sure Vraylar is safe for you, tell your doctor if you have:
heart disease, high blood pressure;
a stroke or blood clot;
high cholesterol or triglycerides (a type of fat in the blood);
liver or kidney disease;
diabetes; or
if you are dehydrated.
Taking antipsychotic medicine in the last 3 months of pregnancy may cause withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking Vraylar without your doctor's advice.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cariprazine on the baby.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
Take Vraylar exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
High doses or long-term use of Vraylar can cause a serious movement disorder that may not be reversible. The longer you use this medicine, the more likely you are to develop this disorder, especially if you are an older adult. Symptoms of this disorder include tremors or other uncontrollable muscle movements.
You may take Vraylar with or without food.
It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.
Tell your doctor if you have any changes in weight while taking this medicine.
Your blood pressure and heart rate will need to be checked often. You may also need frequent blood tests.
Store this medicine in its original packaging at room temperature, away from moisture, heat, and light.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid drinking alcohol. Dangerous side effects could occur.
Avoid driving or hazardous activity until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
While you are taking Vraylar, you may be more sensitive to temperature extremes such as very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.
Get emergency medical help if you have signs of an allergic reaction to Vraylar: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
sudden numbness or weakness (especially on one side of the body);
problems with vision or speech,
a light-headed feeling, like you might pass out;
severe distress or agitation;
a seizure;
uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
trouble swallowing, or accidentally inhaling food or drink;
low white blood cell counts - fever, chills, sore throat, mouth sores, skin sores, sore throat, cough, trouble breathing, feeling light-headed;
high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or
severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.
Vraylar can have long lasting effects on your body. Some side effects could occur for several weeks after you stop using this medicine. You may also have new side effects whenever your dose is changed.
Common Vraylar side effects may include:
involuntary muscle movements;
upset stomach, vomiting;
drowsiness; or
feeling restless.
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.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Taking Vraylar with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Many drugs can interact with cariprazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Vraylar only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Vraylar (www.drugs.com/vraylar.html).
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:
More common
Less common
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:
More common
Less common
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 USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Vraylar (www.drugs.com/vraylar.html).
July 13, 2020
July 13, 2020
July 13, 2020
July 13, 2020
July 13, 2020
June 26, 2020
