Vraylar Side Effects
Generic name: cariprazine
Medically reviewed by Drugs.com. Last updated on Aug 6, 2021.
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.
For the Consumer
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. 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.
Side effects requiring immediate medical attention
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:
- Blurred vision
- inability to move the eyes
- inability to sit still
- increased blinking or spasms of the eyelid
- loss of balance control
- muscle trembling, jerking, or stiffness
- need to keep moving
- pounding in the ears
- shuffling walk
- slow or fast heartbeat
- sticking out of the tongue
- stiffness of the limbs
- trouble with breathing, speaking, or swallowing
- twisting movements of the body
- uncontrolled movements, especially of the face, neck, arms, or legs
- unusual facial expressions
- Bladder pain
- bloody or cloudy urine
- decreased urine output
- difficult, burning, or painful urination
- fast, pounding, or irregular heartbeat or pulse
- frequent urge to urinate
- increased thirst
- loss of consciousness
- lower back or side pain
- muscle aches, pain, or cramps
- sore throat
- stuffy or runny nose
- swelling of the face, ankles, or hands
- thoughts or attempts at killing oneself
- unusual tiredness or weakness
- Burning feeling in the chest or stomach
- dark urine
- difficulty in speaking
- double vision
- general tiredness and weakness
- inability to move the arms, legs, or facial muscles
- inability to speak
- light-colored stools
- muscle spasms or stiffness
- slow speech
- stomach upset
- tenderness in the stomach area
- upper right abdominal pain
- yellow eyes and skin
Incidence not known
- Blistering, peeling, or loosening of the skin
- high fever
- increased sweating
- joint pain
- lip smacking or puckering
- muscle trembling, jerking, or stiffness
- puffing of the cheeks
- rapid or worm-like movements of the tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- severe muscle stiffness
- sores, ulcers, or white spots in the mouth or on the lips
- uncontrolled chewing movements
- unusually pale skin
Side effects not requiring immediate medical attention
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:
- Decreased appetite
- difficulty having a bowel movement
- sleepiness or unusual drowsiness
- stomach pain
- trouble sleeping
- back pain
- difficulty with moving
- dry mouth
- pain in the arms or legs
- weight gain
For Healthcare Professionals
Applies to cariprazine: oral capsule
The most frequently reported adverse effects were extrapyramidal symptoms, akathisia, nausea, vomiting, somnolence, and restlessness.[Ref]
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
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]
Very Common (10% or more): Nausea (up to 13%), constipation (up to 11%), vomiting (up to 10%)
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]
Very Common (10% or more): Weight gain (up to 17%)
Common (1% to 10%): Decreased appetite, dyslipidemia, hyperglycemia, increased appetite
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]
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]
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: 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]
Common (1% to 10%): Cough, nasopharyngitis, oropharyngeal pain
Uncommon (0.1% to 1%): Hiccups
Common (1% to 10%): Fatigue, pyrexia
Frequency not reported: Asthenia, body temperature dysregulation, body temperature increased, falls, late-occurring adverse reactions[Ref]
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]
Common (1% to 10%): Urinary tract infection
Common (1% to 10%): Rash
Frequency not reported: Face edema, face swelling, urticaria
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]
Uncommon (0.1% to 1%): Anemia, eosinophilia
Rare (0.01% to 0.1%): Neutropenia
Uncommon (0.1% to 1%): Blood thyroid stimulating hormone decreased
Rare (0.01% to 0.1%): Hypothyroidism[Ref]
Rare (0.01% to 0.1%): Hypersensitivity
Frequently asked questions
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- Is Vraylar (cariprazine) a controlled substance?
- Does Vraylar make you sleepy?
More about Vraylar (cariprazine)
- During Pregnancy or Breastfeeding
- Dosage Information
- Patient Tips
- Drug Images
- Drug Interactions
- Compare Alternatives
- Support Group
- Pricing & Coupons
- En Español
- 339 Reviews
- Drug class: atypical antipsychotics
- FDA Approval History
Related treatment guides
1. "Product Information. Vraylar (cariprazine)." Actavis Pharma, Inc., Parsippany, NJ.
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.