Vraylar Side Effects

Generic name: cariprazine

Medically reviewed by Philip Thornton, DipPharm. Last updated on Oct 8, 2024.

Note: This document provides detailed information about Vraylar Side Effects associated with cariprazine. Some dosage forms listed on this page may not apply specifically to the brand name Vraylar.

Applies to cariprazine: oral capsule.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. This medicine may cause unwanted effects (eg, muscle problems, withdrawal symptoms) to newborn babies if used during the later part of pregnancy. Tell your doctor right away if you think you have become pregnant.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Check with your doctor right away if you have convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

For diabetic patients: This medicine may cause high blood sugar levels (hyperglycemia). Check with your doctor right away if you have increased thirst or increased urination. Diabetic patients should check their blood and urine sugar levels more often than normal while taking this medicine.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

Cariprazine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may cause dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.

Some side effects may not happen right away and can start a few weeks after you start using this medicine or if your dose increases. Do not change your dose or stop using your medicine without first checking with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

For healthcare professionals

Applies to cariprazine: oral capsule.

General adverse events

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]

See also:

Frequently asked questions

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• How long does Vraylar stay in your system?

Further information

Vraylar side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer