Vraylar

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

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

• Blurred vision
• chills
• dizziness
• drooling
• fever
• headache
• 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
• nervousness
• pounding in the ears
• restlessness
• 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

Less common

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• fast, pounding, or irregular heartbeat or pulse
• frequent urge to urinate
• lower back or side pain
• muscle aches
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

Incidence not known

• Confusion
• convulsions
• double vision
• drooling
• high fever
• increased sweating
• lip smacking or puckering
• muscle trembling, jerking, or stiffness
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• severe muscle stiffness
• uncontrolled chewing movements
• unusually pale skin

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

• Abdominal or stomach pain
• diarrhea
• difficulty having a bowel movement (stool)
• nausea
• sleepiness or unusual drowsiness
• trouble sleeping

Less common

• Acid or sour stomach
• anxiety
• back pain
• belching
• cough
• decreased appetite
• difficulty with moving
• dry mouth
• heartburn
• indigestion
• irritability
• muscle pain or stiffness
• pain in the arms, joints, or legs
• rash
• shaking
• stomach discomfort or upset
• weight gain

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