Cariprazine Side Effects
Applies to cariprazine: oral capsule.
Important warnings
This medicine can cause some serious health issues
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.
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 cariprazine
Along with its needed effects, cariprazine 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 side effects
- 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 side effects
- bladder pain
- bloody or cloudy urine
- confusion
- decreased urine output
- difficult, burning, or painful urination
- dizziness
- 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
- nausea
- seizures
- sore throat
- stuffy or runny nose
- swelling of the face, ankles, or hands
- thoughts or attempts at killing oneself
- unusual tiredness or weakness
- vomiting
Rare side effects
- 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
- indigestion
- light-colored stools
- muscle spasms or stiffness
- slow speech
- stomach upset
- tenderness in the stomach area
- upper right abdominal or stomach pain
- yellow eyes and skin
Incidence not known
- blistering, peeling, or loosening of the skin
- confusion
- cough
- diarrhea
- drooling
- high fever
- increased sweating
- itching
- 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
Other side effects of cariprazine
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 side effects
- decreased appetite
- difficulty having a bowel movement
- sleepiness or unusual drowsiness
- stomach pain
- trouble sleeping
Less common side effects
- anxiety
- back pain
- belching
- difficulty with moving
- dry mouth
- heartburn
- indigestion
- irritability
- pain in the arms or legs
- rash
- shaking
- weight gain
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:
Rexulti
Rexulti (brexpiprazole) is a prescription antipsychotic medication used in the treatment of major ...
Lexapro
Lexapro is used to treat anxiety and major depressive disorder. Learn about side effects ...
Caplyta
Caplyta is used to treat schizophrenia or depression associated with bipolar disorder. It is taken ...
Abilify
Abilify is an antipsychotic medicine used to treat the symptoms of schizophrenia and bipolar ...
Olanzapine
Olanzapine (brand name Zyprexa) is an atypical antipsychotic that may be used to treat adults and ...
Aripiprazole
Easy-to-read patient leaflet for aripiprazole. Includes indications, proper use, special ...
Quetiapine
Quetiapine is an atypical antipsychotic used to treat schizophrenia, bipolar disorder, and major ...
Lamotrigine
Lamotrigine systemic is used for anxiety, bipolar disorder, borderline personality disorder ...
Escitalopram
Escitalopram is an SSRI antidepressant used to treat major depressive disorder in adults and teens ...
Fluoxetine
Fluoxetine is used to treat depression or obsessive-compulsive disorder in adults. Learn about side ...
References
1. (2015) "Product Information. Vraylar (cariprazine)." Actavis Pharma, Inc.
Frequently asked questions
- How long does it take for Vraylar (cariprazine) to work?
- Do Vraylar (cariprazine) side effects go away?
- Does Vraylar (cariprazine) cause weight gain?
- Does caffeine affect Vraylar (cariprazine)?
- Does Vraylar (cariprazine) make you sleepy?
- Is Vraylar (cariprazine) a controlled substance?
More about cariprazine
- Check interactions
- Compare alternatives
- Reviews (587)
- Dosage information
- During pregnancy
- Drug class: atypical antipsychotics
- Breastfeeding
- En español
Patient resources
Other brands
Professional resources
Other brands
Related treatment guides
Further information
Cariprazine 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.