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Cariprazine Side Effects

In Summary

Commonly reported side effects of cariprazine include: oculogyric crisis, trismus, akathisia, basal ganglia disease, bradykinesia, cogwheel rigidity, constipation, drowsiness, dyskinesia, dystonia, extrapyramidal reaction, hypersomnia, hypertonia, hypokinesia, muscle rigidity, nausea, sedation, 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, and restlessness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to cariprazine: oral capsule

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
  • 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

For Healthcare Professionals

Applies to cariprazine: oral capsule, oral kit

General

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%)
Common (1% to 10%): Dizziness, dystonia, somnolence
Rare (less than 0.1%): Ischemic stroke
Frequency not reported: Bradykinesia, cerebrovascular adverse reactions, cognitive impairment, cogwheel rigidity, dyskinesia, extrapyramidal disorder, hypersomnia, masked facies, motor impairment, neuroleptic malignant syndrome, sedation, seizures, stroke, syncope, tardive dyskinesia, 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
Frequency not reported: Abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, dysphagia, drooling, frequent bowel movements, gastrointestinal pain, lip swelling, oromandibular dystonia, salivary hypersecretion, swallowing difficulty, tongue protrusion, tongue swelling[Ref]

Metabolic

Very Common (10% or more): Weight gain (up to 17%)
Common (1% to 10%): Decreased appetite, hyperglycemia
Uncommon (0.1% to 1%): Hyponatremia
Frequency not reported: Diabetes mellitus, dyslipidemia, 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, suicidal ideation
Uncommon (0.1% to 1%): Suicide attempts
Rare (less than 0.1%): Completed suicide
Frequency not reported: Increased mortality in elderly patients with dementia-related psychosis, initial insomnia, middle insomnia, 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: Muscle rigidity, muscle tightness, neck muscle spasm, torticollis, trismus[Ref]

Respiratory

Common (1% to 10%): Cough, nasopharyngitis, oropharyngeal pain
Frequency not reported: Difficulty breathing, pharyngeal edema, throat tightness[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia, hypertension
Frequency not reported: Blood pressure diastolic increased, blood pressure increased, blood pressure systolic increased, heart rate increased, orthostatic hypotension, sinus tachycardia[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 the 9 to 12 mg orally once a day patients.[Ref]

Other

Common (1% to 10%): Fatigue, pyrexia
Frequency not reported: Asthenia, body temperature dysregulation, body temperature increased, falls, late-occurring adverse reactions[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Hyperhidrosis
Frequency not reported: Face edema, face swelling, pruritus, urticaria
Postmarketing reports: Stevens-Johnson syndrome[Ref]

Ocular

Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Cataracts
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%): Pollakiuria[Ref]

Hepatic

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]

Common (1% to 10%): Increase in hepatic enzymes
Rare (less than 0.1%): Hepatitis
Frequency not reported: ALT increased, AST increased, transaminases increased[Ref]

Hematologic

Frequency not reported: Leukopenia, neutropenia, agranulocytosis[Ref]

Hypersensitivity

Frequency not reported: Angioedema, hypersensitivity reaction[Ref]

References

1. "Product Information. Vraylar (cariprazine)." Actavis Pharma, Inc., Parsippany, NJ.

Further information

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.

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