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Cariprazine Side 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
  • 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

For Healthcare Professionals

Applies to cariprazine: oral capsule, oral kit

General

The most frequently reported adverse effects were extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness.[Ref]

Nervous system

Very common (10% or more): Extrapyramidal symptoms (29%), akathisia (21%), headache (18%)
Common (1% to 10%): Dizziness, somnolence, dystonia, Parkinsonism
Rare (less than 0.1%): Ischemic stroke[Ref]

During 6 week schizophrenia placebo controlled trials, 17% of patients reported extrapyramidal symptoms, excluding akathisia and restlessness in the cariprazine 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 cariprazine treated patients 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]

Metabolic

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]

Common (1% to 10%): Decreased appetite, weight gain, increase in blood creatine phosphokinase, hyperglycemia
Infrequent: Hyponatremia, diabetes mellitus
Frequency not reported: Dyslipidemia[Ref]

Cardiovascular

In 3 placebo controlled trials, during a three week period of treating bipolar mania (n=1065), there was no clinically significant difference between cariprazine 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 cariprazine treated patients.[Ref]

Common (1% to 10%): Tachycardia, hypertension
Uncommon (0.1% to 1%): Orthostatic hypotension[Ref]

Dermatologic

Common (1% to 10%): Rash
Infrequent: Hyperhidrosis[Ref]

Gastrointestinal

Very Common (10% or more): Nausea (11%)
Common (1% to 10%): Constipation, vomiting, dyspepsia, abdominal pain, diarrhea, dry mouth, toothache
Infrequent: Gastroesophageal reflux disease, gastritis
Frequency not reported: Dysphagia[Ref]

Psychiatric

Very common (10% or more): Insomnia (13%)
Common (1% to 10%): Restlessness, agitation, anxiety
Rare (less than 0.1%): Completed suicide
Infrequent: Suicide attempts, suicidal ideation[Ref]

Hematologic

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

Hepatic

Transaminase elevations 3 times the upper limit of normal or greater occurred in 1% to 2% of patients in the cariprazine group 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%): Increase in hepatic enzymes
Rare (less than 0.1%): Hepatitis[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Infrequent: Pollakiuria[Ref]

Hypersensitivity

Frequency not reported: Rash, pruritus, urticaria, swollen lips/tongue, face and pharyngeal edema, swelling of the face[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, pain in extremities, stiffness
Rare (less than 0.1%): Rhabdomyolysis[Ref]

Respiratory

Common (1% to 10%): Cough, oropharyngeal pain
Uncommon (0.1% to 1%): Nasopharyngitis[Ref]

Ocular

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

Other

Common (1% to 10%): Fatigue, pyrexia[Ref]

References

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

Some side effects of cariprazine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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