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Rexulti Side Effects

Generic Name: brexpiprazole

Note: This document contains side effect information about brexpiprazole. Some of the dosage forms listed on this page may not apply to the brand name Rexulti.

In Summary

More frequent side effects include: anxiety, dizziness, drowsiness, dyspepsia, fatigue, increased creatine phosphokinase, nasopharyngitis, tremor, weight gain, hypersomnia, and sedation. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to brexpiprazole: oral tablet

Along with its needed effects, brexpiprazole (the active ingredient contained in Rexulti) 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 brexpiprazole:

Rare

  • Chills
  • cold sweats
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • fainting

Incidence not known

  • Black, tarry stools
  • changes in behavior
  • chest pain
  • cough
  • difficulty breathing
  • fast heartbeat
  • fever with or without chills
  • general feeling of tiredness or weakness
  • high fever
  • hoarseness
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • increased sweating
  • lip smacking or puckering
  • loss of bladder control
  • lower back or side pain
  • painful or difficult urination
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • seizures
  • severe muscle stiffness
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sticking out of the tongue
  • swollen glands
  • thoughts of killing oneself
  • trouble breathing, speaking, or swallowing
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual bleeding or bruising
  • unusual facial expressions
  • unusual tiredness or weakness
  • unusually pale skin

Some side effects of brexpiprazole 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

Less common

  • Bloated or full feeling
  • bloody or cloudy urine
  • blurred vision
  • diarrhea
  • difficulty having a bowel movement
  • difficulty with moving
  • dizziness
  • dry mouth
  • excess air or gas in the stomach or bowels
  • fear or nervousness
  • frequent urge to urinate
  • increased appetite
  • increased sweating
  • joint pain
  • muscle ache, cramp, pain, or stiffness
  • passing gas
  • shakiness in the legs, arms, hands, or feet
  • swollen joints
  • trouble sleeping

For Healthcare Professionals

Applies to brexpiprazole: oral tablet

General

The most commonly reported side effects included akathisia, headache, and weight gain.[Ref]

Metabolic

Very common (10% or more): At least 7% increase in body weight (up to 30%)
Common (1% to 10%): At least 7% decrease in body weight, decreased appetite, increased appetite, increased fasting triglycerides, weight increased
Frequency not reported: High density lipoprotein (HDL) changes, low density lipoprotein (LDL) changes, metabolic changes[Ref]

In 6-week fixed-dose trials in patients with major depressive disorder (MDD) receiving this drug plus an antidepressant and in patients with schizophrenia receiving this drug, the proportion of patients with shifts in fasting blood glucose (FBG) from normal or borderline, to high were similar compared with placebo-treated patients. In long-term, open-label studies, 5% (MDD) and 8% (schizophrenia) of patients with normal baseline FBGs experienced a shift to high, while 25% (MDD) and 17% (schizophrenia) of patients with baseline borderline FBGs experienced a shift to high.

In 6-week fixed-dose trials in patients with major depressive disorder (MDD) receiving this drug plus an antidepressant and in patients with schizophrenia receiving this drug, the proportion of patients with changes in fasting total cholesterol, LDL cholesterol, and HDL cholesterol were similar compared with placebo-treated patients. For patients with MDD, changes in fasting triglycerides from normal to high were reported in 5%, 13%, and 9% of patients receiving this drug at 1 mg/day, 2 mg/day, and 3 mg/day, respectively, compared with 6% of placebo-treated patients; for patients with schizophrenia, the change was 10%, 8%, and 10%, in patients receiving 1 mg/day, 2 mg/day, and 4 mg/day, respectively, compared with 6% in placebo-treated patients.

In long-term open-label depression studies, 4% of patients discontinued this drug due to weight gain. Mean change from baseline weight was 2.9 kg at week 26 and 3.1 kg at week 52. A 7% or greater increase in body weight was observed in 30% of patients and 4% demonstrated a 7% or greater decrease in body weight. In long-term open-label schizophrenia studies, 0.6% of patients discontinued this drug due to weight gain. Mean change from baseline weight was 1.3 kg at week 26 and 2 kg at week 52. A 7% or greater increase in body weight was observed in 20% of patients and 10% demonstrated a 7% or greater decrease in body weight.[Ref]

Nervous system

In clinical trials in patients with major depressive disorder, the incidence of EPS-related adverse reactions, excluding akathisia, was 6% (3% in placebo patients). Akathisia occurred in 9% of patients (2% in placebo patients). The incidence of akathisia was dose-related. In clinical trials in patients with schizophrenia, the incidence of EPS-related adverse reactions, excluding akathisia, was 5% (4% in placebo patients). Akathisia occurred in 6% of patients (5% in placebo patients).[Ref]

Very common (10% or more): Akathisia (up to 14%)
Common (1% to 10%): Dizziness, extrapyramidal symptoms (EPS)/syndrome-like adverse reactions, headache, sedation, somnolence, tremor
Uncommon (0.1% to 1%): Syncope
Frequency not reported: Cerebrovascular adverse reactions, cognitive impairment, dyskinesia, dystonia, motor impairment, neck muscle spasm, neuroleptic malignant syndrome, parkinsonism, psychomotor activity, seizure, stroke, tardive dyskinesia[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, blood creatine phosphokinase increased, extremity pain, muscle spasms, musculoskeletal pain
Frequency not reported: Musculoskeletal stiffness, myalgia[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea, dyspepsia, toothache
Frequency not reported: Abdominal distension, abdominal pain, dental caries, dry mouth, dysphagia, flatulence, gastroesophageal reflux disease, nausea, salivary hypersecretion, swallowing difficulty, tongue protrusion[Ref]

Psychiatric

Common (1% to 10%): Anxiety, restlessness
Frequency not reported: Abnormal dreams, bruxism, insomnia, suicidal behaviors/thoughts (adolescents and young adults)
Postmarketing reports: Gambling, impulse control disorders[Ref]

The incidence of restlessness was dose-related in patients with major depressive disorder receiving this drug in combination with an antidepressant.[Ref]

Other

Common (1% to 10%): Fatigue, increased mortality in elderly patients with dementia-related psychosis
Frequency not reported: Asthenia, body temperature dysregulation, falls[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Orthostatic hypotension
Frequency not reported: Atrioventricular block first degree, flushing, hypertension, hypotension, palpitations, sinus bradycardia[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis
Frequency not reported: Difficulty breathing, throat tightness, upper respiratory tract infection[Ref]

Dermatologic

Common (1% to 10%): Pruritus
Frequency not reported: Hyperhidrosis, rash[Ref]

Endocrine

Common (1% to 10%): Blood cortisol decreased
Frequency not reported: Blood prolactin increased/hyperprolactinemia[Ref]

Hematologic

Frequency not reported: Agranulocytosis, leukopenia, neutropenia[Ref]

Ocular

Frequency not reported: Blepharospasm, blurred vision[Ref]

Hepatic

Frequency not reported: Hepatic enzymes increased[Ref]

Genitourinary

Frequency not reported: Urinary tract infection[Ref]

References

1. "Product Information. Rexulti (brexpiprazole)." Otsuka American Pharmaceuticals Inc, Rockville, MD.

2. Cerner Multum, Inc. "Australian Product Information." O 0

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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