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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.
More frequent side effects include: anxiety, dizziness, drowsiness, dyspepsia, fatigue, increased creatine phosphokinase in blood specimen, nasopharyngitis, tremor, weight gain, hypersomnia, and sedated state. See below for a comprehensive list of adverse effects.
Applies to brexpiprazole: oral tablet
Oral route (Tablet)
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Brexpiprazole is not approved for the treatment of patients with dementia-related psychosis. Increased risk of suicidal thinking and behavior was found in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors.
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:
Incidence not known
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:
Applies to brexpiprazole: oral tablet
The most commonly reported side effects included akathisia, headache, and weight gain.
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
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.
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).
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
Common (1% to 10%): Back pain, blood creatine phosphokinase increased, extremity pain, muscle spasms, musculoskeletal pain
Frequency not reported: Musculoskeletal stiffness, myalgia
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
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
The incidence of restlessness was dose-related in patients with major depressive disorder receiving this drug in combination with an antidepressant.
Common (1% to 10%): Fatigue, increased mortality in elderly patients with dementia-related psychosis
Frequency not reported: Asthenia, body temperature dysregulation, falls
Uncommon (0.1% to 1%): Orthostatic hypotension
Frequency not reported: Atrioventricular block first degree, flushing, hypertension, hypotension, palpitations, sinus bradycardia
Common (1% to 10%): Nasopharyngitis
Frequency not reported: Difficulty breathing, throat tightness, upper respiratory tract infection
Common (1% to 10%): Pruritus
Frequency not reported: Hyperhidrosis, rash
Common (1% to 10%): Blood cortisol decreased
Frequency not reported: Blood prolactin increased/hyperprolactinemia
Frequency not reported: Agranulocytosis, leukopenia, neutropenia
Frequency not reported: Blepharospasm, blurred vision
Frequency not reported: Hepatic enzymes increased
Frequency not reported: Urinary tract infection