Rexulti Side Effects

Generic name: brexpiprazole

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 10, 2024.

Note: This document provides detailed information about Rexulti Side Effects associated with brexpiprazole. Some dosage forms listed on this page may not apply specifically to the brand name Rexulti.

Applies to brexpiprazole: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Warning: Increased Mortality in Elderly Patients with Dementia-Related Psychosis and Suicidal Thoughts and Behaviors. Increased Mortality in Elderly Patients with Dementia-Related Psychosis. 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 without agitation associated with dementia due to Alzheimer’s disease.Suicidal Thoughts and Behaviors. Antidepressants increased the risk of suicidal thoughts and behaviors in patients aged 24 years and younger in short-term studies.

Monitor closely for clinical worsening and for emergence of suicidal thoughts and behaviors.

The safety and effectiveness of brexpiprazole have not been established in pediatric patients with major depressive disorder.

Common side effects of Rexulti

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 side effects

• belching
• headache
• heartburn
• inability to sit still
• indigestion
• muscle aches
• need to keep moving
• restlessness
• sleepiness or unusual drowsiness
• stomach discomfort, upset, or pain
• stuffy or runny nose
• weight gain

Less common side effects

• 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

Serious side effects of Rexulti

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 side effects

• 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

For healthcare professionals

Applies to brexpiprazole: oral tablet.

General adverse events

The most commonly reported side effects included akathisia, increased triglycerides, and increased body weight.^[Ref]

Nervous system

• Very common (10% or more): Akathisia (up to 14%)
• Common (1% to 10%): Dizziness, dyskinesia, extrapyramidal symptoms, headache, psychomotor hyperactivity, sedation, somnolence, tremor
• Frequency not reported: Cerebrovascular adverse reactions, cognitive impairment, dystonia, motor impairment, parkinsonism, seizures, stroke, syncope, tardive dyskinesia, tongue protrusion
• Postmarketing reports: Neuroleptic malignant syndrome^[Ref]

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]

Metabolic

• Very common (10% or more): Weight gain (up to 10.5%)
• Common (1% to 10%): Decreased appetite, increased appetite, increased fasting triglycerides
• Frequency not reported: Dyslipidemia^[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]

Musculoskeletal

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

Gastrointestinal

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

Psychiatric

• Common (1% to 10%): Anxiety, restlessness
• Frequency not reported: Abnormal dreams, bruxism, insomnia, other compulsive behaviors, pathological gambling, suicidal behaviors/thoughts
• Postmarketing reports: Sleep-related eating disorder, sleep walking^[Ref]

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

Endocrine

• Common (1% to 10%): Blood cortisol increased
• Frequency not reported: Blood prolactin increased, hyperprolactinemia^[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]

Other

• Common (1% to 10%): Fatigue
• Frequency not reported: Asthenia, body temperature dysregulation, falls, increased mortality^[Ref]

Mortality was increased in older patients with dementia-related psychosis.^[Ref]

Cardiovascular

• Frequency not reported: First degree atrioventricular block, flushing, hypertension, hypotension, orthostatic hypotension, palpitations, sinus bradycardia^[Ref]

Hematologic

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

Ocular

• Frequency not reported: Blepharospasm, blurred vision^[Ref]

Genitourinary

• Frequency not reported: Urinary tract infection^[Ref]

Hepatic

• Frequency not reported: Hepatic enzymes increased^[Ref]

Frequently asked questions

• What is Rexulti used for and how well does it work?
• Why does Rexulti cause weight gain?
• How long does it take for Rexulti to work?
• How does Rexulti work?

Further information

Rexulti 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer