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.

Precautions

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

For some patients, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive illness) or has tried to commit suicide.

Check with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may increase risk of transient ischemic attack or stroke in elderly patients. Tell your doctor right away if you have confusion, double vision, headache, inability to move the arms, legs, or facial muscles, slow speech, or trouble speaking, thinking, or walking while using this medicine.

This medicine may cause tardive dyskinesia (a movement disorder) especially in elderly women. Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having unusual urges, such as gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while using this medicine.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may make it more difficult for your body to cool down. It might also reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might have an upset stomach or vomit. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

This medicine may cause drowsiness, dizziness, trouble with thinking, or trouble with controlling movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded or dizzy.

Do not change the dose or stop using this medicine without checking first with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal (eg, St. John's wort) or vitamin supplements.

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:

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:

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]

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer