Rexulti

Last updated on RxList: 3/23/2021
Rexulti Side Effects Center

What Is Rexulti?

Rexulti (brexpiprazole) is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) and for treatment of schizophrenia.

What Are Side Effects of Rexulti?

Common side effects of Rexulti include:

  • weight gain,
  • agitation,
  • distress,
  • restlessness,
  • constipation,
  • fatigue,
  • runny or stuffy nose,
  • increased appetite,
  • headache,
  • drowsiness,
  • tremor,
  • dizziness, and
  • anxiety.
  • Children, teenagers, and young adults may have suicidal thoughts while taking Rexulti. Tell your doctor if this occurs.

Dosage for Rexulti

The recommended starting dosage for Rexulti as adjunctive treatment for MDD is 0.5 mg or 1 mg once daily, taken orally. The recommended target Rexulti dosage to treat schizophrenia is 2 mg to 4 mg once daily.

What Drugs, Substances, or Supplements Interact with Rexulti?

Rexulti may interact with:

  • strong/moderate CYP2D6 or
  • CYP3A4 inhibitors or strong CYP3A4 inducers

Tell your doctor all medications and supplements you use.

Rexulti During Pregnancy and Breastfeeding

The effects of Rexulti on a fetus are unknown. Neonates whose mothers are exposed to antipsychotic drugs, like Rexulti, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Rexulti during pregnancy. It is unknown if Rexulti passes into breast milk or if it would affect a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Rexulti (brexpiprazole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Schizophrenia: Symptoms, Types, Causes, Treatment See Slideshow
Rexulti Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

High doses or long-term use of brexpiprazole can cause a serious movement disorder that may not be reversible. The longer you use brexpiprazole, the more likely you are to develop this disorder, especially if you are a diabetic or an older adult.

Call your doctor at once if you have:

  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
  • trouble swallowing;
  • feelings of warmth, intolerance to heat;
  • a seizure (convulsions);
  • a light-headed feeling, like you might pass out;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors; or
  • signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common side effects may include:

  • weight gain; or
  • feeling restless or being unable to sit still.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Rexulti (Brexpiprazole Tablets)

QUESTION

Schizophrenia is the most disabling mental illness. See Answer
Rexulti Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Major Depressive Disorder

The safety of REXULTI was evaluated 1,054 patients (18 to 65 years of age) diagnosed with MDD who participated in two 6-week, placebo-controlled, fixed-dose clinical trials in patients with major depressive disorder in which REXULTI was administered at doses of 1 mg to 3 mg daily as adjunctive treatment to continued antidepressant therapy; patients in the placebo group continued to receive antidepressant therapy [see Clinical Studies].

Adverse Reactions Reported As Reasons For Discontinuation Of Treatment

A total of 3% (17/643) of REXULTI-treated patients and 1% (3/411) of placebo-treated patients discontinued due to adverse reactions.

Common Adverse Reactions

Adverse reactions associated with the adjunctive use of REXULTI (incidence of 2% or greater and adjunctive REXULTI incidence greater than adjunctive placebo) that occurred during acute therapy (up to 6-weeks in patients with MDD) are shown in Table 8.

Table 8: Adverse Reactions in Pooled 6-Week, Placebo-Controlled, Fixed-Dose MDD Trials (Studies 1 and 2)*

  Placebo
(N=411)
REXULTI
1 mg/day
(N=226)
2 mg/day
(N=188)
3 mg/day
(N=229)
All REXULTI
(N=643)
Gastrointestinal Disorders
Constipation 1% 3% 2% 1% 2%
General Disorders and Administration Site Conditions
Fatigue 2% 3% 2% 5% 3%
Infections and Infestations
Nasopharyngitis 2% 7% 1% 3% 4%
Investigations
Weight Increased 2% 7% 8% 6% 7%
Blood Cortisol Decreased 1% 4% 0% 3% 2%
Metabolism and Nutrition
Increased Appetite 2% 3% 3% 2% 3%
Nervous System Disorders
Akathisia 2% 4% 7% 14% 9%
Headache 6% 9% 4% 6% 7%
Somnolence 0.5% 4% 4% 6% 5%
Tremor 2% 4% 2% 5% 4%
Dizziness 1% 1% 5% 2% 3%
Psychiatric Disorders
Anxiety 1% 2% 4% 4% 3%
Restlessness 0% 2% 3% 4% 3%
* Adverse reactions that occurred in ≥2% of REXULTI-treated patients and greater incidence than in placebo-treated patients

Dose-Related Adverse Reactions In The MDD Trials

In Studies 1 and 2, among the adverse reactions that occurred at ≥2% incidence in the patients treated with REXULTI +ADT, the incidences of akathisia and restlessness increased with increases in dose.

Schizophrenia

The safety of REXULTI was evaluated in 852 patients (18 to 65 years of age) diagnosed with schizophrenia who participated in two 6-week, placebo-controlled, fixed-dose clinical trials in which REXULTI was administered at daily doses of 1 mg, 2 mg and 4 mg [see Clinical Studies].

Common Adverse Reactions

Adverse reactions associated with REXULTI (incidence of 2% or greater and REXULTI incidence greater than placebo) during short-term (up to 6-weeks) trials in patients with schizophrenia are shown in Table 9.

Table 9: Adverse Reactions in Pooled 6-Week, Placebo-Controlled, Fixed-Dose Schizophrenia Trials (Studies 3 and 4)*

  Placebo
(N=368)
REXULTI
1 mg/day
(N=120)
2 mg/day
(N=368)
4 mg/day
(N=364)
ALL REXULTI
(N=852)
Gastrointestinal Disorders
Dyspepsia 2% 6% 2% 3% 3%
Diarrhea 2% 1% 3% 3% 3%
Investigations
Weight Increased 2% 3% 4% 4% 4%
Blood Creatine Phosphokinase Increased 1% 4% 2% 2% 2%
Nervous System Disorders
Akathisia 5% 4% 5% 7% 6%
Tremor 1% 2% 2% 3% 3%
Sedation 1% 2% 2% 3% 2%
* Adverse reactions that occurred in ≥2% of REXULTI-treated patients and greater incidence than in placebo-treated patients

Extrapyramidal Symptoms

Major Depressive Disorder

The incidence of reported EPS-related adverse reactions, excluding akathisia, was 6% for REXULTI+ADT-treated patients versus 3% for placebo+ADT-treated patients. The incidence of akathisia events for REXULTI+ADT-treated patients was 9% versus 2% for placebo+ADT-treated patients.

In the 6-week, placebo-controlled MDD studies, data was objectively collected on the Simpson Angus Rating Scale (SAS) for extrapyramidal symptoms (EPS), the Barnes Akathisia Rating Scale (BARS) for akathisia and the Abnormal Involuntary Movement Score (AIMS) for dyskinesia. The mean change from baseline at last visit for REXULTI+ADTtreated patients for the SAS, BARS and AIMS was comparable to placebo treated patients. The percentage of patients who shifted from normal to abnormal was greater in REXULTI+ADT-treated patients versus placebo+ADT for the BARS (4% versus 0.6%) and the SAS (4% versus 3%).

Schizophrenia

The incidence of reported EPS-related adverse reactions, excluding akathisia, was 5% for REXULTI-treated patients versus 4% for placebo-treated patients. The incidence of akathisia events for REXULTI-treated patients was 6% versus 5% for placebo-treated patients.

In the 6-week, placebo-controlled, fixed-dose schizophrenia studies, data was objectively collected on the Simpson Angus Rating Scale (SAS) for extrapyramidal symptoms (EPS), the Barnes Akathisia Rating Scale (BARS) for akathisia and the Abnormal Involuntary Movement Scale (AIMS) for dyskinesia. The mean change from baseline at last visit for REXULTI-treated patients for the SAS, BARS and AIMS was comparable to placebo-treated patients. The percentage of patients who shifted from normal to abnormal was greater in REXULTI-treated patients versus placebo for the BARS (2% versus 1%) and the SAS (7% versus 5%).

Dystonia

Symptoms of dystonia may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Other Adverse Reactions Observed During The Premarketing Evaluation Of REXULTI

Other adverse reactions (≥1% frequency and greater than placebo) within the short-term, placebo-controlled trials in patients with MDD and schizophrenia are shown below. The following listing does not include adverse reactions: 1) already listed in previous tables or elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have clinically significant implications, or 5) which occurred at a rate equal to or less than placebo.

Eye Disorders: Vision Blurred

Gastrointestinal Disorders: Nausea, Dry Mouth, Salivary Hypersecretion, Abdominal Pain, Flatulence

Infections and Infestations: Urinary Tract Infection

Investigations: Blood Prolactin Increased

Musculoskeletal and Connective Tissue Disorders: Myalgia

Psychiatric Disorders: Abnormal Dreams, Insomnia

Skin and Subcutaneous Tissue Disorders: Hyperhidrosis

Read the entire FDA prescribing information for Rexulti (Brexpiprazole Tablets)

© Rexulti Patient Information is supplied by Cerner Multum, Inc. and Rexulti Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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