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Brexpiprazole Side Effects

In Summary

More frequently reported 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

In addition to its needed effects, some unwanted effects may be caused by brexpiprazole. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking brexpiprazole:

Rare
  • Chills
  • cold sweats
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from lying or sitting position
  • fainting
Incidence not known:
  • Black, tarry stools
  • changes in behavior
  • chest pain
  • convulsions
  • cough or hoarseness
  • difficulty breathing
  • fast heartbeat
  • fever with or without chills
  • general feeling of tiredness or weakness
  • high fever
  • inability to move 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
  • 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

Minor Side Effects

Some of the side effects that can occur with brexpiprazole may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Acid or sour stomach
  • belching
  • headache
  • heartburn
  • inability to sit still
  • indigestion
  • muscle aches
  • need to keep moving
  • restlessness
  • sleepiness or unusual drowsiness
  • sore throat
  • stomach discomfort, upset, or pain
  • stuffy or runny nose
  • weight gain
Less common:
  • Bloated or full feeling
  • bloody or cloudy urine
  • blurred vision
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • dizziness
  • dry mouth
  • excess air or gas in the stomach or intestines
  • fear or nervousness
  • frequent urge to urinate
  • increased appetite
  • increased sweating
  • joint pain
  • muscle aching or cramping
  • muscle pains 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 common adverse reactions are weight gain and akathisia.[Ref]

Metabolic

Common (1% to 10%): Weight gain, increased appetite, elevated fasting blood glucose[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]

Gastrointestinal

Common (1% to 10%): Constipation, dyspepsia, diarrhea, nausea, dry mouth, salivary hypersecretion, abdominal pain, flatulence[Ref]

Hypersensitivity

Frequency not reported: Rash, facial swelling, urticaria, anaphylaxis[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]

Common (1% to 10%): Akathisia, headache, somnolence, tremor, dizziness, sedation, extrapyramidal-related events (excluding akathisia)[Ref]

Psychiatric

Common (1% to 10%): Anxiety, restlessness, abnormal dreams, insomnia[Ref]

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

Cardiovascular

Uncommon (0.1% to 1%): Orthostatic hypotension[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis[Ref]

Endocrine

Common (1% to 10%): Decreased blood cortisol, increased blood prolactin[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Musculoskeletal

Common (1% to 10%): Increased blood creatine phosphokinase, myalgia[Ref]

Ocular

Common (1% to 10%): Blurred vision[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis[Ref]

References

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

Not all side effects for brexpiprazole may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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