Summary

More frequently reported side effects include: anxiety, dizziness, drowsiness, dyspepsia, fatigue, increased creatine phosphokinase in blood specimen, nasopharyngitis, tremor, weight gain, hypersomnia, and sedated state. Continue reading for a comprehensive list of adverse effects.

Applies to brexpiprazole: oral tablet.

Serious side effects of Brexpiprazole

Along with its needed effects, brexpiprazole 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

• 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

Other side effects of Brexpiprazole

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

• 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

• 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

For Healthcare Professionals

Applies to brexpiprazole: oral tablet.

General

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

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]

Metabolic

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]

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]

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]