Class Name(s):

• 28:16.08.04 Atypical Antipsychotics

Pronunciation:

• (brex pip' ra zole)

Brand Name(s):

• Rexulti^®; also available generically

IMPORTANT WARNING:

Important warning for older adults with dementia:

Older adults with dementia (loss of memory and brain function) may have an increased chance of death if treated with an antipsychotic medication such as brexpiprazole. Older adults with dementia may also have an increased risk of having a stroke or ministroke during treatment with antipsychotics.

Brexpiprazole is not approved by the Food and Drug Administration (FDA) for the treatment of psychosis (loss of touch with reality) without agitation in older adults with dementia due to Alzheimer's disease. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking brexpiprazole.

Important warning for people who have depression:

Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses have a greater risk of becoming suicidal. This is especially of concern at the beginning of your treatment and any time that your dose is changed. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; new or worsening anxiety; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and mania (frenzied, abnormally excited mood). Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Talk to your doctor about the risk(s) of taking brexpiprazole.

WHY is this medicine prescribed?

Brexpiprazole is used to treat:

• schizophrenia (a mental illness that affects how a person thinks, feels and behaves)
• depression, along with another antidepressant medication
• agitation in people with dementia due to Alzheimer's disease

HOW should this medicine be used?

Brexpiprazole comes as a tablet to take by mouth. Take once daily with or without food. Take brexpiprazole at around the same time every day.

Take brexpiprazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of brexpiprazole and gradually increase your dose depending on how well the medication works for you and the side effects you experience.

Brexpiprazole may control your symptoms but will not cure your condition. Continue to take brexpiprazole even if you feel well. Do not stop taking brexpiprazole without talking to your doctor.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking brexpiprazole,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking brexpiprazole. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription or herbal products may interact with brexpiprazole: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking brexpiprazole. Do not start this medication while taking brexpiprazole without discussing with your healthcare provider.
• tell your doctor or if you or anyone in your family has or has ever had diabetes. Tell you doctor if you have or have ever had a stroke, a ministroke (TIA), chest pain, heart disease, a heart attack, an irregular heartbeat, heart failure, trouble keeping your balance, any condition that makes it difficult for you to swallow, high or low blood pressure, seizures, a high level of fats (cholesterol and triglycerides) in your blood, a low number of white blood cells, or kidney or liver disease. Also tell your doctor if you have severe vomiting or diarrhea or signs of dehydration now, or if you develop these symptoms at any time during your treatment.
• tell your doctor if you are pregnant, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking brexpiprazole, call your doctor.
• you should know that brexpiprazole may make you drowsy. Do not drive a car or operate hazardous machinery until you know how this medication affects you.
• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking brexpiprazole or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking brexpiprazole: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
• you should know that brexpiprazole may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking brexpiprazole. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that some people who used medications such as brexpiprazole developed gambling problems or other intense urges or behaviors that were compulsive or unusual for them, such as increased sexual urges or behaviors, excessive shopping, and binge eating. Call your doctor if you have intense urges to shop, eat, have sex, or gamble, or if you are unable to control your behavior. Tell your family members about this risk so that they can call the doctor even if you do not realize that your gambling or any other intense urges or unusual behaviors have become a problem.
• you should know that brexpiprazole may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to exercise or be exposed to extreme heat.
• you should know that brexpiprazole may cause an increase in weight. It is important to have your weight checked periodically while you are taking this medication.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Brexpiprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness, tiredness
• dizziness, feeling unsteady, or having trouble keeping your balance

Some side effects can be serious. If you experience any of these symptoms, or those listed in the IMPORTANT WARNINGS and SPECIAL PRECAUTIONS sections, call your doctor immediately:

• rash, hives, itching; swelling of the eyes, face, mouth, lips, tongue, throat, hands, feet, ankles, or lower legs; difficulty breathing or swallowing
• seizures
• sore throat, cough, fever, chills, difficult or painful urination, or other signs of infection
• fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness
• unusual movements of your face or body that you cannot control
• feeling unsteady, or having trouble keeping your balance, falling down
• tightening of the neck muscles or throat, difficulty swallowing

Brexpiprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to brexpiprazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: November 15, 2025.