Uses

What is Rexulti used for?

Rexulti (brexpiprazole) is commonly used to treat people with depression, schizophrenia, or agitation due to dementia with Alzheimer’s disease.

Rexulti may also be used for other conditions as determined by your healthcare provider.

How does Rexulti work (mechanism of action)?

Rexulti is an antipsychotic medicine that helps to balance chemicals in the brain called dopamine and serotonin. These chemicals are known to affect mood and thoughts. 

How is Rexulti supplied (dosage forms)?

Rexulti is available in the following dosage forms that are taken by mouth.

  • 0.25 mg oral tablets 
  • 0.5 mg oral tablets
  • 1 mg oral tablets
  • 2 mg oral tablets
  • 3 mg oral tablets
  • 4 mg oral tablets

How should I store Rexulti?

Rexulti should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C), for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Rexulti?

The most common side effects of Rexulti are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Weight gain (see below)
  • Sleepiness
  • Dizziness
  • Indigestion or upset stomach
  • Cold-like symptoms
  • Fidgeting, restlessness or feeling like you need to move

There may be other side effects of Rexulti that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Rexulti?

While less common, the most serious side effects of Rexulti are described below, along with what to do if they happen.

Severe Allergic Reactions. Rexulti may cause allergic reactions, which can be serious. Stop taking Rexulti and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Suicidal Thoughts and Actions in Children, Adolescents and Young Adults. Rexulti and antidepressant medicines may cause suicidal thoughts or actions in a small number of people. Depression or other serious mental health conditions are the most important causes of suicidal thoughts or actions. If you or your child is about to harm themselves, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms:

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Neuroleptic Malignant Syndrome (NMS). Antipsychotic medicines, like Rexulti, can cause a rare but serious condition called neuroleptic malignant syndrome (NMS). Stop taking Rexulti and call your healthcare provider right away if you have any of the following symptoms of NMS.

  • High fever
  • Muscle stiffness or rigidity, where it is hard to move
  • Muscle pain
  • Changes in blood pressure or heart rate
  • Increased sweating
  • Confusion or agitation

Uncontrolled Body Movements. Rexulti can cause some people to have movements that they cannot control. This condition, called tardive dyskinesia (TD), can cause jerky movements of your face and body. Call your healthcare provider right away if you have any symptoms of TD.

  • Tongue sticking out
  • Lip smacking or puckering
  • Grimacing
  • Rapid eye blinking
  • Jerking or twisting motion of the arms, legs, or trunk

Increased Blood Sugar or Diabetes. Rexulti may increase your blood sugar levels (hyperglycemia or diabetes). Talk to your healthcare provider about how to maintain healthy blood sugar levels and call them if you have any of the following symptoms of high blood sugar.

  • Increased thirst or hunger
  • Urinating (peeing) more than normal
  • Weak or tired
  • Confusion
  • Breath that smells fruity

Weight Gain. Rexulti may cause weight gain. Track your weight and talk with your healthcare provider about how to maintain a healthy weight.

Increased Fat Levels (Cholesterol and Triglycerides). Rexulti can cause increases in fat levels in your blood that can cause hyperlipidemia or high triglycerides. Increased levels can lead to heart disease, heart attacks, or strokes over time. Talk to your healthcare provider about how to maintain a healthy lifestyle.

Unusual and Uncontrolled Behaviors. Rexulti can cause some people to have strong unusual and uncontrolled urges (compulsions), like gambling, sex, shopping, or eating. Talk to your healthcare provider if you or someone you know notices that you have new or worsened strong urges or behaviors.

Blood Disorders. Rexulti can cause blood disorders, such as low white blood cell levels (leukopenia, neutropenia, or agranulocytosis). Call your healthcare provider right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache 
  • Fast or abnormal heartbeat

Low Blood Pressure Upon Standing (Orthostatic Hypotension). Rexulti may cause orthostatic hypotension (also known as postural hypotension). This is a sudden drop in your blood pressure when you stand up after you have been lying or sitting down. Tell your healthcare provider right away if you have any of the following symptoms when you go from lying or sitting down to standing up.

  • Dizziness, feeling lightheaded, or fainting
  • Confusion
  • Blurry vision
  • Unusual weakness or tiredness

Falls. Rexulti may increase the risk of falls, which could cause broken bones or other injuries. Call your healthcare provider if you have any of the following symptoms that would cause you to fall.

  • Sleepiness
  • Dizziness
  • Decreased blood pressure when changing positions (see above)
  • Slow thinking
  • Problems with balance or movement

Seizures. Some people who have taken Rexulti have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Call your healthcare provider if you experience any of the following signs that a seizure is happening or could happen.

  • Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
  • Stiffening of your arms and legs
  • Feeling anxious, nervous, confused, or a sense of dread
  • Feeling dizzy or lightheaded
  • Falling or losing consciousness

Problems Controlling Body Temperature. Rexulti can cause some people to have issues with controlling their body temperature and decrease your ability to sweat. This may increase your risk of heat stroke. Avoid doing things that can cause you to overheat, hard work or exercise in hot weather, or using hot tubs. Call your healthcare provider if you have any of the following symptoms of increased body temperature or heat exhaustion

  • Dehydrated
  • Confusion
  • Dizziness or fainting
  • Unusual weakness or tiredness
  • Headache
  • Nausea or vomiting
  • Muscle cramps
  • Fast heartbeat

Trouble Swallowing. Rexulti may cause difficulty swallowing liquids or food. Contact your healthcare provider if you experience these symptoms. This could make you more likely to get food or liquids into your lungs.

Decreased Alertness or Coordination. Rexulti can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how olanzapine affects you.

Warnings & Precautions

Who should not use Rexulti?

Allergies to Ingredients. People who are allergic to any of the following should not take Rexulti.

  • Rexulti
  • Brexpiprazole
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Rexulti.

What should I know about Rexulti before using it?

Do not take Rexulti unless it has been prescribed to you by a healthcare provider. Take it as prescribed. Do not take Rexulti “as needed” for the treatment of agitation due to Alzheimer’s disease.  

Do not share Rexulti with other people, even if they have the same condition as you. It may harm them.

Keep Rexulti out of the reach of children.

Rexulti can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Rexulti affects you.

What should I tell my healthcare provider before using Rexulti?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Rexulti is right for you.

In particular, make sure that you discuss any of the following.

Mental Health Problems. Tell your healthcare provider about your recent and current mental health problems, especially if you have had thoughts of suicide or dying or have ever attempted suicide. 

Other Current and Past Health Conditions. Tell your healthcare provider if you have had any of the following.

  • Heart problems or stroke
  • Low or high blood pressure
  • Diabetes, high blood sugar or a family history of diabetes or high blood sugar
  • High cholesterol blood levels (LDL, cholesterol, HDL, or triglycerides) or low HDL cholesterol
  • Seizures
  • Kidney or liver problems
  • Low white blood cell count
  • Trouble swallowing 

Psychosis Related to Dementia. There is a higher risk of stroke and transient ischemic attack (TIA) that can lead to death in older adults who take Rexulti or another antipsychotic and have memory loss or psychosis related to dementia. Rexulti is not approved to treat dementia-related psychosis.

Other Medicines and Supplements. Rexulti may interact with other medicines and supplements. Before using Rexulti, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Rexulti may harm your unborn baby. Taking Rexulti during the third trimester may cause your newborn baby to have muscle problems or withdrawal symptoms. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take Rexulti while you are pregnant or planning to become pregnant. 

If you get pregnant while taking Rexulti, you can sign up for a special registry called the National Pregnancy Registry for Atypical Antipsychotics by calling 866-961-2388 or by visiting womensmentalhealth.org/research/pregnancyregistry. This registry collects safety information about the use of antipsychotic medicines during pregnancy. 

Breastfeeding. It is not known if Rexulti passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Rexulti while breastfeeding. 

How can I get more information about Rexulti?

For more information about Rexulti, you can visit the manufacturer’s website at www.rexulti.com or call them at 800-441-6763.

Interactions

Does Rexulti interact with foods or drinks?

Rexulti can be taken with or without food. There are no known interactions between Rexulti and foods or drinks.

It is unknown if drinking alcohol will affect Rexulti. The risk of changes to your alertness or coordination may be increased if you drink alcohol while taking Rexulti.

Does Rexulti interact with other medicines (drug interactions)?

Other medicines may alter the blood levels of Rexulti. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does Rexulti (brexpiprazole) interact with other drugs you are taking?
Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Rexulti?

If you or someone else has used too much Rexulti, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Rexulti?

If you miss a dose of Rexulti, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses. 

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