Aristada (Aripiprazole Lauroxil) - Intramuscular

Warning:

Aristada is a type of antipsychotic medicine. Adults over 65 with dementia-related psychosis who take antipsychotic medication are at an increased risk of dying. Aristada is not approved to treat dementia-related psychosis.

What Is Aristada?

Aristada is a long-acting, injectable medication used to treat schizophrenia in adults. Aristada belongs to a group of drugs called antipsychotics. Antipsychotics affect the activity of certain natural brain chemicals, including dopamine and serotonin.

The U.S. Food and Drug Administration (FDA) has issued boxed warnings for Aristada. Talk with your healthcare provider about these risks before starting treatment.

Drug Facts

Generic Name: Aripiprazole lauroxil

Brand Name(s): Aristada

Drug Availability: Prescription

Therapeutic Classification: Antipsychotic; second generation (atypical)

Available Generically: No

Controlled Substance: No

Administration Route: Intramuscular

Active Ingredient: Aripiprazole lauroxil

Dosage Form(s): Prefilled intramuscular syringe

What Is Aristada Used For?

Aristada is a long-acting injectable medication used to treat schizophrenia in adults.

Schizophrenia is a mental illness estimated to occur in up to 0.64% of people in the United States. Schizophrenia can affect how people with the disease think, behave, and perceive reality. Symptoms may include:

  • Hallucinations
  • Delusions
  • Unusual, disorganized speech
  • Reduced emotional expression
  • Lack of motivation
  • Difficulty with social relationships

Antipsychotic medicines, like Aristada, can help control schizophrenia symptoms.

How to Take Aristada

Aristada is an intramuscular injection administered by a healthcare provider once every four, six, or eight weeks. If you've never taken aripiprazole (the active ingredient in Aristada), your healthcare provider will likely prescribe Abilify (oral aripiprazole) for up to two weeks before starting Aristada to evaluate your body's reaction.

The first time you receive Aristada, your healthcare provider may also choose to administer Aristada Initio (a different injectable form of aripiprazole) and one dose of Abilify (oral aripiprazole). Alternatively, your healthcare provider may tell you to take oral aripiprazole for up to three weeks after your first Aristada injection.

Storage

Your healthcare provider will store and administer your dose of Aristada.

How Long Does Aristada Take to Work?

Aristada levels take time to build up in your body. After receiving your first dose of Aristada, levels become therapeutic within four to six days. But it may take up to four months to see the full effect. Talk with your healthcare provider about what to expect.

What Are the Side Effects of Aristada?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

You may experience side effects while taking Aristada. Be sure to inform your healthcare provider about any side effects that bother you or don't go away.

Common side effects include:

  • Restlessness
  • Feeling like you need to move (akathisia)

Severe Side Effects

Aristada may cause serious side effects. Contact your healthcare provider immediately if you develop any signs of a severe reaction. Call 911 if your symptoms feel life-threatening.

Serious side effects and their symptoms include:

  • Strokes in older adults with dementia-related psychosis, which can sometimes be deadly
  • A severe and potentially deadly condition called neuroleptic malignant syndrome. Seek emergency medical care if you develop a high fever, stiff muscles, confusion, sweating, or changes in your heart rate or blood pressure.
  • Uncontrollable body movements (tardive dyskinesia) that can affect the face, tongue, or other body parts. Tardive dyskinesia can sometimes be permanent, even after stopping Aristada. Tardive dyskinesia may also develop after stopping Aristada.
  • High blood sugar (hyperglycemia), including extremely high levels, can lead to coma or death. Let your healthcare provider know if you feel thirsty, hungry, nauseous, weak, tired, or confused, need to urinate more than usual, or if your breath smells fruity.
  • Increased triglyceride or cholesterol levels
  • Weight gain
  • Unusual and uncontrollable urges, including gambling, sexual urges, shopping, and binge eating
  • Decreased blood pressure while rising from a seated or lying position (orthostatic hypotension) may cause you to feel lightheaded or faint.
  • Falls that lead to injuries
  • Low white blood cell levels
  • Seizures
  • Problems controlling your body temperature. Be sure to avoid becoming too hot or dehydrated. Don't exercise too much, stay out of the sun, and drink plenty of water.
  • Difficulty swallowing

Report Side Effects

Aristada may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Aristada Should I Take?

Your healthcare provider will determine and administer the appropriate dose of Aristada for you.

Modifications

The following modifications (changes) should be kept in mind when using Aristada:

Severe allergic reaction: Do not take Aristada if you have a known allergy to it or its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: Babies exposed to antipsychotic medicines like Aristada during the third trimester are at risk of developing abnormal muscle movements or withdrawal symptoms after delivery. Babies may experience agitation, trouble feeding, muscle stiffness or weakness, difficulty breathing, tiredness, and tremor. Some babies may recover within hours without specific treatment, while others may need to be hospitalized. Let your healthcare provider know if you're pregnant or plan to become pregnant, and discuss the benefits and risks of taking Aristada during your pregnancy. If you become pregnant while receiving Aristada, talk with your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics.

Breastfeeding: Aristada is present in breast milk, but there isn't enough information about the safety of Aristada in nursing babies. Talk with your healthcare provider if you plan to breastfeed. Discuss the benefits and risks of taking Aristada while nursing and the different ways to feed your baby.

Adults over 65: The safety and effectiveness of using Aristada in adults over 65 have not been determined. However, older adults with dementia-related psychosis treated with antipsychotic drugs like Aristada have an increased risk of dying.

Children: Aristada is not approved to treat children with schizophrenia.

Missed Dose

If you miss your appointment to receive Aristada, reschedule it as soon as possible. Depending on how many days have passed since your last dose, your healthcare provider may tell you to take Abilify (oral aripiprazole) for seven to 21 days after receiving Aristada. Alternatively, your healthcare provider may administer Aristada Initio (a different injectable form of aripiprazole) plus one Ability dose with your Aristada injection.

Try to help yourself remember to keep your appointments and take your medication routinely. If you miss too many doses, Aristada might be less effective at controlling your symptoms.

Overdose: What Happens If I Take Too Much Aristada?

There is limited information available about an Aristada overdose. The symptoms of an overdose with oral aripiprazole (the active ingredient in Aristada) have included:

  • Vomiting
  • Tiredness
  • Tremor

However, seek immediate medical attention if you think you're experiencing an overdose or life-threatening symptoms.

What Happens If I Overdose on Aristada?

If you think you or someone else may have overdosed on Aristada, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Aristada, call 911 immediately.

Precautions

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It is very important that your doctor check your progress at regular visits to allow for changes in your dose and help reduce any unwanted effects. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase risk for stroke in elderly patients with dementia. Tell your doctor right away if you have confusion, difficulty in speaking, slow speech, inability to speak, inability to move the arms, legs, or facial muscles, double vision, or headache while receiving this medicine.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

This medicine may add to the effects of alcohol and other medicines that make you drowsy or less alert. Some examples of these medicines are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics (medicines that numb), including some dental anesthetics. If you are taking any of these medicines, make sure you tell your doctor before you receive aripiprazole injection.

Aripiprazole may cause drowsiness, trouble with thinking, or trouble with controlling movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have any of the following symptoms while receiving this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while receiving this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having unusual urges, such as gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while receiving this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. Avoid places that are very hot. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

What Are Reasons I Shouldn’t Take Aristada?

Do not take Aristada if you're allergic to Aristada or any of its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

What Other Medications Interact With Aristada?

Use caution when taking Aristada with the following medications:

  • Certain human immunodeficiency virus (HIV) medications
  • Clarithromycin 
  • Ketoconazole 
  • Nefazodone 
  • Noxafil (posaconazole)
  • Sporanox (itraconazole)
  • Vfend (voriconazole)
  • Tegretol (carbamazepine)
  • Phenobarbital
  • Dilantin (phenytoin)
  • Primidone
  • Rifampin
  • Wellbutrin (bupropion)
  • Prozac (fluoxetine)
  • Paxil (paroxetine)
  • Quinidine
  • Coreg (carvedilol)
  • Zestril (lisinopril)
  • Minipress (prazosin)
  • Benzodiazepines, such as Ativan (lorazepam)

Many other medications may interact with Aristada. Be sure to inform your healthcare provider and pharmacist about all the medicines you take, including over-the-counter (OTC), nonprescription products, herbal supplements, and vitamins.

What Medications Are Similar?

Aristada is a long-acting injectable antipsychotic which offers the convenience of not having to take oral medication every day. Other long-acting injectable medicines used to treat schizophrenia include:

  • Abilify Maintena (aripiprazole)
  • Zyprexa Relprevv (olanzapine pamoate)
  • Invega Sustenna (paliperidone palmitate)
  • Invega Trinza (paliperidone palmitate)
  • Invega Hafyera (paliperidone palmitate)
  • Risperdal Consta (risperidone)
  • Perseris (risperidone)

These products differ based on how often they must be administered, ranging from once every two weeks to once every six months. Choosing an injectable product will depend on which oral antipsychotics you have tried and tolerated and your other medical conditions and medications.

Frequently Asked Questions

  • What is Aristada used for?

    Aristada is used to control the symptoms of schizophrenia in adults.

  • How does Aristada work?

    Aristada is a long-acting injectable antipsychotic. It affects the activity of certain natural brain chemicals, including dopamine and serotonin. Unlike oral antipsychotics that need to be taken daily, Aristada only needs to be administered once every four to eight weeks. 

  • What are the side effects of Aristada?

    The most common side effects of Aristada include restlessness and feeling like you need to move.

How Can I Stay Healthy While Taking Aristada

If you're taking Aristada, chances are you're looking for an easier and more convenient way to control your schizophrenia symptoms. You may have tried different approaches or treatments. While living with schizophrenia has its challenges, there are ways to help improve your quality of life. Below are some general tips to support your health:

  • Take schizophrenia-related medications as recommended by your healthcare provider.
  • Do not skip appointments, even if you are feeling well.
  • Develop a plan with your healthcare provider to deal with symptoms as they arise to ensure you receive help as soon as possible. Share this plan with your family members.
  • Manage your stress by incorporating relaxation techniques into your daily routine.
  • Eat a healthy diet, stay physically active, and get enough sleep.
  • Ask your healthcare provider or social worker about assistance that may be available for social services. You may be eligible for programs that can help with housing, employment, and transportation.
  • Consider joining a support group to learn from and connect with others living with schizophrenia.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

5 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. DailyMed. Aristada- aripiprazole lauroxil injection, suspension, extended release.

  2. National Institute of Mental Health. Schizophrenia.

  3. DailyMed. Invega hafyera- paliperidone palmitate injection, suspension, extended release.

  4. Correll CU, Kim E, Sliwa JK, et al. Pharmacokinetic characteristics of long-acting injectable antipsychotics for schizophrenia: an overviewCNS Drugs. 2021;35(1):39-59. doi:10.1007/s40263-020-00779-5

  5. SAMHSA. Living well with schizophrenia.

By Christina Varvatsis, PharmD
Christina Varvatsis is a hospital pharmacist and freelance medical writer. She is passionate about helping individuals make informed healthcare choices by understanding the benefits and risks of their treatment options.