This drug has a boxed warning for increased risk of death in older people with dementia-related psychosis. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

For details, see the “Side effects explained” section below.

If you have schizophrenia, your doctor might suggest Aristada (aripiprazole lauroxil) as a treatment option for you. Learning about the possible side effects of Aristada can help you and your doctor decide if it’s a good treatment option for you.

Aristada is a prescription medication that’s used to treat schizophrenia in adults.

Aristada is typically a long-term treatment. A healthcare professional will give you the drug as an injection into a muscle.

Prior to Aristada treatment, you may receive a one-time dose of Aristada Initio (which also contains aripiprazole lauroxil) plus a dose of aripiprazole by mouth. Or your doctor may have you take aripiprazole by mouth for 21 days before your first Aristada dose. Doing this at the start of treatment will help Aristada work faster.

This article will focus on the side effects of Aristada, and not Aristada Initio. Note that the side effects are very similar between these two drugs.

For more information about Aristada, see this in-depth article.

Like other drugs, Aristada can cause mild or serious side effects. Keep reading to learn more.

Some people may experience mild or serious side effects during their Aristada treatment. The most commonly reported side effect of Aristada is:

* For more information about this side effect, see “Extrapyramidal symptoms” in the “Side effects explained” section below.

Aristada may cause mild side effects in some people. Mild side effects that have been reported with Aristada include:

  • insomnia (trouble falling asleep or staying asleep)
  • headache
  • injection-related side effects*
  • weight gain*
  • akathisia
  • restlessness†

* To learn more about this side effect, see the “Side effects explained” section below.
† For more information about this side effect, see “Extrapyramidal symptoms” in the “Side effects explained” section below.

In most cases, these side effects should be temporary. And some may be easily managed, too. But if you have any symptoms that are ongoing or that bother you, talk with your doctor or pharmacist. And don’t stop using Aristada unless your doctor recommends it.

Aristada may cause mild side effects other than the ones listed above. See the Aristada prescribing information for details.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Aristada, visit MedWatch.

Some people may develop severe side effects during Aristada treatment. Based on studies of Aristada, serious side effects may include:

* To learn more about this side effect, see the “Side effects explained” section below.

Certain serious side effects have been reported with the use of medications that are very similar to Aristada. Although the side effects weren’t seen in studies of Aristada, they may still occur with this drug. These include:

* Aristada has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effects explained” section below.
† An allergic reaction is possible after using Aristada. Although this side effect wasn’t reported in studies of Aristada, it has occurred in studies of aripiprazole taken by mouth. (Aristada is an injectable form of the active drug aripiprazole.) To learn more about this side effect, see the “Side effects explained” section below.

If you develop serious side effects during Aristada treatment, call your doctor right away. If the side effects seem life threatening or if you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Learn more about some of the side effects Aristada may cause.

Injection-related side effects

A healthcare professional will give you Aristada as an injection into a muscle in your upper arm or buttock. This can cause an injection-related side effect, such as discomfort in the area of the injection.

In studies of Aristada, injection-related side effects occurred more often with the first dose. After that, they occurred less often with each subsequent dose of the drug.

After an injection, you may experience:

  • pain
  • swelling
  • redness or deepening of skin color
  • thickening of your skin

What might help

Injection-related side effects from Aristada injections tend to be mild. They usually go away on their own within a few days.

If injection-related side effects don’t go away or become severe, tell your doctor. They can suggest ways to manage your symptoms.

Increased risk of death in older people with dementia-related psychosis

Aristada has a boxed warning for increased risk of death in older people with dementia-related psychosis. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about a drug’s effects that may be harmful.

Antipsychotic drugs such as Aristada may increase the risk of death in people ages 65 years and older who have psychosis related to dementia. Psychosis refers to losing touch with reality, and dementia involves declining memory.

Aristada treatment may also increase the risk of stroke in older people who have dementia.

What might help

Due to these risks, Aristada isn’t prescribed for older adults with psychosis related to dementia. If you’re 65 years or older and have dementia-related psychosis, your doctor can discuss safer treatments with you.

Weight gain

Weight gain is a possible side effect of Aristada. In one study, some people gained weight while receiving Aristada treatment.

Aristada belongs to a group of drugs called antipsychotics. Weight gain is a common side effect of this group of drugs.

What might help

During your Aristada treatment, your doctor will check your weight regularly.

To help prevent or manage weight gain while you’re receiving Aristada, there are a few things you can do:

  • Exercise consistently. Exercise can help you burn calories, which may help you manage your weight. Talk with your doctor about a fitness routine that’s safe for you.
  • Try to eat a balanced diet. Consider using a calorie-tracking app to track what you’re eating. Keeping track of your foods and portions can help you choose a balanced diet.
  • Meet with a certified nutritionist or registered dietitian. They can provide personalized guidance for your specific needs and goals.

If you have questions or concerns about weight gain with Aristada, talk with your doctor.

Extrapyramidal symptoms

Like other antipsychotic drugs, Aristada may cause extrapyramidal symptoms (EPS). This term refers to a group of muscle movement disorders.

Certain types of EPS were commonly seen in studies of Aristada:

  • akathisia, which makes you feel like you can’t stay still
  • restlessness

Less commonly, other potentially more severe types of EPS occurred in these studies, including:

Another EPS that may occur is tardive dyskinesia (repeated movements that you can’t control). Although this side effect wasn’t seen in studies of Aristada, it has occurred with antipsychotics such as this drug.

Tardive dyskinesia can be a long-term side effect of antipsychotic drugs. This means that it’s more common with long-term use of this type of medication. And it may not go away after treatment ends.

Symptoms of tardive dyskinesia may include unusual movements of your jaw, face, or mouth, such as:

  • smacking your lips
  • sticking out your tongue

What might help

During your treatment with Aristada, your doctor will monitor you for EPS. If you notice any changes in your movements, tell your doctor. They may adjust your dosage of Aristada or recommend other changes to your treatment plan.

Allergic reaction

Like most drugs, Aristada can cause an allergic reaction in some people. Although this side effect wasn’t reported in studies of Aristada, it has occurred in studies of aripiprazole taken by mouth. (Aristada is an injectable form of the active drug aripiprazole.)

Symptoms can be mild or serious and can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. To manage your symptoms, they may suggest an over-the-counter antihistamine you take by mouth, such as Benadryl (diphenhydramine). Or they may recommend a product you apply to your skin, such as hydrocortisone cream.

If your doctor confirms you had a mild allergic reaction to Aristada, they’ll decide if you should continue using it.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you had a serious allergic reaction to Aristada, they may have you switch to a different treatment.

Keeping track of side effects

During your Aristada treatment, consider keeping notes on any side effects you’re having. Then, you can share this information with your doctor. This is especially helpful to do when you first start taking new drugs or using a combination of treatments.

Your side effect notes can include things such as:

  • what dose of drug you were taking when you had the side effect
  • how soon after starting that dose you had the side effect
  • what your symptoms were from the side effect
  • how it affected your daily activities
  • what other medications you were also taking
  • any other information you feel is important

Keeping notes and sharing them with your doctor will help your doctor learn more about how Aristada affects you. And your doctor can use this information to adjust your treatment plan if needed.

Get answers to some commonly asked questions about Aristada’s side effects.

Is there a higher risk of side effects from an 882-mg injection of Aristada compared with a 662-mg injection?

Not really. In studies of Aristada, some mild side effects occurred slightly more often with the 882-milligram (mg) dose than the 662-mg dose. These include headaches and pain at the injection site.

Your doctor will monitor you for side effects throughout your treatment. Like most drugs, a decrease in dosage may help to ease bothersome side effects. Your doctor will determine the dosage of Aristada that’s right for you and adjust it when necessary.

Does Aristada increase the risk of suicidal behaviors or thoughts?

It isn’t known for sure. In studies, Aristada didn’t increase the risk of suicidal thoughts or behaviors.

Suicide has been reported with Aristada use. But it isn’t known how often this has occurred or if the drug was the cause.

Keep in mind that Aristada is used to treat schizophrenia. And this condition itself can raise a person’s risk of suicide.

If you’re receiving Aristada and you have new or worsened depression or anxiety, tell your doctor. But if you’re having thoughts of harming yourself, immediately call 911 or your local emergency number.

Suicide prevention

If you think someone is at immediate risk of self-harm or hurting another person:

  • Call 911 or your local emergency number.
  • Stay with the person until help arrives.
  • Remove any guns, knives, medications, or other things that may cause harm.
  • Listen, but don’t judge, argue, threaten, or yell.

If you or someone you know is considering suicide, get help from a crisis or suicide prevention hotline. Try the National Suicide Prevention Lifeline at 800-273-8255.

Can Aristada cause a person to develop a gambling addiction?

Maybe. But this behavior wasn’t seen in studies of Aristada.

Compulsive behaviors have been reported with drugs that are very similar to Aristada. They’ve also been reported with aripiprazole since the drug became available to the public. (Aristada is an injectable form of the active drug aripiprazole.)

These drugs cause some people to get intense urges that they can’t stop themselves from acting on. Examples of these compulsive behaviors include gambling addiction, binge eating, and shopping too much.

If you or your family members notice such changes in your behavior during Aristada treatment, tell your doctor. They may adjust your dosage or recommend a different treatment option for you.

Aristada comes with several warnings.

Boxed warning: Increased risk of death in older people with certain conditions

Aristada has a boxed warning for increased risk of death in older people with dementia-related psychosis. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

Antipsychotic drugs such as Aristada may increase the risk of death in people ages 65 years and older who have psychosis related to dementia.

To learn more, see the “Side effects explained” section above.

Other warnings

Aristada may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you start Aristada treatment. The list below includes factors to consider.

Older adults. Aristada hasn’t been studied in adults ages 65 years and older. So it isn’t known for sure if the drug is safe or effective for this age group. If you’re 65 years or older and want to know if Aristada might be a good treatment option for you, talk with your doctor. They can discuss the risks and benefits of this drug for your condition.

Seizures. Aristada may increase the risk of seizures, especially if you’ve had seizures in the past. If you have epilepsy or a history of seizures, talk with your doctor before starting Aristada treatment. They’ll determine whether it’s safe for you to try this medication.

Low white blood cells. Aristada treatment may lower your white blood cell count. If you already have low white blood cell levels, tell your doctor before starting the drug. They’ll likely give you a blood test to find out whether Aristada is safe for you to try.

Diabetes. Aristada may cause high blood sugar levels. For people who already have diabetes, this medication could worsen their condition. If you receive Aristada and have diabetes, your doctor will monitor you closely. They may also prescribe diabetes medication or increase the dosage of any you already take.

Lipid disorders. Aristada may cause changes in the lipids (fats) in your blood, including cholesterol and triglycerides. So it could worsen lipid disorders, such as high cholesterol. If you have cholesterol problems, your doctor will likely prescribe cholesterol medication while you’re receiving Aristada. Or they may increase the dosage of any cholesterol medication you already take.

Altered drug metabolism. Aristada gets broken down in your body by an enzyme called CYP2D6. In some people, this enzyme doesn’t work properly. If this applies to you, your doctor will likely prescribe a lower dose of Aristada.

Allergic reaction. If you’ve had an allergic reaction to Aristada or any of its ingredients, your doctor will likely not prescribe Aristada. Ask your doctor what other medications are better options for you.

Alcohol use and Aristada

Aristada doesn’t directly interact with alcohol.

But doctors typically recommend avoiding alcohol to people with schizophrenia, which Aristada is used to treat. This is because alcohol can possibly worsen this condition.

If you have questions about drinking alcohol during Aristada treatment, talk with your doctor. They can let you know how much alcohol, if any, is safe for you.

Pregnancy and breastfeeding while receiving Aristada

Aristada may not be safe to use during pregnancy.

It’s been reported that people who took a very similar drug during pregnancy gave birth to infants who had certain symptoms. These included agitation, tremor, excessive sleepiness, and breathing problems.

If you’re pregnant or trying to become pregnant, tell your doctor. They can give you more information about the potential risks and benefits of Aristada treatment.

It also is not known if Aristada is safe to use while breastfeeding. If you’re breastfeeding or planning to breastfeed, tell your doctor. They can help you decide on the best ways to feed your child while treating your schizophrenia.

Like other medications used to treat schizophrenia, Aristada may cause mild or serious side effects. Your doctor can tell you more about whether Aristada might be a good fit for your treatment plan.

When you’re considering treatment options for schizophrenia, it’s common to have questions about side effects. Here are some suggestions for what to ask your doctor about Aristada’s side effects:

  • Is there anything I can do to help prevent side effects from Aristada?
  • Do I have a high risk of serious side effects of this medication?
  • Will I have side effects if I miss a dose of Aristada?
  • Should I expect to have any long-term side effects from Aristada?

Q:

How do the side effects of Aristada compare with the side effects of Abilify Maintena?

Anonymous

A:

Aristada and Abilify Maintena can cause many of the same side effects. This isn’t surprising, since both drugs contain a form of aripiprazole as their active drug. (The active drug is the ingredient that makes a medication work.)

Some mild side effects that both Aristada and Abilify Maintena can cause include akathisia and injection site reactions. Headache has been reported with Aristada, while sedation (feeling very tired or sluggish) is possible with Ability Maintena.

These drugs can also cause very similar serious side effects. A few of the serious side effects reported with both Aristada and Abilify Maintena include tardive dyskinesia, metabolism changes, and compulsive behaviors.

If you’d like to learn more about how Aristada and Abilify Maintena compare, check out this article. You can also ask your doctor or pharmacist about other side effects these drugs can cause.

Alex Brewer, PharmD, MBAAnswers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.
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Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.