Aristada is a brand-name prescription drug that’s approved to treat schizophrenia in adults.

Schizophrenia is a mental health condition that can affect your ability to speak, think, and feel or express emotions. For more information about schizophrenia, see the “Aristada uses” section below.

Drug details

Aristada contains the active ingredient aripiprazole lauroxil. It belongs to a drug class called antipsychotic drugs. A drug class is a group of medications that work in a similar way.

Aristada comes as a liquid solution that a healthcare provider gives as an intramuscular injection (an injection into your muscle). Injections may be given monthly, every 6 weeks, or every 2 months, depending on the dose given.

The drug is available in the following strengths: 441 milligrams (mg), 662 mg, 882 mg, and 1,064 mg.

Aristada and Aristada Initio

Aristada and a medication called Aristada Initio both contain the active ingredient aripiprazole lauroxil. But they contain different amounts of this ingredient. And even though they contain the same active ingredient, these medications are used slightly differently.

Aristada is meant to be used as a long-term treatment for schizophrenia. However, Aristada Initio is given only before starting Aristada treatment for schizophrenia. And for this use, Aristada Initio is given with oral* aripiprazole. After you take Aristada or Aristada Initio, your body turns their prodrug† aripiprazole lauroxil into aripiprazole.

Aristada Initio and oral aripiprazole provide a loading dose of aripiprazole. A loading dose is used to help your aripiprazole levels reach your target range more quickly. This helps make sure there’s enough medication in your body for your first dose of Aristada to start working right away.

This article primarily focuses on Aristada, not on Aristada Initio. If you have questions about Aristada Initio, talk with your doctor or pharmacist.

* Oral means you take the drug by mouth.
† A prodrug is inactive when it first enters your body. The drug begins to work only after it undergoes chemical changes in your body. See the “Aristada use with other drugs” section below for more information.

Effectiveness

For information about the effectiveness of Aristada, see the “Aristada uses” section below.

Aristada is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug ingredient in a brand-name medication.

Note: Aristada contains the active ingredient aripiprazole lauroxil, which isn’t available in generic form. But there is a generic form of aripiprazole, which is the active ingredient in a similar brand-name medication called Abilify.

However, these active ingredients aren’t exactly the same. After you take Aristada, your body turns the prodrug* aripiprazole lauroxil into aripiprazole.

* A prodrug is inactive when it first enters your body. The drug begins to work only after it undergoes chemical changes in your body.

The Aristada dosage your doctor prescribes will depend on several factors. These include:

  • the severity of your schizophrenia symptoms
  • other medications you may take

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Aristada comes as a liquid solution that’s given by a healthcare provider as an intramuscular injection (an injection into your muscle).

The drug is available in the following strengths and sizes:

Aristada doseAmount of solution
441 milligrams (mg)1.6 milliliters (mL)
662 mg2.4 mL
882 mg3.2 mL
1,064 mg3.9 mL

Aristada Initio

Aristada Initio is a drug similar to Aristada that may be given as a one-time dose prior to Aristada treatment. Both drugs contain the active ingredient aripiprazole lauroxil. But Aristada Initio is available in only one strength: 675 mg (2.4 mL).

Like Aristada, Aristada Initio comes as a liquid solution that’s given by a healthcare provider as an intramuscular injection. See “Dosage for schizophrenia” just below for details about Aristada Initio.

Dosage for schizophrenia

The table below describes Aristada’s dosing guide and dosing schedule for treating schizophrenia.

Note: Aristada (and Aristada Initio) may be injected into either your deltoid (shoulder) muscle or gluteal (buttocks) muscle. But certain strengths of Aristada may only be injected into the gluteal muscle. The table below describes Aristada’s dosing schedule and injection sites.

Aristada doseDosing scheduleInjection site(s)
441 mgMonthlyShoulder or buttocks
662 mgMonthlyButtocks only
882 mgMonthly, or every 6 weeksButtocks only
1,064 mgEvery 2 monthsButtocks only

Before beginning Aristada treatment, or on the day of your first Aristada injection, you may be given a one-time dose of Aristada Initio. This provides a loading dose of aripiprazole.* A loading dose is used to make sure there’s enough medication in your body for your first dose of Aristada to start working right away.

Aristada Initio is given as a one-time injection. It may be given on the same day as your first Aristada injection. Or it may be given up to 10 days before your first Aristada injection.

* Aristada Initio is given with oral aripiprazole when used for this purpose. After you take Aristada or Aristada Initio, your body turns their prodrug aripiprazole lauroxil into aripiprazole. A prodrug is inactive when it first enters your body. The drug begins to work only after it undergoes chemical changes in your body. See the “Aristada use with other drugs” section below for more information.

What if I miss a dose?

If you miss an injection of Aristada, contact your doctor’s office to reschedule your missed dose as soon as possible. Depending on how much time has passed since your missed dose, and since your last Aristada injection, your doctor may give you a dose of Aristada Initio, a dose of oral (taken by mouth) aripiprazole, or both.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. Writing down your appointment in your calendar or planner can also help.

Will I need to use this drug long term?

Aristada is meant to be used as a long-term treatment. If you and your doctor determine that Aristada is safe and effective for you, you’ll likely take it long term.

Aristada can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Aristada. These lists do not include all possible side effects.

For more information about the possible side effects of Aristada, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Aristada, you can do so through MedWatch.

Mild side effects

Mild side effects* of Aristada can include:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Aristada. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Aristada’s Medication Guide.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Aristada aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Neuroleptic malignant syndrome (a rare and possibly fatal reaction to antipsychotic drugs such as Aristada). Symptoms can include:
    • abnormal blood pressure
    • excessive sweating
    • fast heart rate
    • rigid muscles
  • Low levels of white blood cells or neutrophils (a type of white blood cell). Symptoms can include:
    • fever
  • Problems with how your body regulates temperature. Symptoms can include:
    • redness
    • sweating
  • Dysphagia (trouble swallowing). Symptoms can include:
    • feeling like food is stuck in your throat
    • heartburn
    • pain when swallowing
  • Cognitive impairment (trouble thinking) or motor impairment (trouble moving). Symptoms can include:
    • decreased motor skills
    • trouble thinking clearly
    • feeling tired
  • Orthostatic hypotension (decreased blood pressure caused by changing positions, such as standing up), which can lead to falls.* Symptoms can include:
    • lightheadedness
  • Allergic reaction.*
  • Changes in your metabolism.*
  • Compulsive behaviors (urges that are unusual and hard to control).*
  • Tardive dyskinesia (a movement disorder).*
  • Falls.*
  • Suicide.†

* For more information about this side effect, see “Side effect details” below.
† No statistical data about suicides was reported in clinical studies of Aristada. For more information, see the “Common questions about Aristada” section below.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Aristada. It isn’t known how many people may have had an allergic reaction to Aristada in clinical studies.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth, swelling, or redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Aristada, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Changes in your metabolism

Aristada may cause changes in metabolism. In general, metabolism refers to the processes your body uses to make and use energy.

In clinical studies, Aristada caused the following changes in metabolism:

  • Changes in cholesterol levels. Specifically:
    • In 15% of people, cholesterol levels increased from borderline (200 to 239 mg/dL) to high (240 mg/dL or above).
    • And 8% of people had their LDL cholesterol (“bad” cholesterol) levels increase from borderline (between 100 and 159 mg/dL) to high (160 mg/dL and above).*†
  • Increased blood sugar levels. In 14% of people, blood sugar increased from normal to elevated, as shown on A1c tests.* (A1c tests measure average blood sugar levels over time.)
  • Weight gain. Weight gain of 7% or more of a person’s starting weight was experienced by:
    • 10% of people who took Aristada 441 milligrams (mg)
    • 9% of people who took Aristada 882 mg
    • 6% of people who took a placebo (a treatment with no active drug)

Before beginning treatment with Aristada, your doctor will review your medical history. You and your doctor will discuss anything that may put you at risk for changes in your metabolism. During Aristada treatment, you’ll be monitored for changes in your metabolism. This may include having blood tests.

Tell your doctor if you notice any of the following symptoms while taking Aristada:

  • increased blood sugar levels, which can cause:
    • increased need to urinate
    • increased thirstiness
    • excessive hunger
    • weakness
  • unintended weight gain

Changes in cholesterol levels don’t cause noticeable symptoms in most people. Instead, your doctor will monitor your cholesterol with blood tests while you’re taking Aristada.

If you experience metabolism changes while taking Aristada, your doctor may lower your Aristada dosage. They may also prescribe a medication to treat metabolism changes while you continue taking Aristada. Or your doctor may decide to have you take a medication other than Aristada to treat your condition.

* In these studies, Aristada was not compared with other drugs or with a placebo. (A placebo is a treatment with no active drug.)
† Other changes in cholesterol levels were also seen in clinical studies of Aristada. See Aristada’s prescribing information for details.

Compulsive behaviors

It’s possible for Aristada to cause compulsive (unusual or uncontrollable) urges to do certain things.

Although compulsive behaviors weren’t reported in clinical trials of Aristada, this side effect has occurred in people taking oral* aripiprazole. (Aristada contains the active ingredient aripiprazole lauroxil. After you take Aristada, your body turns the prodrug† aripiprazole lauroxil into aripiprazole.)

Examples of compulsive behaviors that you may experience while taking Aristada include:

  • binge eating
  • gambling (this is reported to be the most common compulsive behavior that occurs with aripiprazole)
  • sexual behaviors or impulses
  • shopping

However, it’s important to note that compulsive behaviors and trouble controlling impulses can be symptoms of schizophrenia, which Aristada is used to treat.

If you have any unusual urges or problems controlling impulses while taking Aristada, be sure to tell your doctor. Your family and friends should also help watch for these behaviors, because you may not notice these impulses developing.

Your doctor will likely lower your Aristada dosage if you have problems with impulse control. Or they may have you stop taking Aristada and try a different medication.

* Oral means you take the drug by mouth.
† A prodrug is inactive when it first enters your body. The drug begins to work only after it undergoes chemical changes in your body. See the “Aristada use with other drugs” section below for more information.

Restlessness and agitation

Aristada can cause akathisia (restlessness and agitation). This can sometimes be a side effect of antipsychotic drugs such as Aristada. Symptoms may include:

  • restlessness and a strong urge to move (which may lead to behaviors such as pacing or crossing and uncrossing legs while seated)
  • irritability
  • anxiety
  • a sense of impatience

In clinical studies, akathisia was a common side effect of Aristada. Specifically, 11% of people who took Aristada had akathisia. In comparison, 4% of people who took a placebo had akathisia. (A placebo is a treatment with no active drug.)

Also, in these clinical studies, restlessness without other symptoms of akathisia was seen in:

  • 3% of people who took Aristada 441 mg
  • 1% of people who took Aristada 882 mg
  • 1% of people who took a placebo

If you experience restlessness, agitation, or other symptoms of akathisia while taking Aristada, contact your doctor. They’ll likely evaluate your symptoms to determine the best way to continue your treatment.

Tardive dyskinesia

Tardive dyskinesia (TD) is a movement disorder that can occur as a side effect of antipsychotic drugs, such as Aristada. However, it isn’t known how many people may have experienced TD in clinical trials of Aristada.

Symptoms of TD can include:

  • jerking of your face and jaw
  • having movements that you can’t control

If you develop TD while taking Aristada, it may go away once you stop taking the drug. However, it’s also possible that TD may be irreversible once it develops.

TD most commonly develops in older people, but it can affect people of any age. Your risk for TD may increase as you continue to take Aristada. For this reason, your doctor will prescribe Aristada at the lowest possible dosage for controlling your symptoms. And they’ll monitor you over time to evaluate whether you need to continue treatment with Aristada.

If you develop symptoms of TD, tell your doctor right away. They can discuss the risks and benefits of continuing your treatment with Aristada.

Risk of falls

It’s possible for Aristada to increase the risk of falls. This is because Aristada can cause side effects that can increase your risk for falls, such as:

For example, Aristada can cause orthostatic hypotension, even in people with normal blood pressure.

With orthostatic hypotension, your blood pressure may become very low when you move from lying or sitting down to standing up. This could cause you to fall when standing up. And if your blood pressure drops low enough, this may cause syncope (fainting). Falling can lead to bone fractures and other injuries.

Aristada may increase your risk for falls if you have a condition that puts you at risk for these side effects or if you take another medication that puts you at risk for these side effects.

If you’re concerned about your risk for falls while taking Aristada, talk with your doctor. They can discuss potential ways to lower your risk for this side effect. Or they may have you take a medication other than Aristada.

Other drugs are available that can treat schizophrenia. Some may be a better fit for you than others. If you’re interested in finding an alternative to Aristada, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Examples of other drugs that may be used to treat schizophrenia include:

You may wonder how Aristada compares with other medications that are prescribed for similar uses. Here we look at how Aristada and Abilify Maintena are alike and different.

Ingredients

Aristada contains the active ingredient aripiprazole lauroxil. Abilify Maintena contains the active ingredient aripiprazole.

These two active ingredients aren’t exactly the same. After you take Aristada, your body turns the prodrug* aripiprazole lauroxil into aripiprazole.

Both Aristada and Abilify Maintena belong to a drug class called antipsychotic drugs. (A drug class is a group of medications that work in a similar way).

* A prodrug is inactive when it first enters your body. The drug begins to work only after it undergoes chemical changes in your body. See the “Aristada use with other drugs” section below for more information.

Uses

The Food and Drug Administration (FDA) has approved both Aristada and Abilify Maintena to treat schizophrenia in adults.

Abilify Maintena is also approved to treat bipolar I disorder in adults.

Drug forms and administration

Aristada comes as a liquid solution that’s given by a healthcare provider as an intramuscular injection (an injection into your muscle).

Abilify Maintena comes as a powder that’s mixed with liquid. Abilify Maintena is also given by a healthcare provider as an intramuscular injection.

Side effects and risks

Aristada and Abilify Maintena both contain a form of aripiprazole. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with either Aristada or Abilify Maintena, as well as mild side effects that both drugs may share.

  • Can occur with Aristada:
  • Can occur with Abilify Maintena:
    • sedation (feeling excessively tired or sluggish)
  • Can occur with both Aristada and Abilify Maintena:
    • injection site pain

Serious side effects

The following serious side effects can occur with both Aristada and Abilify Maintena:

* No statistical data about suicides was reported in clinical studies of Aristada. For more information, see the “Common questions about Aristada” section below.

Effectiveness

The only condition both Aristada and Abilify Maintena are used to treat is schizophrenia in adults.

These drugs haven’t been directly compared in clinical studies. But studies have found both Aristada and Abilify Maintena to be effective for treating schizophrenia in adults.

Costs

According to estimates on GoodRx.com, Aristada costs slightly more than Abilify Maintena. The actual price you’ll pay for either drug depends on your dosage, your insurance plan, your location, and the medical facility or pharmacy where you receive your injections.

Aristada and Abilify Maintena are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

You should take Aristada according to your doctor’s or healthcare provider’s instructions. But you won’t need to learn how to give Aristada. Aristada can only be administered by a healthcare provider.

Aristada is given as an intramuscular injection (an injection into your muscle). The injection site is either the deltoid (shoulder) muscle or the gluteal (buttocks) muscle. This depends on which strength of the drug you’re taking. (See the “Aristada dosage” section above for details.)

When it’s given

Before beginning treatment with Aristada:

  • you may be given a one-time dose of Aristada Initio along with oral* aripiprazole, or
  • starting on the day you receive your first Aristada injection, you may take oral aripiprazole for 21 days

Aristada Initio is a medication that contains the same active ingredient as Aristada, aripiprazole lauroxil. After you take Aristada, your body turns the prodrug† aripiprazole lauroxil into aripiprazole.

Aristada Initio is given as a one-time intramuscular injection. Aristada Initio may be given with oral aripiprazole on the same day as your first Aristada injection. Or these drugs may be given up to 10 days before your first Aristada injection.

Beginning your treatment in one of these ways provides a loading dose of aripiprazole. A loading dose is used to make sure there’s enough medication in your body for your first dose of Aristada to start working right away.

Before beginning your treatment, your healthcare provider will have tests done to make sure you can tolerate oral aripiprazole and that you aren’t allergic to this drug.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. Writing down your appointment in your calendar or planner can also help.

* Oral means the drug is taken by mouth.
† A prodrug is inactive when it first enters your body. The drug begins to work only after it undergoes chemical changes in your body. See the “Aristada use with other drugs” section below for more information.

The Food and Drug Administration (FDA) approves prescription drugs such as Aristada to treat certain conditions. Aristada may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Aristada for schizophrenia

Aristada is approved by the FDA for treating schizophrenia in adults.

Schizophrenia is a disorder that affects your behaviors and thoughts. This disorder can greatly impact a person’s everyday activities and social interactions, as well as the lives of those around them.

Symptoms of schizophrenia typically affect people during teenage or young adult years. Males are usually affected at younger ages than females are.

Symptoms of schizophrenia vary from person to person, but may include:

  • Positive symptoms. These are thoughts or behaviors that occur in people with schizophrenia but not in people who don’t have this condition. Examples of positive symptoms include:
    • changes in body movements
    • hallucinations (seeing or hearing something that’s not really there)
    • unusual thoughts
  • Negative symptoms. These symptoms may cause a person to have very little or no emotion. They also may not want to talk as often as usual.
  • Symptoms that affect your memory and ability to think. Examples include trouble paying attention, focusing, and remembering things.

It’s thought that genetics, environmental factors, and changes in certain neurotransmitters (brain chemicals) all may contribute to the development of schizophrenia.

How Aristada works to treat schizophrenia currently isn’t known. The drug may help reduce symptoms by affecting levels of certain neurotransmitters. See the “How Aristada works” section below for more information.

Effectiveness for schizophrenia

In a clinical study, Aristada was effective for treating schizophrenia in adults.

In this study, people took either oral* aripiprazole† or a placebo‡ every day for 3 weeks. Then people either continued to receive a placebo or switched from taking oral aripiprazole to taking Aristada. These doses were given on days 1, 29, and 57 of the study. The study lasted a total of 12 weeks.

Researchers looked at whether Aristada improved people’s scores on the Positive and Negative Syndrome Scale (PANSS). PANSS scores range from 30 to 210. Lower scores indicate having better control of schizophrenia symptoms.

At the end of the study, the researchers found that:

  • people who took Aristada 441 milligrams (mg) monthly had their PANSS score lowered by an average of nearly 21
  • people who took Aristada 882 mg monthly had their PANSS score lowered by an average of nearly 22
  • people who took a placebo had their PANSS score lowered by an average of nearly 10

* Oral means the drug is taken by mouth.
† Aristada contains the active ingredient aripiprazole lauroxil. After you take Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole. A prodrug is inactive when it first enters your body. The drug begins to work only after it undergoes chemical changes in your body. See the “Aristada use with other drugs” section below for more information.
‡ A placebo is a treatment with no active drug.

Aristada for other conditions

In addition to the use listed above, Aristada may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

And you may wonder if Aristada is used for certain other conditions. Below is information about another possible use for Aristada.

Aristada for bipolar

Aristada isn’t approved for treating bipolar disorder. And it isn’t currently used off-label to treat this condition.

However, Abilify (aripiprazole) is approved to treat manic and mixed episodes related to bipolar I disorder in adults. And Aristada contains the active ingredient aripiprazole lauroxil. After you take Aristada, your body turns the prodrug* aripiprazole lauroxil into aripiprazole.

If you have questions about treating bipolar disorder, talk with your doctor.

* A prodrug is inactive when it first enters your body. The drug begins to work only after it undergoes chemical changes in your body. See the “Aristada use with other drugs” section below for more information.

Aristada and children

Aristada isn’t approved for use in children because the drug hasn’t been studied in children. Aristada is only approved for treating adults with schizophrenia.

For treating schizophrenia, Aristada may be used on its own. Or it may be used with other drugs.

Before beginning Aristada treatment, or starting on the day of your first Aristada injection, your doctor may give you a one-time dose of Aristada Initio along with oral* aripiprazole.

Aristada Initio is a medication that contains the same active ingredient as Aristada, aripiprazole lauroxil. And after you take Aristada or Aristada Initio, your body turns their prodrug† aripiprazole lauroxil into aripiprazole.

Aristada Initio is given as a one-time intramuscular injection. Aristada Initio and oral aripiprazole may be given on the same day as your first Aristada injection. Or these drugs may be given up to 10 days before your first Aristada injection.

Alternatively, your doctor may begin your Aristada treatment by having you take aripiprazole tablets. This is given for 21 days, starting on the day you receive your first Aristada injection.

Beginning your treatment in one of these ways provides a loading dose of aripiprazole. A loading dose is used to make sure there’s enough medication in your body for your first dose of Aristada to start working right away.‡

Your doctor may also prescribe Aristada Initio with oral aripiprazole if you miss a dose of Aristada.

* Oral means the drug is taken by mouth.
† A prodrug is inactive when it first enters your body. The drug only begins to work only after it undergoes chemical changes in your body.
‡ When Aristada is taken by itself, it can take about 27 days for the drug to reach its peak (highest) level in your body. However, when a loading dose is given with Aristada, peak levels are reached in about 4 days instead.

As with all medications, the cost of Aristada can vary. To find current prices for Aristada injections in your area, check out GoodRx.com.


The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the medical facility or pharmacy where you receive your injections.

Before approving coverage for Aristada, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Aristada, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Aristada, or if you need help understanding your insurance coverage, help is available.

Alkermes, Inc., the manufacturer of Aristada, offers a copay savings card that may help lower the cost of Aristada. For more information and to find out if you’re eligible for support, visit the drug’s website.

Generic version

Aristada is not available in a generic form. A generic drug is an exact copy of the active drug ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.

Aristada is approved by the FDA for treating schizophrenia in adults. Aristada’s exact mechanism of action (the way the drug works) in the brain isn’t known. It may treat schizophrenia by affecting receptors (attachment sites) for certain brain chemicals. These brain chemicals may include:

  • dopamine, which helps regulate how you feel and think, and
  • serotonin, which helps regulate your behaviors and mood

It’s thought that schizophrenia (as well as certain other mental health conditions) may cause you to have too much dopamine or serotonin in your brain. See “Aristada uses” above for more information about schizophrenia.

Aristada may work by balancing your dopamine and serotonin levels so you don’t have too much or too little inside your brain. This may make your thoughts and behaviors easier to control.

How long does it take to work?

How long it takes Aristada to work can vary from person to person. It can take around 27 days for the drug to reach its peak (highest) concentrations in the body.

However, you may be given a loading dose of aripiprazole* before starting Aristada treatment or starting on the day of your first Aristada injection. This helps make sure there’s enough medication in your body for your first dose of Aristada to start working right away.

When Aristada is given with a loading dose, peak levels are reached in about 4 days instead.

* Aristada contains the active drug aripiprazole lauroxil. After you take Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole. A prodrug is inactive when it first enters your body. The drug begins to work only after it undergoes chemical changes in your body. See the “Aristada use with other drugs” section above for more information.

Here are answers to some frequently asked questions about Aristada.

Will I have to store Aristada?

No, you shouldn’t need to store Aristada or keep the drug at home. Aristada may only be injected by a healthcare provider. So the drug may be stored by the medical facility or pharmacy where you receive your injections.

Is it safe to drive while I’m using Aristada?

Maybe. It depends on how the drug affects you.

Antipsychotic drugs such as Aristada have been shown to affect thinking, judgment, and coordination. For this reason, Aristada could impact your ability to drive or operate machinery.

For this reason, you shouldn’t drive a car or operate machinery until you know how Aristada will affect you. If you have questions about this, talk with your doctor.

Will Aristada give me unusual and uncontrollable urges to do certain things?

It’s possible for Aristada to cause compulsive behaviors (unusual or uncontrollable urges).

Examples of compulsive behaviors you may have while taking Aristada include:

  • binge eating
  • gambling (this is reported to be the most common compulsive behavior that occurs with aripiprazole*)
  • sexual behaviors or impulses
  • shopping

However, it’s important to note that compulsive behaviors and trouble controlling urges can be symptoms of schizophrenia, which Aristada is used to treat. For more information about compulsive behaviors while taking Aristada, see the “Aristada side effects” section above.

* Aristada contains the active drug aripiprazole lauroxil. After you take Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole. A prodrug is inactive when it first enters your body. The drug begins to work only after it undergoes chemical changes in your body. See the “Aristada use with other drugs” section above for more information.

Am I at risk for falls while I’m taking Aristada?

Possibly. Taking Aristada could increase your risk for falls, depending on how the drug affects you.

Aristada can cause dizziness, sleepiness, changes in blood pressure, and problems with coordination. And these side effects can increase your risk for falling. For more information, see the “Aristada side effects” section above.

If I have diabetes, can I use Aristada?

Maybe. Whether someone with diabetes can use Aristada depends on how well your diabetes is managed. It also depends on whether your doctor thinks the medication is safe for you.

There have been reports of people developing high blood sugar when taking antipsychotic drugs, such as Aristada. And taking Aristada may cause changes in your metabolism. These changes could lead to high blood sugar levels or even diabetes.

If you already have diabetes or high blood sugar, tell your doctor before you start taking Aristada. The drug could make it harder to manage your blood sugar. So your doctor will likely work with you to make sure your blood sugar is monitored more frequently during treatment. This is to ensure your blood sugar doesn’t become too high.

While taking Aristada, be sure to watch for any side effects of high blood sugar, such as feeling more thirsty than usual, urinating more than usual, and feeling weak.

Contact your doctor if these symptoms occur. They can work with you to determine whether Aristada is the best treatment for you.

Does Aristada increase the risk of suicidal thoughts or behaviors?

In clinical studies, Aristada wasn’t shown to increase the risk of suicidal thoughts or behaviors.

Abilify (aripiprazole), which is a drug that’s similar to Aristada, has a boxed warning for increased risk* of suicidal thoughts and behaviors. (A boxed warning is the most serious warning from the FDA.) This is because Abilify is used as an antidepressant, and clinical studies have shown that antidepressants can cause this effect to occur.

In separate clinical studies of adults taking Abilify and Aristada, suicide did occur. However, the exact number of suicides in these studies wasn’t reported. And it isn’t known how much each drug may have contributed to suicidal thoughts or behaviors, if at all.

Aristada is an antipsychotic, not an antidepressant. Since Aristada isn’t used to treat depression, the FDA hasn’t applied this boxed warning to Aristada. However, Aristada does have a boxed warning for increased risk of death in certain older people taking the drug. See “FDA Warning” at the beginning of this article for more information.

It’s important to note that your results from taking Aristada may vary from those seen in clinical studies. And if you have questions about whether Aristada is right for you, talk with your doctor.

If you’re taking Aristada and you have new or worsened depression, or you’re feeling sad or anxious, contact your doctor right away. But if you’re having thoughts of harming yourself, call 911 or your local emergency service.

* Abilify’s boxed warning applies to children and adults ages 24 years and younger taking the drug. See Abilify’s prescribing information for details.

There aren’t any known interactions between drinking alcohol and taking Aristada.

However, alcohol can cause trouble focusing, dizziness, sleepiness, and decreased blood pressure. And Aristada can also cause these side effects. So drinking alcohol while taking Aristada could increase your risk for these side effects.

Studies have found a link between schizophrenia (which Aristada is used to treat) and alcohol use disorders. These studies found that having an alcohol use disorder may make schizophrenia treatment less effective than usual.

For these reasons, if you drink alcohol, be sure to talk with your doctor before you start taking Aristada. They may recommend that you avoid drinking alcohol while taking Aristada.

Aristada can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Aristada and other medications

Below are lists of medications that can interact with Aristada. These lists do not contain all drugs that may interact with Aristada.

Before taking Aristada, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Aristada and drugs that affect its level in your body

Aristada is metabolized (broken down by) enzymes (certain proteins) made in your liver. Specifically, two enzymes called CYP2D6 and CYP3A4 metabolize Aristada.

Some drugs can affect the amount of these enzymes that your liver makes. So taking these drugs with Aristada can alter the level of Aristada in your body. Some drugs may cause Aristada levels to increase, while others may decrease Aristada levels. These types of drugs are described below.

If you’re taking any of the medications listed below, your doctor may adjust the dosage of either Aristada or the other drug.

Aristada and strong CYP3A4 inhibitors

Some medications inhibit (block) CYP3A4 from breaking down Aristada. When this happens, levels of Aristada in your body could increase. And this could increase your risk for side effects from the medication.

Examples of strong CYP3A4 inhibitors include:

Aristada and strong CYP2D6 inhibitors

Some medications inhibit (block) CYP2D6 from breaking down Aristada. When this happens, levels of Aristada in your body could increase. And this could increase your risk for side effects from the medication.

Examples of strong CYP3A4 inhibitors include:

Aristada and strong CYP3A4 inducers

Some medications induce (activate) the CYP3A4 enzyme, causing the enzyme to break down Aristada. When this happens, levels of Aristada in your body could decrease. This could cause the medication to not work as well or to stop working entirely.

Examples of strong CYP3A4 inducers include:

Aristada and certain blood pressure medications

Aristada can interact with certain blood pressure medications. In fact, combining Aristada with certain blood pressure medications could cause your blood pressure to become dangerously low. Because Aristada can lower your blood pressure, taking certain blood pressure drugs with Aristada could cause your blood pressure to become too low.

Examples of blood pressure medications that can interact with Aristada include:

If you’re taking a blood pressure medication, be sure to tell your doctor before you begin taking Aristada. They may have you take a lower dosage of either medication. Or they may have you take different medications for your condition.

Aristada and benzodiazepines

Aristada can interact with a class of drugs called benzodiazepines. (A drug class is a group of drugs that work in a similar way.) Benzodiazepines may be used to treat a variety of conditions, including anxiety and seizures.

Examples of benzodiazepines include:

Both Aristada and aripiprazole* can cause your blood pressure to decrease, especially when changing body positions (such as sitting up or standing up). They may both also cause sedation (excessive tiredness and sluggishness). Taking Aristada together with a benzodiazepine may worsen these effects.

Before taking Aristada, be sure to tell your doctor if you’re taking a benzodiazepine. If your doctor prescribes a benzodiazepine along with Aristada, they’ll monitor your blood pressure more often than usual. And they’ll make sure you aren’t excessively sleepy. Your doctor may also have you try a lower dosage of one or both medications, to help lower your risk for these side effects.

* Aripiprazole can also cause these side effects. After you take Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole. A prodrug is inactive when it first enters your body. The drug begins to work only after it undergoes chemical changes in your body. See the “Aristada use with other drugs” section above for more information.

Aristada and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Aristada. However, you should still check with your doctor or pharmacist before using any of these products while taking Aristada.

Aristada and foods

Aristada is known to interact with grapefruit, which is described below. No other foods have been reported to interact with Aristada. If you have any questions about consuming grapefruit or other foods with Aristada, talk with your doctor.

Aristada and grapefruit

You should avoid eating grapefruit and drinking grapefruit juice while you’re taking Aristada.

This is because grapefruit prevents your liver from breaking down Aristada. When this occurs, the level of Aristada in your body can increase. And this can increase your risk for side effects from the drug. Avoiding grapefruit will help ensure that Aristada levels in your body don’t become too high.

It isn’t known if Aristada is safe to take during pregnancy.

When taken during pregnancy, antipsychotic drugs such as Aristada haven’t been shown to increase the risk of birth defects or miscarriage (loss of pregnancy).

However, taking antipsychotic medications during the third trimester of pregnancy may cause the following symptoms in newborn babies:

  • withdrawal symptoms (which occur when the body stops getting a drug that it’s become dependent upon), such as:
    • agitation
    • tremors (uncontrollable shaking in a part of the body)
    • trouble breathing
  • extrapyramidal symptoms (movement disorders that can be side effects of certain antipsychotic drugs and other drugs), such as tremors or shaking

There aren’t any well-controlled studies of Aristada use during pregnancy in humans.

Animal studies of aripiprazole lauroxil (the active ingredient in Aristada) given to pregnant females didn’t show any negative effects from the drug. And these animal studies used doses 5 to 15 times larger than those used in humans. However, it’s important to note that animal studies don’t always predict what will happen in humans.

Clinical studies have looked at aripiprazole* use during pregnancy in humans. These studies showed that aripiprazole may cause:

If you’re pregnant or planning to become pregnant, talk with your doctor before starting Aristada. They can discuss the risks and benefits of using this drug during pregnancy.

* After you take Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole. A prodrug is inactive when it first enters your body. The drug begins to work only after it undergoes chemical changes in your body. See the “Aristada use with other drugs” section above for more information.

Pregnancy registry for Aristada

If you take Aristada while pregnant, there’s a pregnancy registry that you’re encouraged to join. A pregnancy registry collects information about any effects that a drug may have on a pregnancy. The information is then studied to determine whether the drug is a safe option for use during pregnancy.

For more information or to enroll in the National Pregnancy Registry for Atypical Antipsychotics registry, visit the registry website or call 866-961-2388.

It’s not known if Aristada is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Aristada.

For more information about taking Aristada during pregnancy, see the “Aristada and pregnancy” section above.

It isn’t known whether Aristada is safe to take while breastfeeding. Aripiprazole* does pass into human breast milk. But whether the drug causes any effects in breastfeeding females or breastfed children isn’t known.

If you’re breastfeeding or planning to breastfeed, talk with your doctor before taking Aristada. They can discuss with you the risks and benefits of using this drug while you’re breastfeeding.

* Aristada contains the active drug aripiprazole lauroxil. After you take Aristada, your body turns the prodrug aripiprazole lauroxil into aripiprazole. A prodrug is inactive when it first enters your body. The drug begins to work only after it undergoes chemical changes in your body. See the “Aristada use with other drugs” section above for more information.

This drug comes with several precautions.

FDA warning: Increased risk of death in certain older people

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

People 65 years and older who have certain conditions may have an increased risk for death while taking antipsychotic drugs, such as Aristada.

Specifically, older people with psychosis related to dementia (memory loss) are at increased risk. (With psychosis, you lose touch with reality and you may hear or see things that aren’t really there). Due to this risk, Aristada shouldn’t be used by this group of people.

Other precautions

Before taking Aristada, talk with your doctor about your health history. Aristada may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • CYP2D6 poor metabolizers. Aristada is broken down by an enzyme (a type of protein) called CYP2D6. Having a condition that’s sometimes called CYP2D6 poor metabolizer causes this enzyme to not work as well as it should. If you have this condition, Aristada could build up in your body, which may cause serious side effects. If you’ve been told you’re a CYD2D6 poor metabolizer or have problems with your CYP enzyme, it’s very important to tell your doctor before you take Aristada. Your doctor will start you on a lower-than-usual dosage of Aristada. They may also monitor you for side effects more frequently.
  • Diabetes. Taking Aristada may cause changes in your metabolism, which could lead to having high blood sugar levels or diabetes. If you already have diabetes or high blood sugar, tell your doctor before you start taking Aristada. They’ll likely work with you to make sure your blood sugar is monitored more frequently during your treatment. This helps ensure your blood sugar levels don’t become too high while taking Aristada.
  • Falls. In some people, Aristada can cause dizziness, sleepiness, changes in blood pressure, or problems with coordination. If you have a condition or you take a different medication that also puts you at risk for these side effects, Aristada may increase your risk for falls. And falls can lead to bone fractures and other injuries. If you have a condition or take a medication that increases your risk for falls, talk with your doctor before taking Aristada.
  • Heart problems or stroke. People with a history of heart problems (such as heart failure or heart attack) or stroke may be at higher risk for blood pressure problems while taking Aristada (see “High or low blood pressure” just below). Be sure to tell your doctor about any history of heart problems or stroke before you take Aristada.
  • High or low blood pressure. Aristada can cause your blood pressure to become either too high or too low. Your blood pressure may become very low when you move from lying down or sitting to standing up. This is called orthostatic hypotension. Also, in people who already have blood pressure problems, taking Aristada could make these problems worse. For this reason, your doctor may have you monitor your blood pressure more frequently while you take Aristada.
  • Low white blood cell level. Like other antipsychotic drugs, Aristada may cause a low white blood cell level. This can increase your risk for infections. People who have a history of low white blood cell levels may be at higher risk for this side effect. If you have a history of low white blood cell levels, be sure to tell your doctor before you start treatment with Aristada. They’ll likely want to monitor your white blood cell levels more frequently, at least during your first few months taking Aristada.
  • Risk for high body temperature. Antipsychotic drugs such as Aristada may affect the body’s ability to control its temperature. Engaging in strenuous exercise, taking certain medications, or being exposed to extreme heat can increase your risk for this side effect. Be sure to talk with your doctor about your physical activity, or if you’ll be exposed to extreme weather, before taking Aristada.
  • Trouble swallowing. Antipsychotic drugs such as Aristada may cause problems with swallowing. It can even cause aspiration, which occurs when you breathe in foreign objects such as food or saliva when you swallow. Because of this risk, Aristada should be used with caution in people who already have dysphagia (trouble swallowing). Be sure to talk with your doctor about any swallowing problems you have before taking Aristada.
  • Seizures. If you’ve had seizures in the past, taking an antipsychotic drug such as Aristada may increase your risk for seizures or convulsions (sudden irregular movements). If you have any history of seizures or convulsions, talk with your doctor before you begin taking Aristada.
  • Allergic reaction. If you’ve had an allergic reaction to Aristada or any of its ingredients, you shouldn’t take Aristada. Ask your doctor what other medications are better options for you.
  • Pregnancy. It’s not known if Aristada is safe to take during pregnancy. For more information, see the “Aristada and pregnancy” section above.
  • Breastfeeding. It isn’t known whether Aristada is safe to take while breastfeeding. For more information, see the “Aristada and breastfeeding” section above.

Note: For more information about the potential negative effects of Aristada, see the “Aristada side effects” section above.

Using more than the recommended dosage of Aristada can lead to serious side effects.

Do not use more Aristada than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

  • vomiting
  • drowsiness or sleepiness
  • tremors (uncontrollable shaking in a part of the body)
  • confusion, aggression, and other behavioral changes

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

Disclaimer: Medical News Today 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 other 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.