Aristada (aripiprazole lauroxil) is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat schizophrenia in adults.

Here are some fast facts about Aristada:

  • Active ingredient: aripiprazole lauroxil
  • Drug class: antipsychotic drugs
  • Drug form: solution given by a healthcare professional as an intramuscular injection

Aristada and Aristada Initio

Aristada and Aristada Initio both contain the active ingredient aripiprazole lauroxil. However, Aristada Initio has a greater amount of aripiprazole lauroxil.

Aristada is used long term for the treatment of schizophrenia. Aristada Initio (also used to treat schizophrenia) is given as a one-time injection just before the first dose of Aristada. The increased amount of aripiprazole lauroxil helps the drug start working quickly in your body. To learn more, see the dosage article about Aristada and Aristada Initio.

This article is about side effects that can happen with Aristada. If you have questions about Aristada Initio, ask your doctor or pharmacist.

Like other drugs, Aristada injections can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Aristada, including details about its uses, see this article.

Aristada can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Aristada in clinical trials:

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Aristada use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Aristada’s prescribing information.

Mild side effects that have been reported with Aristada include:

These side effects may be temporary, lasting a few days to weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Aristada and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.

Aristada may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Aristada’s prescribing information.

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

Serious side effects that have been reported and their symptoms include:

* For more information about this side effect, see “Side effect specifics” below.
Aristada has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA).
‡ An allergic reaction is possible after using Aristada. But this side effect wasn’t reported in clinical trials.

Aristada may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Do side effects of the 882-mg strength of Aristada differ from the other strengths?

No. In clinical trials, the side effects were similar among different dosages of Aristada. A few common side effects may include weight gain, pain at the injection site, and headache. To learn more about side effects from Aristada, see the “Aristada side effects” section above.

If you have additional questions about side effects from Aristada, talk with your doctor.

Can Aristada cause diabetes?

It’s possible. There have been reports of people developing increased blood sugar levels while taking aripiprazole tablets. (The tablets are the oral form aripiprazole, which is the active ingredient in Aristada.)

Increased blood sugar levels occurred in people who may have already been at risk of developing diabetes. Being overweight or having a family history of diabetes may increase your risk of the condition. If you already have diabetes or are at risk of developing it, tell your doctor before you start Aristada treatment.

While receiving Aristada, be sure to watch for symptoms of high blood sugar. Symptoms may include extreme thirst, urinating frequently, increased hunger, or feeling weak or tired.

Talk with your doctor if these symptoms occur. They can help determine whether Aristada is the best treatment option for you.

Does Aristada cause unusual urges that are hard to control?

It’s possible for Aristada to cause compulsive behaviors (uncontrollable urges to do certain things). This side effect was not reported in clinical trials of Aristada. However, it has happened in people taking aripiprazole tablets. (The tablets are the oral form aripiprazole, which is the active ingredient in Aristada.)

Examples of these behaviors can include:

It’s important to note that compulsive behaviors can also occur with schizophrenia, which Aristada is used to treat. So, it’s possible these behaviors may not be due to Aristada alone.

Tell your doctor if you develop problems with compulsive behavior. It’s helpful ask a trusted friend or family member to also watch for these behaviors. They may notice changes in your behavior before you do.

Is suicide a concern with Aristada?

Although suicide has been reported in people who received Aristada in clinical trials, it isn’t known if the drug was the cause. Aristada is used to treat schizophrenia, and this disorder may increase the risk of suicide. In the trials, people who received Aristada did not have an increased risk of suicidal thoughts or behaviors.

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

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The National Suicide Prevention Lifeline is available 24 hours per day at 800-273-8255. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 800-273-8255.

Click here for more links and local resources.

Learn more about some of the side effects that Aristada may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Aristada.

Inability to stay still

Aristada can cause akathisia (inability to stay still). Symptoms may include feeling:

  • anxious or irritable
  • impatient
  • restless, especially when sitting

In clinical trials, akathisia was a common side effect of people who received Aristada.

What you can do

If you develop symptoms of Aristada, talk with your doctor. They can help determine whether any changes to your treatment plan are needed.

Metabolism changes

Aristada can cause changes in metabolism (how your body makes and uses energy). In clinical trials, Aristada caused:

Cholesterol level changes shouldn’t cause noticeable symptoms, so your doctor will monitor your levels with blood tests. An increased blood sugar level can cause you to feel more thirsty or hungry than usual. It may also make you feel weak or have an increased need to urinate.

What you can do

While you receive Aristada, tell your doctor if you gain weight without trying to. You should also talk with them if you notice any symptoms of an increased blood sugar level. They can help determine if any changes to your treatment plan are needed.

Neuroleptic malignant syndrome

Neuroleptic malignant syndrome (NMS) is an uncommon side effect that can happen in people taking antipsychotic drugs, including Aristada. This side effect can, in rare cases, be fatal.

Symptoms of NMS can include:

  • high fever, which is a temperature of more than 100.4°F (38°C)
  • stiff muscles
  • feeling confused or disoriented
  • fast or irregular pulse
  • blood pressure that varies between high and normal
  • sweating
  • breakdown of the muscles known as rhabdomyolysis

What you can do

NMS is a medical emergency. If you feel you have any of the symptoms listed above, call 911 or your local emergency number or go to your nearest emergency room.

Increased risk of death in older adults with psychosis due to dementia

Aristada has a boxed warning about a risk of death in older adults with psychosis due to dementia. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). A boxed warning tells doctors and patients about drug effects that may be dangerous.

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

To be specific, older people who have psychosis due to dementia are at an increased risk. (Psychosis refers to having trouble recognizing what is real and what isn’t real. Dementia is a decline in memory, thinking, and communication.) Due to this risk, doctors typically won’t prescribe Aristada to people ages 65 years and older who have psychosis due to dementia.

What you can do

Talk with your doctor to see if Aristada is right for you. If it’s not, they may be able to recommend other possible treatments.

Allergic reaction

As with most drugs, Aristada can cause an allergic reaction in some people. However, this side effect wasn’t reported in clinical trials for Aristada.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your lips, eyelids, feet, or hands
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Aristada. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

There are certain precautions to consider before taking Aristada. This includes a boxed warning from the Food and Drug Administration (FDA).

Boxed warning: Increased risk of death in older adults with psychosis due to dementia

Aristada has a boxed warning for an increased risk of death in older adults with psychosis due to dementia. This is a serious warning from the FDA. For details, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before you take Aristada. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include the following.

Diabetes. Aristada can cause changes in your metabolism, which can lead to increased blood sugar levels. If you have diabetes and are prescribed Aristada, your doctor will monitor you blood sugar levels closely. This helps prevent your levels from becoming too high during your treatment. Also, be sure to tell your doctor if you have a family history of diabetes. (If a family member has the condition, your risk of it may increase.)

Low white blood cell count. Aristada can cause a decrease in white blood cell counts. This can weaken your immune system and lead to infection. If you have or have had a low white blood cell count, you may be at a greater risk for this side effect than usual. Tell your doctor about any problems you’ve had in the past with your white blood cell counts. They’ll likely order regular blood tests to check your levels before and during treatment with Aristada.

Older age with stroke or heart problems. People age 65 years and older with dementia also had a higher risk of strokes and transient ischemic attacks than usual. Before starting Aristada treatment, tell your doctor if you have a history of stroke or heart problems. They can help you weigh the risks and benefits of Aristada. Your doctor can also recommend a different treatment option for you, if necessary.

Low blood pressure. A condition called orthostatic hypotension can happen when you first start Aristada treatment or when your dose is increased. Orthostatic hypotension is when your blood pressure becomes very low when you move from lying down or sitting to standing up. If you already have blood pressure problems, taking Aristada could make these problems worse. While taking Aristada, your doctor may have you monitor your blood pressure more frequently than usual.

Problems swallowing. Aristada, like other antipsychotic drugs, may cause trouble with swallowing. This includes a problem known as aspiration. If you have dysphagia or other swallowing problems, be sure to tell your doctor before starting Aristada treatment. They can determine if it’s safe for you to receive Aristada. Your doctor may also recommend different treatments, such as medication or speech therapy, to help with the symptoms.

Seizures. If you have had seizures in the past, Aristada may increase your risk for seizures or convulsions. Tell your doctor if you have a history of seizures or convulsions before starting Aristada treatment. They can determine if it’s safe for you to start receiving Aristada. Your doctor may also monitor you more closely when you begin treatment or if they adjust your dose.

Conditions or medications that increase the risk of falls. Aristada can cause sleepiness, orthostatic hypotension, lack of coordination, and dizziness. These side effects can make you more likely to fall. If you take certain medications with Aristada or have certain health problems such as stroke, your risk for falls may be greater than usual. Falls can lead to fractures and other injuries.

Before starting Aristada treatment, talk with your doctor about any other medications you take. They’ll determine if it’s safe for you to receive Aristada. Your doctor may also monitor you more closely when you begin treatment and if they adjust your dose.

High body temperature. Aristada can affect how the body regulates its temperature. Certain factors may increase your risk of this side effect. These can include participating in regular strenuous exercise, being exposed to extreme heat, being dehydrated, or taking certain medications.

Before starting Aristada treatment, talk with your doctor about your physical activity. You should also mention if you’ll be exposed to extreme weather. Your doctor can determine if it’s safe for you to start Aristada treatment. They may also monitor you more closely when you begin receiving the medication and if they adjust your dose.

Problems with an enzyme called CYP2D6. Aristada is broken down by an enzyme known as CYP2D6. If this enzyme doesn’t work as well as it should, Aristada could build up in your body. This can cause serious side effects such as vomiting, extreme tiredness, or tremor. Tell your doctor if you’ve ever been told you have problems with this enzyme. They’ll start you on a lower dosage of Aristada and monitor you for side effects more closely.

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 may be better options for you.

Alcohol use with Aristada

There’s no known interaction with alcohol and Aristada. However, alcohol can cause dizziness, low blood pressure, and sleepiness. These are also side effects of Aristada. So consuming alcohol during Aristada treatment may increase your risk of these side effects.

If you drink alcohol, talk with your doctor about how much alcohol, if any, may be safe to consume with Aristada.

Pregnancy and breastfeeding while taking Aristada

It’s not known if Aristada is safe to use during pregnancy. There hasn’t been enough research in humans to determine if the drug is safe to receive while pregnant.

Antipsychotic drugs, such as Aristada, have not been shown to increase the risk of congenital anomalies (commonly known as birth defects). The drugs also have not shown an increased risk of pregnancy loss when taken during pregnancy.

However, using antipsychotic drugs in the third trimester (months 8 to 9) of pregnancy may cause withdrawal symptoms in newborns. (Withdrawal symptoms may occur when your body suddenly stops receiving a drug that it’s dependent on.) Symptoms of withdrawal in newborns may include tremors, trouble breathing, and agitation (very irritable or fussy).

Aristada passes into breast milk, but it’s not known what affect this has on a breastfed child. If you’re breastfeeding or planning to breastfeed, talk with your doctor. They can recommend safe and healthy ways to feed your child.

When side effects happen with Aristada, they tend to be mild. However, in rare cases, the drug can cause serious side effects. Talk with your doctor if you develop side effects that are severe or bothersome.

If you’d like to learn more about Aristada, talk with your doctor or pharmacist. They can help answer any questions you have about side effects of taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

  • More information about Aristada. For details about other aspects of Aristada, refer to this article.
  • Dosage details. You can find out about Aristada’s dosage with this article.
  • Drug comparison. To learn how Aristada compares with Abilify Maintena, read this article.
  • A look at your condition. For details about mental health and schizophrenia, see our mental health hub and list of schizophrenia articles.

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 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.