Understanding potential side effects of Aristada injections and appropriate responses
Aristada, a prescribed injection under the brand name, is utilized for managing schizophrenia in adults. Similar to other medications, it may induce side effects such as weight gain, discomfort at the injection site, and impaired mobility.
For a comprehensive understanding of Aristada, including its applications, refer to this article.
Aristada and Aristada Initio
Both Aristada and Aristada Initio contain the active ingredient aripiprazole lauroxil. Aristada is indicated for prolonged usage in schizophrenia treatment. Aristada Initio is administered as a single injection right before the primary dose of Aristada to accelerate the medication's effect in the body. To learn additional details, visit the dosage article about Aristada and Aristada Initio.
This article focuses on the side effects of Aristada. If you have questions about Aristada Initio, consult your doctor or pharmacist.
More common side effects of Aristada
Aristada may cause various side effects, some of which are more frequent than others. These side effects may be temporary, persisting for a few days to weeks. However, if they continue beyond this time or become bothersome or severe, consult your doctor or pharmacist.
In clinical trials, some frequent side effects reported with Aristada include:
- weight gain
- discomfort at the injection site
- headache
- difficulty sleeping
- increased level of an enzyme called creatine phosphokinase, which can be a sign of muscle injury
- impaired mobility*
* For more details, see the "Side effect specifics" section later in this article.
Mild side effects of Aristada
Mild side effects may emerge during Aristada usage. Refer to Aristada's prescribing information for a more comprehensive list.
Mild side effects reported with Aristada include:
- weight gain
- discomfort at the injection site
- headache
- difficulty sleeping
- impaired mobility*
These side effects may be temporary, lasting for a few days to weeks. However, if they persist or become bothersome or severe, contact your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects. If you develop a side effect during Aristada treatment and wish to inform the FDA, visit MedWatch.
* For more details, see the "Side effect specifics" section later in this article.
Serious side effects of Aristada
Aristada may cause serious side effects. The following is not an exhaustive list of potential harmful effects. For further information, reference Aristada's prescribing information.
If you encounter serious side effects while using Aristada, contact your doctor immediately. If the side effects appear life-threatening or you believe you're experiencing a medical emergency, seek immediate help by dialing 911 or your local emergency number.
Serious side effects reported and their symptoms include:
- Reduced white blood cell counts, including neutrophils. Symptoms may include:
- persistent infections
- fever
- Cognitive or motor impairment. Symptoms may include:
- difficulty thinking clearly
- trouble moving or walking
- fatigue
- Trouble regulating body temperature. Symptoms may include:
- feeling warm or sweaty
- Difficulty swallowing. Symptoms may include:
- heartburn
- discomfort while swallowing
- sensation of something stuck in the throat
- Orthostatic hypotension (drop in blood pressure upon standing). Symptoms may include:
- dizziness or lightheadedness
- fainting or loss of consciousness
- Dystonia (unintentional tightening of neck muscles). Symptoms may include:
- tightness in the throat
- difficulty breathing
- tongue protrusion
- Increased level of an enzyme called creatine phosphokinase, which may indicate muscle injury. Symptoms may include:
- muscle pain or discomfort
- confusion
- weakness
- Tardive dyskinesia (persistent repetitive movements). Symptoms may include:
- excessive blinking
- lip smacking
- pursing of the lips
- Falls, potentially due to drowsiness, orthostatic hypotension, lack of coordination, or dizziness
- Neuroleptic malignant syndrome.*
- Metabolic changes.*
- Increased risk of death in older adults with psychosis due to dementia.*†
- Allergic reaction.*‡
* For more details, see the "Side effect specifics" section later in this article.† Aristada includes a "boxed warning" for this side effect, which is the most serious warning from the Food and Drug Administration (FDA).‡ An allergic reaction is possible after using Aristada, but this side effect was not reported in clinical trials.
Aristada, at various dosages, can lead to a variety of side effects. Here are some frequently asked questions about these side effects and their answers.
Does the severity of side effects change depending on the 882-mg strength of Aristada?
No, in clinical trials, the side effects were found to be comparable across different Aristada dosages. Common side effects may include weight gain, discomfort at the injection site, and headaches. For more details on Aristada's side effects, refer to the earlier segments of this article.
Should you have further questions about Aristada's side effects, consult your healthcare provider.
Can Aristada induce diabetes?
There's a possibility. Reports indicate that individuals might develop elevated blood sugar levels while using aripiprazole tablets (the oral form of aripiprazole). Aristada, being an injection, contains aripiprazole lauroxil, which is metabolized into aripiprazole.
Elevated blood sugar levels have been observed in people who had a predisposition to diabetes. Factors like obesity and a family history of diabetes might increase this risk. If you have diabetes or are predisposed to it, inform your doctor before beginning Aristada treatment.
Pay close attention to symptoms of high blood sugar during Aristada usage. These might include excessive thirst, frequent urination, increased hunger, or feelings of weakness or fatigue.
Inform your doctor if these symptoms emerge. Doing so can help them determine whether Aristada is the most suitable treatment option for you.
Can Aristada lead to uncontrollable urges?
Aristada treatment could potentially cause compulsive behaviors (uncontrollable urges to engage in specific activities). This side effect was not reported in Aristada's clinical trials. However, it has been observed in individuals using aripiprazole tablets (Aristada contains aripiprazole lauroxil, which transforms into aripiprazole in the body).
Examples of these behaviors include:
- excessive gambling
- strong sexual urges
- binge eating
- excessive shopping
It's crucial to note that compulsive behaviors may also be associated with schizophrenia, which Aristada is used to treat. Therefore, it's plausible that these behaviors might not be solely due to Aristada.
Notify your doctor if you develop issues with compulsive behavior. It may also be helpful to involve a trusted friend or family member in monitoring your behavior, as they might notice changes before you do.
Is there a risk of suicide with Aristada?
Although suicide has been reported in Aristada's clinical trials, it remains unclear whether the drug was the cause. Aristada is employed to treat schizophrenia, and this disorder might potentially increase the risk of suicide. In the trials, people receiving Aristada did not exhibit an increase in suicidal thoughts or behaviors.
If you're taking Aristada and are experiencing new or worsening depression or anxiety, communicate with your doctor. However, if you're experiencing thoughts of self-harm, immediately contact 911 or your local emergency services.
Suicide prevention
If you detect someone at immediate risk of self-harm, suicide, or harming another person:
- Initiate the open-ended question: "Are you contemplating suicide?"
- Listen attentively without judgment.
- Contact 911 or your local emergency services, or text TALK to 741741 to interact with a trained crisis counselor.
- Remain with the person until professional assistance arrives.
- Safely remove any potential lethal objects, weapons, medications, or other hazards, if feasible.
If you or someone you know is experiencing thoughts of suicide, a prevention hotline can provide aid. The 988 Suicide and Crisis Lifeline is available 24/7 at 988. During a crisis, people who are hard of hearing can contact their preferred relay service or dial 711 then 988.
Access additional links and local resources.
Information on specific side effects
Dive deeper into certain side effects that Aristada may induce. To learn the frequency of side effects observed in clinical trials, refer to Aristada's prescribing information.
Inability to keep still
Aristada might cause akathisia (the inability to stay still). Symptoms may include:
- Feeling anxious or irritable
- Being impatient
- Experiencing restlessness, particularly when seated
In clinical trials, akathisia was a regularly reported side effect among those receiving Aristada.
What you can do
Should you develop symptoms of akathisia, consult your doctor. This will help them decide if adjustments to your treatment plan are necessary.
Metabolism alterations
Aristada might cause changes in metabolism (how the body generates and utilizes energy). In clinical trials, Aristada led to:
- Weight gain
- Increased cholesterol levels
- Elevated blood sugar levels
Cholesterol level changes usually won't cause noticeable symptoms, so your doctor will monitor your levels with blood tests. An increased blood sugar level might make you feel excessively thirsty, hungry, or with an elevated need to urinate.
What you can do
During Aristada treatment, inform your doctor if you gain weight unintentionally. Additionally, discuss any symptoms of an increased blood sugar level with them. They can determine whether adjustments to your treatment plan are required.
Antipsychotic-induced Neuroleptic Malignant Syndrome (NMS) is an uncommon side effect that can manifest in individuals consuming antipsychotic medications, such as Aristada. Although uncommon, this side effect can be life-threatening.
Signs of NMS may include:
- A fever surpassing 100.4°F (38°C)
- Rigid muscles
- Feelings of confusion or disorientation
- An irregular or fast heart rate
- Varying blood pressure, fluctuating between high and normal
- Sweating
- Muscle deterioration known as rhabdomyolysis
How to Respond
NMS is considered a medical emergency. If you suspect that you're experiencing any of the aforementioned symptoms, contact your local emergency number (such as 911 in the US) or visit your nearest emergency room promptly.
Enhanced Mortality Risk in Elderly Individuals with Psychosis due to Dementia
Aristada carries a black box warning regarding the heightened risk of death in elderly individuals dealing with psychosis due to dementia. A black box warning is the most severe warning issued by the Food and Drug Administration (FDA). This warning alerts doctors and patients about potentially harmful drug effects.
Individuals over 65 years of age may have an elevated risk of death while taking antipsychotic medications like Aristada, particularly those with psychosis due to dementia.
To clarify, elderly adults who have psychosis as a result of dementia are at a higher risk. This risk may discourage doctors from prescribing Aristada to individuals over 65 years old with psychosis due to dementia.
What to Do
Engage in a conversation with your doctor to establish if Aristada is the appropriate treatment for you. If not, they may suggest alternative treatments.
Allergic Reactions
Like many medications, Aristada can cause an allergic reaction in some individuals. However, this side effect was not observed in Aristada's clinical trials.
The severity of the reaction can vary, presenting as:
- Skin rashes
- Itching
- Flushing
- Swelling in the skin, often manifesting under the lips, eyelids, feet, or hands
- Swelling of the mouth, tongue, or throat, which could make breathing difficult
What to Do
For mild signs of an allergic reaction, contact your doctor immediately. They may suggest ways to alleviate your symptoms and assess whether you should continue receiving Aristada. Yet, if your symptoms are severe and you believe you're experiencing a medical emergency, call 911 or your local emergency number immediately.
Aristada's Precautions
Consider the following precautions before commencing Aristada treatment:
Black Box Warning: Increased Risk of Death in Elderly Individuals with Psychosis due to Dementia
Aristada carries a black box warning for an elevated risk of death in elderly individuals dealing with psychosis due to dementia. For more details, refer to the “Side effect specifics” section earlier in this article.
Additional Precautions
Before initiating Aristada therapy, discuss your medical history with your doctor. If you have specific health conditions or factors that might impact your wellbeing, Aristada may not be the ideal treatment for you. Relevant conditions and factors to consider include:
Diabetes: Aristada can trigger alterations in your metabolism, leading to elevated blood sugar levels. If you have diabetes and are prescribed Aristada, your doctor will closely monitor your blood sugar levels. This helps maintain your blood sugar within the desired range during your treatment. Additionally, disclose any family history of diabetes to your doctor.
Low white blood cell count: Aristada can potentially cause a decrease in white blood cell counts. This can compromise your immune system, making you more susceptible to infection. Individuals with previous low white blood cell count issues may be at an increased risk of this side effect. Inform your doctor about any prior complications you've encountered with your white blood cell counts. They'll routinely carry out blood tests to monitor your levels before and during your treatment with Aristada.
Older age with stroke or heart problems: Elderly individuals with dementia have a higher risk of strokes and transient ischemic attacks compared to the average population. Before initiating Aristada therapy, share your stroke or heart problems history with your doctor. They can assist you in weighing the risks and benefits of Aristada treatment and may suggest alternative treatments if necessary.
Low blood pressure: A condition called orthostatic hypotension can occur when you start Aristada therapy or when your dose is heightened. Orthostatic hypotension is marked by a significant drop in blood pressure when transitioning from a lying or sitting position to standing. If you already suffer from low blood pressure issues, Aristada may exacerbate these problems. While receiving Aristada, your doctor may advise more frequent blood pressure monitoring than usual.
Dysphagia or swallowing problems: Antipsychotic medications, including Aristada, can cause swallowing difficulties. This may include aspiration, a problem in which food or liquid enters the windpipe instead of the esophagus. If you have dysphagia or other swallowing problems, inform your doctor prior to initiating Aristada therapy. They can assess whether Aristada is a safe treatment option and may recommend alternative treatments, such as medications or speech therapy.
Seizure incidences: Previous experiences of seizures or convulsions may enhance your vulnerability to seizures or fits when utilizing Aristada. Share these experiences with your doctor before initiating Aristada treatment to ascertain if the therapy is secure for you. They might also watch you more closely during the initiation of treatment or when the dose is adjusted.
Increased fall risk: Aristada may induce sleepiness, orthostatic hypotension, impaired coordination, and dizziness. Such side effects can increase your likelihood of falling. If you use specific medications with Aristada or have certain medical issues such as cerebrovascular accident, your risk of falls might be elevated compared to average. Falls can result in fractures and other injuries.
Discuss any other medications you take with your doctor prior to beginning Aristada treatment. They'll evaluate whether it's safe for you to obtain Aristada. Your doctor might also monitor you more closely during the initiation of treatment and when the dose is adjusted.
Temperature regulation issues: Aristada can influence the body's temperature regulation capabilities. Factors such as engaging in regular strenuous exercise, experiencing extreme heat, dehydration, or using certain medications may enhance your susceptibility to this adverse effect.
Before commencing Aristada treatment, speak to your doctor about your physical activity level. Also, inform them if you will be exposed to extreme weather conditions. Your doctor can assess whether it's secure for you to initiate Aristada treatment. They might also monitor you more closely during the medication's administration and when the dose is adjusted.
Problems with the CYP2D6 enzyme: Aristada is metabolized by an enzyme known as CYP2D6. If this enzyme function less effectively than normal, Aristada could accumulate in your body. This can lead to serious side effects such as vomiting, extreme fatigue, or tremors. Inform your doctor if you have ever been advised you have issues with this enzyme. They will start you on a lower dosage of Aristada and monitor you closely for side effects.
Allergic reaction: If you have previously experienced an allergic reaction to Aristada or any of its components, your doctor might not prescribe Aristada. Discuss alternative medication options with your doctor.
Alcohol and Aristada
There's no known interaction between alcohol and Aristada. Alcohol can, nonetheless, cause dizziness, low blood pressure, and sleepiness. These side effects are also associated with Aristada, and consuming alcohol during treatment may exacerbate them.
If you consume alcohol, consult with your doctor about the safe amount, if any, to consume in conjunction with Aristada.
Pregnancy and breastfeeding with Aristada
The safety of Aristada during pregnancy is not fully established. Insufficient human research is available to determine whether the drug is safe to administer during pregnancy.
Antipsychotic drugs, including Aristada, have not been shown to increase the risk of congenital anomalies (birth defects) or pregnancy loss when taken during pregnancy. However, using antipsychotic drugs during the third trimester of pregnancy may result in withdrawal symptoms in newborns.
If you decide to initiate Aristada treatment while pregnant, consider registering with the National Pregnancy Registry for Atypical Antipsychotics. This registry collects information about potential side effects of Aristada and similar drugs on pregnancies. For more information, visit the registry website or contact 866-961-2388.
Aristada is excreted in breast milk, but the effects on the nursing infant are uncertain. If you're breastfeeding or plan to breastfeed, discuss safe and healthy feeding options with your doctor.
When to contact your doctor
Mild side effects are often observed with Aristada. However, in unusual instances, the drug can produce severe or bothersome side effects. Consult your doctor if you develop severe or troublesome side effects.
If you wish to learn more about Aristada, speak with your doctor or pharmacist. They can provide answers to any questions you might have regarding the drug's side effects.
Additionally, you can conduct independent research. These articles may provide additional information:
- More details about Aristada: For a detailed overview of other aspects of Aristada, refer to this article.
- Dosage information: You can find information about Aristada's dosage in this article.
- Drug comparison: To compare Aristada with Abilify Maintena, read this article.
- Understanding your condition: Learn about mental health and schizophrenia at our mental health hub and review our schizophrenia articles.
Warning: Medical News Today has taken every step to ensure that all data is accurate, all-inclusive, and up-to-date. However, this piece should not be utilized as a stand-in for the counsel and competence of a legitimate medical practitioner. You should always confer with your doctor or another healthcare professional before ingesting any medication. The drug-related information presented here is susceptible to change and is not intended to cover every potential application, dosage, precautions, warnings, drug interactions, allergic responses, or negative side effects. The omission of warnings or other drug-related information does not imply that the drug or drug combination is safe, effective, or suitable for all individuals or specific uses.
After considering the provided text, here are two sentences that incorporate the words 'side' and 'effects' and follow from the discussion:
- In the clinical trials, some frequent side effects reported with Aristada include weight gain, discomfort at the injection site, and impaired mobility.
- It's important to note that while Aristada may cause serious side effects, these are less common compared to the more frequent side effects such as weight gain or discomfort at the injection site.
