Exploring Side Effects of Rexulti and Suggestions for Management
Exploring Side Effects of Rexulti and Suggestions for Management
Rexulti carries alert warnings. The sternest warning from the Food and Drug Administration (FDA) is an alert warning. For further insights, delve into the "Side effect specifics" section.
Additional prevalent side effects of Rexulti
Below are some of the more typical side effects reported by individuals who used Rexulti during clinical trials. The side effects can differ based on the medical condition the medication is meant to treat.
More prevalent side effects in individuals taking Rexulti for depression incorporate:
- restlessness and inability to stay still (akathisia)
- weight gain
- drowsiness
More prevalent side effects in individuals taking Rexulti for schizophrenia include:
- akathisia
- weight gain
More prevalent side effects in individuals taking Rexulti for agitation due to dementia from Alzheimer’s disease include:
- common cold (nasopharyngitis)
- dizziness
Mild side effects of Rexulti
Mild side effects can arise in individuals using Rexulti. This list does not encompass all conceivable mild side effects of the drug. For additional information, consult Rexulti’s prescribing information.
Mild side effects reported with Rexulti comprise:
- weariness
- sleeplessness
- restlessness and inability to stay still (akathisia)
- headaches
- uncontrollable shaking (tremors)
- common cold (nasopharyngitis)
- dizziness
These symptoms might be temporary, lasting a few days or weeks. However, if the symptoms persist longer, or worsen, communicate with your doctor or pharmacist.
Noteworthy: Upon the approval of a drug by the FDA, they track and scrutinize side effects. If you develop a side effect while taking Rexulti and wish to inform the FDA, visit MedWatch.
Potentially serious side effects of Rexulti
Rexulti may result in serious side effects. The following list might not encompass all conceivable serious side effects of the drug. For more information, consult Rexulti’s prescribing information.
If you develop serious side effects while taking Rexulti, contact your doctor immediately. If the side effects seem life-threatening or you believe you're experiencing a medical emergency, immediately contact 911 or your local emergency number.
Serious side effects reported and their symptoms include:
- neuroleptic malignant syndrome, which might manifest as:
- confusion
- rapid heart rate
- fever
- abnormally high or low blood pressure
- rigid muscles
- sweating
- tardive dyskinesia, which might manifest as:
- excessive blinking
- trouble controlling facial movements or tongue movements
- uncontrollable arm movements
- high blood sugar, which might manifest as:
- excessive thirst
- excessive hunger
- needing to urinate more frequently than usual
- weakness
- fatigue
- orthostatic hypotension, which might manifest as:
- dizziness upon standing up after you've been sitting or lying down
- seizures, which might manifest as:
- loss of consciousness
- confusion
- uncontrollable movements of your arms or legs
- neck spasms, which might manifest as:
- difficulty breathing
- difficulty swallowing
- food getting stuck in your throat
- body temperature regulation problems, which might manifest as:
- difficulty cooling down after exercise or heat exposure
- stroke, which might manifest as:
- confusion
- numbness or weakness in your arms, face, or legs
- difficulty speaking
- difficulty seeing from one or both of your eyes
- increased blood cholesterol or triglyceride levels
- severely low white blood cell count, which might increase your risk of infections
- risk of death in certain older adults*
- risk of suicidal thoughts and behaviors in certain children and younger adults*
- weight gain**
- allergic reaction***
*Rexulti has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see “Side effect specifics.”** This side effect was a common occurrence in Rexulti’s clinical trials, regardless of the medical condition it was used to treat.*** An allergic reaction is possible after taking Rexulti. However, this side effect was not reported in clinical trials.*
Rexulti and weight gain
Weight gain can be a side effect of Rexulti. This was a prevalent side effect reported in Rexulti’s clinical trials, regardless of the medical condition it was used to treat.
For some individuals, this weight gain can be significant. Some individuals in these trials discontinued taking Rexulti due to weight gain.
The quantity of weight gained might depend on various factors, such as your dosage of Rexulti, your medical condition, your diet, your exercise level, and other health issues you might have.
What you can do
While taking Rexulti, your doctor will closely monitor your weight. They may instruct you to monitor and record your weight at home as well to track any increases.
If you're concerned about experiencing weight gain while on Rexulti, it's crucial to discuss this with your doctor or pharmacist. They can provide advice on maintaining a healthy weight and suggest alternative treatments if necessary.
Side Effect Details
Delve deeper into some potential side effects of Rexulti.
Fatigue
Fatigue is a potential side effect of Rexulti treatment. Even if you get a good night's sleep, the drug may leave you feeling tired.
To learn more about the frequency of fatigue in clinical trials, consult the drug's prescribing information.
Interesting fact: Insomnia is also a possible side effect of Rexulti. Learn more about it in the relevant section.
What you can do
Your doctor may advise against driving or operating machinery until you're certain that Rexulti isn't making you feel fatigued.
If you're experiencing persistent or bothersome fatigue, reach out to your doctor or pharmacist. They may suggest methods to boost your energy levels. In some cases, they may even recommend switching to a different medication.
Headaches
Headaches are a potential side effect of Rexulti. In many cases, these headaches may disappear after a few days or weeks of treatment.
For additional information on the prevalence of headaches in clinical trials, review the prescribing information for Rexulti.
What you can do
If you're dealing with headaches while on Rexulti, speak with your doctor or pharmacist. They may be able to identify any underlying causes and suggest potential remedies, such as over-the-counter pain relievers.
If your headaches are severe or persistent, your doctor may recommend switching to a different medication.
Insomnia
Insomnia (difficulty falling or staying asleep) is a potential side effect of Rexulti.
What you can do
If you find yourself struggling with insomnia while taking Rexulti, inform your doctor or pharmacist. They may suggest strategies to improve your daytime energy levels or recommend sleep aids, such as melatonin or improved sleep hygiene. In some instances, they may recommend switching to a different medication.
Risk of death in older adults (65 and over)
Rexulti carries a black box warning regarding the risk of death in older adults (65 and over) with certain mental health conditions. This is the most serious warning from the FDA.
Antipsychotic drugs, like Rexulti, can increase the risk of death in older adults with psychosis related to dementia. As a result, Rexulti is not approved for the treatment of psychosis (without agitation) associated with dementia due to Alzheimer's disease.
However, Rexulti can be prescribed for agitation associated with dementia due to Alzheimer's disease.
What you can do
Before starting Rexulti, your doctor will review your medical history to ensure it's a safe and effective treatment for you. If you have concerns about this black box warning, discuss them with your doctor.
Risk of suicidal thoughts in children and younger adults (24 and under)
Rexulti has a black box warning regarding the risk of suicidal thoughts and behaviors in children and young adults (24 and under). This is the most serious warning from the FDA.
Like other medications used to treat depression, Rexulti has been shown to increase the risk of suicidal thoughts and behaviors in children and young adults. This risk is particularly high during the initial stages of treatment and when doses are adjusted.
Remember that mental health conditions, including depression, also increase the likelihood of suicidal thoughts and behaviors.
What you can do
Before taking Rexulti, your doctor will discuss these risks with you. They may also suggest having a trusted person monitor your behaviors, feelings, moods, and thoughts while you're on Rexulti.
While you're on Rexulti, be aware of any changes in your behavior, especially sudden changes. Your doctor may recommend switching to a different medication if necessary.
Suicide prevention
If you or someone else is at immediate risk of suicide, self-harm, or harming another person:
- Ask the difficult question: "Are you considering suicide?"
- Listen without judgment.
- Contact 911 or your local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
- Stay with the person until professional help arrives.
- Secure any potentially harmful objects if it's safe to do so.
If you or someone else is experiencing suicidal thoughts, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, individuals who are hard of hearing can use their preferred relay service or dial 711 then 988.
Find more resources and links.
Similar to many medications, Rexulti might trigger an hypersensitivity reaction in certain individuals. This side effect wasn't noted during medical trials.
The symptoms can range from mild to severe and include:
- skin rashes
- itching
- blushing
- swelling in various body parts, such as the lips, eyelids, feet, or hands
- swelling of the mouth, tongue, or throat, which may hinder breathing
What you can do
For mild symptoms of a hypersensitivity reaction, promptly get in touch with your doctor. They might suggest methods to ease your symptoms and determine if continuing with Rexulti is advisable. However, if your symptoms are severe and you suspect a medical emergency, contact 911 or your local emergency number immediately.
Commonly Asked Questions about Rexulti's Side Effects
Rexulti may produce several side effects. Below are some frequently asked questions about the drug's side effects along with their answers.
Do Rexulti side effects change depending on the drug's strength?
Yes, the risk of certain side effects may differ based on the strength of the medication you're taking. Rexulti tablets are available in the following strengths:
- 0.25 milligrams (mg)
- 0.5 mg
- 1 mg
- 2 mg
- 3 mg
- 4 mg
During clinical trials, individuals taking 3 mg of Rexulti daily reported akathisia (a sensation of restlessness and inability to stay still) more frequently than those taking 2 mg or 1 mg.
If you'd like to know more about specific side effects of Rexulti that might differ by strength, consult the medication's prescribing information. You can also talk to your doctor or pharmacist for further information.
Can stopping Rexulti treatment trigger withdrawal side effects?
Yes, stopping Rexulti treatment might result in withdrawal side effects. Withdrawal refers to undesirable effects that can transpire when you abruptly stop taking a drug that your body has grown dependent on. (With dependence, your body requires a drug to function normally.)
Withdrawal wasn't reported during clinical trials of Rexulti. However, withdrawal has been observed in people who abruptly stopped taking similar drugs, such as Abilify (aripiprazole). Abilify and Rexulti belong to the same class of drugs known as atypical antipsychotics.
Withdrawal symptoms might include:
- sleep disorders
- irritability
- feelings of agitation or restlessness
- uncontrolled tremors
Because of the risk of withdrawal, do not stop taking Rexulti without first discussing it with your doctor. If you would like to stop taking Rexulti, your doctor can suggest a plan to help you gradually taper off Rexulti.
Tapering off involves gradually decreasing your dosage over time. This is safer than abruptly stopping the drug and can lower your risk of withdrawal.
If you have concerns about withdrawal effects associated with Rexulti, do not hesitate to speak with your doctor or pharmacist.
How long do Rexulti side effects persist?
The duration varies. Some side effects of Rexulti might be temporary and last a few days or weeks.
Most mild side effects, such as headaches and tremors, should subside on their own. However, some other side effects, such as weight gain or akathisia, might not resolve with time.
If you experience side effects that persist for a lengthy period, trouble you, or worsen, make sure to communicate with your doctor.
Warnings for Rexulti
Read on for essential warnings you should consider before taking Rexulti.
Boxed warnings
This drug carries the following boxed warnings, which are significant warnings from the FDA:
- risk of death in older adults with psychosis related to dementia
- risk of suicidal thoughts and behaviors in children and young adults aged 24 years and younger
For more information, see "Side effect specifics."
Other warnings
Before you take Rexulti, make sure to discuss your medical history with your doctor. This medication might not be suitable for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:
Diabetes: Taking Rexulti might lead to increases in blood sugar levels. If you have diabetes, Rexulti might cause your blood sugar to rise to dangerously high levels. Although rare, this can result in serious complications such as diabetic ketoacidosis, which can be fatal. Therefore, if you have diabetes, talk to your doctor about how to monitor your blood sugar while taking Rexulti.
Heart problems: Taking Rexulti might cause orthostatic hypotension (a sudden drop in blood pressure upon changing positions). If you have any heart problems, such as heart disease or issues with your heart's electrical pathways, speak with your doctor before taking Rexulti. They can help determine whether the drug is safe for you to use. If your doctor prescribes Rexulti for your condition, they'll also recommend how to monitor your blood pressure during treatment.
High Lipid Levels: Suffering from high lipid levels in your blood means you have excess amounts of cholesterol or triglycerides. It's crucial to discuss with your physician if Rexulti might worsen these conditions, considering your specific lipid levels.
Kidney or Liver Problems: Rexulti is processed by your kidneys and liver. Individuals with existing kidney issues or liver damage may require a reduced Rexulti dosage. Consult with your doctor about your particular condition and whether utilizing Rexulti is safe for you.
Seizure Disorders: Rexulti use can potentially increase the likelihood of seizures. Those with a history of seizures or epilepsy may be more susceptible. Consult your doctor about Rexulti safety based on your individual seizure history.
Low White Blood Cell Counts: Certain drugs similar to Rexulti can lead to decreased white blood cell counts. It's uncertain if Rexulti has the identical impact, but it's safest to consult your doctor if you have low white blood cell counts before starting Rexulti therapy.
Allergic Reactions: Avoid Rexulti if you've previously experienced an allergic reaction to the medication or its components. Consult your doctor for alternative treatments.
Alcohol and Rexulti
There's uncertainty as to whether Rexulti interacts with alcohol.
If you have liver damage, such as alcoholic liver disease or cirrhosis, it's essential to speak with your doctor about the impact of these conditions on Rexulti metabolism and potential side effects.
Excessive alcohol consumption can impact Rexulti levels – so consult your doctor on the safe intake limits during Rexulti treatment.
Pregnancy, Breastfeeding, and Rexulti
No research has been conducted on Rexulti safety during pregnancy, so it is unknown if it's safe while pregnant. Reports suggest potential withdrawal symptoms in newborns exposed to Rexulti during gestation.
It's also unclear if Rexulti use is safe while breastfeeding.
Before considering Rexulti, discuss with your doctor if you're pregnant, breastfeeding, or planning on becoming pregnant or breastfeeding.
Withdrawal refers to unpleasant effects that may occur when abruptly ending medication use, when the body has developed dependency to the drug, as it aids in maintaining typical body functions. For more details, see the "Can Rexulti cessation cause withdrawal symptoms?" section in the FAQ section.
Disclaimer: Medical News Today has tried its best to ensure that all information is correct, complete, and up-to-date. However, please remember that this article should not replace the expertise and advice of a licensed medical professional. Always consult your doctor or another healthcare expert before taking any medication. The drug information shared here may not cover all potential uses, dosages, precautions, warnings, drug interactions, allergic reactions, or side effects. In the absence of specific warnings for certain drugs, it does not imply that the drug is safe for all patients or for all purposes.
After discussing the side effects of Rexulti in various medical conditions, it's important to note that some individuals may experience additional side effects, known as "mild side effects," while using the medication. These side effects can include weariness, sleeplessness, restlessness and inability to stay still (akathisia), headaches, uncontrollable shaking (tremors), common cold (nasopharyngitis), and dizziness. These symptoms might be temporary, lasting a few days or weeks.
Furthermore, the Food and Drug Administration (FDA) tracks and scrutinizes side effects of approved drugs. If you develop a side effect while taking Rexulti and wish to inform the FDA, you can visit MedWatch to report it.