Lybalvi Effects Ranging from Mild to Severe and Strategies for Management
Lybalvi, a brand-name oral tablet, is commonly prescribed for managing bipolar I disorder and schizophrenia. Like other medications, it may lead to side effects such as weight gain, dry mouth, and dizziness.
For bipolar disorder, Lybalvi can serve as a standalone short-term or long-term (maintenance) treatment for manic or mixed episodes. It can also be utilized in conjunction with valproate or lithium (Lithobid) to manage manic or mixed episodes. For a comprehensive overview of Lybalvi, including detailed usage information, refer to this article.
Commoner Lybalvi side effects
Lybalvi may cause various side effects, some more frequent than others. These side effects might be temporary, extending from a few days to weeks. If they persist beyond this period, worsen, or become severe, discuss them with your doctor or pharmacist.
These are some common Lybalvi side effects reported during clinical trials:
- weight gain
- tiredness
- dry mouth
- constipation
- headache*
For further information regarding this side effect, see the "Side effect specifics" section below.
Milder Lybalvi side effects
Mild side effects may arise during Lybalvi usage. This list does not comprehensive all mild Lybalvi side effects. For more details, consult Lybalvi's prescribing information.
Mild side effects reported with Lybalvi include:
- weight gain
- tiredness
- dry mouth
- constipation
- increased appetite
- dizziness
- tremor (involuntary shaking)
- back pain
- speech issues
- increased saliva production
- memory loss
- indigestion
- numbness or tingling in your arms or legs
- weakness
- headache*
- mild allergic reaction*
These side effects might be temporary, lasting a few days to weeks. If they persist beyond this period, worsen, or become severe, consult your doctor or pharmacist.
Note: Post-FDA drug approval, they monitor side effects for medications. If you experience a side effect while using Lybalvi and wish to report it to the FDA, visit MedWatch.
*For more information regarding this side effect, see the "Side effect specifics" section below.
More serious Lybalvi side effects
While many side effects reported with Lybalvi are mild, serious side effects are possible as well.
Lybalvi may lead to serious side effects. The following list may not encompass all possible serious Lybalvi side effects. For more details, refer to the Lybalvi prescribing information.
In case you experience serious side effects while using Lybalvi, contact your doctor right away. If the side effects appear life-threatening or you believe you're experiencing a medical emergency, immediately call 911 or your local emergency number.
Serious side effects reported and their symptoms include:
- Difficulty swallowing. Indications may include:
- drooling
- episodes of coughing, choking, or gagging when eating
- hoarseness
- Neuroleptic malignant syndrome (a severe neurological condition linked to the use of antipsychotic medications). Signs can include:
- fever
- disorientation
- excessive sweating
- alterations in your heart rate, breathing, pulse, or blood pressure
- rigid muscles
- Drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS is a severe, potentially fatal allergic reaction to certain medications. Symptoms can include:
- skin rash
- fever
- organ failure, such as lung, heart, liver, or kidney issues
- enlarged lymph nodes
- High blood sugar and diabetes, which can lead to coma or be fatal. Symptoms can include:
- intense thirst
- heightened hunger
- exhaustion
- confusion
- sweet-smelling breath
- Low white cell count. Symptoms can include:
- fever
- shivers
- ongoing infection or recurring infections
- Seizures. Symptoms can include:
- body stiffening
- uncontrollable movements
- loss of consciousness
- High prolactin levels. (Prolactin is a hormone released by the pituitary gland that aids in the production of breast milk). Symptoms can include:
- menstrual cycle changes
- headache
- production of breast milk, if you’re not pregnant or breastfeeding
- Opioid withdrawal. Symptoms can include:
- anxiety
- fever
- heightened heart rate
- abdominal pain
- Risk of deadly opioid overdose. Indicators may include:
- shallow or slow breathing
- vomiting
- pinpoint (abnormally small) pupils
- loss of consciousness
- Tardive dyskinesia (uncontrollable body movements). Symptoms can include:
- involuntary facial movements
- chewing or smacking of lips together
- increased blinking frequency
- Fainting and falls.
- Enhanced mortality risk in older adults with psychosis due to dementia.*
- High cholesterol or triglyceride levels.†
- Alterations in blood pressure.†
- Severe anaphylactic reaction.†‡
* Lybalvi carries a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effect specifics” section below.† For more information about this side effect, see “Side effect specifics” below.‡ A severe allergy is possible after taking Lybalvi. However, this side effect wasn’t reported in clinical trials.
Frequently Asked Questions about the side effects of Lybalvi
Lybalvi may result in various side effects. Below are some commonly asked questions about the medication’s side effects and their answers.
Does Lybalvi cause long-term side effects?
Possibly. Some of Lybalvi’s side effects might improve after a few days or weeks, especially mild side effects. For instance, nausea or dizziness may lessen as your body adjusts to Lybalvi.
However, there are side effects that can be long-term. Examples include low white blood cell count, diabetes, tardive dyskinesia, and neuroleptic malignant syndrome. These side effects may require prolonged treatment.
Everyone’s experience with Lybalvi’s side effects can vary. Consult with your doctor if you have questions or concerns about long-term side effects.
Is bleeding a side effect of Lybalvi?
No, bleeding is not a side effect of Lybalvi treatment. Bleeding was not reported in clinical trials of individuals taking this medication.
Lybalvi may decrease your white blood cell levels as a side effect. However, this does not cause bleeding. Instead, low white blood cell levels can increase your risk of infection.
If you notice that you’re bleeding more frequently or easily than usual, inform your doctor. They can help determine the cause of your bleeding and suggest the most suitable treatment options.
What side effects does Lybalvi cause after treatment is stopped?
You should not experience side effects after discontinuing treatment with Lybalvi. This medication was not reported to cause withdrawal symptoms. Withdrawal symptoms occur when the body becomes dependent on a substance and then its use is suddenly stopped.
However, it's important to note that one of the active ingredients in Lybalvi, samidorphan, can lead to opioid withdrawal. This can occur in individuals who are physically dependent on opioids and take Lybalvi.
Opioid withdrawal can be severe and may require hospitalization. For this reason, do not take Lybalvi for at least 7 days after you stop taking short-acting opioids.* And do not take Lybalvi for at least 14 days after you stop taking long-acting opioids.
Also, if you discontinue taking Lybalvi, your condition may worsen. This medication is used to treat certain types of bipolar I disorder or schizophrenia.† Therefore, stopping treatment with Lybalvi might cause the symptoms of your condition to reappear.
If you'd like to discontinue using Lybalvi, discuss this with your physician. They can assist in determining the best strategy for ending your treatment and might suggest alternative medications for your condition.
Short-term opioids are processed faster by the body than long-term opioids. For more details about Lybalvi's uses, refer to this source.
Does Lybalvi have any side effects in adolescents?
Lybalvi is only authorized for use in adults (18 years and above). It was not examined in children under 18 years of age. Consequently, the effects of the drug on children under 18 are not known.
Generally, both older and younger adults reported similar side effects when using Lybalvi. However, young adults might have an increased risk of developing dystonia (persistent and unusual muscle contractions) while using this medication.
If you have concerns about Lybalvi's side effects, consult your doctor or pharmacist.
Side effect particulars
Gain more insights into some of the side effects that Lybalvi might induce. For information on how often side effects occurred during clinical trials, refer to Lybalvi's prescribing information.
Increased risk of death in elderly adults with psychosis due to dementia
Lybalvi has a warning box related to the risk of death in elderly adults experiencing psychosis due to dementia. A warning box is the most serious warning issued by the Food and Drug Administration (FDA). Its purpose is to alert patients and doctors about the potential risks of using a medication.
Elderly adults (65 years and above) with psychosis due to dementia might have an increased risk of death from any antipsychotic drug, including Lybalvi. (Psychosis involves difficulty distinguishing between reality and fantasy, while dementia involves memory, thinking, and communication challenges.)
Most deaths in people with psychosis due to dementia were related to the heart or infections. The risk of heart failure or severe infections like pneumonia is possible with Lybalvi.
What you can do
Due to these risks, Lybalvi will not be prescribed for elderly adults with psychosis due to dementia. Your doctor might suggest an alternative treatment option for your condition.
Changes in blood pressure
Some individuals might experience changes in blood pressure while using Lybalvi. Specifically, this medication can cause orthostatic hypotension (low blood pressure when standing). This side effect was infrequent in Lybalvi's clinical trials.
Symptoms of orthostatic hypotension can include dizziness, blurry vision, fainting, or confusion. It may also result in lightheadedness or fainting when you stand up too quickly from a seated or lying position.
You might have an increased risk of orthostatic hypotension when you first start using Lybalvi or when your dose is increased.
What you can do
If you notice symptoms of changes in blood pressure, inform your doctor immediately. They may suggest monitoring your blood pressure throughout your treatment. In some cases, they may recommend an alternative treatment option for you.
Headache
Headaches may occur while using Lybalvi. Headaches were one of the most common side effects reported by individuals using this medication in clinical trials.
Specifically, headaches were reported in people using Lybalvi for schizophrenia. This side effect was not reported in people using Lybalvi to treat bipolar I disorder.
What you can do
If you experience headaches during your treatment with Lybalvi, discuss this with your doctor. They may suggest methods to reduce the frequency of your headaches. They may also recommend taking an over-the-counter pain medication, such as acetaminophen (Tylenol) or ibuprofen (Advil, Motrin), to treat your headaches.
High cholesterol or triglycerides
It's possible to develop high cholesterol or high triglycerides while using Lybalvi. This side effect was not one of the most common side effects reported during Lybalvi's clinical trials.
High cholesterol or triglycerides rarely cause symptoms. But these conditions can be detected with a blood test.
What you can do
Your doctor may recommend a blood test to check your cholesterol and triglycerides before starting Lybalvi treatment. Then, they may monitor your levels throughout your treatment to ensure they do not become too high.
If you develop high cholesterol or high triglycerides, your doctor will likely recommend a medication to lower your levels. In some cases, they may suggest an alternative treatment option for you.
Allergic reaction
As with most drugs, Lybalvi can cause an allergic reaction in some people. However, this side effect was not reported during Lybalvi's clinical trials.
Symptoms can be mild or severe and include:
- skin rash
- itching
- flushing
- swelling under the skin, usually in the eyelids, lips, hands, or feet
- swelling of the mouth, tongue, or throat, which can make it hard to breathe
If you're experiencing mild symptoms of an allergic reaction, reach out to your doctor promptly. They might suggest methods to alleviate your symptoms and advise if you should continue using Lybalvi. However, if your symptoms are severe and you think you're experiencing a medical emergency, immediately contact 911 or your local emergency number.
Cautions for Lybalvi
Before starting Lybalvi, discuss any health issues you have with your doctor.
Boxed warning: Higher risk of death in older adults with psychosis due to dementia
Lybalvi carries a boxed warning for an enhanced risk of death in elderly adults experiencing psychosis as a result of dementia. This is a serious caution from the Food and Drug Administration (FDA). Check out the "Side effect details" section above for more details.
Other cautions
It's crucial to discuss your medical history with your doctor before using Lybalvi. This medication might not be the best fit for you if you have certain medical issues or factors that influence your health. These are referred to as drug-condition or drug-factor interactions.
Make sure to speak with your doctor if any of the following apply to you:
- usage of opioids
- a history of using illegal drugs
- blood pressure issues, such as low or high blood pressure
- kidney problems
- high blood sugar, diabetes, or a family history of either
- high cholesterol or triglycerides
- low white blood cell levels
- trouble swallowing
- a history of seizures or seizure disorders
- digestive problems
- a history of breast cancer
- high prolactin level
- trouble urinating
- prostate problems
- a history of heart problems or stroke
- a previous allergic reaction to this or a similar drug
Alcohol and Lybalvi
Your doctor is likely to advise against drinking alcohol during your Lybalvi treatment. This is because alcohol can heighten the risk of certain side effects, such as orthostatic hypotension. (For more information, check out the "Side effect details" section above.)
If you're using Lybalvi, consult your doctor to find out if alcohol is safe for you to consume.
Pregnancy and breastfeeding with Lybalvi
The safety of using Lybalvi during pregnancy hasn't been confirmed. If you take Lybalvi during your third trimester, your baby may have an increased risk of withdrawal symptoms. (Withdrawal symptoms manifest when your body becomes accustomed to a substance and then you suddenly cease its use.) Your baby may also have an increased risk of respiratory distress (trouble breathing), tremor, or variations in muscle tone or sleepiness.
When olanzapine (one of Lybalvi's active ingredients) was studied during pregnancy, it didn't seem to increase the risk of congenital anomalies in fetuses. (Congenital anomalies are also known as birth defects.) However, it's unknown what impact samidorphan (the other active ingredient in Lybalvi) may have on a fetus.
If you become pregnant while using Lybalvi, your doctor will recommend you register for the pregnancy registry for antipsychotic drugs. A is a compilation of information about side effects and risks associated with taking a medication during pregnancy. If you're interested in registering, speak with your doctor. You can also call 866-961-2388 or visit this website.
It's not known if Lybalvi is safe to use while breastfeeding. Olanzapine is known to be transferred into breast milk. Studies show that the drug may cause infants to become more drowsy than usual, fussy, and have feeding difficulties. It's unknown what effects samidorphan may have while breastfeeding. (Olanzapine and samidorphan are Lybalvi's active ingredients.)
If you are pregnant, planning to become pregnant, or breastfeeding, discuss using Lybalvi with your doctor. They can help determine the best treatment option for you.
When to speak with your doctor
It's possible to experience side effects from Lybalvi usage. Many side effects are mild. However, some individuals may experience serious side effects as well.
If you'd like to learn more about Lybalvi, chat with your doctor or pharmacist. They can provide answers to any questions you have about Lybalvi's side effects.
Besides speaking with your doctor, you can conduct your own research. These articles might be helpful:
- More information about Lybalvi. For further details about various aspects of Lybalvi, review this article.
- Cost. To find out about the cost of Lybalvi therapy, check out this article.
- Dosages. To learn about Lybalvi's dosages, review this article.
- Interactions. For details about Lybalvi's potential interactions, consult this article.
- Understanding your condition. To gain insights into mental health, visit our mental health hub.
Alert: Medical Daily has taken every measure to guarantee the information presented is medically accurate, thorough, and updated. However, this article should not be considered a substitute for the advice of a licensed medical practitioner. It's always prudent to consult your doctor or other health expert before initiating any medication. The pharmaceutical details provided in this piece might be subject to change and are not intended to encompass all possible uses, instructions, precautions, warnings, drug interactions, allergic reactions, or side effects. The absence of such details for a particular drug does not imply that the drug or drug combination is secure, effective, or appropriate for all individuals or specific uses.
- Patients with mental health conditions such as bipolar disorder or schizophrenia may be prescribed Lybalvi to manage their symptoms, but they should be aware of its potential side effects, including dry mouth, constipation, and dizziness.
- For some individuals, milder side effects like dry mouth, constipation, and increased saliva production may occur when taking Lybalvi. If these persist or worsen, it's essential to discuss them with a doctor or pharmacist.
- It's crucial for people using Lybalvi to keep an eye out for more serious side effects, such as difficulty swallowing, neuroleptic malignant syndrome, drug reaction with eosinophilia and systemic symptoms, and seizures. Immediate medical attention is required if these symptoms occur.
- Mental health patients should not only focus on managing their symptoms using medication but also prioritize their overall health, including taking time to exercise, eat a balanced diet, and regularly seek support from mental health professionals.
