Side Effects of Lybalvi: What You Need to Know
If you have mood disorders, your doctor might suggest a treatment like lybalvi. It is a prescription drug used to treat conditions in adults.
- It is possible that there is a mental illness called schizophrenia.
- There is a disorder of the brain called the Bipolar Disorder.
The active ingredients in Lybalvi are olanzapine and samidorphan. (An active ingredient is what makes a drug work.)
Lybalvi comes as a tablet you swallow. If you and your doctor agree that it’s safe and working well for you, you’ll likely take Lybalvi long term. It may also be used as a short-term treatment for There is a disorder of the brain called the Bipolar Disorder. in some people.
For more information about Lybalvi, including details about its uses, see this in-depth article.
Like other drugs, it can cause mild to serious side effects. There are side effects and risks of Lybalvi.
Some people may experience side effects during treatment. Some of the reported side effects of Lybalvi are listed.
The side effects explained section is where you can learn more about this side effect.
Not everyone who uses lybalvi will have these side effects. The drug may cause other side effects. There are more information about the possible side effects of Lybalvi.
Mild side effects can be caused by the medication. There are examples that have been reported with this drug.
- It is too sleepy.
- The mouth is dry.
- There is a throbbing head.
- Increased appetite.
- akathisia (intense restlessness)
- increased liver enzymes, which can be a sign of liver damage in extreme cases
- It is a problem of the colon.
- There are tremors.
- high cholesterol
- weight gain
- mild allergic reaction*
The side effects explained section is where you can learn more about this side effect.
These side effects should be temporary. Some may be easy to manage. If you have any symptoms that bother you, talk to your doctor or pharmacist. Unless your doctor recommends it, you should not stop taking it.
Lybalvi may cause mild side effects other than those listed above. See the drug’s prescribing information for details.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Lybalvi, visit MedWatch.
There are serious side effects with the drug.
There have been serious side effects with this drug.
- There is a neurological syndrome.
- hyperglycemia (high blood sugar) or diabetes
- orthostatic hypotension (dizziness or lightheadedness when standing up)
- blood cell problems, including
- leukopenia (low white blood cell level)
- neutropenia (low neutrophil level)
- There was a seizure.
- There are problems with regulating body temperature.
- high level of prolactin (a hormone made in your brain)
- increased risk of death in older adults with dementia-related psychosis*
- tardive dyskinesia†
- severe allergic reaction‡
If you develop serious side effects while taking the drug, call your doctor. If the side effects seem life threatening or you think you have a medical emergency, immediately call the emergency number.
* Lybalvi has a
† To learn more about this side effect, see the “Side effects explained” section below.
‡ An allergic reaction is possible after taking Lybalvi. But it’s not clear whether this side effect occurred in studies.
There are many questions about the side effects of Lybalvi.
Will I experience side effects after stopping Lybalvi treatment?
Stopping treatment with Lybalvi isn’t expected to cause withdrawal symptoms. (These are side effects that can happen when you stop taking a drug that your body has become dependent on.) Dependence wasn’t reported in Lybalvi’s studies.
But since olanzapine* became available for use, certain withdrawal symptoms have been reported. Examples include nausea, vomiting, and sweating. It’s not known for certain whether these side effects may occur after stopping Lybalvi.
And stopping Lybalvi treatment could cause a return or worsening of symptoms from the condition you’re using the drug to treat. For example, It is possible that there is a mental illness called schizophrenia. symptoms may come back or worsen if you stop taking Lybalvi to treat that condition.
If you have questions about the drug, you should talk to your doctor. They can give you information about other treatment options for your condition.
Olanzapine is one of the active ingredients.
Does Lybalvi cause bleeding?
No, bleeding was not a side effect reported in Lybalvi’s studies.
If you have questions or are concerned about bleeding from the patient, talk to your doctor or pharmacist.
Will Lybalvi affect my cholesterol levels?
It’s possible. Changes in cholesterol were a common side effect in Lybalvi’s studies.
Specifically, people taking Lybalvi in these studies were more likely to have an increase in their triglyceride levels. (Triglycerides are a kind of fat found in your blood.) Having high triglyceride levels can increase your risk of heart disease.
If you are concerned about your levels, talk to your doctor. They can tell you how they will keep an eye on these levels. They can discuss possible treatments for high triglycerides with you.
Learn about the side effects of lybalvi.
Increased risk of death in older adults with dementia-related psychosis
Lybalvi has a boxed warning about an increased risk of death when used in adults ages 65 years and older with dementia-related psychosis. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).
Older adults with dementia-related psychosis weren’t included in Lybalvi’s studies. But this increased risk applies to all antipsychotic drugs (including Lybalvi), based on a large review of studies.
What might help
Adults 65 years and older with dementia-related psychosis should not use lybalvi. Doctors will look at other treatments.
Weight gain is a side effect of all drugs.
In one of the drug’s studies, 4 weeks of Lybalvi treatment led to an average weight gain of about 3 kilograms (kg)* per person. In this same study, people who took a placebo (a pill with no active drug) gained less than 0.2 kg on average.
The weight is 2.2 pounds.
What might help
Your doctor will monitor your weight while you take Lybalvi and you may be asked to do the same at home.
If you have concerns about your weight, talk to your doctor. They can suggest ways to maintain a healthy weight. This may include stopping the treatment you are on.
Tardive dyskinesia (TD) is a rare, serious, and possibly irreversible side effect that Lybalvi may cause. It’s a known side effect of antipsychotic drugs, including Lybalvi.
You can develop movements in your face or mouth with the help of the tool. These movements can include grimacing, thrusting out your tongue, or smacking your lips. You may have uncontrollable movements in your arms, legs, hands, and other parts of your body.
Elderly females are thought to have the highest risk of having a problem with the drug. During your treatment, you can experience the phenomenon of TD. It is thought that your risk may increase as you take the drug longer. Even if you stop taking it, it may not go away.
* In this article, we use the term “female” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.
What might help
If you notice symptoms of TD, immediately contact your doctor. They may want you to stop taking the drug.
If you have a serious condition that requires treatment, they may have you continue. In this case, your doctor may prescribe a medication to help you with the symptoms of the disease. Examples include:
Treatment with Lybalvi may cause lethargy as a side effect. Symptoms of lethargy include:
- fatigue (low energy)
- There is brain fog.
- sluggishness can be physical, mental or both.
Changes in your mood can be caused by lethargy.
What might help
If you are feeling unwell while taking lybalvi, talk to your doctor. They can check for other causes. They may recommend lifestyle modifications.
- A healthy diet is what you should be eating.
- drinking lots of fluids
- Reducing stress levels is something you can do.
- Getting enough sleep.
Your doctor may suggest that you stop taking the drug if you are becoming tired. They will discuss other treatment options with you if that is the case.
Like most drugs, Lybalvi can cause an allergic reaction in some people. It’s not clear whether allergic reactions happened in Lybalvi’s studies, but they have been reported since it was approved for use. Symptoms can be mild to serious and include:
- There is a skin rash.
- It is itchy.
- flushing (temporary warmth, redness, or deepening of skin color)
- “It’s usually under your skin, but it can be anywhere.”
- It can be hard to breathe if you have swelling of your mouth, tongue, or throat.
- Drugs can cause a reaction with eosinophilia and systemic symptoms.
What might help
If you have a mild rash, call your doctor. They may suggest a treatment to help you. Examples include:
- an antihistamine you take by mouth, such as Benadryl (diphenhydramine)
- You apply a product to your skin.
If your doctor confirms that you have an allergic reaction to Lybalvi, they will decide if you should continue taking it.
If you have a severe allergic reaction, you should call the emergency number. These symptoms could be life threatening and need immediate medical care.
If your doctor confirms you have had a serious allergic reaction to Lybalvi, they may have you switch to a different treatment.
Keeping track of side effects
Take notes on any side effects you are having during your treatment. You can share this information with your doctor. This is helpful when you are starting to use a combination of treatments.
Side effect notes can include things.
- When you had the side effect, what dose of the drug was taking?
- How soon did you experience the side effect?
- What are your symptoms?
- How did it affect your daily activities?
- What other drugs were you taking?
- Other information is important to you.
Sharing notes with your doctor will help them learn more about how you are affected by the drug. If needed, they can use this information to adjust your treatment plan.
There are important considerations to keep in mind before starting treatment. There is a boxed warning about the increased risk of death in certain adults.
Boxed warning: Increased risk of death in older adults with dementia-related psychosis
Lybalvi has a
Antipsychotic drugs such as Lybalvi should not be used to treat psychosis related to dementia in adults ages 65 years and older. Antipsychotics have been shown to increase the risk of death in this population.
To learn more, see “Side effects explained” above.
If you have certain medical conditions, lybalvi may not be right for you. These are drug-condition interactions. Other factors may affect whether or not you should use lybalvi.
Before starting Lybalvi, you should talk to your doctor about your health history. The list has factors to consider.
Blood pressure or heart problems. Lybalvi can affect your blood pressure, causing it to be too high or low. If you already have blood pressure or heart problems (such as heart disease), taking Lybalvi may worsen your condition. You may also be at an increased risk of blood pressure-related side effects. Your doctor can tell you more about the safety of taking Lybalvi if you have blood pressure or heart problems.
Diabetes. Taking Lybalvi can affect your blood sugar level and may cause high blood sugar or even diabetes. If you already have diabetes, taking this drug may make it harder to manage your blood sugar level. Your doctor can tell you more about whether it’s safe for you to take Lybalvi. And they can recommend ways to manage your blood sugar if they prescribe this drug for you.
Kidney problems. Your body relies on your kidneys to remove Lybalvi from your system after you take a dose. If you have a severe kidney problem (such as end-stage kidney disease), Lybalvi levels may build up dangerously high in your body. Your doctor can tell you more about whether Lybalvi may be safe with your kidney problem, or they may suggest a safer treatment option.
Cholesterol problems. Taking Lybalvi can affect your cholesterol levels and may cause them to be too high. If you have existing cholesterol problems, taking Lybalvi may make them worse. But high cholesterol can often be treated. So unless your cholesterol levels are dangerously high, it’s probably safe for you to take Lybalvi. If your doctor prescribes Lybalvi for you, they can tell you more about treatments for managing your cholesterol levels.
Blood cell problems. Although it’s rare, treatment with Lybalvi can affect your blood cell levels. Taking this drug may cause problems such as a low level of white blood cells. If you already have blood cell problems, taking Lybalvi may worsen your condition. Your doctor can tell you more about whether this treatment option is safe for you.
Seizure. While rare, antipsychotic drugs such as Lybalvi can cause There was a seizure. as a side effect. If you already have There was a seizure.s, taking this drug could worsen your condition. Your doctor can tell you more about whether it’s safe for you to take Lybalvi.
Difficulty swallowing. If you have trouble swallowing, ask your doctor whether it’s safe for you to take Lybalvi. Taking antipsychotic drugs, including Lybalvi, may worsen this condition. It can also increase your risk of aspiration (inhaling a substance into your airway).
High prolactin levels or breast cancer. Like certain other antipsychotics, Lybalvi may increase the level of a hormone called prolactin in your body. If you already have a high level of prolactin, Lybalvi could worsen your condition. If you have breast cancer or have had it in the past, Lybalvi could cause your cancer to worsen or return. This is because about 1 in 3 breast cancers grows in the presence of prolactin. Your doctor can tell you more about whether it’s safe for you to take Lybalvi.
Prostate or urinary problems. If you have prostate or certain urinary problems (such as urinary retention), Lybalvi could worsen your condition. Your doctor can tell you more about whether it’s safe for you to take Lybalvi if you have prostate or urinary problems.
Allergic reaction. If you’ve had an allergic reaction to Lybalvi or any of its ingredients, your doctor will likely not prescribe it for you. Ask them about other treatments that might be better options.
Alcohol and Lybalvi
It is best to avoid alcohol while taking lybalvi. Alcohol can increase your risk of side effects from drugs. These side effects can be serious.
- blood pressure changes, which may lead to falls or other injuries
- drowsiness or It is too sleepy.
If you drink alcohol, talk to your doctor about whether a different treatment option is safer for you.
Pregnancy and breastfeeding while taking Lybalvi
There is information on taking lybalvi while pregnant or breastfeeding.
Lybalvi and pregnancy
It is not known if it is safe to take lybalvi while pregnant. The drug may cause problems in the newborn if used during the third trimester.
- drug-induced movement disorders, including muscle There are tremors.
- withdrawal symptoms, including agitation, It is too sleepy., and difficulty feeding
It’s important to note that untreated It is possible that there is a mental illness called schizophrenia. or There is a disorder of the brain called the Bipolar Disorder. (the conditions Lybalvi is used to treat) can also cause problems during pregnancy, including preterm birth.
If you are pregnant or thinking of becoming pregnant, talk to your doctor about possible treatments. If you and your doctor agree that you will take the drug while you are pregnant, join the pregnancy registry. The safety of drugs taken during pregnancy is collected by the registries. This helps doctors and patients make decisions about what to do with pregnant people.
To learn more or join the registry, call 866-961-2388 or visit the registry’s website.
Lybalvi and breastfeeding
Olanzapine, one of the active ingredients* in Lybalvi, is known to pass into human breast milk. It may cause side effects such as It is too sleepy. or irritability in a breastfed child.
“It’s up to you and your doctor whether or not you take lybalvi while breastfeeding. They can give you information on other feeding options and other treatments.”
An active ingredient is what makes a drug work.
Mild side effects of the drug are more common than serious ones. If you have a medical condition or take a medication, you are more likely to have serious side effects.
Discuss the topic of Lybalvi with your doctor. Ask questions that will help you feel comfortable. Some examples can help you get started.
- How do the side effects of Lybalvi compare to other drugs?
- Does my risk of side effects depend on the amount of medicine I take?
- Will other drugs increase my risk of side effects when I take lybalvi?
- Is my risk of side effects higher when I start treatment?
If you do, call your doctor right away.
- Become pregnant during your treatment.
- have symptoms of tardive dyskinesia
- have symptoms of an allergic reaction
If you have bipolar I disorder, consider signing up for Healthline’s online newsletter for lifestyle tips, personal stories, and more.
Disclaimer: Healthline 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.