If you have certain mood disorders, your doctor might suggest Lybalvi as a treatment option. It’s a prescription drug used to treat the following conditions in adults:

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 bipolar disorder in some people.

For more information about Lybalvi, including details about its uses, see this in-depth article.

Like other drugs, Lybalvi can cause mild to serious side effects. Keep reading to learn more about the side effects and risks of Lybalvi.

Some people may experience mild to serious side effects during Lybalvi treatment. Examples of Lybalvi’s commonly reported side effects include:

* To learn more about this side effect, see the “Side effects explained” section below.

Keep in mind that not everyone who uses Lybalvi will have these side effects. And these aren’t the only side effects the drug may cause. Below is more information about other possible mild and serious side effects from Lybalvi.

Like most medications, Lybalvi can cause mild side effects. Examples that have been reported with this drug include:

* To learn more about this side effect, see the “Side effects explained” section below.

In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bother you, talk with your doctor or pharmacist. And do not stop taking Lybalvi unless your doctor recommends 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.

Serious side effects are possible with Lybalvi, although they’re not common.

Serious side effects that have been reported with this drug include:

If you develop serious side effects while taking Lybalvi, 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.

* Lybalvi has 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 effects explained” section below.
† 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.

Get answers to some common questions about Lybalvi’s side effects.

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, schizophrenia symptoms may come back or worsen if you stop taking Lybalvi to treat that condition.

Talk with your doctor if you have questions about Lybalvi or would like to stop taking it. They can advise you on what to expect and tell you about other treatment options for your condition.

* Olanzapine is one of the active ingredients in Lybalvi.

Does Lybalvi cause bleeding?

No, bleeding was not a side effect reported in Lybalvi’s studies.

A large review of studies found that some antipsychotic drugs (Lybalvi is a kind of antipsychotic) increase the risk of bleeding. But this study was conducted before Lybalvi was approved for use. So, the study did not include Lybalvi or look specifically at the risk of bleeding with this drug.

If you have questions or are concerned about bleeding from Lybalvi, talk with 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.

Talk with your doctor if you’re concerned about your triglyceride levels. They can tell you how they’ll monitor these levels while you’re taking Lybalvi. They can also discuss possible treatments for high triglycerides with you.

Learn more about some of the side effects Lybalvi may cause.

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

Due to the increased risk of death, Lybalvi should not be used in adults ages 65 years and older with dementia-related psychosis. Doctors will consider other treatments for their condition instead.

Weight gain

Like all antipsychotic drugs, treatment with Lybalvi may result in weight gain as a side effect.

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.

* One kg equals about 2.2 pounds (lbs.).

What might help

Your doctor will monitor your weight while you’re taking Lybalvi and may want you to monitor it at home too.

If you have concerns about your weight while taking Lybalvi, talk with your doctor. They can make diet and exercise recommendations and suggest ways to maintain a weight that is healthy for you. This may include stopping Lybalvi and trying a different treatment for your condition.

Tardive dyskinesia

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.

With TD, you develop involuntary movements in parts of your body, most commonly your face or mouth. These movements can include grimacing, thrusting out your tongue, or smacking your lips, among others. You may also have uncontrollable movements in your arms, legs, hands, or other parts of your body.

TD can affect anyone taking an antipsychotic, but elderly females* are thought to have the highest risk. TD can occur at any time during your Lybalvi treatment. It’s thought your risk may increase the longer you take the drug. Even if you stop taking Lybalvi, TD may or 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 while taking Lybalvi, immediately contact your doctor. They may have you stop taking the drug.

But depending on the severity of the condition you’re using Lybalvi to treat, they may have you continue treatment despite TD. In this case, your doctor may prescribe a medication to help ease the symptoms of TD. Examples include:

Lethargy

Treatment with Lybalvi may cause lethargy as a side effect. Symptoms of lethargy include:

  • fatigue (low energy)
  • brain fog
  • sluggishness, which can be physical, mental, or both

Lethargy can also cause changes in your mood.

What might help

Talk with your doctor if you’re feeling lethargic while taking Lybalvi. They can check for other possible causes of these symptoms. And they may recommend lifestyle modifications, such as:

  • eating a healthy diet
  • drinking plenty of fluids
  • reducing your stress levels
  • getting enough sleep

If your lethargy is affecting your daily activities, your doctor may suggest you stop taking Lybalvi. If so, they’ll discuss other treatment options for your condition with you.

Allergic reaction

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:

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:

  • an antihistamine you take by mouth, such as Benadryl (diphenhydramine)
  • a product you apply to your skin, such as hydrocortisone cream

If your doctor confirms you’ve had a mild allergic reaction to Lybalvi, they’ll decide if you should continue taking it.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Lybalvi, they may have you switch to a different treatment.

Keeping track of side effects

During your Lybalvi treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start taking new drugs or using a combination of treatments.

Your side effect notes can include things such as:

  • what dose of the drug you were taking when you had the side effect
  • how soon you had the side effect after starting that dose
  • what your symptoms were
  • how it affected your daily activities
  • what other medications you were taking
  • any other information you feel is important

Keeping notes and sharing them with your doctor will help them learn more about how Lybalvi affects you. They can then use this information to adjust your treatment plan if needed.

Before starting Lybalvi treatment, there are important considerations to keep in mind. These include 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 boxed warning for the increased risk of death in older adults with dementia-related psychosis. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

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.

Other warnings

Lybalvi may not be right for you if you have certain medical conditions. These are known as drug-condition interactions. Other factors may also affect whether Lybalvi is a good treatment option for you.

Talk with your doctor about your health history before starting Lybalvi. The list below includes 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 seizure as a side effect. If you already have seizures, 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’s best to avoid alcohol while you’re taking Lybalvi. This is because alcohol can increase your risk of or worsen certain side effects the drug may cause. These side effects include:

If you consume alcohol, talk with your doctor about whether a different treatment option might be safer for you.

Pregnancy and breastfeeding while taking Lybalvi

Below is information on taking Lybalvi while pregnant or breastfeeding.

Lybalvi and pregnancy

It’s not known for certain if it’s safe to take Lybalvi while pregnant. But if used during the third trimester, the drug may cause problems in the newborn, such as:

It’s important to note that untreated schizophrenia or bipolar disorder (the conditions Lybalvi is used to treat) can also cause problems during pregnancy, including preterm birth.

Talk with your doctor about possible treatments for your condition if you’re pregnant or thinking of becoming pregnant. If you and your doctor agree that you’ll take Lybalvi while you’re pregnant, consider joining the drug’s pregnancy registry. Pregnancy registries collect information about the safety of certain drugs when taken during pregnancy. This helps doctors and patients make decisions about which treatments are safe for 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 sleepiness or irritability in a breastfed child.

Whether or not you take Lybalvi while breastfeeding will be up to you and your doctor. They can provide you with information on other feeding options as well as other treatments for your condition.

* An active ingredient is what makes a drug work.

Like most drugs, Lybalvi can cause side effects, with mild ones being more common than serious ones. Several of Lybalvi’s serious side effects are more likely to happen if you have certain medical conditions or take certain medications.

If you’re considering Lybalvi, talk with your doctor. Ask questions that will help you feel comfortable about this and other treatment options. Some examples to help you get started are:

  • How do the side effects of Lybalvi compare with those of other drugs used to treat my condition?
  • Does my risk of side effects from Lybalvi depend on the dosage I’m prescribed?
  • Will other drugs I take increase my risk of side effects when taken with Lybalvi?
  • Is my risk of side effects from Lybalvi highest when I first start treatment?

Call your doctor right away if you:

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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.