Side Effects of Caplyta: What You Need to Know
Caplyta (lumateperone) is a prescription drug that’s used to treat schizophrenia and depressive episodes related to bipolar disorder. Caplyta can cause side effects (also called adverse effects) that range from mild to serious. Examples include dizziness and dry mouth.
Caplyta is used in adults to treat:
- schizophrenia
- depressive episodes related to bipolar disorder
The active ingredient in Caplyta is lumateperone. (An active ingredient is what makes a drug work.) The drug comes as a capsule that you swallow.
Keep reading to learn about the common, mild, and serious side effects that Caplyta can cause. For a general overview of the drug, including details about its uses, see this article.
Some people may experience mild to serious side effects during their Caplyta treatment. These are just a few of the more common side effects reported by people who took Caplyta in studies. These side effects can vary depending on what condition the drug is being used to treat.
More common side effects in people taking Caplyta for schizophrenia include:
More common side effects in people taking Caplyta for bipolar depression include:
- dizziness
- decreased alertness
- nausea
- drowsiness
- dry mouth*
* To learn more about this side effect, see the “Side effects explained” section below.
People who take Caplyta may experience mild side effects. These either go away with time or can be managed with treatment. These side effects usually aren’t bothersome enough to make someone stop taking the drug. Examples of mild side effects that have been reported with Caplyta include:
- dizziness
- nausea
- drowsiness
- headache
- decreased alertness
- weight gain
- dry mouth*
* 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, too. But if you have any symptoms that are ongoing or that bother you, talk with your doctor or pharmacist. And do not stop taking Caplyta unless your doctor recommends it.
Caplyta may cause mild side effects other than the ones listed above. See the Caplyta 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 Caplyta, visit MedWatch.
Treatment with Caplyta may lead to serious side effects. These are not common, but you should let your doctor know if you experience them. Serious side effects that have been reported with Caplyta include:
- low blood pressure on standing up
- increased blood sugar level
- high cholesterol
- seizures
- trouble regulating body temperature
- neuroleptic malignant syndrome (a severe condition that may include muscle rigidity and kidney failure)
- trouble swallowing
- boxed warnings:
- increased risk of death in older adults with dementia-related psychosis*
- risk of suicidal thoughts or behaviors in children and young adults*
* Caplyta 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.If you develop serious side effects while taking Caplyta, call your doctor right away. If the side effects seem life threatening or if you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Here are answers to some common questions about Caplyta’s side effects.
Are there side effects of stopping Caplyta treatment?
Yes, stopping treatment with any antipsychotic medication, such as Caplyta, can cause effects. Caplyta did not cause withdrawal effects in studies, but symptoms of the condition it’s being used to treat can reappear. (Withdrawal refers to effects that can occur when you stop taking a drug you’re dependent on.) Your doctor will let you know how to safely stop taking Caplyta if you need to end treatment.
Your doctor may recommend stopping Caplyta treatment if you have one of these side effects:
- tardive dyskinesia
- a drop in white blood cell count below a certain level
- suicidal thoughts or behaviors
- neuroleptic malignant syndrome
Another reason you may stop taking Caplyta is if you’re starting a different medication for your condition.
If you’re pregnant and taking Caplyta, stopping treatment may cause withdrawal symptoms in the newborn. For more information, see the “Warnings for Caplyta” section below. If you’re pregnant or can become pregnant, talk with your doctor about the risks and benefits of taking Caplyta during this time.
Can Caplyta cause any cardiac side effects?
Maybe. Caplyta studies reported increases in cholesterol and blood sugar levels among those taking the drug. In turn, these side effects can increase your risk of heart and blood vessel problems.
Caplyta belongs to a group of drugs called antipsychotics. This group of drugs is associated with serious cardiac side effects. Examples include increased risk of cardiac arrhythmia (abnormal heartbeat) and sudden cardiac death. Studies of Caplyta did not report any serious cardiac side effects.
The drug’s manufacturer did not study Caplyta in people who had a heart attack or heart failure. If you have a history of heart disease, talk with your doctor about the risks and benefits of taking Caplyta.
Does drinking lots of water help with Caplyta’s side effects?
Yes, it’s a good idea to drink a lot of water during Caplyta treatment. To help prevent a few of the drug’s side effects, it’s recommended that you avoid becoming dehydrated.
One side effect reported in studies of Caplyta is difficulty regulating body temperature. Drinking lots of water can help you avoid getting too hot while taking Caplyta. Other things to try for this side effect include not exercising too strenuously and staying out of bright sunlight in hot weather.
Another side effect of Caplyta is low blood pressure. If you don’t drink enough fluids, the risk of this side effect is greater.
Ask your doctor about other ways to help prevent Caplyta’s side effects.
Learn more about some of the side effects Caplyta may cause.
Increased risk of death in older adults with dementia-related psychosis
Caplyta has a boxed warning for increased risk of death in older adults who have psychosis related to dementia. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA). They alert doctors and patients about drug effects that may be dangerous.
Studies have shown that antipsychotic drugs such as Caplyta increase the risk of death in adults ages 65 and older with dementia-related psychosis. Dementia involves memory loss, and psychosis refers to losing touch with reality.
Due to this risk, doctors usually will not prescribe Caplyta to older adults with dementia-related psychosis.
What might help
If you’re an older adult with psychosis related to dementia, your doctor likely won’t prescribe Caplyta. They’ll discuss with you other treatments for your condition.
Dry mouth
In studies of Caplyta, dry mouth was a common side effect. It occurred in people taking the drug to treat either schizophrenia or depressive episodes related to bipolar disorder.
What might help
There are ways to treat this side effect so you can keep taking Caplyta.
Increasing how much water you drink is one option. This may help prevent some of Caplyta’s other side effects. (For more information, see the “FAQs about Caplyta’s side effects” section above.) And drinking more water is good for your overall health.
You can also try sucking on sugar-free lozenges or chewing sugar-free gum when your mouth feels dry. If you use a product that contains sugar, be sure to rinse your mouth with water. This helps decrease your risk of oral thrush (a yeast infection inside the mouth).
Your dentist may recommend a mouth spray to increase saliva production.
If you have dry mouth from taking Caplyta, talk with your doctor about strategies to treat it.
Tardive dyskinesia
Tardive dyskinesia is a rare side effect reported in studies of antipsychotic drugs such as Caplyta. It involves unusual, sudden movements that the person experiencing this side effect can’t control. These movements often occur in the arms, legs, eyes, and tongue.
This side effect can happen during your Caplyta treatment or after your treatment has ended. It can sometimes be permanent.
What might help
Because this side effect is serious, your doctor will likely not prescribe Caplyta if you’re able to take a different medication instead.
If you have this side effect, your doctor will likely have you take a different drug for your condition. Tardive dyskinesia will sometimes go away after a person switches medications. Talk with your doctor about the risks of tardive dyskinesia from taking Caplyta.
Low white blood cells
Low white blood cell levels have been reported in studies of Caplyta. This was a rare but serious side effect.
Your body uses white blood cells to fight infections. So if you don’t have enough of these cells, you’re more likely to catch a serious infection from a virus, bacterium, or fungus. Risk of serious infection increases in people who already have immune system problems before starting Caplyta.
What might help
Before you begin treatment with Caplyta, your doctor will check your white blood cell levels with a blood test. They’ll periodically monitor your white blood cell count while you take Caplyta to make sure your levels stay normal. If they fall below a certain safe level, your doctor may temporarily pause your treatment or recommend a different medication for your condition.
Suicidal thoughts and behaviors
In addition to being an antipsychotic drug, Caplyta is also an antidepressant that’s used to treat depressive episodes related to bipolar disorder. Antidepressants are known to increase suicidal thoughts and behaviors in children and young adults up to the age of 24 years. (Note that Caplyta isn’t prescribed for use in children.)
The risk of this side effect is higher when a person first starts Caplyta treatment or their doctor changes their dose.
Symptoms to watch for include:
- mood changes
- anxiety
- sleep changes
- feeling alone
- not enjoying activities that you used to enjoy
What might help
Due to the risk of suicidal thoughts and behaviors, doctors will closely monitor people who are 24 years or younger during Caplyta treatment.
Talk with your doctor about how you will be monitored during Caplyta treatment. If you notice any concerning symptoms, let your doctor know right away.
- Call 911 or your local emergency number.
- Stay with the person until help arrives.
- Remove any guns, knives, medications, or other things that may cause harm.
- Listen, but don’t judge, argue, threaten, or yell.
Allergic reaction
Like most drugs, Caplyta can cause an allergic reaction in some people. Mild allergic reactions were reported in studies.
Symptoms can be mild or serious and can include:
- skin rash
- itchiness
- flushing (temporary warmth, redness, or deepening of skin color)
- swelling under your skin, usually in your eyelids, lips, hands, or feet
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What might help
If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. To manage symptoms, they may suggest an over-the-counter antihistamine you take by mouth, such as Benadryl (diphenhydramine). Or they may recommend a product you apply to your skin, such as hydrocortisone cream.
If your doctor confirms you had a mild allergic reaction to Caplyta, 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 had a serious allergic reaction to Caplyta, they may have you switch to a different treatment.
- what dose of drug you were taking when you had the side effect
- how soon after starting that dose you had the side effect
- what your symptoms were from the side effect
- how it affected your daily activities
- what other medications you were also taking
- any other information you feel is important
In certain situations, it may not be safe to take Caplyta. Read on to learn more about possible warnings for this drug.
Boxed warnings
Caplyta has the boxed warnings listed below. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).
- Increased risk of death in older adults with dementia-related psychosis. Caplyta is part of a group of drugs called antipsychotics. Drugs in this group increase the risk of death in adults ages 65 and older with dementia-related psychosis.
- Risk of suicidal thoughts or behaviors in children and young adults. Caplyta is also an antidepressant. Drugs of this type increase the risk of suicidal thoughts and suicidal actions. This risk is higher in younger people who take these drugs.
To learn more, see the “Side effects explained” section above.
Other warnings
Caplyta may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you take Caplyta. The list below includes factors to consider.
Heart problems. Caplyta may cause blood sugar and cholesterol levels to increase. These changes can increase your risk of heart problems, such as heart attack or heart failure. Before you start taking Caplyta, talk with your doctor about any heart conditions in your medical history.
Stroke. Older adults with dementia-related psychosis who took Caplyta were more likely to have a stroke. But Caplyta has a boxed warning for increased risk of death in older adults with dementia-related psychosis. (For details, see the “Side effects explained” section above.) So it’s unlikely a doctor would prescribe this to you if you’re an older adult with dementia-related psychosis. Instead, they’ll recommend a drug other than Caplyta for your condition.
Blood pressure problems. Treatment with Caplyta may cause either high blood pressure or low blood pressure. High blood pressure is a risk factor for heart attack or stroke. And low blood pressure puts you at risk of fainting. If you already have high or low blood pressure, talk with your doctor about how to take Caplyta safely.
Diabetes. Caplyta can cause high blood sugar. This may lead to more serious conditions such as diabetes or a medical emergency called ketoacidosis. If you already have diabetes, taking Caplyta can increase your risk of ketoacidosis. Your doctor will recommend monitoring your blood sugar more closely during Caplyta treatment.
High cholesterol. Taking Caplyta can increase your cholesterol and triglyceride levels. If you already have high cholesterol, you may have a higher risk of heart and blood vessel problems when you take Caplyta. This includes serious problems such as heart attack or stroke. Your doctor will monitor your cholesterol and triglyceride levels more closely during Caplyta treatment.
Seizures. Certain people who take Caplyta may have seizures. If you have a history of seizures, talk with your doctor about whether Caplyta is safe for you to take.
Kidney or liver problems. If you have kidney or liver problems, talk with your doctor about whether you can take Caplyta. Your doctor may adjust your dose or monitor you carefully.
Low white blood cell levels. People being treated with Caplyta may have decreased levels of white blood cells. That makes them more likely to get a serious infection. If you already have a medical condition or are taking a drug that decreases your immune system function, talk with your doctor.
Allergic reaction. If you’ve had an allergic reaction to Caplyta or any of its ingredients, your doctor will likely not prescribe Caplyta. Ask them what other medications are better options for you.
Alcohol and Caplyta
Alcohol and Caplyta do not interact. But alcohol and Caplyta can both cause nausea. Drinking alcohol while taking Caplyta may increase your risk of this side effect.
If you drink alcohol, talk with your doctor about whether it’s safe for you to take Caplyta.
Pregnancy and breastfeeding while taking Caplyta
It’s not clear whether Caplyta is safe to take during pregnancy. The manufacturer reports that some newborns experience withdrawal symptoms when exposed to Caplyta in the third trimester of pregnancy. These symptoms ranged from mild to severe and included:
- shakiness
- drowsiness
- trouble breathing
- trouble feeding
- restlessness
- overactivity or underactivity of muscles
If you’re pregnant or planning to become pregnant, talk with your doctor about the risks and benefits of taking Caplyta.
If you take Caplyta while you’re pregnant, consider participating in the pregnancy exposure registry for this drug. The registry collects information about the effects of drugs such as Caplyta during pregnancy. This can help determine whether a drug is safe to take while pregnant. For information about this pregnancy exposure registry, call 866-961-2388 or visit the registry website.
It’s not known whether Caplyta passes into breast milk or what effects it might have on a breastfeeding child. If you’re breastfeeding or planning to breastfeed, talk with your doctor about the risks and benefits of taking Caplyta while breastfeeding.
Like other medications, Caplyta may cause mild or serious side effects. You may want to ask your doctor questions about Caplyta’s side effects to help you decide whether it’s a good treatment for your condition. Here are a few to get you started:
- Will Caplyta make the side effects from my other medications worse?
- How can I tell if I’m experiencing a serious side effect from Caplyta?
- Could taking Caplyta make my depression get worse?
- Are there ways for me to decrease my risk of side effects with Caplyta?
To learn more about Caplyta, see these articles:
- All About Caplyta
- All About Caplyta’s Dosage
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