Caplyta (lumateperone) is a brand-name prescription medication. It’s approved by the Food and Drug Administration (FDA) to treat schizophrenia and bipolar depression* in adults.

Caplyta is typically used as a long-term treatment.

Here are some fast facts about Caplyta:

  • Active ingredient: lumateperone
  • Drug class: atypical antipsychotics
  • Drug form: capsule
  • FDA approval year: 2019

Like other drugs, Caplyta can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Caplyta, including details about its uses, see this article.

* For this use, Caplyta may be prescribed by itself or in combination with lithium or valproate.

Caplyta can cause certain adverse effects (side effects), some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Caplyta in clinical trials. These side effects can vary depending on which 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:

* For more information about this side effect, see “Side effect specifics” below.
† This side effect occurred when Caplyta was taken in combination with lithium or valproate.

Mild side effects can occur with Caplyta use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Caplyta’s prescribing information.

Mild side effects that have been reported with Caplyta for schizophrenia include:

* To learn more about this side effect, see “Side effect specifics” below.

Mild side effects that have been reported with Caplyta for bipolar depression include:

These side effects may be temporary, lasting a few days to weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Caplyta and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.
† This side effect occurred when Caplyta was taken in combination with lithium or valproate.

Caplyta may cause serious side effects, but these are not common. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Caplyta’s prescribing information.

If you develop serious side effects while taking Caplyta, 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.

Serious side effects that have been reported and their symptoms can include:

* To learn more, see the “Side effect specifics” section below.
† An allergic reaction is possible after using Caplyta. But this side effect wasn’t reported in clinical trials
Caplyta has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA).

Caplyta may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Does Caplyta cause any cardiac side effects?

It’s possible. Caplyta can cause orthostatic hypotension (a drop in blood pressure when moving from sitting to standing up). Symptoms include dizziness, fainting, and falling. Take your time when changing body positions to help with this possible side effect of Caplyta.

Caplyta has a boxed warning about the increased risk of death in older people with psychosis due to dementia. This is the most serious warning from the Food and Drug Administration (FDA). In clinical trials, causes of death included heart failure and stroke.

If you have questions about cardiac side effects and Caplyta, talk with your doctor.

Are there any side effects of stopping Caplyta treatment?

Stopping treatment with Caplyta may cause symptoms of schizophrenia or bipolar depression to return. (These are conditions that Caplyta is approved to treat.)

If you have questions about Caplyta’s side effects, talk with your doctor. Note that you should not stop taking Caplyta or change your dose without talking with your doctor.

Can Caplyta be taken to treat bipolar disorder?

No, Caplyta is not approved to treat bipolar disorder. Caplyta is only approved to treat bipolar depression and schizophrenia in adults.

If you have questions about treating bipolar disorder or if Caplyta is right for you, talk with your doctor.

Learn more about some of the side effects that Caplyta may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Caplyta.

Weight gain

In clinical trials, weight gain occurred in people taking Caplyta. This side effect was not common. If you gain weight while taking Caplyta, talk with your doctor. Weight gain may be a symptom of a more serious side effect, such as diabetes or increased cholesterol and triglyceride levels.

What you can do

Before you start taking Caplyta, you may want to weigh yourself. You can keep track of your weight during treatment. If you have weight gain during treatment with Caplyta, talk with your doctor. They can suggest ways to maintain a weight that’s healthy for you.

Dizziness

Caplyta may cause dizziness. In clinical trials, this side effect was common.

Caplyta can also cause orthostatic hypotension, especially when you first start taking the drug. With orthostatic hypotension, your blood pressure can get too low when moving from sitting to standing. Symptoms include falling, fainting, and dizziness.

Dizziness may be more common if you have a history of heart problems such as heart attack, stroke, or problems with heart rhythm.

What you can do

To lower your risk of dizziness when taking Caplyta, take your time when changing body positions. If you have concerns about dizziness while taking Caplyta, talk with your doctor. Be sure to tell them about all of the medications you take and if you’ve had any heart problems in the past.

Dry mouth

In clinical trials, dry mouth was a common side effect of treatment with Caplyta. Typically, this is a mild side effect.

What you can do

Talk with your doctor if you have dry mouth while taking Caplyta. For tips on ways to help with dry mouth, see this article.

Allergic reaction

As with most drugs, Caplyta can cause an allergic reaction in some people. But this side effect wasn’t reported in clinical trials.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under the skin of the lips, eyelids, feet, or hands
  • swelling of the mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Caplyta. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Increased risk of death in older adults with psychosis due to dementia

Caplyta has a boxed warning about the increased risk of death in older adults with psychosis due to dementia. Because of this risk, Caplyta is not approved to treat dementia-related psychosis in older adults.

In clinical trials, the causes of death in older adults included heart failure, stroke, and pneumonia.

What you can do

If you are a healthcare professional for an older adult with dementia-related psychosis, be sure their doctor knows about all of the medications they take.

Risk of suicidal thoughts and behaviors

Treatment with Caplyta increases your risk of suicidal thoughts and behaviors. Caplyta has a boxed warning about this side effect. This is the most serious warning from the Food and Drug Administration (FDA).

In clinical trials, this side effect was more common in children and people ages 24 years and younger. This risk of suicidal thoughts and behaviors can happen when a person starts taking Caplyta or when the dosage is increased.

What you can do

While taking Caplyta, call your doctor right away if you have:

  • sudden changes in your mood, behavior, feelings, or thoughts
  • thoughts of suicide or harming yourself
  • new or worsening depression
  • new or worsening anxiety
  • agitation or restlessness
  • panic attacks
  • feelings of anger or violence
  • impulsive behavior

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Click here for more links and local resources.

Before taking Caplyta, there are several precautions to consider. These include two boxed warnings.

Boxed warnings

Caplyta has boxed warnings for increased risk of death in older adults with psychosis due to dementia and a risk of suicidal thoughts and behaviors. These are serious warnings from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before taking Caplyta. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:

History of epilepsy or seizures. Tell your doctor if you have a history of epilepsy or seizures. Taking Caplyta may increase your risk of seizures if you have epilepsy or have had seizures in the past. Your doctor can help determine if Caplyta is safe for you.

Low blood pressure. Caplyta may increase your risk of orthostatic hypotension. This risk is higher if you have low blood pressure, take blood pressure medication, or have cardiovascular disease. Talk with your doctor if you have low blood pressure. They may monitor your blood pressure during treatment with Caplyta.

Low white blood cell level. Taking Caplyta can decrease your level of white blood cells, including neutrophils. Your doctor may monitor your white blood cell levels with blood tests throughout treatment with Caplyta.

Overheating or dehydration. Caplyta can affect how your body regulates its temperature. This may cause you to become overheated or dehydrated. While taking Caplyta, it is important to stay hydrated. To avoid overheating, you should not do strenuous exercise, use a sauna, or spend long periods in hot weather. Talk with your doctor about the risks of overheating and dehydration with Caplyta.

Liver disease. If you have moderate to severe liver disease, you should not take Caplyta. Tell your doctor if you’ve had any liver problems in the past.

Allergic reaction. If you’ve had an allergic reaction to Caplyta or any of its ingredients, your doctor will likely not prescribe Caplyta. Ask your doctor what other medications are better options for you.

Alcohol use with Caplyta

There aren’t any known interactions between alcohol and Caplyta.

However, drinking alcohol could worsen certain side effects of Caplyta. These can include fatigue, dizziness, nausea, and vomiting.

Drinking alcohol can also worsen mental health conditions, such as schizophrenia and bipolar depression. (Caplyta is approved to treat schizophrenia and bipolar depression)

If you consume alcohol, talk with your doctor about how much is safe for you to drink while taking Caplyta.

Pregnancy and breastfeeding while taking Caplyta

It is not known if it’s safe to take Caplyta while you’re pregnant. Newborns who were exposed to Caplyta in the third trimester have had withdrawal symptoms and abnormal muscle movements after birth.

You should not take Caplyta if you are breastfeeding. Breastfed children exposed to antipsychotic medications, such as Caplyta, have had abnormal muscle movements and excessive sleepiness in clinical trials.

If you have questions about pregnancy or feeding options while taking Caplyta, talk with your doctor.

Treatment with Caplyta can cause mild and serious side effects. Most side effects are mild and usually go away on their own after a few days to weeks. However, Caplyta can cause serious side effects in rare cases. You should talk with your doctor if you have any side effects that last, are bothersome, or are serious.

If you’d like to learn more about Caplyta, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

Disclaimer: Medical News Today 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.