Caplyta Side Effects

Generic name: lumateperone

Medically reviewed by Drugs.com. Last updated on Jul 12, 2024.

Note: This document provides detailed information about Caplyta Side Effects associated with lumateperone. Some dosage forms listed on this page may not apply specifically to the brand name Caplyta.

Applies to lumateperone: oral capsule.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. This medicine may cause unwanted effects to newborn babies if used during the later part of pregnancy.

For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.

This medicine may increase risk of transient ischemic attack or stroke in elderly patients. Tell your doctor right away if you have confusion, double vision, headache, inability to move the arms, legs, or facial muscles, slow speech, or trouble speaking, thinking, or walking while using this medicine.

Check with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

Lumateperone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, a cough or hoarseness, lower back or side pain, or painful or difficult urination.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may cause some people to become may cause drowsiness, trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Common side effects of Caplyta

Some side effects of lumateperone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Serious side effects of Caplyta

Along with its needed effects, lumateperone (the active ingredient contained in Caplyta) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lumateperone:

For healthcare professionals

Applies to lumateperone: oral capsule.

General adverse events

The most commonly reported side effects included sedation/somnolence, nausea, dry mouth, and dizziness.^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Orthostatic hypotension^[Ref]

Endocrine

• Common (1% to 10%): Increased blood prolactin^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, dry mouth, vomiting, diarrhea, abdominal pain (includes abdominal discomfort, abdominal pain, upper abdominal pain, lower abdominal pain)

Antipsychotic drugs:

• Frequency not reported: Esophageal dysmotility, dysphagia^[Ref]

Hematologic

• Frequency not reported: Leukopenia, neutropenia

Antipsychotic drugs:

• Frequency not reported: Agranulocytosis^[Ref]

Hepatic

• Common (1% to 10%): Increased hepatic transaminases (includes increased ALT, increased AST, increased hepatic enzymes, abnormal liver function test)^[Ref]

Metabolic

• Very common (10% or more): Shifts in insulin values from normal to high (up to 12%)
• Common (1% to 10%): Decreased appetite, shifts in fasting glucose from normal to high
• Frequency not reported: Hyperglycemia, increased hemoglobin A1c levels

Antipsychotic drugs:

• Frequency not reported: Metabolic changes (including hyperglycemia [some cases extreme and associated with ketoacidosis, hyperosmolar coma, death], diabetes mellitus, dyslipidemia, weight gain)^[Ref]

In pooled data from short-term (4- to 6-week) trials of adult patients with schizophrenia, mean changes from baseline and the proportion of patients with shifts from normal to greater than normal levels of fasting glucose in patients treated with this drug were similar to those in patients treated with placebo. In an uncontrolled trial of this drug for up to 1 year in patients with stable schizophrenia, the percentages of patients with shifts in fasting glucose and insulin values from normal to high were 8% and 12%, respectively; 4.7% of patients with normal hemoglobin A1c (less than 6.5%) at baseline developed elevated levels (at least 6.5%) postbaseline.

In data from short-term (6-week) monotherapy and adjunctive therapy bipolar depression trials, mean changes from baseline and the proportion of patients with shifts from normal to greater than normal levels of fasting glucose and insulin in patients treated with this drug were similar to those in patients treated with placebo.^[Ref]

Musculoskeletal

• Common (1% to 10%): Increased creatine phosphokinase^[Ref]

Nervous system

• Very common (10% or more): Somnolence/sedation (up to 24%), headache (up to 14%), dizziness (includes dizziness, postural dizziness; up to 11%)
• Common (1% to 10%): Extrapyramidal symptoms (EPS; including akathisia, extrapyramidal disorder, muscle spasms, restlessness, musculoskeletal stiffness, dyskinesia, dystonia, muscle twitching, tardive dyskinesia, tremor, drooling, involuntary muscle contractions, movement disorder, gait disturbance)
• Uncommon (0.1% to 1%): Syncope

Antipsychotic drugs:

• Frequency not reported: Cerebrovascular adverse reactions, stroke, transient ischemic attack, neuroleptic malignant syndrome, tardive dyskinesia^[Ref]

In the 4- to 6-week schizophrenia trials, the frequency of reported events related to EPS (including akathisia, extrapyramidal disorder, muscle spasms, restlessness, musculoskeletal stiffness, dyskinesia, dystonia, muscle twitching, tardive dyskinesia, tremor, drooling, involuntary muscle contractions) was 6.7% for this drug and 6.3% for placebo.

In the 6-week monotherapy bipolar depression trials, the frequency of reported reactions related to EPS (including muscle spasms, dyskinesia, extrapyramidal disorder, movement disorder, tremor, restlessness, akathisia) was 1.3% for this drug and 1.1% for placebo. In the 6-week adjunctive therapy bipolar depression trial, the frequency of reported reactions related to EPS (including tremor, muscle spasms, akathisia, extrapyramidal disorder, gait disturbance, restlessness) was 4% for this drug and 2.3% for placebo.

In placebo-controlled trials in older patients with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke.^[Ref]

Ocular

• Common (1% to 10%): Blurred vision^[Ref]

Other

• Common (1% to 10%): Fatigue, increased total cholesterol, increased triglycerides, increased low-density lipoprotein (LDL) cholesterol
• Frequency not reported: Weight gain, weight loss

Antipsychotic drugs:

• Frequency not reported: Increased mortality (in older patients with dementia-related psychosis), adverse alterations in lipids, weight gain^[Ref]

In pooled data from short-term (4- to 6-week) trials of adult patients with schizophrenia, mean changes from baseline and the proportion of patients with shifts to higher levels of fasting total cholesterol and triglycerides were similar in patients treated with this drug and placebo. In an uncontrolled trial of this drug for up to 1 year in patients with stable schizophrenia, the percentages of patients with a shift from normal to high were 8%, 5%, and 4% for total cholesterol, triglycerides, and LDL cholesterol, respectively.

In data from short-term (6-week) monotherapy and adjunctive therapy bipolar depression trials, mean changes from baseline and the proportion of patients with shifts to higher levels of fasting total cholesterol and triglycerides were similar in patients treated with this drug and placebo. In an uncontrolled trial of this drug for up to 6 months in patients with bipolar depression, the proportion of patients with a shift from normal to high were 10%, 5%, and 2% for total cholesterol, triglycerides, and LDL cholesterol, respectively.

In pooled data from trials of adult patients with schizophrenia, mean changes from baseline and the proportion of patients with an increase in weight at least 7% from baseline to end of study was similar in patients treated with this drug and placebo. In an uncontrolled trial of this drug for up to 1 year in patients with stable schizophrenia, the mean change in body weight was about -2 kg at Day 175 and about -3.2 kg at Day 350.

In data from short-term (6-week) monotherapy and adjunctive therapy bipolar depression trials, mean changes from baseline and the proportion of patients with an increase in weight at least 7% from baseline to end of study were similar in patients treated with this drug and placebo. In an uncontrolled trial of this drug for up to 6 months in patients with bipolar depression, the mean change in body weight was -0.01 kg at Day 175.

Analyses of 17 placebo-controlled trials (modal duration: 10 weeks), mainly in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that in placebo-treated patients. Over the course of a typical 10-week trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in placebo-treated patients. Although the causes were varied, most deaths were either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.^[Ref]

Respiratory

• Common (1% to 10%): Upper respiratory tract infection
• Frequency not reported: Difficulty breathing

Antipsychotic drugs:

• Frequency not reported: Aspiration^[Ref]

See also:

Frequently asked questions

• What is the mechanism of action for Caplyta?
• Caplyta savings card: Do I qualify and how much can I save?
• How long does it take Caplyta to work?
• Does Caplyta cause weight gain?

Further information

Caplyta side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer