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Lumateperone Side Effects

Medically reviewed by Drugs.com. Last updated on July 17, 2020.

For the Consumer

Applies to lumateperone: oral capsule

Warning

  • There is a higher chance of death in older adults who take this drug for mental problems caused by dementia. Most of the deaths were linked to heart disease or infection. This drug is not approved to treat mental problems caused by dementia.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Very bad dizziness or passing out.
  • Seizures.
  • Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
  • Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
  • A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
  • Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping this drug, but it may not go away. The risk is greater with diabetes and in older adults, especially older women. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling sleepy.
  • Dizziness.
  • Upset stomach.
  • Dry mouth.
  • Weight gain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to lumateperone: oral capsule

General

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

Nervous system

Very common (10% or more): Sedation/somnolence (up to 24%)

Common (1% to 10%): Dizziness, extrapyramidal symptoms

Frequency not reported: Cerebrovascular adverse reactions, drooling, dyskinesia, dystonia, extrapyramidal disorder, involuntary muscle contractions, postural dizziness, prolonged abnormal muscle group contractions, restlessness, seizures, stroke, syncope, tardive dyskinesia, tremor[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth, nausea, vomiting

Frequency not reported: Swallowing difficulty, tongue protrusion[Ref]

Musculoskeletal

Common (1% to 10%): Creatine phosphokinase increased

Frequency not reported: Motor impairment, muscle spasms, muscle twitching, musculoskeletal stiffness, neck muscle spasms[Ref]

Other

Common (1% to 10%): Fatigue

Frequency not reported: Body temperature dysregulation, falls, increased mortality (in older patients with dementia-related psychosis), neuroleptic malignant syndrome[Ref]

Hepatic

Common (1% to 10%): Liver transaminases increased

Frequency not reported: ALT increased, AST increased, liver enzymes increased, liver function test abnormal[Ref]

Metabolic

Common (1% to 10%): Decreased appetite

Frequency not reported: Metabolic changes[Ref]

Psychiatric

Frequency not reported: Akathisia, cognitive impairment, dysphagia, throat tightness[Ref]

Hematologic

Frequency not reported: Agranulocytosis, leukopenia, neutropenia[Ref]

Respiratory

Frequency not reported: Difficulty breathing[Ref]

Cardiovascular

Frequency not reported: Orthostatic hypotension[Ref]

References

1. "Product Information. Caplyta (lumateperone)." Intra-Cellular Therapies, Inc., New York, NY.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.