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Lumateperone Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 22, 2022.

For the Consumer

Applies to lumateperone: oral capsule

Warning

Oral route (Capsule)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lumateperone is not approved for the treatment of patients with dementia-related psychosis.Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of lumateperone have not been established in pediatric patients.

Side effects requiring immediate medical attention

Along with its needed effects, lumateperone 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:

Incidence not known

  • Black, tarry stools
  • blurred vision
  • chest pain
  • confusion
  • cough or hoarseness
  • double vision
  • dry mouth
  • fast heartbeat
  • fever with or without chills
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of tiredness or weakness
  • headache
  • high fever
  • inability to move the arms, legs, or facial muscles
  • inability to move the eyes
  • inability to speak
  • increased blinking or spasms of the eyelid
  • increased hunger
  • increased sweating
  • increased thirst
  • increased urination
  • lip smacking or puckering
  • loss of bladder control
  • lower back or side pain
  • nausea
  • numbness or tingling in the face, arms, or legs
  • painful or difficult urination
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • seizures
  • severe muscle stiffness
  • slow speech
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sticking out of the tongue
  • stomach pain
  • sweating
  • swollen glands
  • tiredness
  • trouble in breathing, speaking, or swallowing
  • trouble thinking or walking
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual facial expressions
  • unusual tiredness or weakness
  • unusually pale skin
  • vomiting

Side effects not requiring immediate medical attention

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:

More common

  • Dizziness
  • dry mouth
  • sleepiness or unusual drowsiness
  • weight gain

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. (2020):

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.