Important Safety Information

Medicines like CAPLYTA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). CAPLYTA is not approved for treating people with dementia-related psychosis.

Tell your doctor right away if you have any of the following serious side effects:

  • Stroke (cerebrovascular problems) in elderly people that can lead to death.
  • Neuroleptic malignant syndrome (NMS): high fever, confusion, changes in your breathing, heart rate, and blood pressure, stiff muscles, and increased sweating; these may be symptoms of a rare but potentially fatal condition. Contact your doctor or go to the emergency room if you experience signs and symptoms of NMS.
  • Uncontrolled body movements (tardive dyskinesia, TD) in your face, tongue, or other body parts. TD may not go away, even if you stop taking CAPLYTA. It may also occur after you stop taking your medication.
  • Problems with your metabolism including high blood sugar, diabetes, increased fat (cholesterol and triglyceride) levels in your blood and weight gain. Your doctor should check your blood sugar, fat levels and weight before you start and during your treatment with CAPLYTA. Extremely high blood sugar levels can lead to coma or death. Tell your doctor if you have symptoms of high blood sugar, which include feeling very thirsty, hungry, sick to your stomach, weak/tired or needing to urinate more than usual.
  • Low white blood cell count. Your doctor may do blood tests during the first few months of treatment with CAPLYTA.
  • Decreased blood pressure (orthostatic hypotension). You may feel lightheaded, dizzy, or faint when you rise too quickly from a sitting or lying position.
  • Falls. CAPLYTA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause broken bones or other injuries.
  • Seizures (convulsions)
  • Sleepiness and trouble concentrating: Until you know how CAPLYTA affects you, do not drive, operate heavy machinery, or do other dangerous activities.
  • Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated while taking CAPLYTA.
  • Difficulty swallowing

The most common side effects of CAPLYTA include sleepiness or drowsiness and dry mouth.

These are not all of the possible side effects of CAPLYTA. You should notify your doctor if you become pregnant or intend to become pregnant while taking CAPLYTA. CAPLYTA may cause extrapyramidal (abnormal involuntary movements) and/or withdrawal symptoms in newborn babies exposed to CAPLYTA during the third trimester. When taking CAPLYTA, you should not breastfeed. Tell your doctor if you have liver problems and about all the medicines you're taking, since there are some risks for drug interactions. Avoid eating grapefruit or drinking grapefruit juice during treatment with CAPLYTA. Grapefruit and grapefruit juice may affect the amount of CAPLYTA in your blood. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Prescribing Information, including Boxed Warning.