Caplyta – A New Antipsychotic Medication for Schizophrenia
Caplyta (lumateperone) is an antipsychotic medication first approved in December 2019 and authorized for the treatment of schizophrenia. Caplyta has been referred to as a “third generation” or “novel” antipsychotic drug — though like its predecessors, the mechanism of action for treating schizophrenia is described by regulators as “unknown.” 1
Caplyta’s most potent effects are on both serotonin receptors and transporters, as well as moderate binding effects on dopamine, and glutamate. Similar but lesser effects are noted on muscarine and histamine receptors according to research and the drug label.
Caplyta was approved to treat schizophrenia, and the clinical trials prior to the drug’s approval were limited to persons with schizophrenia. Post marketing studies were also done on persons diagnosed with major depression and bipolar conditions. Subsequently, many prescriptions have been written for these conditions as well. About 68% of patients in these studies reported side effects during the trials. Although the chemical structure of lumateperone is known, its mechanism of action is not fully understood.6
The natural hormones listed above each have an extensive range of functions in the human body, and is perhaps helps explain why the range of side effects of Caplyta is similarly extensive.2
Learn more about how methods of neurotransmitter rehabilitation can support this important function of human health.
Caplyta Side Effects
Some of the following Caplyta side effects are listed on the drug’s label from schizophrenic participants in the drug trials.
Others are taken from the literature on pre-marketing safety trials published in the Schizophrenia Research Journal. In these safety trials, Caplyta was switched with another or other antipsychotic medications. After 6 weeks of lumateperone treatment, the patients were switched back to 2 weeks on their previous antipsychotic medication or an entirely different one. Some were again switched back to lumateperone. The purpose of these studies was to understand more about the safety of switching antipsychotic drugs back and forth.
It should be noted that withdrawals from one or another drug may have entered the mix, but were not the focus of trials, and not mentioned in the literature.
Since the drug Caplyta, generic lumateperone, is classed as an antipsychotic, the drug manufacturer and the regulators list side effects related to the overall drug class, as research has shown a similar profile between many of the drugs in this class.
Other data was drawn from the FDA adverse event report summary on Caplyta which is massive, and is available online. At the time of this writing, the FAERS report is current up to April 28 2026. The adverse side effects in the summary below, were drawn from the references cited. 1-4
Side effects of Caplyta may include:
- Increased death rate in dementia patients (nearly double that of placebo)
- Deaths in other patient populations 4
- Suicidal ideation, death by suicide
- Mania
- Anxiety
- Agitation
- Crying spells
- Irritability, anger
- Rash, itching
- Disturbed gait
- Depression
- Numbness
- Electric shock sensations
- Brain fog, cognitive impairment
- Insomnia
- Nightmares
- Psychosis
- Hallucination, delusion
- Stroke
- Chest pain
- Heart palpitations, increased heart rate
- Flu-like symptoms
- Neuroleptic malignant syndrome
- Tardive dyskinesia (can emerge even after short duration of use or low dosage, or can emerge after long-term use and can persists after withdrawal)
- Other extra pyramidal side effects such as muscle spasms, restlessness, tremor, drooling
- Akathisia
- Panic attacks
- Confusion
- Stiffness, twitching, involuntary muscle contractions
- Muscle weakness, painful muscles
- Abdominal pain
- Weight gain
- Weight decrease
- Sinus dysfunction
- Shortness of breath
- Restless legs syndrome
- Diabetes
- Hyperglycemia, can lead to coma, death
- Lowered white blood cell count
- Sexual dysfunction
- Orthostatic hypotension (fainting, lightheadedness on standing up)
- High blood pressure
- Loss of consciousness
- Dizziness, vertigo
- Headache, migraine
- Falls, fractures, injuries
- Somnolence (daytime sleepiness, drowsiness, fatigue)
- Excessive sleep
- Motor and sensory instability, feeling drunk or drugged, impaired balance, abnormal gait)
- Seizures
- Cognitive impairment
- Overheating
- Chills
- Burning sensation, burning skin
- Difficulty swallowing (dysphagia)
- Nausea, vomiting
- Decreased appetite
- Dry mouth
- Diarrhea
- Elevated liver enzymes (transaminitis)
