What the label lists and what reports show
Lumateperone side effects
Lumateperone's FDA label: “Most common adverse reactions in clinical trials (incidence ≥ 5% and greater than twice placebo) were ( 6.1 ): Schizophrenia: somnolence/sedation and dry mouth.” FAERS holds 7,088 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (719 reports).
- No generic listed
- Boxed warning
Check it at the source: the lumateperone FDA label on DailyMed (effective June 20, 2025, Intra-Cellular Therapies, Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of CAPLYTA?CAPLYTA may cause serious side effects, including: See “ What is the most important information I should know about CAPLYTA? ” Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS) is a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS: high fever changes in your breathing, heart rate, and blood pressure increased sweating confusion stiff muscles Uncontrolled body movements (tardive dyskinesia). CAPLYTA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking CAPLYTA. Tardive dyskinesia may also start after you stop taking CAPLYTA. […]
Source: FDA drug label, Intra-Cellular Therapies, Inc, effective June 20, 2025 (SPL set db730b06-6351-47fd-8183-e61e61bbead5), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions in clinical trials (incidence ≥ 5% and greater than twice placebo) were ( 6.1 ): Schizophrenia: somnolence/sedation and dry mouth.
Table 5: Adverse Reactions Reported in ≥2% of Patients Treated with CAPLYTA + Background ADT and at Greater Incidence than in Patients Treated with Placebo + Background ADT in Pooled 6-Week Adjunctive MDD Trials
| Reaction | CAPLYTA 42 mg + ADT (N=483) | Placebo + ADT (N=481) |
|---|---|---|
| Headache 1 | 19% | 13% |
| Dizziness 2 | 17% | 5% |
| Dry Mouth | 13% | 3% |
| Somnolence/Sedation | 12% | 2% |
| Nausea | 9% | 4% |
| Fatigue | 8% | 2% |
| Diarrhea | 5% | 1% |
| Tremor | 4% | <1% |
| Vomiting | 3% | 2% |
| Vertigo | 3% | <1% |
| Insomnia | 3% | 2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning, Warnings and Precautions (5.1) ] Suicidal Thoughts and Behaviors [see Boxed Warning, Warnings and Precautions (5.2) ] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis [see Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.4) ] Tardive Dyskinesia [see Warnings and Precautions (5.5) ] Metabolic Changes [see Warnings and Precautions (5.6) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.7) ] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.8) ] Falls [see Warnings and Precautions (5.9) ] Seizures [see Warnings and Precautions (5.10) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.11) ] Body Temperature Dysregulation [see Warnings and Precautions (5.12) ] Dysphagia [see Warnings and Precautions (5.13) ] Most common adverse reactions in clinical trials (incidence ≥ 5% and greater than twice placebo) were ( 6.1 ): Schizophrenia: somnolence/sedation and dry mouth. Bipolar depression: somnolence/sedation, dizziness, nausea, dry mouth. MDD: dizziness, dry mouth, somnolence/sedation, nausea, fatigue, diarrhea.
Source: FDA drug label, Intra-Cellular Therapies, Inc, effective June 20, 2025 (SPL set db730b06-6351-47fd-8183-e61e61bbead5), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,088 reports list lumateperone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 61 are coded as a death and 569 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2024 (1,997, against a median of 170 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 17 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lumateperone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions