Lumateperone side effects: what 7,085 FDA adverse event reports show
Brand names
Caplyta
Who reports
7,085 reports · 28% serious · 61 with death outcome · 69% female
Used for
CAPLYTA is indicated for: Treatment of schizophrenia in adults . Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate .
What it is
Lumateperone is an atypical antipsychotic present as lumateperone tosylate salt with the chemical name 4-((6b R ,10a S )-3-methyl-2,3,6b,9,10,10 a -hexahydro-1 H ,7 H -pyrido[3',4':4,5]pyrrolo[1,2,3- de ]quinoxalin-8-yl)-1-(4-fluoro-phenyl)-butan-1-one 4-methylbenzenesulfonate.
Boxed warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 129 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Mania | 284 | 52.0 46.4–58.4ROR 54.1 · χ² 13,922 / p <1e-300 | 51.0 EB05 46.2 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 46.5 | no trial data cached |
| Akathisia (inner restlessness) | 177 | 38.9 33.6–45.0ROR 39.8 · χ² 6,410 / p <1e-300 | 38.2 EB05 33.7 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.6 | no trial data cached |
| Sedation | 274 | 31.4 28.0–35.3ROR 32.6 · χ² 7,962 / p <1e-300 | 31.0 EB05 28.1 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.3 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 200 | 20.9 18.2–24.0ROR 21.5 · χ² 3,750 / p <1e-300 | 20.7 EB05 18.4 · IC025 +4.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 48.1 | no trial data cached |
| Hallucination, auditory | 83 | 15.5 12.5–19.2ROR 15.7 · χ² 1,107 / p 6e-243 | 15.3 EB05 12.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 34.5 · ♀ 47% (drug 69%) | no trial data cached |
| Paranoia | 73 | 12.5 10.0–15.7ROR 12.6 · χ² 759 / p 2e-167 | 12.3 EB05 10.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 | no trial data cached |
| Brain fog | 60 | 12.2 9.5–15.7ROR 12.3 · χ² 604 / p 9e-134 | 11.9 EB05 9.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Schizophrenia | 49 | 12.0 9.0–15.8ROR 12.0 · χ² 480 / p 1e-106 | 11.6 EB05 9.0 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 23.6 · ♀ 26% (drug 69%) | no trial data cached |
| Psychotic disorder | 115 | 11.6 9.6–13.9ROR 11.7 · χ² 1,096 / p 1e-240 | 11.4 EB05 9.7 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 23.7 | no trial data cached |
| Hypersomnia | 89 | 9.2 7.5–11.3ROR 9.3 · χ² 643 / p 4e-142 | 9.0 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Burning sensation | 216 | 9.1 8.0–10.4ROR 9.4 · χ² 1,558 / p <1e-300 | 9.0 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Neuroleptic malignant syndrome | 36 | 9.0 6.5–12.4ROR 9.0 · χ² 247 / p 7e-56 | 8.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 18.3 | no trial data cached |
| Euphoric mood | 29 | 8.3 5.8–12.0ROR 8.4 · χ² 180 / p 3e-41 | 7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Restless legs syndrome | 47 | 7.7 5.8–10.2ROR 7.7 · χ² 265 / p 8e-60 | 7.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Dyskinesia (involuntary movements) | 103 | 7.5 6.2–9.1ROR 7.6 · χ² 576 / p 1e-127 | 7.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.5 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 44 | 7.5 5.6–10.0ROR 7.5 · χ² 240 / p 2e-54 | 7.0 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.6 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 224 | 7.2 6.4–8.2ROR 7.4 · χ² 1,202 / p 1e-263 | 7.1 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 15.0 | no trial data cached |
| Restlessness | 88 | 7.1 5.8–8.8ROR 7.2 · χ² 456 / p 2e-101 | 6.9 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Dystonia | 46 | 7.0 5.3–9.3ROR 7.0 · χ² 231 / p 2e-52 | 6.6 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.7 | no trial data cached |
| Delusion | 36 | 6.9 5.0–9.5ROR 6.9 · χ² 175 / p 3e-40 | 6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Extrapyramidal disorder | 57 | 6.7 5.2–8.7ROR 6.8 · χ² 272 / p 2e-61 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.3 | no trial data cached |
| Dry mouth | 180 | 6.6 5.7–7.6ROR 6.7 · χ² 849 / p 6e-187 | 6.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Bipolar disorder | 23 | 6.2 4.1–9.4ROR 6.2 · χ² 96 / p 7e-23 | 5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 10.7 | no trial data cached |
| Somnolence (drowsiness) | 416 | 6.1 5.6–6.7ROR 6.5 · χ² 1,795 / p <1e-300 | 6.1 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Muscle twitching | 46 | 5.9 4.4–7.9ROR 5.9 · χ² 182 / p 9e-42 | 5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Feeling cold | 55 | 5.8 4.5–7.6ROR 5.9 · χ² 216 / p 4e-49 | 5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Sexual dysfunction | 22 | 5.6 3.7–8.5ROR 5.6 · χ² 78 / p 5e-19 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 9% (drug 69%) | no trial data cached |
| Unevaluable event | 135 | 5.3 4.5–6.2ROR 5.4 · χ² 466 / p 1e-103 | 5.2 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Irritability | 107 | 5.3 4.4–6.4ROR 5.3 · χ² 366 / p 8e-82 | 5.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Middle insomnia | 33 | 5.3 3.7–7.4ROR 5.3 · χ² 109 / p 7e-26 | 4.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 79% consumer | no trial data cached |
| Dizziness postural | 17 | 5.2 3.3–8.4ROR 5.3 · χ² 54 / p 9e-14 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=3 | no trial data cached |
| Anger | 58 | 5.1 3.9–6.5ROR 5.1 · χ² 185 / p 2e-42 | 4.9 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Agitation | 116 | 4.7 3.9–5.6ROR 4.7 · χ² 331 / p 3e-74 | 4.6 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Initial insomnia | 16 | 4.6 2.8–7.6ROR 4.7 · χ² 42 / p 4e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Serotonin syndrome | 30 | 4.6 3.2–6.6ROR 4.7 · χ² 82 / p 6e-20 | 4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Nightmare | 54 | 4.6 3.5–6.0ROR 4.6 · χ² 149 / p 2e-34 | 4.4 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Feeling hot | 95 | 4.6 3.8–5.6ROR 4.6 · χ² 263 / p 2e-59 | 4.5 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Incontinence | 16 | 4.5 2.7–7.3ROR 4.5 · χ² 40 / p 1e-10 | 4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 0.8 | no trial data cached |
| Dysarthria (slurred speech) | 56 | 4.4 3.4–5.7ROR 4.4 · χ² 144 / p 2e-33 | 4.3 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Migraine | 140 | 4.4 3.7–5.2ROR 4.4 · χ² 362 / p 6e-81 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dizziness | 719 | 4.3 4.0–4.6ROR 4.6 · χ² 1,843 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Nausea | 549 | 2.1 1.9–2.2ROR 2.1 · χ² 310 / p 1e-69 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Headache | 488 | 2.3 2.1–2.5ROR 2.4 · χ² 371 / p 6e-83 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Somnolence (drowsiness) | 416 | 6.1 5.6–6.7ROR 6.5 · χ² 1,795 / p <1e-300 | 6.1 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Mania | 284 | 52.0 46.4–58.4ROR 54.1 · χ² 13,922 / p <1e-300 | 51.0 EB05 46.2 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 46.5 | no trial data cached |
| Anxiety | 282 | 2.9 2.6–3.3ROR 3.0 · χ² 360 / p 1e-80 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Sedation | 274 | 31.4 28.0–35.3ROR 32.6 · χ² 7,962 / p <1e-300 | 31.0 EB05 28.1 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.3 | no trial data cached |
| Feeling abnormal | 273 | 3.4 3.0–3.8ROR 3.5 · χ² 455 / p 3e-101 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Insomnia (trouble sleeping) | 252 | 2.8 2.5–3.2ROR 2.9 · χ² 292 / p 7e-66 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 224 | 7.2 6.4–8.2ROR 7.4 · χ² 1,202 / p 1e-263 | 7.1 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 15.0 | no trial data cached |
| Burning sensation | 216 | 9.1 8.0–10.4ROR 9.4 · χ² 1,558 / p <1e-300 | 9.0 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Tremor (shaking) | 207 | 3.7 3.2–4.2ROR 3.8 · χ² 405 / p 2e-90 | 3.7 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 200 | 20.9 18.2–24.0ROR 21.5 · χ² 3,750 / p <1e-300 | 20.7 EB05 18.4 · IC025 +4.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 48.1 | no trial data cached |
| Depression | 182 | 2.4 2.0–2.7ROR 2.4 · χ² 142 / p 4e-33 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.0 | no trial data cached |
| Dry mouth | 180 | 6.6 5.7–7.6ROR 6.7 · χ² 849 / p 6e-187 | 6.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Mania — n=284, PRR 52.0
- Hallucination, auditory — n=83, PRR 15.5
- Paranoia — n=73, PRR 12.5
- Brain fog — n=60, PRR 12.2
- Hypersomnia — n=89, PRR 9.2
- Euphoric mood — n=29, PRR 8.3
- Restless legs syndrome — n=47, PRR 7.7
- Delusion — n=36, PRR 6.9
- Feeling cold — n=55, PRR 5.8
- Sexual dysfunction — n=22, PRR 5.6
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Lumateperone?
In FDA FAERS, the most frequently co-reported reaction terms for Lumateperone are dizziness, nausea, headache, somnolence, mania, anxiety. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Lumateperone have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Do FAERS signals prove that Lumateperone causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID db730b06-6351-47fd-8183-e61e61bbead5, effective 20250620; matched on
openfda.generic_name.exact:"LUMATEPERONE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 169 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.