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Lumateperone Side Effects

The most commonly reported side effects of lumateperone include dizziness, nausea, and headache, based on 5,751 FDA adverse event reports from 2016 to 2025. 4.8% of reports found the drug to be ineffective.

Lumateperone side effects

Percentages show how often each reaction appears relative to total reports for lumateperone.

1
Dizziness10.7%613
2
Nausea7.9%452
3
Headache7.2%413
4
Somnolence5.9%341
5
Off Label Use5.7%330
6
Drug Ineffective4.8%275
7
Mania4.2%240
8
Feeling Abnormal4.1%238
9
Sedation4.0%231
10
Anxiety3.8%220
11
Insomnia3.7%210
12
Fatigue3.5%202
13
Vomiting3.3%191
14
Burning Sensation3.2%184
15
Suicidal Ideation3.1%180

These are voluntary reports and do not establish that lumateperone caused these reactions.

Report severity

29.1%Serious1,671 reports
8.3%Hospitalizations477 reports
0.9%Fatal53 reports

Seriousness is determined by the reporter, not by OpenClaim.

Lumateperone drug interactions

Other drugs that appear in adverse event reports alongside lumateperone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Lithium1.8%104
2
Quetiapine-fumarate1.2%69
3
Olanzapine1.2%68
4
Aripiprazole1.2%67
5
Lurasidone-hydrochloride1.1%63
6
Cariprazine-hydrochloride1.1%61
7
Lamotrigine1.0%60
8
Divalproex-sodium0.9%54
9
Bupropion0.8%45
10
Valbenazine0.7%43
11
Risperidone0.7%40
12
Amphetamine0.6%33
13
Dupilumab0.5%29
14
Dextroamphetamine0.5%28
15
Venlafaxine0.5%26

Taken alongside

1
Lamotrigine5.9%340
2
Lithium2.9%169
3
Bupropion2.9%164
4
Clonazepam2.8%162
5
Gabapentin2.6%151
6
Quetiapine-fumarate2.3%134
7
Trazodone-hydrochloride2.0%114
8
Hydroxyzine1.9%108
9
Ergocalciferol1.9%107
10
Levothyroxine-sodium1.8%102
11
Buspirone-hydrochloride1.8%101
12
Amphetamine1.7%99
13
Dextroamphetamine1.7%98
14
Alprazolam1.6%92
15
Sertraline-hydrochloride1.6%92

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports lumateperone side effects

60.7% of lumateperone adverse event reports involve female patients and 28.2% involve male patients. The largest age group is adult at 92%. These figures reflect who reports side effects, not underlying risk.

Sex

Female60.7%
Male28.2%
Unknown11.2%

Age group

< 2<0.1%
2–11<0.1%
12–170.5%
18–6491.9%
65+7.4%

What is lumateperone used for

Conditions and purposes for which patients were taking lumateperone when the adverse event was reported.

Affective DisorderAgitationAngerAnxiety DisorderAutism Spectrum DisorderAdjuvant TherapyAffect LabilityAffective DisorderAggressionAgitationAngerAntipsychotic TherapyAnxietyAnxiety DisorderApathy

Showing 15 of 109 indications

Lumateperone brand names and reporting trend

Lumateperone is sold under brand names including Lumateperone, Lumateperone Tosylate.

Brand names

Lumateperone95
Lumateperone Tosylate14

Quarterly reports (20162025)

201620242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking lumateperone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.