Caplyta and Agitation - a phase IV clinical study of FDA data

Summary:

Agitation is reported as a side effect among people who take Caplyta (lumateperone tosylate), especially for people who are female, 30-39 old, have been taking the drug for < 1 month also take Cymbalta, and have Bipolar disorder.

The phase IV clinical study analyzes which people have Agitation when taking Caplyta. It is created by eHealthMe based on reports of 3,083 people who have side effects when taking Caplyta from the FDA, and is updated regularly.

What is Caplyta?

Caplyta has active ingredients of lumateperone tosylate. eHealthMe is studying from 3,109 Caplyta users. Check the latest studies of Caplyta.

What is Agitation?

Agitation (state of anxiety or nervous excitement) is found to be associated with 2,276 drugs and 3,312 conditions by eHealthMe. Check the latest studies of Agitation.

On Jul, 10, 2026

3,083 people reported to have side effects when taking Caplyta.
Among them, 94 people (3.05%) have Agitation.

Among these 94 people:

How long have people been on Caplyta when they have Agitation? *

What is the gender of people who have Agitation when taking Caplyta? *

female: 52.87 %
male: 47.13 %

What is the age of people who have Agitation when taking Caplyta? *

What are other drugs people take besides Caplyta? *

What are other side effects people have besides Agitation? *

Stress And Anxiety: 13 people, 13.83%
Insomnia (sleeplessness): 12 people, 12.77%
Dyskinesia (abnormality or impairment of voluntary movement): 9 people, 9.57%
Memory Loss: 9 people, 9.57%
Hyperhidrosis (abnormally increased sweating): 9 people, 9.57%
Aggression: 8 people, 8.51%
Tremor (trembling or shaking movements in one or more parts of your body): 8 people, 8.51%
Fatigue (feeling of tiredness): 8 people, 8.51%
Headache (pain in head): 8 people, 8.51%
Feeling Abnormal: 7 people, 7.45%

What are the existing conditions these people have? *

Bipolar Disorder (mood disorder): 34 people, 36.17%
Schizophrenia (a mental disorder characterized by a breakdown of thought processes): 21 people, 22.34%
Bipolar Ii Disorder (characterized by at least one episode of hypomania and at least one episode of major depression): 6 people, 6.38%
Depression: 5 people, 5.32%
Attention Deficit Hyperactivity Disorder (a chronic condition including attention difficulty, hyperactivity, and impulsiveness): 4 people, 4.26%
Schizoaffective Disorder (a mental disorder characterized by disordered thought): 3 people, 3.19%
Schizoaffective Disorder Bipolar Type (mental illness featuring schizophrenia and a mood disorder with mania): 2 people, 2.13%
Psychotic Disorder: 2 people, 2.13%
Bipolar I Disorder (mood disorder that is characterized by at least one manic or mixed episode): 2 people, 2.13%
Stress And Anxiety: 1 person, 1.06%

* Approximation only. Some reports may have incomplete information.

Do you take Caplyta and have Agitation?

- Check whether Agitation is associated with a drug or a condition
- Predict drug outcomes for up to one year with AI
- Get an AI agent to monitor your drugs continuously

Related studies:

Effectiveness of, long term effects of, and alternative drugs to Caplyta:

Caplyta (3,109 reports)

Agitation treatments and more:

Agitation (142,107 reports)

Browse all side effects of Caplyta:

a b c d e f g h i j k l m n o p q r s t u v w x y z

Browse all the drugs that are associated with Agitation:

Agitation (2,276 drugs)

Browse all the conditions that are associated with Agitation:

Agitation (3,312 conditions)

Related publications that referenced our studies

Teimoory M, Arefi M, Behnoush B, Bastani B, "Promethazine and Treatment Refractory Agitation in Clonidine Toxicity", International Journal of Medical Toxicology and Forensic Medicine, 2013 Mar .
Teimoory M, Arefi M, Behnoush B, Bastani B, "Promethazine and Treatment Refractory Agitation in Clonidine Toxicity", International Journal of Medical Toxicology and Forensic Medicine, 2013 Mar .

How the study uses the data?

The study uses data from the FDA. It is based on lumateperone tosylate (the active ingredients of Caplyta) and Caplyta (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.

How to use the study?

DO NOT STOP MEDICATIONS without first consulting your doctor. If there are any serious or long term adverse effects discovered in the study, discuss the study with your doctor to ensure that proper medication management will be in place if applicable.

Who is eHealthMe?

With medical big data and proven AI/ML algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. We study millions of patients and 5,000 more each day. Results of our real-world drug study have been referenced on 800+ peer-reviewed medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API).

WARNING, DISCLAIMER, USE FOR PUBLICATION

WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

DISCLAIMER: All material available on eHealthMe.com is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. All information is observation-only. Our phase IV clinical studies alone cannot establish cause-effect relationship. Different individuals may respond to medication in different ways. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. The use of the eHealthMe site and its content is at your own risk.

If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.