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

Summary:

Mania is reported as a side effect among people who take Caplyta (lumateperone tosylate), especially for people who are female, 50-59 old, have been taking the drug for < 1 month also take Latuda, and have Bipolar disorder.

The phase IV clinical study analyzes which people have Mania 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 Mania?

Mania (a state of abnormally elevated or irritable mood) is found to be associated with 924 drugs and 1,156 conditions by eHealthMe. Check the latest studies of Mania.

On Aug, 11, 2026

3,083 people reported to have side effects when taking Caplyta.
Among them, 120 people (3.89%) have Mania.

Among these 120 people:

* Approximation only. Some reports may have incomplete information.

Do you take Caplyta and have Mania?

- Check whether Mania 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)

Mania treatments and more:

Mania (24,994 reports)

How severe was Mania and when was it recovered:

Mania in Caplyta

Expand to all the drugs that have ingredients of lumateperone tosylate:

Mania and drugs with ingredients of lumateperone tosylate

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

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 Mania:

Mania (924 drugs)

Browse all the conditions that are associated with Mania:

Mania (1,156 conditions)

Related publications that referenced our studies

Ersoy MA, Ersoy HT, "Manic symptoms associated with isotretinoin and methylphenidate combination: a case report", Klinik Psikofarmakoloji Bülteni-Bulletin of Clinical Psychopharmacology, 2014 Sep .
Pong YH, Lu YC, Tsai VF, Huang PL, Hsieh JT, Chang HC, "Acute manic and psychotic symptoms following subcutaneous leuprolide acetate in a male patient without prior psychiatric history: A case report and literature review", Urological Science, 2014 Mar .
Harris YT, Harris AZ, "Cabergoline associated with first episode mania", Psychosomatics, 2012 Jan .
Ersoy MA, Ersoy HT, "Manic symptoms associated with isotretinoin and methylphenidate combination: a case report", Klinik Psikofarmakoloji Bülteni-Bulletin of Clinical Psychopharmacology, 2014 Sep .
Pong YH, Lu YC, Tsai VF, Huang PL, Hsieh JT, Chang HC, "Acute manic and psychotic symptoms following subcutaneous leuprolide acetate in a male patient without prior psychiatric history: A case report and literature review", Urological Science, 2014 Mar .
Harris YT, Harris AZ, "Cabergoline associated with first episode mania", Psychosomatics, 2012 Jan .

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.