Saphris and Bipolar i disorder - a phase IV clinical study of FDA data

Summary:

Bipolar i disorder is reported as a side effect among people who take Saphris (asenapine maleate), especially for people who are female, 50-59 old, have been taking the drug for < 1 month also take Xyrem, and have Cataplexy.

The phase IV clinical study analyzes which people have Bipolar i disorder when taking Saphris. It is created by eHealthMe based on reports of 8,449 people who have side effects when taking Saphris from the FDA, and is updated regularly.

What is Saphris?

Saphris has active ingredients of asenapine maleate. It is often used in bipolar i disorder. eHealthMe is studying from 8,688 Saphris users. Check the latest studies of Saphris.

What is Bipolar i disorder?

Bipolar i disorder (mood disorder that is characterized by at least one manic or mixed episode) is found to be associated with 380 drugs and 831 conditions by eHealthMe. Check the latest studies of Bipolar i disorder.

eHealthMe: drug outcomes in the real world

eHealthMe runs one of the largest post-marketing drug safety studies in the world. We study millions of patients and 5,000 more each day. Our data-driven phase IV clinical trials have been referenced on 800+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Tools to study our phase IV findings are available to the public, anonymous and free >>>.

On Sep, 04, 2026

8,449 people reported to have side effects when taking Saphris.
Among them, 26 people (0.31%) have Bipolar i disorder.

Among these 26 people:

How long have people been on Saphris when they have Bipolar i disorder? *

What is the gender of people who have Bipolar i disorder when taking Saphris? *

female: 56 %
male: 44 %

What is the age of people who have Bipolar i disorder when taking Saphris? *

What are other drugs people take besides Saphris? *

What are other side effects people have besides Bipolar i disorder? *

Suicidal Ideation: 7 people, 26.92%
Insomnia (sleeplessness): 6 people, 23.08%
Drowsiness: 5 people, 19.23%
Restless Leg Syndrome (a powerful urge to move your legs): 4 people, 15.38%
Left Ventricular Hypertrophy (the thickening of the myocardium (muscle) of the left ventricle of the heart): 3 people, 11.54%
Muscle Hypertrophy (a term for the growth and increase of the size of muscle cells): 3 people, 11.54%
Indigestion: 3 people, 11.54%
Night Sweats (sweating in night): 3 people, 11.54%
Overdose: 3 people, 11.54%
Feeling Drunk: 3 people, 11.54%

What are the existing conditions these people have? *

Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 5 people, 19.23%
Cataplexy (loss of muscle tone accompanied by full conscious awareness): 5 people, 19.23%
Depression: 3 people, 11.54%
Stress And Anxiety: 2 people, 7.69%
Sleep Disorder: 2 people, 7.69%
Schizoaffective Disorder (a mental disorder characterized by disordered thought): 2 people, 7.69%
Thrombocytopenia (decrease of platelets in blood): 1 person, 3.85%
Relapsing-Remitting Multiple Sclerosis (reoccurrence of an inflammatory disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged): 1 person, 3.85%
Paranoia (psychotic disorder characterized by delusions of persecution with or without grandeur): 1 person, 3.85%
Pain: 1 person, 3.85%

* Approximation only. Some reports may have incomplete information.

Do you take Saphris and have Bipolar i disorder?

- Check whether Bipolar i disorder 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 Saphris:

Saphris (8,688 reports)

Browse all side effects of Saphris:

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 Bipolar i disorder:

Bipolar i disorder (380 drugs)

Browse all the conditions that are associated with Bipolar i disorder:

Bipolar i disorder (831 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on asenapine maleate (the active ingredients of Saphris) and Saphris (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.