Apriso and Insomnia exacerbated - a phase IV clinical study of FDA data

Summary:

Insomnia exacerbated is reported as a side effect among people who take Apriso (mesalamine), especially for people who are female, 60+ old, have been taking the drug for 1 - 6 months also take Humira, and have Pain.

The phase IV clinical study analyzes which people have Insomnia exacerbated when taking Apriso. It is created by eHealthMe based on reports of 3,303 people who have side effects when taking Apriso from the FDA, and is updated regularly.

What is Apriso?

Apriso has active ingredients of mesalamine. It is often used in ulcerative colitis. eHealthMe is studying from 3,439 Apriso users. Check the latest studies of Apriso.

What is Insomnia exacerbated?

Insomnia exacerbated (severe sleeplessness) is found to be associated with 2,687 drugs and 976 conditions by eHealthMe. Check the latest studies of Insomnia exacerbated.

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 Jul, 03, 2026

3,303 people reported to have side effects when taking Apriso.
Among them, 66 people (2.0%) have Insomnia exacerbated.

Could Apriso cause Insomnia exacerbated?

Among these 66 people:

How long have people been on Apriso when they have Insomnia exacerbated? *

What is the gender of people who have Insomnia exacerbated when taking Apriso? *

female: 87.69 %
male: 12.31 %

What is the age of people who have Insomnia exacerbated when taking Apriso? *

What are other drugs people take besides Apriso? *

What are other side effects people have besides Insomnia exacerbated? *

Stress And Anxiety: 21 people, 31.82%
Fatigue (feeling of tiredness): 19 people, 28.79%
Pain: 18 people, 27.27%
Dyspnea (difficult or laboured breathing): 18 people, 27.27%
Diarrhea: 16 people, 24.24%
Weight Increased: 16 people, 24.24%
Drug Ineffective: 14 people, 21.21%
Abdominal Pain: 14 people, 21.21%
Joint Pain: 13 people, 19.70%
Back Pain: 13 people, 19.70%

What are the existing conditions these people have? *

High Blood Pressure: 10 people, 15.15%
Thyroid Diseases: 10 people, 15.15%
Neuropathy Peripheral (surface nerve damage): 10 people, 15.15%
Pain: 10 people, 15.15%
Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 9 people, 13.64%
Cardiac Disorder: 9 people, 13.64%
Diabetes: 7 people, 10.61%
Depression: 7 people, 10.61%
Wheezing (a high-pitched whistling sound made while you breath): 6 people, 9.09%
Rosacea (a skin condition that causes facial redness): 6 people, 9.09%

* Approximation only. Some reports may have incomplete information.

Do you take Apriso and have Insomnia exacerbated?

- Check whether Insomnia exacerbated 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 Apriso:

Apriso (3,439 reports)

Browse all side effects of Apriso:

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 Insomnia exacerbated:

Insomnia exacerbated (2,687 drugs)

Browse all the conditions that are associated with Insomnia exacerbated:

Insomnia exacerbated (976 conditions)

Related publications that referenced our studies

Jacobsson H, Eriksen J, Karlén P, "Mesalazine-induced renal calculi", The American journal of case reports, 2015 Jan .
Jacobsson H, Eriksen J, Karlén P, "Mesalazine-induced renal calculi", The American journal of case reports, 2015 Jan .

How the study uses the data?

The study uses data from the FDA. It is based on mesalamine (the active ingredients of Apriso) and Apriso (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.