Mesalamine and Encephalopathy - a phase IV clinical study of FDA data

Summary:

Encephalopathy is reported as a side effect among people who take Mesalamine (mesalamine), especially for people who are female, 60+ old, have been taking the drug for 1 - 6 months also take Metronidazole, and have Female genital-digestive tract fistula.

The phase IV clinical study analyzes which people have Encephalopathy when taking Mesalamine. It is created by eHealthMe based on reports of 27,767 people who have side effects when taking Mesalamine from the FDA, and is updated regularly.

What is Mesalamine?

Mesalamine has active ingredients of mesalamine. It is often used in ulcerative colitis. eHealthMe is studying from 28,053 Mesalamine users. Check the latest studies of Mesalamine.

What is Encephalopathy?

Encephalopathy (functioning of the brain is affected by some agent or condition) is found to be associated with 1,459 drugs and 1,606 conditions by eHealthMe. Check the latest studies of Encephalopathy.

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 Aug, 30, 2026

27,767 people reported to have side effects when taking Mesalamine.
Among them, 29 people (0.1%) have Encephalopathy.

Among these 29 people:

How long have people been on Mesalamine when they have Encephalopathy? *

What is the gender of people who have Encephalopathy when taking Mesalamine? *

female: 60.71 %
male: 39.29 %

What is the age of people who have Encephalopathy when taking Mesalamine? *

What are other drugs people take besides Mesalamine? *

What are other side effects people have besides Encephalopathy? *

Hypotension (abnormally low blood pressure): 7 people, 24.14%
Anaemia (lack of blood): 5 people, 17.24%
Hepatic Enzyme Increased: 5 people, 17.24%
Respiratory Acidosis (respiratory failure or ventilatory failure, causes the ph of blood and other bodily fluids to decrease): 5 people, 17.24%
Nausea (feeling of having an urge to vomit): 4 people, 13.79%
Clostridium Difficile Colitis (inflammation of colon by clostridium difficile bacteria infection): 4 people, 13.79%
Diarrhea: 4 people, 13.79%
Device Related Infection: 4 people, 13.79%
Cytokine Release Syndrome (immediate complication occurring with the use of anti-t cell antibody infusions): 4 people, 13.79%
Rashes (redness): 4 people, 13.79%

What are the existing conditions these people have? *

Female Genital-Digestive Tract Fistula (abnormal passage between genital tract and digestive system): 4 people, 13.79%
Ankylosing Spondylitis (type of arthritis affecting the spine): 3 people, 10.34%
Liver Disorder (liver diseases): 3 people, 10.34%
Bone Marrow Conditioning Regimen: 3 people, 10.34%
Mantle Cell Lymphoma (cancer of lymphocytes, a type of white blood cell): 3 people, 10.34%
B-Cell Lymphoma Refractory (blood cancer affecting b cells-relapsed): 2 people, 6.90%
Peritonitis (inflammation of the peritoneum, the thin tissue that lines the inner wall of the abdomen and covers most of the abdominal organs): 2 people, 6.90%
Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 2 people, 6.90%
Influenza Like Illness: 1 person, 3.45%
Inappropriate Antidiuretic Hormone Secretion: 1 person, 3.45%

* Approximation only. Some reports may have incomplete information.

Do you take Mesalamine and have Encephalopathy?

- Check whether Encephalopathy 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 Mesalamine:

Mesalamine (28,053 reports)

Encephalopathy treatments and more:

Encephalopathy (27,832 reports)

Browse all side effects of Mesalamine:

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 Encephalopathy:

Encephalopathy (1,459 drugs)

Browse all the conditions that are associated with Encephalopathy:

Encephalopathy (1,606 conditions)

Related publications that referenced our studies

Kapoor A, Kumar V, Beniwal S, Dutta S, Goyal S, Kumar HS, "Posterior reversible encephalopathy syndrome in non-Hodgkin's lymphoma: Not necessarily reversible!", Clinical Cancer Investigation Journal, 2015 Mar .
Jacobsson H, Eriksen J, Karlén P, "Mesalazine-induced renal calculi", The American journal of case reports, 2015 Jan .
Kapoor A, Kumar V, Beniwal S, Dutta S, Goyal S, Kumar HS, "Posterior reversible encephalopathy syndrome in non-Hodgkin's lymphoma: Not necessarily reversible!", Clinical Cancer Investigation Journal, 2015 Mar .
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 Mesalamine) and Mesalamine (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.