Pentasa and Foetal death - a phase IV clinical study of FDA data

Summary:

Foetal death is reported as a side effect among people who take Pentasa (mesalamine), especially for people who are female, 30-39 old, have been taking the drug for 6 - 12 months also take Humira, and have Abdominal pain.

The study is created by eHealthMe based on reports of 22,797 people who have side effects when taking Pentasa from the FDA, and is updated regularly.

What is Pentasa?

Pentasa has active ingredients of mesalamine. It is often used in crohn's disease. eHealthMe is studying from 23,326 Pentasa users. Check the latest studies of Pentasa.

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, 03, 2026

22,797 people reported to have side effects when taking Pentasa.
Among them, 25 people (0.11%) died.

Among these 25 people:

How long have people been on Pentasa when they died? *

What is the gender of people who died when taking Pentasa? *

female: 100 %
male: 0.0 %

What is the age of people who died when taking Pentasa? *

What are other drugs people take besides Pentasa? *

What are other side effects people have before they died? *

Abortion Spontaneous (naturally occurring miscarriage): 7 people, 28.00%
Maternal Exposure During Pregnancy (use of substance during pregnancy): 4 people, 16.00%
Stillbirth (a birth of dead foetus): 3 people, 12.00%
Endometriosis (appearance of endometrial tissue outside the uterus and causing pelvic pain): 2 people, 8.00%
Streptococcal Infection: 1 person, 4.00%
Rectal Haemorrhage (bleeding from anus): 1 person, 4.00%
Hyponatremia (abnormally low level of sodium in the blood; associated with dehydration): 1 person, 4.00%
Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body): 1 person, 4.00%
Consciousness - Decreased: 1 person, 4.00%
Beta Haemolytic Streptococcal Infection (infection with streptococcus pyogenes, a beta-haemolytic bacterium cause mild to moderately severe respiratory tract, skin, and soft tissue): 1 person, 4.00%

What are the existing conditions these people have? *

Gastrointestinal Disorder (functional problems of gastrointestinal tract): 2 people, 8.00%
Abdominal Pain: 2 people, 8.00%
Labor Induction: 1 person, 4.00%
Foetal Exposure During Pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect): 1 person, 4.00%
Breast Cancer: 1 person, 4.00%
Bacterial Infection: 1 person, 4.00%
Ankylosing Spondylitis (type of arthritis affecting the spine): 1 person, 4.00%

* Approximation only. Some reports may have incomplete information.

Related studies:

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

Pentasa (23,326 reports)

Expand to all the drugs that have ingredients of mesalamine:

Foetal death and drugs with ingredients of mesalamine (44 reports)

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 Pentasa:

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 Foetal death:

Foetal death (290 drugs)

Browse all the conditions that are associated with Foetal death:

Foetal death (315 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 Pentasa) and Pentasa (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.