Leflunomide and Gastrointestinal perforation - a phase IV clinical study of FDA data

Summary:

Gastrointestinal perforation is reported as a side effect among people who take Leflunomide (leflunomide), especially for people who are female, 60+ old, have been taking the drug for 6 - 12 months also take Actemra, and have Ankylosing spondylitis.

The phase IV clinical study analyzes which people have Gastrointestinal perforation when taking Leflunomide. It is created by eHealthMe based on reports of 81,713 people who have side effects when taking Leflunomide from the FDA, and is updated regularly.

What is Leflunomide?

Leflunomide has active ingredients of leflunomide. It is often used in rheumatoid arthritis. eHealthMe is studying from 82,105 Leflunomide users. Check the latest studies of Leflunomide.

What is Gastrointestinal perforation?

Gastrointestinal perforation (hole in the digestive tract) is found to be associated with 929 drugs and 1,394 conditions by eHealthMe. Check the latest studies of Gastrointestinal perforation.

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

81,713 people reported to have side effects when taking Leflunomide.
Among them, 99 people (0.12%) have Gastrointestinal perforation.

Could Leflunomide cause Gastrointestinal perforation?

Among these 99 people:

How long have people been on Leflunomide when they have Gastrointestinal perforation? *

What is the gender of people who have Gastrointestinal perforation when taking Leflunomide? *

female: 91.11 %
male: 8.89 %

What is the age of people who have Gastrointestinal perforation when taking Leflunomide? *

What are other drugs people take besides Leflunomide? *

What are other side effects people have besides Gastrointestinal perforation? *

Drug Ineffective: 45 people, 45.45%
Diverticulitis (digestive disease which involves the formation of pouches (diverticula) within the bowel wall): 20 people, 20.20%
Diarrhea: 19 people, 19.19%
Joint Pain: 19 people, 19.19%
Joint Injury: 14 people, 14.14%
Swelling: 14 people, 14.14%
Musculoskeletal Stiffness (stiffness of the body's muscles, joints, tendons, ligaments and nerves): 12 people, 12.12%
Gastrointestinal Disorder (functional problems of gastrointestinal tract): 12 people, 12.12%
Gait Disturbance: 12 people, 12.12%
Sepsis (a severe blood infection that can lead to organ failure and death): 11 people, 11.11%

What are the existing conditions these people have? *

Ankylosing Spondylitis (type of arthritis affecting the spine): 10 people, 10.10%
Psoriatic Arthropathy (inflammation of the skin and joints with kin condition which typically causes patches (plaques) of red, scaly skin to develop): 6 people, 6.06%
Depression: 6 people, 6.06%
Psoriasis (immune-mediated disease that affects the skin): 3 people, 3.03%
Pain: 3 people, 3.03%
Hyperphosphataemia (electrolyte disturbance in which there is an abnormally elevated level of phosphate in the blood): 2 people, 2.02%
Joint Pain: 2 people, 2.02%
Colitis (inflammation of colon): 1 person, 1.01%
Dyslipidaemia (abnormal amount of lipids): 1 person, 1.01%
Gastritis (inflammation of stomach): 1 person, 1.01%

* Approximation only. Some reports may have incomplete information.

Do you take Leflunomide and have Gastrointestinal perforation?

- Check whether Gastrointestinal perforation 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 Leflunomide:

Leflunomide (82,105 reports)

Browse all side effects of Leflunomide:

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 Gastrointestinal perforation:

Gastrointestinal perforation (929 drugs)

Browse all the conditions that are associated with Gastrointestinal perforation:

Gastrointestinal perforation (1,394 conditions)

How the study uses the data?

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