Gilenya and Clostridium difficile colitis - a phase IV clinical study of FDA data

Summary:

Clostridium difficile colitis is reported as a side effect among people who take Gilenya (fingolimod), especially for people who are female, 30-39 old, have been taking the drug for 1 - 6 months also take Neurontin, and have Diarrhea.

The phase IV clinical study analyzes which people have Clostridium difficile colitis when taking Gilenya. It is created by eHealthMe based on reports of 111,612 people who have side effects when taking Gilenya from the FDA, and is updated regularly.

What is Gilenya?

Gilenya has active ingredients of fingolimod. It is often used in multiple sclerosis. eHealthMe is studying from 111,893 Gilenya users. Check the latest studies of Gilenya.

What is Clostridium difficile colitis?

Clostridium difficile colitis (inflammation of colon by clostridium difficile bacteria infection) is found to be associated with 1,042 drugs and 1,782 conditions by eHealthMe. Check the latest studies of Clostridium difficile colitis.

On Jul, 13, 2026

111,612 people reported to have side effects when taking Gilenya.
Among them, 14 people (0.01%) have Clostridium difficile colitis.

Could Gilenya cause Clostridium difficile colitis?

Among these 14 people:

How long have people been on Gilenya when they have Clostridium difficile colitis? *

What is the gender of people who have Clostridium difficile colitis when taking Gilenya? *

female: 71.43 %
male: 28.57 %

What is the age of people who have Clostridium difficile colitis when taking Gilenya? *

What are other drugs people take besides Gilenya? *

What are other side effects people have besides Clostridium difficile colitis? *

Urinary Tract Infection: 6 people, 42.86%
Diarrhea: 6 people, 42.86%
Osteomyelitis (infection of bone): 4 people, 28.57%
Abdominal Pain: 3 people, 21.43%
Haemorrhoids (a swollen vein or group of veins in the region of the anus): 3 people, 21.43%
Clostridium Test Positive: 3 people, 21.43%
Dehydration (dryness resulting from the removal of water): 3 people, 21.43%
Nausea (feeling of having an urge to vomit): 3 people, 21.43%
Fever: 3 people, 21.43%
Osteitis (a general term for inflammation of bone): 2 people, 14.29%

What are the existing conditions these people have? *

Urinary Tract Infection: 2 people, 14.29%
Mucous Stools (mucous with stool): 2 people, 14.29%
Haematochezia (passage of stools containing blood): 2 people, 14.29%
Diarrhea: 2 people, 14.29%
Stress And Anxiety: 1 person, 7.14%
Osteopenia (a condition where bone mineral density is lower than normal): 1 person, 7.14%
Neuralgia (pain in one or more nerves): 1 person, 7.14%
Muscle Spasticity (tight or stiff muscles and an inability to control those muscles): 1 person, 7.14%
Insomnia (sleeplessness): 1 person, 7.14%
Impaired Gastric Emptying: 1 person, 7.14%

* Approximation only. Some reports may have incomplete information.

Do you take Gilenya and have Clostridium difficile colitis?

- Check whether Clostridium difficile colitis 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 Gilenya:

Gilenya (111,893 reports)

Browse all side effects of Gilenya:

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 Clostridium difficile colitis:

Clostridium difficile colitis (1,042 drugs)

Browse all the conditions that are associated with Clostridium difficile colitis:

Clostridium difficile colitis (1,782 conditions)

Related publications that referenced our studies

Christopher KL, Elner VM, Demirci H, "Conjunctival Lymphoma in a Patient on Fingolimod for Relapsing-Remitting Multiple Sclerosis", Ophthalmic Plastic & Reconstructive Surgery, 2017 May .
Alroughani R, "Fingolimod-associated amenorrhea: a report of three cases", Multiple Sclerosis Journal, 2014 Jan .
Christopher, K. L., Elner, V. M., & Demirci, H. , "Conjunctival lymphoma in a patient on fingolimod for relapsing-remitting multiple sclerosis", Ophthalmic plastic and reconstructive surgery , 2014 Jan .
Christopher KL, Elner VM, Demirci H, "Conjunctival Lymphoma in a Patient on Fingolimod for Relapsing-Remitting Multiple Sclerosis", Ophthalmic Plastic & Reconstructive Surgery, 2017 May .
Alroughani R, "Fingolimod-associated amenorrhea: a report of three cases", Multiple Sclerosis Journal, 2014 Jan .
Christopher, K. L., Elner, V. M., & Demirci, H. , "Conjunctival lymphoma in a patient on fingolimod for relapsing-remitting multiple sclerosis", Ophthalmic plastic and reconstructive surgery , 2014 Jan .

How the study uses the data?

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