Gilenya and Hepatic lesion - a phase IV clinical study of FDA data

Summary:

Hepatic lesion is reported as a side effect among people who take Gilenya (fingolimod), especially for people who are female, 50-59 old, have been taking the drug for 1 - 2 years also take Vitamin D, and have Diarrhea.

The phase IV clinical study analyzes which people have Hepatic lesion 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 Hepatic lesion?

Hepatic lesion is found to be associated with 672 drugs and 622 conditions by eHealthMe. Check the latest studies of Hepatic lesion.

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, 02, 2026

111,612 people reported to have side effects when taking Gilenya.
Among them, 23 people (0.02%) have Hepatic lesion.

Among these 23 people:

How long have people been on Gilenya when they have Hepatic lesion? *

What is the gender of people who have Hepatic lesion when taking Gilenya? *

female: 82.61 %
male: 17.39 %

What is the age of people who have Hepatic lesion when taking Gilenya? *

What are other drugs people take besides Gilenya? *

What are other side effects people have besides Hepatic lesion? *

Weight Decreased: 4 people, 17.39%
Transaminases Increased: 4 people, 17.39%
Back Pain: 4 people, 17.39%
Hepatic Steatosis (fatty liver disease): 4 people, 17.39%
Lymph Follicular Hypertrophy (an increase in the size of the lymph node follicles): 3 people, 13.04%
Musculoskeletal Pain (pain affects the bones, muscles, ligaments, tendons, and nerves): 3 people, 13.04%
Hepatic Function Abnormal: 2 people, 8.70%
Jaundice - Yellow Skin (a yellowish pigmentation of the skin): 2 people, 8.70%
Hyperplastic Cholecystopathy (disease of the gallbladder): 2 people, 8.70%
High Blood Pressure: 2 people, 8.70%

What are the existing conditions these people have? *

Vitamin B12 Deficiency: 1 person, 4.35%
Sinusitis (inflammation of sinus): 1 person, 4.35%
Pain: 1 person, 4.35%
Muscle Spasticity (tight or stiff muscles and an inability to control those muscles): 1 person, 4.35%
Migraine (headache): 1 person, 4.35%
Lung Disorder (lung disease): 1 person, 4.35%
Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 1 person, 4.35%
Hypertonic Bladder (bladder-storage function that causes a sudden urge to urinate): 1 person, 4.35%
Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 1 person, 4.35%
Diarrhea: 1 person, 4.35%

* Approximation only. Some reports may have incomplete information.

Do you take Gilenya and have Hepatic lesion?

- Check whether Hepatic lesion 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)

Hepatic lesion treatments and more:

Hepatic lesion (5,726 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 Hepatic lesion:

Hepatic lesion (672 drugs)

Browse all the conditions that are associated with Hepatic lesion:

Hepatic lesion (622 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.