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Gilenya and Papilloedema - a phase IV clinical study of FDA data

Summary:

Papilloedema 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 5 - 10 years also take Neurontin, and have Eye oedema.

The phase IV clinical study analyzes which people have Papilloedema 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 Papilloedema?

Papilloedema (optic disc swelling) is found to be associated with 498 drugs and 775 conditions by eHealthMe. Check the latest studies of Papilloedema.

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, 38 people (0.03%) have Papilloedema.

Could Gilenya cause Papilloedema?

Among these 38 people:

How long have people been on Gilenya when they have Papilloedema? *

  • < 1 month: 6.67 %
  • 1 - 6 months: 6.67 %
  • 6 - 12 months: 26.67 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 26.67 %
  • 5 - 10 years: 33.33 %
  • 10+ years: 0.0 %

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

  • female: 74.29 %
  • male: 25.71 %

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

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 8.33 %
  • 20-29: 4.17 %
  • 30-39: 8.33 %
  • 40-49: 29.17 %
  • 50-59: 33.33 %
  • 60+: 16.67 %

What are other drugs people take besides Gilenya? *

  1. Albuterol: 6 people, 15.79%
  2. Neurontin: 6 people, 15.79%
  3. Ampyra: 5 people, 13.16%
  4. Atrovent: 5 people, 13.16%
  5. Baclofen: 5 people, 13.16%
  6. Triamcinolone: 5 people, 13.16%
  7. Claritin: 5 people, 13.16%
  8. Nasonex: 5 people, 13.16%
  9. Serevent: 5 people, 13.16%
  10. Norethindrone Acetate And Ethinyl Estradiol: 4 people, 10.53%

What are other side effects people have besides Papilloedema? *

  1. Vision Blurred: 18 people, 47.37%
  2. Headache (pain in head): 15 people, 39.47%
  3. Visual Acuity Reduced (reduced clearness of vision): 10 people, 26.32%
  4. Weakness: 8 people, 21.05%
  5. Macular Oedema (fluid and protein deposits collect on or under the macula of the eye (a yellow central area of the retina) and causes it to thicken): 7 people, 18.42%
  6. Malaise (a feeling of general discomfort or uneasiness): 7 people, 18.42%
  7. Appetite - Decreased (decreased appetite occurs when you have a reduced desire to eat): 6 people, 15.79%
  8. Muscle Spasms (muscle contraction): 6 people, 15.79%
  9. Diplopia (double vision): 6 people, 15.79%
  10. Intracranial Pressure Increased (high pressure inside the skull and thus in the brain tissue and cerebrospinal fluid): 5 people, 13.16%

What are the existing conditions these people have? *

  1. Type 1 Diabetes: 1 person, 2.63%
  2. Tumor: 1 person, 2.63%
  3. Thrombocytopenia (decrease of platelets in blood): 1 person, 2.63%
  4. Rickets (softening of bones): 1 person, 2.63%
  5. Primary Progressive Multiple Sclerosis (primary progressive inflammatory disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged): 1 person, 2.63%
  6. Paroxysmal Nocturnal Haemoglobinuria (haemoglobin in the urine): 1 person, 2.63%
  7. Pain: 1 person, 2.63%
  8. High Blood Pressure: 1 person, 2.63%
  9. Headache (pain in head): 1 person, 2.63%
  10. Eye Oedema (swelling or thickening of the macula, the area of the retina responsible for central vision): 1 person, 2.63%

* Approximation only. Some reports may have incomplete information.

Do you take Gilenya and have Papilloedema?

- Check whether Papilloedema 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:

Papilloedema treatments and more:

How severe was Papilloedema and when was it recovered:

Expand to all the drugs that have ingredients of fingolimod:

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 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 Papilloedema:

Browse all the conditions that are associated with Papilloedema:

Related publications that referenced our studies

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.

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