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Gilenya and Neurological decompensation - a phase IV clinical study of FDA data

Summary:

Neurological decompensation is reported as a side effect among people who take Gilenya (fingolimod), especially for people who are female, 40-49 old, have been taking the drug for 1 - 6 months also take Tysabri, and have Depression.

The phase IV clinical study analyzes which people have Neurological decompensation 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 Neurological decompensation?

Neurological decompensation (inability of brain to maintain proper function) is found to be associated with 262 drugs and 451 conditions by eHealthMe. Check the latest studies of Neurological decompensation.

On Jul, 29, 2026

111,612 people reported to have side effects when taking Gilenya.
Among them, 35 people (0.03%) have Neurological decompensation.

Could Gilenya cause Neurological decompensation?

Among these 35 people:

How long have people been on Gilenya when they have Neurological decompensation? *

  • < 1 month: 17.65 %
  • 1 - 6 months: 70.59 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 11.76 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

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

  • female: 88.57 %
  • male: 11.43 %

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

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 3.33 %
  • 30-39: 33.33 %
  • 40-49: 43.33 %
  • 50-59: 20.0 %
  • 60+: 0.0 %

What are other drugs people take besides Gilenya? *

  1. Tysabri: 7 people, 20.00%
  2. Mitoxantrone: 4 people, 11.43%
  3. Abilify: 3 people, 8.57%
  4. Sertraline: 2 people, 5.71%
  5. Lovenox: 2 people, 5.71%
  6. Lioresal: 2 people, 5.71%
  7. Tecfidera: 1 person, 2.86%
  8. Rebif: 1 person, 2.86%
  9. Copaxone: 1 person, 2.86%

What are other side effects people have besides Neurological decompensation? *

  1. Quadriplegia (a four limb paralysis): 12 people, 34.29%
  2. Central Nervous System Lesion (an abnormality in tissue of brain or spinal cord): 11 people, 31.43%
  3. Speech Impairment (Adult) (inability to speak (adult)): 10 people, 28.57%
  4. Swallowing Difficulty: 10 people, 28.57%
  5. Rebound Effect (take-back effect): 9 people, 25.71%
  6. Consciousness - Decreased: 8 people, 22.86%
  7. Confusional State: 8 people, 22.86%
  8. Cognitive Disorder (mental health disorders affects learning, memory, perception, and problem solving): 7 people, 20.00%
  9. Muscle Spasticity (tight or stiff muscles and an inability to control those muscles): 7 people, 20.00%
  10. Hemiparesis (weakness on one side of the body): 6 people, 17.14%

What are the existing conditions these people have? *

  1. Quadriplegia (a four limb paralysis): 4 people, 11.43%
  2. Disturbance In Attention: 4 people, 11.43%
  3. Depression: 4 people, 11.43%
  4. Secondary Progressive Multiple Sclerosis (a stage of ms which comes after relapsing remitting ms in many cases): 3 people, 8.57%
  5. Psychotic Disorder: 3 people, 8.57%
  6. Haemodynamic Test Abnormal: 3 people, 8.57%
  7. Muscle Spasticity (tight or stiff muscles and an inability to control those muscles): 2 people, 5.71%
  8. Insomnia (sleeplessness): 2 people, 5.71%

* Approximation only. Some reports may have incomplete information.

Do you take Gilenya and have Neurological decompensation?

- Check whether Neurological decompensation 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:

Neurological decompensation treatments and more:

How severe was Neurological decompensation 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 Neurological decompensation:

Browse all the conditions that are associated with Neurological decompensation:

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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