Gilenya and International normalised ratio increased - a phase IV clinical study of FDA data

Summary:

International normalised ratio increased is reported as a side effect among people who take Gilenya (fingolimod), especially for people who are female, 60+ old, have been taking the drug for < 1 month also take Prozac, and have Birth control.

The phase IV clinical study analyzes which people have International normalised ratio increased 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 International normalised ratio increased?

International normalised ratio increased is found to be associated with 1,333 drugs and 1,727 conditions by eHealthMe. Check the latest studies of International normalised ratio increased.

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, 15 people (0.01%) have International normalised ratio increased.

Could Gilenya cause International normalised ratio increased?

Among these 15 people:

How long have people been on Gilenya when they have International normalised ratio increased? *

What is the gender of people who have International normalised ratio increased when taking Gilenya? *

female: 66.67 %
male: 33.33 %

What is the age of people who have International normalised ratio increased when taking Gilenya? *

What are other drugs people take besides Gilenya? *

What are other side effects people have besides International normalised ratio increased? *

Blood Glucose Increased: 7 people, 46.67%
C-Reactive Protein Increased: 5 people, 33.33%
Blood Creatinine Increased: 5 people, 33.33%
Lymphocyte Count Decreased: 4 people, 26.67%
Pleural Effusion (water on the lungs): 4 people, 26.67%
Dyspnea (difficult or laboured breathing): 4 people, 26.67%
Blood Creatine Phosphokinase Increased: 4 people, 26.67%
Urinary Tract Infection: 4 people, 26.67%
High Blood Pressure: 4 people, 26.67%
Aspartate Aminotransferase Increased: 4 people, 26.67%

What are the existing conditions these people have? *

Stress And Anxiety: 1 person, 6.67%
Sleep Disorder: 1 person, 6.67%
Partial Seizures (seizures which affect only a part of the brain at onset): 1 person, 6.67%
Pain: 1 person, 6.67%
Nasopharyngitis (inflammation of the nasopharynx): 1 person, 6.67%
Lung Neoplasm Malignant (cancer tumour of lung): 1 person, 6.67%
Itching: 1 person, 6.67%
Hypersensitivity: 1 person, 6.67%
High Blood Pressure: 1 person, 6.67%
Birth Control: 1 person, 6.67%

* Approximation only. Some reports may have incomplete information.

Do you take Gilenya and have International normalised ratio increased?

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Related studies:

Effectiveness of, long term effects of, and alternative drugs to Gilenya:

Gilenya (111,893 reports)

International normalised ratio increased treatments and more:

International normalised ratio increased (40,071 reports)

How severe was International normalised ratio increased and when was it recovered:

International normalised ratio increased in Gilenya

Expand to all the drugs that have ingredients of fingolimod:

International normalised ratio increased and drugs with 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 International normalised ratio increased:

International normalised ratio increased (1,333 drugs)

Browse all the conditions that are associated with International normalised ratio increased:

International normalised ratio increased (1,727 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.