Drug Safety Information for GILENYA (Fingolimod)

Safety-related Labeling Changes for GILENYA (FINGOLIMOD) Rx Drug: FDA Link

Tumefactive multiple sclerosis and Thrombocytopenia Safety label updated

Adverse Drug Reactions for GILENYA* (Fingolimod)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with GILENYA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
4Multiple sclerosis relapse1432
6Gait disturbance1026
10Vision blurred858
12Heart rate decreased830
13Central nervous system lesion808
15Back pain755
17Visual impairment723
18White blood cell count decreased685
19Lymphocyte count decreased678
20Muscular weakness631

* This side effect also appears in "Top 10 Side Effects of GILENYA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking GILENYA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Multiple sclerosis54100
2Relapsing-remitting multiple sclerosis12104
3Product used for unknown indication2597
4Multiple sclerosis relapse607
5Renal transplant442
6Secondary progressive multiple sclerosis199
7Progressive relapsing multiple sclerosis73
8Progressive multiple sclerosis55
9Multiple sclerosis relapse prophylaxis44

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for GILENYA

Total Reports Filed with FDA: 79280

Number of FDA Adverse Event Reports by Patient Age for GILENYA

Total Reports Filed with FDA: 79280*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fingolimod (Fty 720, Gilenya, Fty720)

Charts are based on 79280 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and GILENYA Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on GILENYA's side effects.