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
1	Fatigue	2701
2	Headache	1712
3	Dizziness	1462
4	Multiple sclerosis relapse	1432
5	Nausea	1259
6	Gait disturbance	1026
7	Hypoaesthesia	901
8	Asthenia	896
9	Dyspnoea	863
10	Vision blurred	858
11	Fall	836
12	Heart rate decreased	830
13	Central nervous system lesion	808
14	Malaise	780
15	Back pain	755
16	Pain	747
17	Visual impairment	723
18	White blood cell count decreased	685
19	Lymphocyte count decreased	678
20	Muscular weakness	631

* 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
1	Multiple sclerosis	54100
2	Relapsing-remitting multiple sclerosis	12104
3	Product used for unknown indication	2597
4	Multiple sclerosis relapse	607
5	Renal transplant	442
6	Secondary progressive multiple sclerosis	199
7	Progressive relapsing multiple sclerosis	73
8	Progressive multiple sclerosis	55
9	Multiple sclerosis relapse prophylaxis	44
10	Rhinoscleroma	32

*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.

Historical 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.