Gilenyafingolimod
According to the FDA label: Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
81,628 adverse event reports submitted to the FDA (2007–2026)
Top Reported Adverse Events
The most frequently reported events in association with Gilenya in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
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Fatigue 10,595 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Multiple Sclerosis Relapse 7,250 reports
A return or worsening of multiple sclerosis symptoms. It often appears in reports as part of the condition being treated.
Full definition in the glossary →Headache 7,121 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Dizziness 5,273 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →White Blood Cell Count Decreased 3,932 reports
A blood test result showing a low level of white blood cells, which help fight infection.
Full definition in the glossary →Gait Disturbance 3,743 reports
Difficulty walking normally, such as an unsteady or altered way of walking.
Full definition in the glossary →Hypoaesthesia 3,665 reports
Reduced sense of touch or numbness in part of the body. Also spelled hypoesthesia in American English.
Full definition in the glossary → See all drugs reporting this event →Fall 3,418 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →- Lymphocyte Count Decreased 3,404 reports
Nausea 3,358 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Malaise 3,066 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Memory Impairment 2,940 reports
Difficulty remembering things.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 2,907 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Pain 2,841 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →- Central Nervous System Lesion 2,832 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 60,677 |
| Male | 16,978 |
| Unknown | 355 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 620 |
| 18-34 | 9,053 |
| 35-49 | 18,218 |
| 50-64 | 12,914 |
| 65-74 | 1,705 |
| 75+ | 115 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Gilenya. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 41,056 |
| Other Serious | 32,361 |
| Hospitalization | 10,786 |
| Disability | 1,288 |
| Life-Threatening | 1,171 |
| Death | 1,112 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Gilenya. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2007 | 1 |
| 2010 | 13 |
| 2011 | 2,682 |
| 2012 | 4,662 |
| 2013 | 4,226 |
| 2014 | 3,074 |
| 2015 | 8,196 |
| 2016 | 10,022 |
| 2017 | 10,260 |
| 2018 | 11,493 |
| 2019 | 11,029 |
| 2020 | 6,536 |
| 2021 | 3,850 |
| 2022 | 2,992 |
| 2023 | 1,440 |
| 2024 | 671 |
| 2025 | 411 |
| 2026 (partial) | 70 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Gilenya
In FDA adverse event reports that mention Gilenya, these medications appeared most often in the same report.
- Ergocalciferol (6,080 reports)
- Dalfampridine (3,394 reports)
- Baclofen (3,287 reports)
- Gabapentin (3,092 reports)
- Ibuprofen (1,537 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026