What the label lists and what reports show
Fingolimod side effects
Fingolimod's FDA label: “Most common adverse reactions (incidence ≥ 10% and greater than placebo): Headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.” FAERS holds 86,658 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (10,895 reports).
- Generic listed
Check it at the source: the fingolimod FDA label on DailyMed (effective July 22, 2026, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of GILENYA?GILENYA can cause serious side effects, including: See “What is the most important information I should know about GILENYA?” swelling and narrowing of the blood vessels in your brain. A condition called PRES (Posterior Reversible Encephalopathy Syndrome) has happened rarely in adults taking GILENYA. Symptoms of PRES usually get better when you stop taking GILENYA. However, if left untreated, it may lead to a stroke. Call your healthcare provider right away if you have any of the following symptoms: ◦ sudden severe headache ◦ sudden confusion ◦ sudden loss of vision or other changes in your vision ◦ seizure liver damage. GILENYA may cause liver damage. Your healthcare provider should do blood tests to check your liver before you start taking GILENYA and periodically during treatment. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective July 22, 2026 (SPL set cc9e1c8c-0e2b-44e2-878b-27057f786be9), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 10% and greater than placebo): Headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.
Table 1: Adverse Reactions Reported in Adult Studies 1 and 3 (Occurring in ≥ 1% of Patients and Reported for GILENYA 0.5 mg at ≥ 1% Higher Rate Than for Placebo)
| Adverse drug reactions | GILENYA 0.5 mg N = 783 % | Placebo N = 773 % |
|---|---|---|
| Influenza | 11 | 8 |
| Sinusitis | 11 | 8 |
| Bronchitis | 8 | 5 |
| Herpes zoster | 2 | 1 |
| Tinea versicolor | 2 | < 1 |
| Bradycardia | 3 | 1 |
| Headache | 25 | 24 |
| Migraine | 6 | 4 |
| Nausea | 13 | 12 |
| Diarrhea | 13 | 10 |
| Abdominal pain | 11 | 10 |
| Asthenia | 2 | 1 |
| Back pain | 10 | 9 |
| Pain in extremity | 10 | 7 |
| Alopecia | 3 | 2 |
| Actinic keratosis | 2 | 1 |
| Liver transaminase elevations (ALT/GGT/AST) | 15 | 4 |
| Blood triglycerides increased | 3 | 1 |
| Cough | 12 | 11 |
| Dyspnea | 9 | 7 |
| Vision blurred | 4 | 2 |
| Hypertension | 8 | 4 |
| Lymphopenia | 7 | < 1 |
| Leukopenia | 2 | < 1 |
| Skin papilloma | 3 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in labeling: Bradyarrhythmia and Atrioventricular Blocks [see Warnings and Precautions (5.1)] Infections [see Warnings and Precautions (5.2)] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.3)] Macular Edema [see Warnings and Precautions (5.4)] Liver Injury [see Warnings and Precautions (5.5)] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.6)] Respiratory Effects [see Warnings and Precautions (5.7)] Fetal Risk [see Warnings and Precautions (5.8)] Severe Increase in Disability After Stopping GILENYA [see Warnings and Precautions (5.9)] Tumefactive Multiple Sclerosis [see Warnings and Precautions (5.10)] Increased Blood Pressure [see Warnings and Precautions (5.11)] Malignancies [see Warnings and Precautions (5.12)] Immune System Effects Following GILENYA Discontinuation [see Warnings and Precautions (5.13)] Hypersensitivity Reactions [see Warnings and Precautions (5.14)] Most common adverse reactions (incidence ≥ 10% and greater than placebo): Headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective July 22, 2026 (SPL set cc9e1c8c-0e2b-44e2-878b-27057f786be9), via openFDA; the full label on DailyMed
What do FAERS reports show?
86,658 reports list fingolimod among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,262 are coded as a death and 11,941 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Fingolimod: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions