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Gilenya Side Effects

Generic name: fingolimod

Medically reviewed by Philip Thornton, DipPharm. Last updated on Feb 1, 2022.

Note: This document contains side effect information about fingolimod. Some of the dosage forms listed on this page may not apply to the brand name Gilenya.

In Summary

Common side effects of Gilenya include: infection, back pain, diarrhea, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, and increased liver enzymes. Other side effects include: blurred vision, bradycardia, bronchitis, increased gamma-glutamyl transferase, lymphocytopenia, migraine, dizziness, dyspnea, hypertension, increased serum transaminases, and tinea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to fingolimod: oral capsule

Side effects requiring immediate medical attention

Along with its needed effects, fingolimod (the active ingredient contained in Gilenya) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fingolimod:

More common

Less common

  • Black, tarry stools
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • headache, severe and throbbing
  • hoarseness
  • lightheadedness, dizziness, or fainting
  • lower back or side pain
  • painful or difficult urination
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unusual bleeding or bruising

Incidence not known

  • Agitation
  • back pain
  • change in size, shape, or color of existing mole
  • confusion
  • difficulty in moving
  • difficulty in speaking
  • double vision
  • drowsiness
  • epileptic seizure that will not stop
  • hives, itching, skin rash
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • irritability
  • joint stiffness or swelling
  • loss of consciousness
  • mole that leaks fluid or bleeds
  • mood or mental changes
  • muscle pain, cramps, or stiffness
  • new mole
  • redness of the skin
  • seeing, hearing, or feeling things that are not there
  • slow speech
  • stiff neck
  • swelling of the eyelids, face, lips, hands, or feet
  • troubled swallowing
  • weight loss
  • yellow skin and eyes

Side effects not requiring immediate medical attention

Some side effects of fingolimod may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Pain or tenderness around the eyes and cheekbones
  • stuffy nose

Less common

  • Decreased weight
  • depression
  • eye pain
  • hair loss or thinning of the hair
  • itching in the genitals or other skin areas
  • lack or loss of strength
  • scaling
  • stomach pain
  • skin rash, encrusted, scaly, and oozing

For Healthcare Professionals

Applies to fingolimod: oral capsule


The most common adverse events were headache, influenza, diarrhea, back pain, liver transaminase elevations, and cough.[Ref]


Common (1% to 10%): Hypertension, first degree AV block, bradycardia

Uncommon (0.1% to 1%): Symptomatic bradycardia, second degree AV block

Rare (0.01% to 0.1%): Peripheral arterial occlusive disease

Very rare (less than 0.01%): Hemophagocytic syndrome

Frequency not reported: Heart rate decrease, Mobitz type I (Wenckebach) block, Mobitz type II block

Postmarketing reports: Third degree AV block, AV block with junctional escape, transient asystole, peripheral arterial occlusive disease[Ref]


Very common (10% or more): ALT/AST increased (14%)

Common (1% to 10%): Elevation in liver transaminases, GGT increased, hepatic enzyme increased, liver function test abnormal[Ref]

In the majority of cases, elevations in liver enzymes occurred within 6 to 9 months and returned to normal within approximately 2 months following discontinuation of fingolimod.[Ref]


Very common (10% or more): Influenza viral infection (13%), sinusitis (10.9%), infections

Common (1% to 10%): Herpes viral infection, bronchitis, gastroenteritis, tinea infection

Uncommon (0.1% to 1%): Pneumonia

Frequency not reported: Fatal herpetic infection, fatal varicella zoster virus infection[Ref]

Infections occurred at a rate similar to placebo.[Ref]

Nervous system

Symptoms of posterior reversible encephalopathy syndrome included sudden onset of severe headache, altered mental status, visual disturbances, and seizure.[Ref]

Very common (10% or more): Headache (25%)

Common (1% to 10%): Dizziness, paresthesia, migraine

Rare (less than 0.1%): Posterior reversible encephalopathy syndrome, ischemic and hemorrhagic stroke

Frequency not reported: Neurological atypical disorders

Postmarketing reports: Syncope[Ref]


Very common (10% or more): Diarrhea (12%)[Ref]


Common (1% to 10%): Lymphopenia, leukopenia

Uncommon (0.1% to 1%): Neutrophil count decreased[Ref]


Macular edema occurred at a dramatically higher rate in patients with a history of uveitis.[Ref]

Common (1% to 10%): Vision blurred, eye pain

Uncommon (0.1% to 1%): Macular edema[Ref]


Very common (10% or more): Cough (10%)

Common (1% to 10%): Dyspnea, reduction in diffusion lung capacity, reduction in FEV1[Ref]


Very common (10% or more): Back pain (12%)[Ref]


Common (1% to 10%): Alopecia, eczema, pruritus[Ref]


Common (1% to 10%): Weight decreased, blood triglycerides increased[Ref]


Common (1% to 10%): Asthenia

Postmarketing reports: Unexplained death[Ref]


Common (1% to 10%): Depression

Uncommon (0.1% to 1%): Depressed mood[Ref]


Frequency not reported: Lymphoma[Ref]


Postmarketing reports: Rash, urticaria, angioedema

Frequently asked questions


1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Gilenya (fingolimod)." Novartis Pharmaceuticals (2010):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.