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Gilenya Side Effects

Generic name: fingolimod

Medically reviewed by Philip Thornton, DipPharm. Last updated on Feb 26, 2023.

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

Applies to fingolimod: oral capsule, oral tablet disintegrating.

Serious side effects of Gilenya

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

  • Blurred vision
  • chest tightness
  • chills
  • cough
  • cough-producing mucus
  • diarrhea
  • difficult or labored breathing
  • dizziness
  • fever
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • pounding in the ears
  • runny nose
  • seizures
  • shivering
  • slow or fast heartbeat
  • sore throat
  • sweating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting

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
  • bleeding gums
  • blood in the urine or stools
  • 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
  • pinpoint red spots on the skin
  • 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
  • trouble swallowing
  • weight loss
  • yellow skin and eyes

Other side effects of Gilenya

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, oral tablet disintegrating.

General

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

Cardiovascular

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]

Hepatic

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]

Immunologic

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]

Gastrointestinal

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

Hematologic

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

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

Ocular

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]

Respiratory

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

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

Musculoskeletal

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

Dermatologic

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

Metabolic

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

Other

Common (1% to 10%): Asthenia

Postmarketing reports: Unexplained death[Ref]

Psychiatric

Common (1% to 10%): Depression

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

Oncologic

Frequency not reported: Lymphoma[Ref]

Hypersensitivity

Postmarketing reports: Rash, urticaria, angioedema

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

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.

Medical Disclaimer