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Fingolimod Side Effects

In Summary

Commonly reported side effects of fingolimod 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

Along with its needed effects, fingolimod 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
  • cough
  • 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
  • Confusion
  • difficulty in speaking
  • double vision
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • slow speech
  • weight loss
  • yellow skin and eyes

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
  • Back pain
  • 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
  • itching skin
  • lack or loss of strength
  • scaling
  • stomach pain
  • skin rash, encrusted, scaly, and oozing
  • weakness

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]


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): ALT/AST increased (14%)
Common (1% to 10%): Elevation in liver transaminases, GGT increased, hepatic enzyme increased, liver function test abnormal[Ref]


Infections occurred at a rate similar to placebo.[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]

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


1. "Product Information. Gilenya (fingolimod)." Novartis Pharmaceuticals, East Hanover, NJ.

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

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

Some side effects of fingolimod may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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