Gilenya Side Effects

Generic Name: fingolimod

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

Not all side effects for Gilenya may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to fingolimod: oral capsule

In addition to its needed effects, some unwanted effects may be caused by fingolimod (the active ingredient contained in Gilenya). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking fingolimod:

More common
  • Blurred vision
  • 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
  • shivering
  • slow or fast heartbeat
  • sore throat
  • sweating
  • tightness in the chest
  • 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
  • cough or hoarseness
  • headache, severe and throbbing
  • 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

Some of the side effects that can occur with fingolimod may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Back pain
  • pain or tenderness around the eyes and cheekbones
  • stuffy nose
Less common
  • Abdominal or stomach pain
  • decreased weight
  • depression
  • eye pain
  • hair loss or thinning of the hair
  • itching in the genital or other skin areas
  • itching skin
  • lack or loss of strength
  • scaling
  • skin rash, encrusted, scaly, and oozing
  • weakness

For Healthcare Professionals

Applies to fingolimod: oral capsule

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

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

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]

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

References

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

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