Gilenya Side Effects
Generic Name: fingolimod
Medically reviewed by Drugs.com. Last updated on Feb 9, 2020.
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.
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:
- Blurred vision
- cough-producing mucus
- difficult or labored breathing
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- muscle aches and pains
- pounding in the ears
- runny nose
- slow or fast heartbeat
- sore throat
- tightness in the chest
- trouble sleeping
- unusual tiredness or weakness
- Black, tarry stools
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- 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
Incidence not known
- back pain
- change in size, shape, or color of existing mole
- difficulty in moving
- difficulty in speaking
- double vision
- epileptic seizure that will not stop
- hives, itching, skin rash
- inability to move the arms, legs, or facial muscles
- inability to speak
- 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:
- Pain or tenderness around the eyes and cheekbones
- stuffy nose
- Decreased weight
- eye pain
- hair loss or thinning of the hair
- itching in the genitals or other skin areas
- lack or loss of strength
- stomach pain
- skin rash, encrusted, scaly, and oozing
For Healthcare Professionals
Applies to fingolimod: oral capsule
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]
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
Very common (10% or more): Diarrhea (12%)[Ref]
Common (1% to 10%): Lymphopenia, leukopenia
Uncommon (0.1% to 1%): Neutrophil count decreased[Ref]
Common (1% to 10%): Vision blurred, eye pain
Uncommon (0.1% to 1%): Macular edema[Ref]
Very common (10% or more): Cough (10%)
Very common (10% or more): Back pain (12%)[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]
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
Frequently asked questions
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- Does Gilenya cause hair loss?
- How much does Gilenya cost?
- Where is Gilenya manufactured and by whom?
- What does Gilenya do for multiple sclerosis (MS)?
More about Gilenya (fingolimod)
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- Drug class: selective immunosuppressants
- FDA Alerts (5)
- FDA Approval History
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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.