Gilenya Side Effects
Generic name: fingolimod
Note: This document provides detailed information about Gilenya Side Effects associated with fingolimod. Some dosage forms listed on this page may not apply specifically 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 side effects
- 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 side effects
- 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 side effects
- pain or tenderness around the eyes and cheekbones
- stuffy nose
Less common side effects
- 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 adverse events
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
- 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
- Common (1% to 10%): Vision blurred, eye pain
- Uncommon (0.1% to 1%): Macular edema[Ref]
Macular edema occurred at a dramatically higher rate in patients with a history of uveitis.[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
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
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2010) "Product Information. Gilenya (fingolimod)." Novartis Pharmaceuticals
Frequently asked questions
- Gilenya vs Tecfidera. How do they compare?
- Can Gilenya cause high blood pressure?
- Can Gilenya cause weight gain?
- Can Gilenya cause headaches?
- Gilenya and the covid-19 vaccine, what should I know?
- What are the new drugs used for multiple sclerosis (MS)?
- How much does Gilenya cost?
- What happens when you stop taking Gilenya?
- Does Gilenya suppress the immune system?
More about Gilenya (fingolimod)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (96)
- Drug images
- Dosage information
- Patient tips
- During pregnancy
- Generic availability
- Support group
- FDA approval history
- Drug class: selective immunosuppressants
- Breastfeeding
- En español
Patient resources
Other brands
Professional resources
Other brands
Related treatment guides
Further information
Gilenya side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.
