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

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
  • 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
  • shortness of breath
  • slow or fast heartbeat
  • sore throat
  • sweating
  • tightness in the chest
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
  • wheezing
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 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
  • 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


In general, the most frequently reported side effects (incidence greater than 10%) have included headache, influenza, diarrhea, back pain, increased liver enzymes, and cough. Increased liver enzymes were the only adverse effect which lead to treatment interruption (3.8%).


Cardiovascular side effects have included hypertension (6%) and bradycardia (4%).


Dermatologic side effects have included alopecia (4%), eczema (3%), and pruritus (3%).


Gastrointestinal side effects have included diarrhea (12%) and gastroenteritis (5%).


Hematologic side effects have included lymphopenia (4%) and leucopenia (3%).


Hepatic side effects have included increased aspartate/alanine (AST/ALT) aminotransferases (14%) and increased gamma glutamyl transpeptidase (GGT; 5%).


Immunologic side effects have included influenza viral infection (13%), herpes viral infection (9%), and tinea infections (4%).


Metabolic side effects have included weight loss (5%) and increased serum triglycerides (3%).


Musculoskeletal side effects have included back pain (12%).

Nervous system

Nervous system side effects have included headache (25%), dizziness (7%), paresthesia (5%), and migraine (5%).


Ocular side effects have included blurred vision (4%), eye pain (3%), and macular edema.


Other side effects have included asthenia (3%).


Psychiatric side effects have included depression (8%).


Respiratory side effects have included cough (10%), dyspnea (8%), bronchitis (8%), and sinusitis (7%).

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