Gilenya Side Effects

Gilenya (fingolimod) is an immunosuppressant. It works by keeping immune cells trapped in your lymph nodes so they can’t reach the central nervous system (brain and spinal cord).

Gilenya is used to treat relapsing multiple sclerosis (MS) in adults. This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

You should not use Gilenya if you are allergic to fingolimod, or if you have certain serious heart conditions, especially:

  • severe heart failure (that required you to be in the hospital);
  • “AV block” or sick sinus syndrome (unless you have a pacemaker);
  • a recent (within the past 6 months) heart attack, stroke, “mini-stroke” or TIA, chest pain (unstable angina), or other serious heart problem; or
  • if you take any of these heart rhythm medications — amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Tambocor), dronedarone (Multaq), ibutilide (Corvert), mexiletine (Mexitil), procainamide (Procan, Pronestyl), propafenone, (Rythmol), quinidine (Quin-G), or sotalol (Betapace).

Before you take Gilenya, tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month before taking Gilenya.

To make sure you can safely take Gilenya, tell your doctor if you have any of these other conditions:

  • an active or chronic infection;
  • a very slow heart rate (fewer than 55 beats per minute);
  • low blood pressure or a history of fainting;
  • high blood pressure, heart disease, congestive heart failure;
  • a history of Long QT syndrome;
  • diabetes;
  • liver or kidney disease;
  • asthma or other breathing disorder; or
  • history of an eye condition called uveitis.

FDA pregnancy category C. It is not known whether Gilenya will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Use effective birth control while you are using Gilenya and for at least 2 months after your treatment ends. Fingolimod can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Gilenya. Do not give this medication to anyone under 18 years old without medical advice.

Get emergency medical help if you have any of these signs of an allergic reaction to Gilenya: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • slow heart rate, dizziness, feeling very weak or tired;
  • chest pain, pounding heartbeats or fluttering in your chest;
  • sudden numbness or weakness, severe headache, problems with speech or walking;
  • wheezing, chest tightness, trouble breathing, cough with yellow or green mucus;
  • fever, chills, body aches, flu symptoms, nausea and vomiting, sores in your mouth and throat;
  • swelling, warmth, redness, oozing, itchy rash, or other signs of skin infection;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • vision problems, blurred vision, eye pain, increased sensitivity to light, or having a blind spot or shadows in the center of your vision (vision problems may occur 3 to 4 months after you start taking Gilenya).

Less serious Gilenya side effects may include:

  • headache, tired feeling;
  • back pain;
  • diarrhea; or
  • stuffy nose, sinus pain, or cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.