Get emergency medical help if you have signs of an allergic reaction to Gilenya: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Fingolimod may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.
Also call your doctor at once if you have:
shiny nodules on your skin, sores that do not heal, unusual moles that change in color or size;
blurred vision, eye pain, or a blind spot or shadows in the center of your vision (may occur 3 to 4 months after you start taking fingolimod);
new or worsened breathing problems;
sores in your mouth and throat, cold sores, sores on your genital or anal area;
blood vessel problems in the brain - headache, confusion, change in mental status, sudden vision loss, seizure (convulsions);
heart problems - chest pain, slow or irregular heartbeats, and feeling dizzy or tired;
liver problems -nausea, upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or
signs of infection - fever, chills, body aches, tiredness, nausea and vomiting, neck stiffness, increased sensitivity to light.
Common Gilenya side effects may include:
headache, back pain;
stomach pain, diarrhea;
pain in your arms or legs;
cough, stuffy nose, flu symptoms; or
abnormal liver function tests.
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.
 Gilenya side effects (more detail)
