The info in the FDA link is not a FDA warning. It's actually from Novartis' Gilenya Medication Guide, which has been approved by the FDA. With any medication you take, you should always make sure one is included every time you get a bottle/packet since the information may change. And yes, infections are a recognized side-effect of Gilenya:
What are possible side effects of GILENYA?
GILENYA can cause serious side effects. See “What is the most important information I should know about GILENYA?” Serious side effects include:
Breathing Problems: Some people who take GILENYA have shortness of breath. Call your doctor right away if you have trouble breathing.
Liver problems: GILENYA may cause liver problems. Your doctor should do blood tests tocheck your liver before you start taking GILENYA. Call your doctor right away if you have any of the following symptoms of liver problems: nausea, vomiting, stomach pain, loss of appetite, tiredness, your skin or the whites of your eyes turn yellow, dark urine.
The most common side effects of GILENYA include: headache, flu, diarrhea, back pain, abnormal liver tests, cough.
Infections GILENYA can increase your risk of serious infections. GILENYA lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 2 months of stopping treatment. Your doctor may do a blood test before you start taking GILENYA. Call your doctor right away if you have any of these symptoms of an infection: fever, tiredness, body aches, chills, nausea, vomiting.
Macular edema can cause some ofthe same vision symptoms as an MS attack (optic neuritis). You may not notice anysymptoms with macular edema. Macular edema usually starts in the first 3 to 4 months afteryou start taking GILENYA. Your doctor should test your vision before you start taking GILENYA and 3 to 4 months after you start taking GILENYA, or any time you notice vision changes during treatment with GILENYA. Your risk of macular edema may be higher if youhave diabetes or have had an inflammation of your eye called uveitis. Call your doctor right away if you have any of the following: blurriness or shadows in the center of your vision, a blind spot in the center of your vision, sensitivity to light, unusually colored (tinted) vision.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of GILENYA. For more information, ask your doctoror pharmacist. Call your doctor for medical advice about side effects. You may report side effectsto FDA at 1-800-FDA-1088.
I strongly urge you to call your doctor and report your side effects to the FDA. Hope you feel better soon, Julie.