SIDE EFFECTS: Cough, headache, back pain, or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Fingolimod may increase the risk of skin cancer and lymphoma. Tell your doctor right away if you notice any new or changing skin growths/moles, or swollen lymph nodes. This medication can weaken your immune system/increase the risk of infection while you are taking it and for 2 months after your last dose. You may be more likely to get a serious (possibly fatal) infection (such as bronchitis, pneumonia, herpes). Tell your doctor right away if you develop any signs of an infection such as persistent cough/sore throat, difficulty breathing, fever/chills, cold/flu symptoms, sores, or blisters. Do not start fingolimod if you already have an infection. Fingolimod may increase the risk of a rare (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). This may sometimes occur even after treatment has stopped. Symptoms of PML can seem like a worsening MS attack. Tell your doctor right away if you have any new or worsening symptoms that have lasted for several days, such as clumsiness or problems with strength, balance, speech, eyesight, or thinking. Get medical help right away if you have any very serious side effects, including: shortness of breath, chest pain, severe dizziness/fainting, slow/irregular/pounding/fast heartbeat, unusual tiredness/weakness, eye pain/sensitivity to light, vision changes (such as blurred vision, blind spot/shadows in the center of your vision, color changes), mental changes (such as sudden confusion), seizure, sudden/severe headache. This medication may rarely cause serious liver problems. Tell your doctor right away if you experience: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also How to Use section. Before taking fingolimod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, bronchitis, emphysema, sleep apnea), current/recent/returning infection (including hepatitis and tuberculosis), diabetes, fainting, certain eye problems (macular edema, uveitis), heart problems (such as slow/irregular heartbeat, heart failure, previous heart attack, chest pain, QT prolongation in the EKG), high blood pressure, liver disease, stroke or "mini-stroke"/transient ischemic attack (TIA). Have all necessary immunizations done before starting this medication. Do not have immunizations/vaccinations while you are taking fingolimod and for 2 months after your last dose without the consent of your doctor. Also, avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose and people who have infections that may spread to others (such as chickenpox, flu). Wash your hands well to prevent the spread of infections. This medication may increase your risk of developing skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Your doctor may direct you to avoid phototherapy while you use this product. Ask your doctor for details. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Fingolimod is not recommended for use during pregnancy. It may harm an unborn baby. Discuss with your doctor the use of reliable forms of birth control while taking this medication and for 2 months after your last dose. If you become pregnant or think you may be pregnant, tell your doctor right away. It is unknown if this drug passes into breast milk. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some of the products that may interact with this drug include: ketoconazole, drugs that slow down your heartbeat (including digoxin, beta-blockers such as atenolol/metoprolol, calcium channel blockers such as diltiazem/verapamil), certain drugs for irregular heartbeat (including amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, sotalol), other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.