Fingolimod is an oral medication used to treat symptoms of relapsing-remitting multiple sclerosis (RRMS). Better known by its brand name, Gilenya, this type of sphingosine l-phosphate receptor modulator is one of the newer forms of RRMS treatments.

The purpose of this type of medication is to decrease the amount of cells that cause nerve damage. Fingolimod also helps prevent lymphocytes (white blood cells) from entering the central nervous system. And it may help stop acute (rapid, but occasional) MS symptoms, such as:

  • muscle spasms
  • weakness and numbness
  • bladder control problems
  • speech and vision impairments

As with other RRMS drugs, you should be aware of side effects before taking this medicine. A few reports of serious risks have been associated with fingolimod.

First Dose of Fingolimod

Fingolimod is an oral medication in the form of a 0.5 mg capsule. According to the National Institutes of Health (NIH), you should take this medicine once a day, and at the same time each day. You may take fingolimod with or without a meal.

Your doctor will instruct you to take the first capsule of the prescription in a medical office. You may be monitored for any unusual side effects. The NIH reports that some patients may be observed for at least six hours.

Fingolimod can cause changes in heart rate, so your doctor will need to make sure that the medication is safe for long-term use. Signs of a decreased heartbeat after first use include:

  • sudden fatigue
  • dizziness
  • chest pain

Such effects are common with your first dose, but should not occur every time you take fingolimod. Call your doctor right away if you experience slow heartbeat at home after your second dose. Low blood pressure and vision changes are other side effects reported after the first use of fingolimod.

Common Side Effects

Fingolimod can also pose the risk of other side effects after the first dose. These include:

  • diarrhea
  • coughing
  • headaches
  • hair loss
  • depression
  • muscle weakness
  • dry, itchy skin

Fingolimod can cause liver problems. Jaundice, yellowing of the skin and eyes, is one sign of liver problems. A history of liver disease warrants regular blood tests to ensure that this medication is safe for you.

FDA Warnings

Oral medication can be a relief for many MS patients accustomed to taking their medicines via injection. Still, fingolimod is a fairly new drug compared to the injections available on the market. According to the National Institute of Neurological Disorders and Stroke (NINDS), fingolimod has been on the market since 2010. This is the first oral pill for MS ever approved by the U.S. Food and Drug Administration (FDA).

Severe reactions are rare, but the FDA reported a death in 2011 directly linked to the first use of fingolimod. The exact cause of death was unknown. In 2013, the FDA also reported a case of rare brain infection, formally referred to as progressive multifocal leukoencephalopathy (PKL), in a European patient after using fingolimod. This condition occurs when the myelin of the brain is damaged. This was the first and only reported case of PKL from fingolimod as of March, 2014.

Discuss any concerns with your doctor, but don’t stop taking your medicine unless your doctor instructs to.

Long-Term Risks

Consider your risk for serious complications before taking fingolimod. Keep in mind that such instances are rare, but the frequency of rare side effects is unknown. The FDA continues to investigate the case of PKL, as well as the 2011 death associated with fingolimod.

This medicine poses a long-term risk of infections. This is partly because fingolimod suppresses lymphocytes, which can naturally help your body fight infections. While you need lymphocytes to prevent infections, their admission into the central nervous system can be detrimental in MS.

No studies have been conducted in patients under 18 years old, according to the National Multiple Sclerosis Society. For this reason, your doctor may not choose to prescribe it if you’re under 18.


Since there is no cure for MS, medicines like fingolimod are relied on to improve quality of life. It can also help reduce the onset of permanent disability.

The National Multiple Sclerosis Society has reported promising results for patients looking to switch MS medications. Patients in a one-year study had 52 percent fewer relapses compared with interferon beta-1a (Avonex). A two-year study of patients revealed 54 percent fewer relapses compared with a placebo.

However, just as other prescription MS medications can cause side effects, fingolimod can too. You and your doctor can weigh the benefits and possible risks of taking this medication. Let your doctor know about all over-the-counter medications, prescription drugs, and herbal supplements that you currently take. This will help to determine the most effective form of treatment for you, and will prevent any negative drug interactions.