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Drugs reference index «Rilutek»



Generic Name: riluzole (Oral route)


Commonly used brand name(s):

In the U.S.

  • Rilutek

Available Dosage Forms:

  • Tablet

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: Glutamate Antagonist

Uses For Rilutek

Riluzole is used to treat patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Riluzole is not a cure for ALS, but it may extend survival in the early stages of the disease, and/or may extend the time until a tracheostomy may be needed.

Riluzole is available only with your doctor's prescription.

Before Using Rilutek

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of riluzole in children with use in other age groups.


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of riluzole in the elderly with use in other age groups, this medicine has been used in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults.


Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Sulfasalazine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Tacrine
  • Theophylline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Kidney disease or
  • Liver disease—Higher blood levels of riluzole may occur, increasing the chance of side effects

Proper Use of Rilutek

Riluzole should be taken on a regular basis and at the same time of the day (for example, in the morning and the evening).

Riluzole should be taken on an empty stomach. Take this medicine at least one hour before meals or two hours after meals.


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For ALS:
      • Adults—Oral, 50 milligrams (mg) every twelve hours.
      • Children up to 18 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Rilutek

If you become ill with a fever, report this to your doctor promptly. Fever may be a sign of infection.

This medicine may cause dizziness or drowsiness. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Avoid drinking alcoholic beverages. It is not known if drinking alcohol while taking riluzole may cause liver problems.

Rilutek Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common
  • Diarrhea
  • nausea
  • vomiting
  • worsening of some symptoms of ALS, including spasticity and tiredness or weakness
Less common
  • Difficulty in breathing
  • increased cough
  • pneumonia
  • Bloody or cloudy urine, frequent urge to urinate, or painful or difficult urination
  • convulsions (seizures)
  • fast or pounding heartbeat
  • fever, chills, or continuing sores in mouth
  • hypertension (high blood pressure)
  • increased thirst, irregular heartbeat, mood or mental changes, or muscle cramps, pain, or weakness
  • lack of coordination
  • lack of energy
  • mental depression
  • pain, tenderness, bluish color, or swelling of foot or leg
  • redness, scaling, or peeling of the skin
  • swelling of eyelids, mouth, lips, tongue, and/or throat
  • swelling of face
  • trouble in swallowing
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal pain or gas
  • dizziness
  • drowsiness
  • loss of appetite
  • numbness or tingling around the mouth
Less common
  • Back or muscle pain or stiffness
  • constipation
  • general feeling of discomfort or illness
  • hair loss
  • headache
  • irritation or soreness of mouth
  • runny nose
  • skin rash or itching
  • trouble in sleeping

This medicine may also cause the following side effect that your doctor will watch for:

More common
  • Liver problems

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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  • Rilutek Prescribing Information (FDA)
  • Rilutek Concise Consumer Information (Cerner Multum)
  • Rilutek MedFacts Consumer Leaflet (Wolters Kluwer)
  • Riluzole Professional Patient Advice (Wolters Kluwer)

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