July 29, 2016
Recommended Topic Related To:

Rilutek

"By Rita Rubin
WebMD Health News

Reviewed By Brunilda Nazario, MD

Jan. 3, 2014 -- What does it mean when doctors say a person is brain-dead? WebMD asked critical care specialist Isaac Tawil, MD, an assistant"...

A A A

Rilutek




Rilutek Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 9/18/2015

Rilutek (riluzole) is a benzothiazole drug indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Rilutek is available as a generic. Rilutek extends survival and/or time to tracheostomy. Side effects of Rilutek include weakness, drowsiness, nausea, stomach pain, dizziness, spinning sensation, decreased lung function, diarrhea, constipation, muscle stiffness, numbness or tingly feeling in or around your mouth, headache, or runny nose.

Rilutek is available as 50mg tablets; the dose is 50 mg every 12 hours. No increased benefit can be expected from higher daily doses, but adverse events are increased. There have been no clinical studies designed to evaluate the interaction of Rilutek with other drugs. As with all drugs, the potential for integration by a variety of mechanisms is a possibility. Rilutek should be prescribed with care in patients with current evidence or history of abnormal liver function. Rilutek should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women should not breast feed during treatment. The safety and efficacy of Rilutek in the pediatric population has not been done.

Our Rilutek (riluzole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Rilutek in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using riluzole and call your doctor at once if you have a serious side effect such as:

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms;
  • chest discomfort, dry cough, trouble breathing;
  • cough with yellow or green mucus; or
  • stabbing chest pain, feeling short of breath.

Less serious side effects may include:

  • dizziness, spinning sensation;
  • muscle stiffness;
  • weakness, drowsiness;
  • numbness or tingly feeling in or around your mouth;
  • mild nausea, diarrhea, stomach pain, constipation;
  • headache; or
  • runny nose.

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.

Read the entire detailed patient monograph for Rilutek (Riluzole)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Rilutek Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, lightheadedness, drowsiness, tiredness, nausea, vomiting, diarrhea, loss of appetite, stomach pain, or numbness/tingling around the mouth 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.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, chills, cough, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious signs of liver problems occur: yellowing eyes/skin, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Rilutek (Riluzole)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rilutek FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are described below and elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Reactions In Controlled Clinical Trials

In the placebo-controlled clinical trials in patients with ALS (Study 1 and 2), a total of 313 patients received RILUTEK 50 mg twice daily [see Clinical Studies]. The most common adverse reactions in the RILUTEK group (in at least 5% of patients and more frequently than in the placebo group) were asthenia, nausea, dizziness, decreased lung function, and abdominal pain. The most common adverse reactions leading to discontinuation in the RILUTEK group were nausea, abdominal pain, constipation, and elevated ALT.

There was no difference in rates of adverse reactions leading to discontinuation in females and males. However, the incidence of dizziness was higher in females (11%) than in males (4%). The adverse reaction profile was similar in older and younger patients. There were insufficient data to determine if there were differences in the adverse reaction profile in different races.

Table 1 lists adverse reactions that occurred in at least 2% of RILUTEK-treated patients (50 mg twice daily) in pooled Study 1 and 2, and at a higher rate than placebo.

Table 1: Adverse Reactions in Pooled Placebo-Controlled Trials (Studies 1 and 2) in Patients with ALS

  RILUTEK 50 mg twice daily
(N=313)
Placebo
(N=320)
Asthenia 19% 12%
Nausea 16% 11%
Decreased lung function 10% 9%
Hypertension 5% 4%
Abdominal pain 5% 4%
Vomiting 4% 2%
Arthralgia 4% 3%
Dizziness 4% 3%
Dry mouth 4% 3%
Insomnia 4% 3%
Pruritus 4% 3%
Tachycardia 3% 1%
Flatulence 3% 2%
Increased cough 3% 2%
Peripheral edema 3% 2%
Urinary Tract Infection 3% 2%
Circumoral paresthesia 2% 0%
Somnolence 2% 1%
Vertigo 2% 1%
Eczema 2% 1%

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of RILUTEK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Rilutek (Riluzole)

Rilutek - User Reviews

Rilutek User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Rilutek sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


WebMD Daily

Get breaking medical news.