Rilutek

Last updated on RxList: 5/26/2020
Rilutek Side Effects Center

What Is Rilutek?

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.

What Are Side Effects of Rilutek?

Side effects of Rilutek include:

Dosage for Rilutek

Rilutek is available as 50mg tablets; the dose is 50 mg every 12 hours.

What Drugs, Substances, or Supplements Interact with Rilutek?

Rilutek may interact with acetaminophen, allopurinol, amitriptyline, auranofin, cancer medications, methyldopa, omeprazole, sulfasalazine, theophylline, tuberculosis medications, birth control pills or other hormones, methotrexate, ACE inhibitors, antibiotics, antifungals, cholesterol medications, HIV/AIDS medications, nonsteroidal anti-inflammatory drugs (NSAIDs), or seizure medications. Tell your doctor all medications and supplements you use.

Rilutek During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant while using Rilutek; it is unknown if it will harm a fetus. It is unknown if Rilutek passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

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.

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Rilutek Consumer Information

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Get emergency medical help if you have 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:

  • sudden chest pain, wheezing, feeling short of breath;
  • dry cough, or cough with mucus;
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat; or
  • liver problems--nausea, loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, jaundice (yellowing of the skin or eyes).

Side effects may be more likely to occur in people of Japanese descent.

Common side effects may include:

  • increased blood pressure;
  • numbness or tingling around your mouth;
  • weakness;
  • dizziness;
  • stomach pain, nausea; or
  • breathing problems.

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)

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Rilutek Professional Information

SIDE EFFECTS

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

  • Hepatic Injury [see WARNINGS AND PRECAUTIONS]
  • Neutropenia [see WARNINGS AND PRECAUTIONS]
  • Interstitial lung disease [see WARNINGS AND PRECAUTIONS]

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)
Asthenia19%12%
Nausea16%11%
Decreased lung function10%9%
Hypertension5%4%
Abdominal pain5%4%
Vomiting4%2%
Arthralgia4%3%
Dizziness4%3%
Dry mouth4%3%
Insomnia4%3%
Pruritus4%3%
Tachycardia3%1%
Flatulence3%2%
Increased cough3%2%
Peripheral edema3%2%
Urinary Tract Infection3%2%
Circumoral paresthesia2%0%
Somnolence2%1%
Vertigo2%1%
Eczema2%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.

  • Acute hepatitis and icteric toxic hepatitis [see WARNINGS AND PRECAUTIONS]
  • Renal tubular impairment
  • Pancreatitis

Read the entire FDA prescribing information for Rilutek (Riluzole)

© Rilutek Patient Information is supplied by Cerner Multum, Inc. and Rilutek Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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