Rilutek Side Effects

Generic name: riluzole

Medically reviewed by Drugs.com. Last updated on Apr 5, 2024.

Note: This document provides detailed information about Rilutek Side Effects associated with riluzole. Some dosage forms listed on this page may not apply specifically to the brand name Rilutek.

Applies to riluzole: oral film, oral suspension, oral tablet.

Common side effects of Rilutek

Some side effects of riluzole 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 side effects

• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• lack or loss of strength

Less common side effects

• difficulty moving
• dizziness or lightheadedness
• dry mouth
• excess air or gas in the stomach or bowels
• feeling of constant movement of self or surroundings
• full feeling
• muscle stiffness
• passing gas
• rapid weight gain
• sensation of spinning
• skin rash, encrusted, scaly and oozing
• sleepiness or unusual drowsiness
• stomach pain
• tingling of the hands or feet
• unusual weight gain or loss

Serious side effects of Rilutek

Along with its needed effects, riluzole (the active ingredient contained in Rilutek) 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 immediately if any of the following side effects occur while taking riluzole:

Less common side effects

• bladder pain
• bloody or cloudy urine
• blurred vision
• chills
• cough
• dark urine
• diarrhea
• difficult, burning, or painful urination
• fast, pounding, or irregular heartbeat or pulse
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• increased cough
• itching skin
• joint pain
• loss of appetite
• lower back or side pain
• muscle aches and pains
• nausea
• nervousness
• persistent loss of appetite or weight loss
• pounding in the ears
• right upper quadrant tenderness
• runny nose
• shivering
• slow heartbeat
• sore throat
• trouble sleeping
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Incidence not known

• black, tarry, stools
• decreased frequency or amount of urine
• difficult breathing
• increased thirst
• nausea
• pale skin
• swelling of the face, fingers, or lower legs
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• weight gain

Get emergency help immediately if any of the following symptoms of overdose occur while taking riluzole:

Symptoms of overdose

• agitation
• back pain
• bluish-colored lips, fingernails, or palms
• blurred vision
• coma
• confusion
• dark urine
• difficulty breathing
• dizziness or lightheadedness
• drowsiness
• fever
• headache
• irritability
• memory loss
• pale skin
• rapid heart rate
• seeing, hearing, or feeling things that are not there
• seizures
• sore throat
• stiff neck
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

For healthcare professionals

Applies to riluzole: oral film, oral suspension, oral tablet.

General adverse events

The most commonly reported adverse reactions have included asthenia, nausea, dizziness, decreased lung function, and abdominal pain.^[Ref]

Hepatic

• Very common (10% or more): At least 1 ALT elevation of above upper limit of normal (ULN)
• Common (1% to 10%): ALT elevation above 5 x ULN
• Rare (0.01% to 0.1%): Hepatitis, jaundice, hepatocellular damage
• Frequency not reported: Drug-induced hepatic injury
• Postmarketing reports: Acute hepatitis and icteric toxic hepatitis^[Ref]

In clinical trials, ALT elevations above 5 times the upper limit of normal (5 X ULN) were reported in 2% of patients, about 50% had at least 1 elevated ALT, and 8% had at least one elevated ALT level above 3 x ULN. Drug-induced hepatic injury, including fatalities, have been reported.

Study data indicate that Asian patients may be more susceptible to liver function test abnormalities; 3.2% (194/5995) of Asian patients and 1.8% (100/5641) of Caucasian patients experienced liver function test abnormalities.^[Ref]

Hematologic

• Uncommon (0.1% to 1%): Anemia
• Rare (0.01% to 0.1%): Erythropenia, leucopenia, thrombocytopenia
• Very rare (less than 0.01%): Neutropenia^[Ref]

There have been 3 reports (n=5000) of marked neutropenia where absolute neutrophil count was less than 500/mm3, all within first 2 months of treatment. In one case, neutrophil counts rose on continued treatment. In a second case, counts rose after therapy was stopped. A third case was associated with marked anemia with uncertain etiology^[Ref]

Respiratory

• Common (1% to 10%): Decreased lung function, increased cough,
• Uncommon (0.1% to 1%): Respiratory failure, interstitial lung disease
• Rare (0.01% to 0.1%): Asphyxia, respiratory distress.
• Frequency not reported: Hypersensitivity pneumonitis

Gastrointestinal

• Very common (10% or more): Nausea (16%)
• Common (1% to 10%): Abdominal pain, vomiting, dry mouth, flatulence
• Uncommon (0.1% to 1%): Pancreatitis
• Rare (0.01% to 0.1%): Gastrointestinal disorder, gastric ulcer, gastrointestinal hemorrhage, gastrointestinal irritation, melena^[Ref]

Nervous system

• Common (1% to 10%): Dizziness, circumoral paresthesia, somnolence^[Ref]

In clinical trials, the incidence of dizziness was greater in females than males (11% vs 4%). There was no difference in rates of adverse reactions leading to discontinuation between genders.^[Ref]

Hypersensitivity

• Very rare (less than 0.01%): Angioedema
• Frequency not reported: Anaphylaxis

Psychiatric

• Common (1% to 10%): Insomnia
• Rare (0.01% to 0.1%): Completed suicide, confusion, delirium, hallucination, personality change due to a general medical condition
• Very rare (less than 0.01%): Amnesia

Renal

• Postmarketing reports: Renal tubular impairment

Musculoskeletal

• Common (1% to 10%): Arthralgia^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension, tachycardia, peripheral edema
• Rare (0.01% to 0.1%): Angina unstable, atrial fibrillation, cardiac failure
• Very rare (less than 0.01%): Arrhythmia

Metabolic

• Rare (0.01% to 0.1%): Dehydration
• Very rare (less than 0.01%): Hyponatremia

Other

• Very common (10% or more): Asthenia (19%)
• Common (1% to 10%): Vertigo, malaise, pyrexia

Dermatologic

• Common (1% to 10%): Pruritus, eczema
• Rare (0.01% to 0.1%): Dermatitis

Genitourinary

• Common (1% to 10%): Urinary tract infection

Frequently asked questions

• What is the difference between Rilutek, Tiglutik and Exservan?

Further information

Rilutek side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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