Tiglutik Side Effects
Generic name: riluzole
Medically reviewed by Drugs.com. Last updated on Apr 17, 2025.
Note: This document provides detailed information about Tiglutik Side Effects associated with riluzole. Some dosage forms listed on this page may not apply specifically to the brand name Tiglutik.
Applies to riluzole: oral film, oral suspension, oral tablet.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Check with your doctor right away if you have a rash, stomach pain, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Riluzole can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Check with your doctor right away if you start having breathing problems, dry cough, chest pain, fever, or chills. These could be symptoms of a serious lung problem.
Tell your doctor if you have Japanese ancestry. You may need a lower dose of this medicine to avoid unwanted effects.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Common side effects of Tiglutik
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 Tiglutik
Along with its needed effects, riluzole (the active ingredient contained in Tiglutik) 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
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References
1. (2001) "Product Information. Rilutek (riluzole)." Rhone Poulenc Rorer
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
Frequently asked questions
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Further information
Tiglutik 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.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.