Riluzole

Pronunciation: RIL-ue-zole.

Generic name
riluzole
Brand names
Rilutek (tablet, all 6 markets reviewed), Tiglutik / Teglutik (oral suspension, United States/United Kingdom/Australia), Exservan (oral film, United States)
Drug class
Glutamate-modulating agent (neuroprotective agent for amyotrophic lateral sclerosis)
Form
Tablet (50 mg), oral suspension (5 mg/mL or 50 mg/10 mL depending on market), or oral film (dissolves on the tongue), depending on brand and market
Route
Oral
Legal status
Prescription-only in all markets reviewed; in New Zealand, prescribing is further restricted to authorised prescribers acting in collaboration with, or following consultation with, Motor Neurone Disease/neurology/palliative-care specialists.

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Rilutek; Teglutik (oral liquid suspension); Rilukem and Pharmacor Riluzole (generic tablets) (6) · Full directory

What riluzole is and how it works

Riluzole is a prescription medicine used to treat amyotrophic lateral sclerosis (ALS, also called motor neurone disease), a progressive disease affecting the nerve cells that control muscle movement. It is not a cure, but it can help extend survival or delay the need for a breathing tube or ventilator. (1) (5)

Riluzole does not carry a boxed warning, but it does require real, active safety monitoring: your prescriber will check your liver function before you start and regularly afterward, because rare but real liver problems can occur, especially in the first few months. It can also rarely cause a serious drop in a type of white blood cell (neutrophils), so tell your prescriber promptly about any fever or signs of infection. Take it exactly as prescribed, and keep all your monitoring blood test appointments.

Mechanism of action: how riluzole works

The mechanism by which riluzole exerts its therapeutic effect in ALS is unknown, though it is thought to relate to modulating excess glutamate neurotransmission, which is implicated in motor-neurone injury. (1)

What riluzole is used for

Amyotrophic lateral sclerosis (ALS)

Used to treat ALS (motor neurone disease), to extend survival or delay the time until a tracheostomy or mechanical ventilation is needed. It is not a cure and does not reverse existing nerve damage. (1) (3) (5)

Before taking riluzole

Do not take / not appropriate for

  • Do not take riluzole if you have had a severe allergic reaction (including anaphylaxis) to riluzole or any ingredient in the product. (all countries) (1)

Tell your clinician about

  • Any history of liver disease, or if you drink alcohol regularly.
  • Any other medicines you take that can affect the liver, or that affect the CYP1A2 liver enzyme (which can change riluzole levels).
  • Whether you are pregnant, planning to become pregnant, or breastfeeding.
  • Any breathing problems or lung disease.
  • If you smoke, since smoking can affect how riluzole is processed by the body.
(1)

How to take riluzole

  • Take riluzole exactly as your prescriber directs, usually 50 mg twice daily.
  • Take riluzole at least 1 hour before or 2 hours after a meal, since food can reduce how well it is absorbed.
  • If you are prescribed the oral suspension (Tiglutik/Teglutik) or oral film (Exservan) instead of tablets, follow the specific instructions for that formulation, since dosing devices and administration differ.
  • Keep all scheduled liver-function blood tests, especially in the first 3 months of treatment.
  • Do not stop taking riluzole without talking to your prescriber, even if you are not sure it is helping -- your prescriber needs to weigh the overall picture before any change is made.
  • Tell your prescriber right away if you develop fever, signs of infection, yellowing of the skin or eyes, unusual tiredness, or new breathing symptoms.
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)

Missed dose

If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose, in which case skip the missed dose and continue your regular schedule -- do not take a double dose. Ask your pharmacist or prescriber if you are unsure.

Overdose

Seek emergency medical attention or contact Poison Control immediately if too much riluzole has been taken. Reported overdose symptoms (at 30-60 times the recommended dose) have included severe confusion, coma, drowsiness, memory problems, and a blood disorder called methemoglobinaemia. There is no specific antidote; treatment is supportive. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Weakness or fatigue (asthenia).

What to notice: Weakness or fatigue (asthenia).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Nausea.

What to notice: Nausea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Reduced lung function on testing.

What to notice: Reduced lung function on testing.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Abdominal pain.

What to notice: Abdominal pain.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Dizziness.

What to notice: Dizziness.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (5)

Serious warnings

Liver problems (hepatotoxicity) — high caution

Symptoms: Yellowing of the skin or eyes (jaundice), dark urine, unusual tiredness, loss of appetite, or nausea.

Action: Your prescriber will check your liver function with blood tests before you start riluzole, monthly for the first 3 months, and periodically afterward. Contact your prescriber promptly if you notice any of these symptoms -- riluzole may need to be stopped if liver test results are significantly abnormal or if jaundice develops. (1) (5)

Severe drop in white blood cells (neutropenia) — high caution

Symptoms: Fever, chills, sore throat, or other signs of infection, especially within the first 2 months of treatment.

Action: Contact your prescriber or seek urgent medical care promptly if you develop a fever or signs of infection -- a blood test may be needed to check your white blood cell count. (1)

Interstitial lung disease — high caution

Symptoms: New or worsening shortness of breath, cough, or breathing difficulty not explained by ALS itself.

Action: Contact your prescriber promptly -- riluzole needs to be stopped immediately if this rare lung condition develops. (1)

Severe allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat, difficulty breathing, or a widespread rash, which can indicate anaphylaxis.

Action: Seek emergency medical help immediately -- anaphylaxis has been reported with riluzole. (1)

Interactions

  • Medicines that inhibit the CYP1A2 liver enzyme can raise riluzole levels and increase the risk of side effects. (1)
  • Medicines that induce (speed up) the CYP1A2 liver enzyme can lower riluzole levels and reduce how well it works. (1)
  • Other medicines that can affect the liver, and regular alcohol use, may increase the risk of liver problems when combined with riluzole. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Riluzole has not been fully established as safe in human pregnancy, and animal studies suggest a possible risk to the developing baby. Discuss the risks and benefits with your prescriber if you are pregnant or planning a pregnancy. (1) (2) (3) (4) (5) (6) (7)

Breastfeeding

It is not known whether riluzole passes into human breast milk, though it has been detected in the milk of lactating animals. Discuss with your prescriber before breastfeeding while taking riluzole. (1) (2) (3) (4) (5) (6) (7)

Elderly

No overall differences in safety or effectiveness were seen in patients aged 65 and older, and no dose adjustment is needed based on age alone. (1) (2) (3) (4) (5) (6) (7)

Hepatic_impairment

Riluzole requires close liver monitoring in everyone, and your prescriber will use particular caution if you already have liver disease; specific dose-adjustment guidance for hepatic impairment was not detailed in the sources reviewed for this dossier. (1) (2) (3) (4) (5) (6) (7)

Renal_impairment

Specific dosing guidance for kidney impairment was not detailed in the sources reviewed for this dossier; discuss with your prescriber if you have kidney disease. (1) (2) (3) (4) (5) (6) (7)

Monitoring

Before starting

  • Baseline liver function tests (serum aminotransferases)
  • Review of other medicines that affect the liver or CYP1A2 enzyme
  • Assessment of lung function

During treatment

  • Liver function tests monthly for the first 3 months of treatment, then periodically.
  • Prompt evaluation of any fever or signs of infection, especially in the first 2 months, to check for neutropenia.
  • Monitoring for new or worsening breathing symptoms that could indicate interstitial lung disease.
  • In New Zealand, prescribing decisions are made in collaboration with, or following consultation with, specialists experienced in Motor Neurone Disease care.
(1) (7)

Storage

Store at controlled room temperature, 20-25degC (68-77degF), with excursions permitted between 15-30degC (59-86degF), and protect from bright light.

Professional information

Clinician-facing context only, sourced from the current US FDA/DailyMed generic riluzole prescribing information; verify against the current full local label before prescribing.

United States / United Kingdom / European Union / Canada / Australia / New Zealand

Indication: Amyotrophic lateral sclerosis (ALS)

Dose summary: 50 mg orally every 12 hours (100 mg/day total), taken at least 1 hour before or 2 hours after a meal. No dose adjustment based on age, sex, or weight.

Renal context: Not separately detailed in the sources reviewed for this dossier. (1) (7)

Mechanism of action

Hepatic guidance

Baseline and monthly (first 3 months), then periodic, liver-function monitoring is required for all patients; riluzole is not recommended if ALT exceeds 5x ULN, and should be discontinued if bilirubin rises or other evidence of liver dysfunction appears.

Overdose note

Reported overdose symptoms (1.5-3 g, 30-60x the recommended dose) include acute toxic encephalopathy, coma, drowsiness, memory loss, and methemoglobinaemia. No specific antidote; supportive care only. (1)

Frequently asked questions

Does riluzole have a boxed warning?

No. Riluzole's current US FDA label does not carry a boxed warning. It does, however, carry real Warnings and Precautions that require active monitoring -- liver function tests before and regularly during treatment, watching for severe drops in a type of white blood cell (neutropenia), and watching for a rare lung condition (interstitial lung disease). (1)

Why do I need regular liver blood tests on riluzole?

Riluzole can rarely cause liver problems, most often within the first few months of treatment. Your prescriber will check your liver function before you start, monthly for the first 3 months, and periodically afterward, so any problem can be caught early -- riluzole may need to be stopped if your results are significantly abnormal. (1) (5)

Is riluzole only available as a tablet?

No. While the original tablet (Rilutek) and generic tablets are the most widely available form, an oral suspension (Tiglutik/Teglutik) and, in the United States, a dissolving oral film (Exservan) are also real, approved alternatives for people who have difficulty swallowing tablets. (2) (3)

What is the mechanism of action of riluzole?

The mechanism by which riluzole exerts its therapeutic effect in ALS is unknown, though it is thought to relate to modulating excess glutamate neurotransmission, which is implicated in motor-neurone injury. (1)

What is the generic name of Riluzole?

The generic name is riluzole. It is sold under brand names including Rilutek (tablet, all 6 markets reviewed), Tiglutik / Teglutik (oral suspension, United States/United Kingdom/Australia), Exservan (oral film, United States). (1) (2) (3)

What class of drug is riluzole?

Riluzole is classed as: Glutamate-modulating agent (neuroprotective agent for amyotrophic lateral sclerosis). (1) (2) (3)

References

  1. RILUZOLE tablet, film coated -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information (generic riluzole tablet) · United States · accessed 2026-07-30 · source 1
  2. Rilutek (tablet), Tiglutik (oral suspension), and Exservan (oral film) -- three real US riluzole formulationsWeb-search summary of US FDA approval history for riluzole formulations (Rilutek, Tiglutik, Exservan) · United States · accessed 2026-07-30 · source 2
  3. Riluzole 50mg film-coated tablets (multiple manufacturers, including Rilutek/Zambon, generic Ranbaxy/Glenmark) and Teglutik 5 mg/mL oral suspension -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom · United Kingdom · accessed 2026-07-30 · source 3
  4. Rilutek (riluzole) -- European Public Assessment Report (EPAR), plus EMA-authorised generic Riluzole ZentivaEuropean Medicines Agency (EMA) -- centralised procedure EPAR · European Union · accessed 2026-07-30 · source 4
  5. RILUTEK (riluzole) -- Health Canada Product Monograph, plus Mylan-Riluzole generic Product MonographHealth Canada product monograph (Sanofi-Aventis Canada; generic Mylan-Riluzole) · Canada · accessed 2026-07-30 · source 5
  6. RILUTEK riluzole 50mg tablet, TEGLUTIK oral liquid suspension, RILUKEM and PHARMACOR RILUZOLE generic tablets -- ARTG registrationsTherapeutic Goods Administration (TGA), Australia -- ARTG registrations · Australia · accessed 2026-07-30 · source 6
  7. RILUTEK (riluzole) -- New Zealand Data Sheet (CCDS v1, DS v8, 20 June 2022), plus PHARMAC prescribing-restriction consultation documentsMedsafe, New Zealand -- New Zealand Data Sheet · New Zealand · accessed 2026-07-30 · source 7

Brand names by country

Single-ingredient riluzole names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Teglutik5 mg/mL · edw pharma, inc
  • TIGLUTIK50 mg0mL · italfarmaco spa

United Kingdom

  • Rilutek; generic riluzole 50mg tablets (Ranbaxy, Glenmark); Teglutik oral suspension (Martindale Pharma) (3)MHRA licensed emc smpc confirmed · 50 mg tablet, 5 mg/mL oral suspension · Zambon UK Limited (Rilutek); Martindale Pharma (Teglutik); generic manufacturers

Canada

  • RILUTEK

Australia

  • Rilutek; Teglutik (oral liquid suspension); Rilukem and Pharmacor Riluzole (generic tablets) (6)TGA ARTG registered · 50 mg tablet, 50 mg/10 mL oral suspension · Sanofi-Aventis Australia Pty Ltd (Rilutek); Asteri Pharma Pty Ltd (Teglutik); Pharmacor Pty Ltd (Rilukem/Pharmacor Riluzole)

New Zealand

  • Rilutek (7)Medsafe data sheet confirmed restricted prescribing · 50 mg tablet · not independently confirmed beyond data-sheet existence in this pass
View brands in additional countries.

European Union

Rilutek; Riluzole Zentiva (generic) (4)