Uses
TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Source: US FDA prescribing information
- Presentations
- 3
- Brands
- 1
- Manufacturers
- 2
- Available from stock
- 0
Riluzole is a benzothiazole indicated for the treatment of amyotrophic lateral sclerosis (ALS). It is available as tablets, oral liquid and oral suspension. MedsAcross supplies Riluzole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Benzothiazole
- ATC classification
- N07XX02 Riluzole · Other nervous system medicines, subgroup N07X, subgroup N07XX
- US FDA first approval
- 12 December 1995
- EU status
- Authorised
- Orphan designation
- Yes
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Tablet, Oral liquid, Oral suspension
- Identifiers
- UNII 7LJ087RS6FRxCUI 35623CAS 1744-22-5DrugBank DB00740Q415744
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
The mechanism by which riluzole exerts its therapeutic effects in patients with ALS is unknown.
Source: US FDA prescribing information
Dosing overview
Recommended dosage: 50 mg (10 mL), twice daily, taken orally or via percutaneous endoscopic gastrostomy tubes (PEG-tubes), every 12 hours. Measure serum aminotransferases before and during treatment. Take at least 1 hour before or 2 hours after a meal
Source: US FDA prescribing information
Contraindications
TIGLUTIK is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred). Patients with a history of severe hypersensitivity reactions to riluzole or to any of its components
Source: US FDA prescribing information
Warnings and precautions
Hepatic injury: Use of TIGLUTIK is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times the upper limit of normal, discontinue TIGLUTIK if there is evidence of liver dysfunction. Neutropenia: Advise patients to report any febrile illness. Interstitial lung disease: Discontinue TIGLUTIK if interstitial lung disease develops. Pancreatitis: There have been postmarketing reports of acute pancreatitis.If pancreatitis is suspected, promptly discontinue TIGLUTIK
Source: US FDA prescribing information
Side effects
The following adverse reactions are described below and elsewhere in the labeling: Hepatic Injury Neutropenia Interstitial Lung Disease Pancreatitis Most common adverse reactions (incidence greater than or equal to 5% and greater than placebo) were oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain
Source: US FDA prescribing information
Interactions
Strong to moderate CYP1A2 inhibitors: Co-administration may increase TIGLUTIK-associated adverse reactions. Strong to moderate CYP1A2 inducers: Co-administration may result in decreased efficacy. Hepatotoxic drugs: TIGLUTIK-treated patients that take other hepatotoxic drugs may be at increased risk for hepatotoxicity
Source: US FDA prescribing information
Storage
Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F), and protect from bright light. Do not freeze. Store upright.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
3 presentations of Riluzole, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Riluzole 50 mg tabletOralGeneric name | — | US FDA | Available on request |
| Tiglutik 50 mg/10 mL oral liquidOral | Edw Pharma | US FDA | Available on request |
| Tiglutik 50 mg/10 mL oral suspensionOral | Italfarmaco | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions
Conditions linked to Riluzole in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Riluzole available for export from India?
Yes, on request. MedsAcross lists 3 presentations of Riluzole and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Riluzole have?
The catalogue lists 1 brand names for Riluzole, including Tiglutik.
Is Riluzole approved by the US FDA?
Yes. The US FDA first approved Riluzole on 12 December 1995, according to Drugs@FDA.
Is Riluzole authorised in the European Union?
Yes. Riluzole has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Riluzole need cold chain shipping?
No listed presentation of Riluzole is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Riluzole in?
Riluzole is classified under ATC code N07XX02 (Riluzole).
References
- TIGLUTIK prescribing information (Edw Pharma). U.S. National Library of Medicine, DailyMed. Retrieved 27 July 2026
- Rilutek: European public assessment report (EPAR). European Medicines Agency. Retrieved 21 August 2024
- Riluzole Zentiva: European public assessment report (EPAR). European Medicines Agency. Retrieved 15 May 2025
Request Riluzole for export supply
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