Riluzole
Other Nervous System Drugs
Sold as Teglutik · RILUTEK
- Drug class
- Other Nervous System Drugs
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 20
- FDA reports (12 mo)
- 159
Overview
Riluzole is an active pharmaceutical ingredient in the Other Nervous System Drugs group (N07XX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 13 | May 15, 2026 |
| CA Canada | Health Canada | 3 | March 22, 2025 |
| EU European Union | EMA | 2 | May 15, 2025 |
| US United States | FDA | 2 | December 31, 2025 |
GBUnited Kingdom· MHRA
13 products
Uses
1). Emylif has not been shown to be effective in the late stages of ALS.
How to take
CACanada· Health Canada
3 products
Uses
AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 5 WARNINGS AND PRECAUTIONS .........................................................................................
5 ADVERSE REACTIONS........................................................................................................... 9 DRUG INTERACTIONS .........................................................................................................
17 DOSAGE AND ADMINISTRATION ..................................................................................... 18 OVERDOSAGE .......................................................................................................................
19 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 20 STORAGE AND STABILITY ................................................................................................. 22 DOSAGE FORMS, COMPOSITION AND PACKAGING .....................................................
EUEuropean Union· EMA
2 products
Uses
Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). 1). Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.
There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS.
Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor neurone disease.
How to take
USUnited States· FDA
2 products
2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [4].
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 159 reports total. [5]
- Death 20
- Abdominal Discomfort 9
- Fatigue 9
- Muscular Weakness 9
- Amyotrophic Lateral Sclerosis 8
- Weight Decreased 8
- Dyspnoea 7
- Abdominal Pain Upper 6
- Disease Progression 6
- Dizziness 6
- Gait Disturbance
Drug interactions
Known interactions involving Riluzole. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL316540013 · revised May 15, 2026
- [2]Health Canada (DPD) · 02242763 · revised March 22, 2025
- [3]European Medicines Agency · EMEA/H/C/002622 · revised May 15, 2025
- [4]FDA DailyMed · 0f2b5cfc-a23d-69… · revised December 31, 2025 [PDF]
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.