Prescription medicine
Riluzole Brand names: Tiglutik; first approved as Rilutek
Riluzole (Rilutek) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $0.293 per riluzole 50 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
Check it at the source: the riluzole FDA label on DailyMed (effective July 10, 2020, Glenmark Pharmaceuticals Inc., USA); the NDA 20599 record on Drugs@FDA; every riluzole label on DailyMed.
Highlights of the record
FDA label of July 10, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageRiluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Forms and strengths
- 50 mg
- 50 mg/10ml
Film-coated tablet; suspension; tablet; liquid.
On the market
- Earliest approval on file
- December 12, 1995 Rilutek, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first January 29, 2003; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 5 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- March 12, 2029 Tiglutik Kit oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.293 per tablet Riluzole 50 mg tablet
- Shortage (FDA)
- 1 of 4 presentations limited or unavailable updated October 1, 2026
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest October 20, 2023; 2 more by firms not listed as its makers
- FAERS reports
- 2,164 through July 30, 2026
What is riluzole used for?
From the label: indications and usageRiluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (ALS)
FDA pharmacologic class: Benzothiazole.
Source: FDA drug label (riluzole), Glenmark Pharmaceuticals Inc., USA, effective July 10, 2020 (SPL set f1ce57e8-d3fe-422c-8724-3101c258898a), via openFDA; the full label on DailyMed
Is there a generic for riluzole (Rilutek)?
The FDA approved the first generic riluzole on January 29, 2003. 9 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists riluzole from 5 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Rilutek tablets; a patent listed only for Tiglutik Kit oral suspension runs to March 12, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1995 earliest approval on file
- 2003 first generic approved
- 2029 last listed patent
- 2024 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for riluzole (Rilutek)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.293 per Riluzole 50 mg tablet, down 6% from $0.310 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Riluzole 50 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Riluzole 50 mg tablet | Generic | $0.293 per tablet | $8.80 | -6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is riluzole in shortage?
The FDA Drug Shortage Database lists 1 of 4 riluzole presentations as limited or unavailable (updated October 1, 2026); the first entry was posted on January 26, 2024. 3 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0304-1) | EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.) | Current | October 1, 2026 |
| Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0305-1) | EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.) | Current | October 1, 2026 |
| Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0306-1) | EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.) | Current | October 1, 2026 |
| Tiglutik, Oral Suspension, 50 mg/10 mL (NDC 70726-0303-1) | EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.) | Current | October 1, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has riluzole been recalled?
The FDA's Enforcement Report lists 3 recalls naming riluzole since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of riluzole and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 20, 2023 | Class II | ITF PHARMA INC | Failed Viscosity Specifications: Out-of-specification test results for viscosity |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; RILUZOLE Tablet, 50 mg may be potentially mislabeled as traZODone HCl, Tablet, 150 mg, NDC 50111044101, Pedigree: W003245, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: RILUZOLE, Tablet, 50 mg may have potentially been mislabeled as the following drug: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the riluzole label say about other medicines?
The riluzole label names 9 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Allopurinol | drug interactions | Clinical trials in ALS patients excluded patients on concomitant medications which were potentially hepatotoxic (e.g., allopurinol, methyldopa, sulfasalazine). |
| Ciprofloxacin | drug interactions | The concomitant use of strong or moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton) with riluzole may increase the risk of riluzole-associated adverse reactions [see Clinical Pharmacology ( 12.3 )]. |
| Fluvoxamine | drug interactions | The concomitant use of strong or moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton) with riluzole may increase the risk of riluzole-associated adverse reactions [see Clinical Pharmacology ( 12.3 )]. |
| Methoxsalen | drug interactions | The concomitant use of strong or moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton) with riluzole may increase the risk of riluzole-associated adverse reactions [see Clinical Pharmacology ( 12.3 )]. |
| Methyldopa | drug interactions | Clinical trials in ALS patients excluded patients on concomitant medications which were potentially hepatotoxic (e.g., allopurinol, methyldopa, sulfasalazine). |
| Mexiletine | drug interactions | The concomitant use of strong or moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton) with riluzole may increase the risk of riluzole-associated adverse reactions [see Clinical Pharmacology ( 12.3 )]. |
| Sulfasalazine | drug interactions | Clinical trials in ALS patients excluded patients on concomitant medications which were potentially hepatotoxic (e.g., allopurinol, methyldopa, sulfasalazine). |
| Vemurafenib | drug interactions | The concomitant use of strong or moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton) with riluzole may increase the risk of riluzole-associated adverse reactions [see Clinical Pharmacology ( 12.3 )]. |
| Zileuton | drug interactions | The concomitant use of strong or moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton) with riluzole may increase the risk of riluzole-associated adverse reactions [see Clinical Pharmacology ( 12.3 )]. |
Source: FDA drug label (riluzole), Glenmark Pharmaceuticals Inc., USA, effective July 10, 2020 (SPL set f1ce57e8-d3fe-422c-8724-3101c258898a), via openFDA; the full label on DailyMed
What do FAERS reports show for riluzole?
The FDA Adverse Event Reporting System holds 2,164 reports that list riluzole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 500 are coded as a death and 517 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Riluzole side effects
- the label's list beside FAERS reports
- Riluzole shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other