Uses
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Source: US FDA prescribing information
- Presentations
- 3
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Edaravone is a prescription medicine indicated for the treatment of amyotrophic lateral sclerosis (ALS). It is available as injection and kits for intravenous use. MedsAcross supplies Edaravone 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
- ATC classification
- N07XX14 Edaravone · Other nervous system medicines, subgroup N07X, subgroup N07XX
- US FDA first approval
- 5 May 2017
- EU status
- Application withdrawn
- Orphan designation
- Yes
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Intravenous
- Dosage forms
- Injection, Kit
- Identifiers
- UNII S798V6YJRPRxCUI 1921877CAS 89-25-8DrugBank DB12243Q335099
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
The mechanism by which RADICAVA and RADICAVA ORS exert their therapeutic effect in patients with ALS is unknown.
Source: US FDA prescribing information
Dosing overview
RADICAVA: The recommended dosage is 60 mg administered as an intravenous infusion over 60 minutes. RADICAVA ORS: The recommended dosage is 105 mg (5 mL) taken orally or via feeding tube in the morning after overnight fasting. Food should not be consumed for 1 hour after administration except water. For RADICAVA and RADICAVA ORS: Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period. Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods
Source: US FDA prescribing information
Contraindications
RADICAVA and RADICAVA ORS are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in this product. Hypersensitivity reactions and anaphylactic reactions have occurred. Patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in RADICAVA and/or RADICAVA ORS
Source: US FDA prescribing information
Warnings and precautions
Hypersensitivity Reactions: Advise patients to seek immediate medical care. Sulfite Allergic Reactions: RADICAVA and RADICAVA ORS contain sodium bisulfite, which may cause allergic type reactions, including anaphylactic symptoms and asthmatic episodes in susceptible people
Source: US FDA prescribing information
Side effects
The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Sulfite Allergic Reactions Most common adverse reactions (at least 10% of patients treated with RADICAVA and greater than placebo) are contusion, gait disturbance, and headache
Source: US FDA prescribing information
Storage
Store RADICAVA at up to 25°C (77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F). RADICAVA ORS Pharmacy Store RADICAVA ORS refrigerated between 2°C to 8°C (36°F to 46°F) and protect from light. Do not freeze. Patient Store RADICAVA ORS upright at room temperature between 20°C to 25°C (68°F to 77°F). Protect from light. Store in overwrapped package to protect from oxygen degradation until time of use. Store upright. Protect from light.
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 Edaravone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Edaravone 30 mg/100 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Radicava Ors kit Cold chain | Shionogi | US FDA | Available on request |
| Edaravone 60 mg/100 mL injectionIntravenousGeneric name | — | 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 Edaravone in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Edaravone available for export from India?
Yes, on request. MedsAcross lists 3 presentations of Edaravone and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Edaravone have?
The catalogue lists 1 brand names for Edaravone, including Radicava Ors.
Is Edaravone approved by the US FDA?
Yes. The US FDA first approved Edaravone on 5 May 2017, according to Drugs@FDA.
Does Edaravone need cold chain shipping?
At least one listed presentation of Edaravone must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Which ATC class is Edaravone in?
Edaravone is classified under ATC code N07XX14 (Edaravone).
References
- RADICAVA ORS prescribing information (Shionogi). U.S. National Library of Medicine, DailyMed. Retrieved 5 May 2026
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