Edaravone: uses, dosing, side effects & brands
Edaravone is a medicine sold in the U.S. under 2 brand and generic names, for amyotrophic lateral sclerosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats (across its forms)
- Amyotrophic Lateral Sclerosis
- Available as
- Solution · Kit
- Sold as
- 2 products — Radicava and Radicava Ors
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How Radicava Ors is dosed
From the FDA label for Radicava Ors (application NDA215446). Other edaravone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
RADICAVA: The recommended dosage is 60 mg administered as an intravenous infusion over 60 minutes ( 2.1 ) 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 ( 2.1 , 2.3 ) For RADICAVA and RADICAVA ORS: Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period ( 2.1 ) Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods ( 2.1 ) 2.1 Dosage Information The recommended dosage of RADICAVA and RADICAVA ORS is as follows: RADICAVA: an intravenous infusion of 60 mg administered over a 60-minute period RADICAVA ORS: 105 mg (5 mL) taken orally or via feeding tube in the morning after overnight fasting [see Dosage and Administration (2.3) ] Administer RADICAVA or RADICAVA ORS according to the following schedule: An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug-free period Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods 2.2 Preparation and Administration Information for RADICAVA Injection RADICAVA is for intravenous infusion only. Preparation Do not use if the oxygen indicator has turned blue or purple before opening the package . Once the overwrap…
Everything below is the FDA label for Radicava Ors (kit). Edaravone is also sold as solution, and those are different medicines to take — follow the label for the one you were prescribed.
Radicava Ors side effects
The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Sulfite Allergic Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (at least 10% of patients treated with RADICAVA and greater than placebo) are contusion, gait disturbance, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In randomized, placebo-controlled trials, 184 patients with ALS were administered RADICAVA 60 mg in treatment cycles for 6 months. The population consisted of Japanese patients who had a median age of 60 years (range 29-75) and were 59% male. Most (93%) of these patients were living independently at the time of screening. Most Common Adverse Reactions Observed During Clinical Studies Table 2 lists the adverse reactions that occurred in ≥2% of patients in the RADICAVA-treated group and that occurred at least 2% more frequently than in the placebo-treated group in randomized placebo-controlled ALS…
Who shouldn’t take Radicava Ors
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 [see Warnings and Precautions (5.1 , 5.2) ]. Patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in RADICAVA and/or RADICAVA ORS ( 4 )
Every edaravone product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Solution | No data | — | View → | |
| 2 | 70/100 | Prescription | Kit | No data | — | View → |
What people report to the FDA about edaravone
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,003 reports naming edaravone, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- cerebral infarction105 reports
- amyotrophic lateral sclerosis66 reports
- pneumonia40 reports
- haemorrhagic cerebral infarction33 reports
- hepatic function abnormal32 reports
- pyrexia32 reports
- pneumonia aspiration31 reports
- cerebral haemorrhage28 reports
Read these as a signal, not a rate. A report does not mean edaravone caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is Radicava Ors?
Radicava Ors (Edaravone) is a medication used to treat Amyotrophic Lateral Sclerosis.
Can you take edaravone with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run edaravone against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is edaravone sold under?
We track 2 edaravone-containing products in the U.S.: Radicava and Radicava Ors. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does edaravone come in?
Across the brands we track, edaravone is currently marketed as solution and kit, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic edaravone?
We do not currently list a generic-labelled edaravone product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Edaravone: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/edaravone
- MLA
- “Edaravone: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/edaravone.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for edaravone on DailyMed (NIH) ↗.