Edaravone Injection
Edaravone is an intravenous medication used to treat amyotrophic lateral sclerosis (ALS).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 5 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Edaravone (Radicava) is an IV (into-the-vein) drug for ALS (amyotrophic lateral sclerosis), thought to protect nerve cells as an antioxidant; it is one of a handful of ALS treatments, often added to riluzole, on the market since about 2017 and available as a generic. Most people tolerate it well, noticing mainly bruising, headache or unsteadiness walking. The one thing to watch for is a serious allergic reaction, including anaphylaxis, so get emergency help for hives, trouble breathing or a sudden drop in blood pressure. Infusions come in cycles, daily for a set stretch then a drug-free rest, and the aim is slowing ALS, not reversing it.
Clinical pearls
- Radicava contains sodium bisulfite, a sulfite preservative, so tell the infusion team about any sulfite allergy, especially if you have asthma.
- A spreading rash, redness or welts after an infusion can signal an allergic-type reaction, so call your prescriber.
- Radicava ORS, an oral suspension, treats ALS without a needle, an option for people who find repeated IV infusions hard.
- Animal studies suggest edaravone may harm a developing baby, and breast milk data are lacking, so raise pregnancy plans before starting.
Patient information guide A plain-language walkthrough of Edaravone Injection, written from its FDA label.
What Edaravone Injection is used for
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Edaravone injection is used to treat a specific neurological disease. Here is the full list of supported uses:
- Radicava (edaravone injection, intravenous): Treatment of amyotrophic lateral sclerosis (ALS) — a progressive disease that damages the nerve cells responsible for controlling muscle movement
How Edaravone Injection works
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The exact way Radicava works in people with ALS is not currently known. Edaravone is broken down in the body into inactive byproducts and cleared mostly through the urine. It does not accumulate in the bloodstream with repeated dosing, and at doses well above those used clinically, it does not cause significant changes to heart rhythm.
Edaravone Injection dosage
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Radicava is given as an intravenous (IV) infusion — a healthcare professional administers it directly into a vein over about 60 minutes. It follows a specific cycle schedule:
- First cycle: Daily infusions for 14 days, followed by a 14-day drug-free rest period
- All later cycles: Daily infusions for 10 days out of every 14-day period, followed by a 14-day rest period
Do not adjust your schedule without talking to your prescriber. If you miss a dose, contact your care team for guidance.
Dosing details from the FDA-approved label
From the Edaravone Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- RADICAVA (edaravone injection) - intravenous
- 60 mg administered as an intravenous infusion over 60 minutes (as two consecutive 30 mg infusion bags over a total of 60 minutes, approximately 1 mg per minute [3.33 mL per minute])
- 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 b
- RADICAVA ORS (oral suspension) - oral or via feeding tube
- 105 mg (5 mL) taken orally or via feeding tube in the morning after overnight fasting
- 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
- Food should not be consumed for 1 hour after administration except water; fasting before dose: 8 hours after high-fat meal, 4 hours after low-fat meal, 2 hours after caloric supplement
- Switching from RADICAVA to RADICAVA ORS
- Patients treated with 60 mg of RADICAVA intravenous infusion may be switched to 105 mg (5 mL) RADICAVA ORS using the same dosing frequency
- Follow RADICAVA ORS food consumption recommendations
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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 package is opened, use within 24 hours [see How Supplied/Storage and Handling (16.1 , 16.2) ]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Administration Administer each 60 mg dose of RADICAVA injection as two consecutive 30 mg intravenous infusion bags over a total of 60 minutes (infusion rate approximately 1 mg per minute [3.33 mL per minute]). Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction [see Warnings and Precautions (5.1 , 5.2) ] . Other medications should not be injected into the infusion bag or mixed with RADICAVA. 2.3 Preparation and Administration Information for RADICAVA ORS Oral Suspension See the Instruction for Use for further preparation and administration details.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Edaravone Injection side effects
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The most common side effects seen in clinical trials with Radicava include:
Common side effects
- Bruising (contusion)
- Difficulty walking (gait disturbance)
- Headache
- Skin rash or dermatitis
- Eczema
- Breathing problems or low oxygen levels
- Sugar in the urine (glycosuria)
- Fungal skin infection (tinea)
When to get medical help
- Get emergency help right away if you have hives, trouble breathing, low blood pressure, or any sign of a severe allergic reaction (anaphylaxis)
- Call your doctor if you notice redness, welts, or a spreading skin rash — these can be signs of a hypersensitivity reaction
- If you have asthma or are sensitive to sulfites, tell your doctor before starting — Radicava contains sodium bisulfite, which can trigger serious breathing reactions in some people
Edaravone Injection warnings and precautions
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- Serious allergic reactions (hypersensitivity and anaphylaxis): Reactions including skin redness, welts, a widespread rash (erythema multiforme), hives, trouble breathing, and dangerous drops in blood pressure have been reported. Stop the infusion immediately and get emergency help if any of these develop.
- Sulfite sensitivity: Radicava contains sodium bisulfite. This ingredient can cause allergic-type reactions — including severe, potentially life-threatening breathing episodes — especially in people with asthma or known sulfite sensitivity. Tell your doctor if this applies to you before your first dose.
Edaravone Injection interactions
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The FDA label for Radicava does not identify specific drug-drug or drug-food interactions to be aware of. Always tell your doctor and pharmacist about every medication, supplement, and herbal product you take.
- Do not add other medications to the Radicava IV infusion bag — mixing can cause compatibility problems
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Edaravone Injection
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- Known allergy to edaravone or any Radicava ingredient: Do not use — this is a contraindication
- Asthma or sulfite sensitivity: Use with caution; Radicava contains sodium bisulfite, which can trigger serious reactions
- Pregnancy: Animal studies showed harm to developing offspring; there are no adequate human studies — discuss risks and benefits with your doctor
- Breastfeeding: No human data available on whether edaravone passes into breast milk; weigh the benefits of breastfeeding against potential risk with your doctor
- Children: Safety and effectiveness in pediatric patients have not been established
- Older adults (65+): No meaningful difference in safety or effectiveness was seen in clinical trials, though individual sensitivity cannot be ruled out
- Mild to moderate kidney impairment: Small increases in drug exposure were seen but are not considered clinically significant; no dose adjustment is needed — however, the effect of severe kidney impairment has not been studied
What Edaravone Injection does in the body
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At doses at least five times higher than the recommended clinical dose, edaravone does not cause a meaningful change in the QT interval — the part of the heart's electrical cycle linked to dangerous rhythm problems. This means Radicava is not expected to cause heart rhythm issues at standard treatment doses.
How your body processes Edaravone Injection
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When Radicava is given by IV infusion, peak drug levels in the blood are reached by the end of the infusion. Edaravone is about 92% bound to proteins in the blood, mainly albumin. It is broken down in the liver into inactive byproducts (a sulfate and a glucuronide form) and cleared mainly through the urine — roughly 60–80% of the dose is excreted as the glucuronide within 48 hours. The drug's half-life (the time for the body to clear half the dose) is approximately 4.5 to 9 hours. Edaravone does not build up in the bloodstream with repeated dosing.
How to store Edaravone Injection
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Store RADICAVA at up to 25°C (77°F). Protect from light. Store in overwrapped package to protect from oxygen degradation until time of use.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Edaravone Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Edaravone Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Radicava actually used for?
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How is this medication given — do I take it at home?
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What side effects should I watch out for?
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I have asthma — is it safe for me to take this?
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Is it safe to use during pregnancy or while breastfeeding?
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How will I know if the medication is working?
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Is Edaravone Injection available over the counter?
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When was Edaravone Injection first available?
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Who makes Edaravone Injection?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Edaravone Injection on HelloPharmacist
Edaravone Injection forms and strengths (how it comes)
Edaravone Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Radicava is used to treat amyotrophic lateral sclerosis (ALS)
- Radicava is given as an intravenous (IV) infusion over 60 minutes, administered by a healthcare provider
- Radicava is given on a cycle: daily for 14 days, then a 14-day break for the first cycle; subsequent cycles are daily for 10 out of 14 days, then a 14-day break
- Radicava should not be mixed with other medications in the infusion bag
- Radicava infusion should be stopped immediately if any signs of an allergic reaction appear
Edaravone Injection on the U.S. market: products, makers and brands
How Edaravone Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
4 companies list 5 Edaravone Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2017. Brand names on the directory include Radicava, Radicava Ors; the rest are generics.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Edaravone Injection is used (Medicaid data)
A general measure of how commonly Edaravone Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q3–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Edaravone Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Edaravone Injection prescribed? Of the 1,601 medications we measure, Edaravone Injection ranks #1,540 by Medicaid prescriptions — more than 4% of them.
Utilization by Edaravone Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
100 ML edaravone 0.3 MG/ML Injection
Summed across the 2 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1924316
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Edaravone Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 12 listed Edaravone Injection NDCs with Medicaid activity.
Compare Edaravone Injection products
A representative set of FDA-listed product records for Edaravone Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 30 mg/100 mL | Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 60 mg/100 mL | Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 30 mg/100 mL | Intravenous | Piramal Critical Care Inc. | ANDA | View NDC → |
| 30 mg/100 mL | Intravenous | Sandoz Inc | ANDA | View NDC → |
| 60 mg/100 mL | Intravenous | XGen Pharmaceuticals DJB, Inc. | ANDA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Edaravone Injection NDCs →
Edaravone Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Edaravone Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Edaravone Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Edaravone Injection FDA approval history
How Edaravone Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Edaravone Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Edaravone recalls since July 2021.
✅No Edaravone recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1921877 2 dose forms · 3 strengths
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Dose form (SCDF) Injection RxCUI 1921880In current FDA listingsClinical drug / strength (SCD) 100 ML edaravone 0.3 MG/MLRxCUI 1924316100 ML edaravone 0.6 MG/MLRxCUI 2681044 -
Dose form (SCDF) Oral Suspension RxCUI 2602116No current FDA listingClinical drug / strength (SCD) 21 MG/MLRxCUI 2602117
Look up RxCUI 1921877 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Edaravone Injection supply and shortage status
Whether Edaravone Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Edaravone Injection brand names
Edaravone Injection is sold under 2 brand names in the FDA directory — Radicava, Radicava Ors. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Edaravone Injection: manufacturers and labelers
4 companies list Edaravone Injection products with the FDA. By number of product records, the largest are Gland Pharma Limited, Piramal Critical Care Inc., Sandoz Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Edaravone Injection drug class (RxNorm)
Edaravone Injection belongs to the Other nervous system drugs class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Edaravone Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Mitsubishi Tanabe Pharma America, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →