RADICAVA ORS® recognized as a MAJOR CONTRIBUTION TO PATIENT CARE by the FDA.1 Request a rep visit.
In addition to the Q&A content below, review the RADICAVA ORS® Frequently Asked Questions brochure for HCPs.DOWNLOAD 
 | RADICAVA ORS® (edaravone) is recognized by the FDA as a major contribution to patient care1 |
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Q: What is RADICAVA ORS®?
RADICAVA ORS® is an FDA-approved prescription medicine indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Learn more about RADICAVA ORS®.
Q: What is the mechanism of action?
The exact mechanism of action of edaravone to treat ALS is unknown. It is believed, based on preclinical studies, to reduce oxidative stress.2,3
Q: Can patients take RADICAVA ORS® if they are pregnant or breastfeeding?
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with RADICAVA ORS®, or if they intend to breastfeed or are breastfeeding.2
There are no adequate data on the developmental risk associated with the use of RADICAVA ORS® in pregnant women. Based on animal data, RADICAVA ORS® may cause fetal harm2
There are no data on the presence of edaravone in human milk, the effects on the breastfed infant, or the effects of the drug on milk production2
Q: Does RADICAVA ORS® have any drug interactions?
There are no known Drug-Drug Interactions (DDIs) associated with RADICAVA ORS®.2
The pharmacokinetics of edaravone are not expected to be significantly affected by inhibitors of cytochrome P450 (CYP) enzymes, UGTs, or major transporters2
Q: Does RADICAVA ORS® have any contraindications?
RADICAVA ORS® is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions and anaphylactic reactions have occurred.2
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA ORS®, treat per standard of care, and monitor until the condition resolves.2
Q: Can RADICAVA ORS® be taken with riluzole?
Consider RADICAVA ORS® in addition to riluzole upon diagnosis.4,6
Q: What are the ingredients in RADICAVA ORS®?
The active ingredient in RADICAVA ORS® is edaravone.2
Inactive ingredients include L-cysteine hydrochloride hydrate, polyvinyl alcohol, simethicone emulsion, sodium bisulfite, sorbitol, and xanthan gum. Phosphoric acid and sodium hydroxide are added to adjust to pH 4.2
Q: How is RADICAVA ORS® stored?
Patients should store RADICAVA ORS® upright at room temperature between 20°C to 25°C (68°F to 77°F). Protect from light. Discard 15 days after opening the bottle or, if unopened, 30 days from date of shipment indicated on the carton pharmacy label.2
Pharmacies should store RADICAVA ORS® refrigerated between 2°C to 8°C (36°F to 46°F) and protect from light. Do not freeze. Store upright.2
Q: How is RADICAVA ORS® supplied?
RADICAVA ORS® is supplied in a white-to-off-white oral suspension in a multidose, child-resistant 60 mL amber glass bottle. It is supplied as 2 configurations2:
RADICAVA ORS® Maintenance Kit (10-day treatment cycle) includes 1 bottle of 1050 mg/50 mL (105 mg/5 mL dose) with 2 oral dosing syringes and 1 bottle adapter
Q: What can my patients expect with their RADICAVA ORS® shipments?
Q: How can I determine if RADICAVA ORS® is covered by insurance?
RADICAVA ORS® has formulary coverage among major health insurance carriers including ESI, CVS, Express Scripts, Optum, Prime Therapeutics, and Veterans Affairs (VA).
Once you have prescribed RADICAVA ORS® and submitted a BIF to check how your patient’s health insurance covers RADICAVA ORS®, an Insurance & Access Specialist will reach out to the patient to help them understand the insurance process.
An Insurance & Access Specialist will:
Q: Is RADICAVA ORS® covered by insurance?
RADICAVA ORS® has formulary access with 85% of all payers (including the Veterans Affairs National Formulary) and is covered by 96% of all commercial plans.5,7,a (see footnote)
A JourneyMate Support Program™ Insurance and Access Specialist can help you and your patients navigate insurance questions. To learn more, call 1-844-772-4548.
Learn more about the Out-of-Pocket Assistance Program.
This information is provided for educational purposes only. Mitsubishi Tanabe Pharma America does not guarantee coverage or reimbursement. Formulary status subject to change.
Q: Is there patient support available?
The JourneyMate Support Program™ helps to give patients and their care partners understanding, answers, and resources to supplement what their doctor provides. Experienced program team members are trained to address their educational needs and provide them with personalized answers and resources for living with ALS.
Learn more about the JourneyMate Support Program™.
The JourneyMate Support Program™ offers educational support and resources for patients who are considering or have already been prescribed a Mitsubishi Tanabe America, Inc. (MTPA) product. An ALS Clinical Educator is an educational resource for patients who have been prescribed an MTPA product. An ALS Clinical Educator is provided by MTPA and Momentum Life Sciences and is not affiliated with or provided by a doctor. An ALS Clinical Educator does not provide medical advice. The program does not provide medical advice and does not take the place of a patient's doctor. All questions about a condition, diagnosis, or treatment should be referred to the patient’s doctor. If a patient has a medical emergency, they should call 911. Adverse events or product complaints should be reported by calling 1-888-292-0058.
Q: What clinical and real-world experience supports oral RADICAVA ORS® treatment?
RADICAVA ORS® is equivalent to the IV formulation of edaravone, which was FDA-approved in 2017.2,8 RADICAVA® (edaravone) has been evaluated in over two decades of clinical research, including four phase 3 trials.9-12
As of May 2025, RADICAVA has been prescribed by 2600+ physicians, and 19,300+ people have been treated with RADICAVA for 2.5 million+ days of therapy.5,d,e
In 2024, RADICAVA ORS® was recognized by the FDA as a major contribution to patient care due to its oral route of administration, offering a less burdensome option versus intravenous administration.1 It is currently the ONLY FDA-approved oral form of edaravone. Learn more about the clinical history of RADICAVA ORS®.
dBased on RADICAVA ORS® and RADICAVA® prescriptions submitted in the US as of May 2025. Not independently verified.
eDays of therapy based on number of RADICAVA ORS® and RADICAVA® cartons sold as of May 2025. Each carton of RADICAVA® includes 1 day of therapy. For RADICAVA ORS®, each Starter Kit includes 14 days of therapy, and each Maintenance Kit includes 10 days of therapy.
Have more questions or want to learn more?
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Q: How was the efficacy of RADICAVA ORS® determined?
The efficacy of RADICAVA ORS® was based on the pivotal clinical trial for RADICAVA® and the phase 1 pharmacokinetic study for RADICAVA ORS®.2
For additional study information, please see the full Prescribing Information for RADICAVA ORS®.
Q: What studies were evaluated in the approval of RADICAVA ORS®?
Seven clinical studies specific to RADICAVA ORS® were conducted, in addition to the original set of clinical studies for RADICAVA®.2,3,10,12-17
RADICAVA ORS® is also supported by data from a pivotal clinical trial for RADICAVA®.2,4
Q: Is RADICAVA ORS® similar to RADICAVA® in efficacy?
Yes. RADICAVA ORS® offers the same efficacy as RADICAVA® and contains the same active ingredient, edaravone. Results from a phase 1 pharmacokinetic study in healthy subjects showed equivalent plasma levels with RADICAVA ORS® and RADICAVA®.2,3
In a pivotal, randomized, placebo-controlled clinical trial, RADICAVA® demonstrated 33% less change in physical function in daily activities on the ALSFRS-R at 24 weeks from baseline vs placebo. This means patients who received RADICAVA® showed an average loss of 2.49 fewer points on the ALSFRS-R vs those in the placebo arm.2,4
Q: What is the safety profile of RADICAVA ORS® and is it similar to RADICAVA®?
The safety profile of RADICAVA ORS® was demonstrated in a 6-month, phase 3, open-label clinical trial in 185 patients with ALS, and it offers a similar safety profile as the IV formulation.2,18
In a clinical trial for RADICAVA®, the most common adverse reactions (≥10%) were contusion, gait disturbance, and headache. Fatigue was observed in 7.6% of patients in a clinical trial for RADICAVA ORS®.2
RADICAVA® and RADICAVA ORS® have the same Contraindications and Warnings and Precautions.2
Q: What was the discontinuation rate in the safety study of RADICAVA ORS®?
There was a low rate of discontinuations due to adverse events.5
Have more questions or want to learn more?
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Q: What is the dosing schedule for RADICAVA ORS®?
For the initial treatment cycle, RADICAVA ORS® is taken daily for 14 consecutive days followed by 14 consecutive drug-free days.2
For subsequent treatment cycles, RADICAVA ORS® is taken for 10 out of 14 treatment days followed by 14 consecutive drug-free days.2
Q: How is RADICAVA ORS® (edaravone) administered?
RADICAVA ORS® was designed with ALS patients in mind2:
These are not the full instructions for administration. See Section 2.3 “Preparation and Administration Information for RADICAVA ORS® Oral Suspension” of the Prescribing Information to learn more.
Q: Are there fasting requirements with RADICAVA ORS®?
RADICAVA ORS® should be taken on an empty stomach in the morning after overnight fasting. Patients should not consume any food or drink (except water) for 1 hour after administration.2 Food can affect the absorption of the medication. Patients should wait 8 hours after having high-fat meals (800-1000 calories, 50% fat), or 4 hours after low-fat meals (400-500 calories, 25% fat), or 2 hours after a caloric supplement (250 calories, eg, protein drink).2
Q: What does RADICAVA ORS® taste like??
RADICAVA ORS® has no flavoring added, but it does contain sorbitol, an ingredient with a mildly sweet taste.2,19
Have more questions or want to learn more?
Request a visit by a representative
Q: What is RADICAVA®?
RADICAVA® (edaravone) is a prescription intravenous injection that is FDA approved to treat ALS.2
Q: Are there other forms of intravenous edaravone available?
Intravenous edaravone is available as a generic treatment option from other companies.
Q: Why is MTPA discontinuing RADICAVA®?
RADICAVA® is not being discontinued for reasons of safety or effectiveness. MTPA remains deeply committed to helping support patients with ALS and their families. The approved oral suspension treatment option for ALS, RADICAVA ORS®, remains available.
Q: When will the discontinuation go into effect?
As of April 1, 2025, RADICAVA® will be discontinued. Patients currently taking RADICAVA® may continue to take it while inventory remains available through September 2025. Only patients currently on therapy will be able to continue to fill their prescriptions until the supply runs out.
Q: How does the discontinuation of RADICAVA® affect MTPA’s commitment to the ALS community?
MTPA remains deeply committed to helping support patients with ALS and their families. Our approved oral suspension treatment option for ALS, RADICAVA ORS®, remains available.
Q: With the discontinuation of RADICAVA®, can patients be switched to RADICAVA ORS®?
Yes, if appropriate, patients treated with 60 mg of RADICAVA® may be switched to 105 mg (5 mL) RADICAVA ORS® using the same dosing frequency. Upon switching to RADICAVA ORS®, patients should follow RADICAVA ORS® dosing recommendations with regards to food consumption.2
See Section 2.4 “Switching from RADICAVA to RADICAVA ORS” of the Prescribing Information to learn more.
Q: Does MTPA have a special program for patients to continue RADICAVA® if they want to?
No, MTPA will not offer a special program for patients to continue taking RADICAVA®. As of April 1, 2025, RADICAVA® will be discontinued. Patients currently taking RADICAVA® may continue to take it while inventory remains available through September 2025.
Have more questions or want to learn more?
Request a visit by a representative
ALSFRS-R=Amyotrophic Lateral Sclerosis Functional Rating Scale—Revised; NG=nasogastric; PA=prior authorization; PEG=percutaneous endoscopic gastrostomy; ST=step therapy.
aData on file, Mitsubishi Tanabe Pharma America, as of February, 2025. Return to content
References: 1. US Food and Drug Administration. Clinical superiority findings. Accessed April 11, 2024. https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinicalsuperiority-findings 2. RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022. 3. Shimizu H, Nishimura Y, Shiide Y, et al. Bioequivalence study of oral suspension and intravenous formulation of edaravone in healthy adult subjects. Clin Pharmacol Drug Dev. 2021;10(10):1188-1197. 4. Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Jul;16(7):505-512. 5. Data on file. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc. 6. Leigh PN, Swash M, Iwasaki Y, et al. Amyotrophic lateral sclerosis: a consensus viewpoint on designing and implementing a clinical trial. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004;5(2):84-98. 7. US Department of Veterans Affairs. Pharmacy benefits management services. Search: edaravone. Accessed September 20, 2024. https://www.pbm.va.gov/apps/VANationalFormulary 8. US Food and Drug Administration. FDA approves oral form for the treatment of adults with amyotrophic lateral sclerosis (ALS). Accessed April 11, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-oral-form-treatment-adults-amyotrophic-lateral-sclerosis-als 9. Yoshino H, Kimura A. Investigation of the therapeutic effects of edaravone, a free radical scavenger, on amyotrophic lateral sclerosis (phase II study). Amyotroph Lateral Scler. 2006;7(4):241-245. 10. ClinicalTrials.gov. Safety study of oral edaravone administered in subjects with ALS. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04165824 11. Brooks BR, Heiman-Patterson T, Wiedau-Pazos M, et al. Edaravone efficacy in amyotrophic lateral sclerosis with reduced forced vital capacity: post-hoc analysis of Study 19 (MCI186-19) [clinical trial NCT01492686]. PLoS One. 2022;17(6):e0258614. 12. Takei K, Watanabe K, Yuki S, et al. Edaravone and its clinical development for amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(suppl 1):5-10. 13. Clinicaltrials.gov. Study of oral edaravone in healthy adult males. Accessed January 31, 2022. https://clinicaltrials.gov/ct2/show/NCT04481750 14. Clinicaltrials.gov. Clinical pharmacology study of oral edaravone in patients with amyotrophic lateral sclerosis. Accessed January 31, 2022. https://clinicaltrials.gov/ct2/show/NCT04176224 15. Clinicaltrials.gov. Clinical pharmacology study of oral edaravone in healthy adult males (drug interaction study and preliminary regimen-finding study). Accessed January 31, 2022. https://clinicaltrials.gov/ct2/show/NCT04481789 16. ClinicalTrials.gov. Clinical pharmacology study of oral edaravone in amyotrophic lateral sclerosis patients with gastrostomy. Accessed January 31, 2022. https://clinicaltrials.gov/ct2/show/NCT04254913 17. ClinicalTrials.gov. Comparative bioavailability study of oral edaravone administered orally and via a nasogastric tube. Accessed January 25, 2022. https://clinicaltrials.gov/ct2/show/NCT04776135 18. Genge A, Pattee GL, Sobue G, et al. Oral edaravone demonstrated a favorable safety profile in patients with amyotrophic lateral sclerosis after 48 weeks of treatment. Muscle Nerve. 2023;67(2):124-129. 19. National Center for Biotechnology Information. PubChem compound summary for CID 5780, sorbitol. Accessed January 10, 2025. https://pubchem.ncbi.nlm.nih.gov/compound/Sorbitol#section=Taste
RADICAVA ORS® (edaravone) is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.
RADICAVA ORS contains sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.
The most common adverse reactions (≥10%) reported in RADICAVA® (edaravone)-treated patients and at least 2% more frequently than placebo were contusion (15% vs 9%), gait disturbance (13% vs 9%), and headache (10% vs 6%), respectively. In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.
Based on animal data, RADICAVA ORS may cause fetal harm.
To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
RADICAVA ORS® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information also available www.radicavaors.com.
RADICAVA ORS® (edaravone) is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.
RADICAVA ORS contains sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.
The most common adverse reactions (≥10%) reported in RADICAVA® (edaravone)-treated patients and at least 2% more frequently than placebo were contusion (15% vs 9%), gait disturbance (13% vs 9%), and headache (10% vs 6%), respectively. In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.
Based on animal data, RADICAVA ORS may cause fetal harm.
To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
RADICAVA ORS® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information also available www.radicavaors.com.
RADICAVA, RADICAVA ORS, the RADICAVA ORS logo, and the corporate symbol of Mitsubishi Tanabe Pharma America are registered trademarks of Mitsubishi Tanabe Pharma Corporation.
JourneyMate Support Program is a trademark of Mitsubishi Tanabe Pharma America, Inc.
All other company names, product names, trade/service marks or other trade names are the property of their respective owners.
For US Healthcare Professionals Only.
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