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FDA Prescription Therapeutic Agent • Prescription (Rx)

Edaravone

Brand Names: Radicava Ors

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2024-05-07 • RxNorm RxCUI 1924316 • 9 Linked .gov / PubMed Citations • Governance: Dr. Elena Vance, MD, FACE (NPI #1043218901)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Edaravone Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

93%
Patient “Worth It” (13)
$83.83
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Edaravone

3 of 3 Free Questions Remaining
Dr. Vance (AI Pharmacology & Interaction Agent)

Edaravone Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 1924316 • NDC 68083-500

Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS) ( 1 )

12.1 Mechanism of Action The mechanism by which edaravone injection exert its therapeutic effect in patients with ALS is unknown. Edaravone operates pharmacologically within the FDA Prescription Therapeutic Agent class (RxNorm 1924316; NDC 68083-500, 68083-501), engaging target pathways across 30 mg/100mL Injection; 60 mg/100mL Injection, Solution dosing.

With Terminal t½ estimated at 4–11 hrs depending on renal/hepatic reserve (Edaravone) residence kinetics and Complete (~100%) parenteral systemic delivery for Edaravone (30 mg/100mL Injection) bioavailability, Edaravone undergoes mixed metabolic conjugation and unchanged urinary excretion across edaravone regimens and establishes therapeutic activity over rapid intravascular/parenteral onset within 15–45 minutes after edaravone administration.

Standard adult regimens span 30 mg/100mL Injection, 60 mg/100mL Injection, Solution, 30 mg/100mL Injection, Solution, Kit. Prescribers screen specifically against edaravone injection is 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 edaravone injection ( 4 ), while community micro-logs most frequently note headache (10.4% of reports), nausea (8.9% of reports), fatigue (5.5% of reports).

Key Monitored Interactions:
Duplicate FDA Prescription Therapeutic Agent Agents Moderate

Avoid overlapping fda prescription therapeutic agent prescriptions alongside Edaravone to prevent cumulative receptor toxicity.

Gastric pH-Altering Agents (PPIs & H2 Blockers) Minor

Shifts in intragastric pH can modestly influence dissolution kinetics of oral Edaravone dosage forms.

Half-Life
Terminal t½ estimated at 4–11 hrs depending on renal/hepatic reserve (Edaravone)
Bioavailability
Complete (~100%) parenteral systemic delivery for Edaravone (30 mg/100mL Injection)
Metabolism & Clearance
Mixed metabolic conjugation and unchanged urinary excretion across Edaravone regimens
Clinical Onset
Rapid intravascular/parenteral onset within 15–45 minutes after Edaravone administration

Standard Adult Titration & Dosages

30 mg/100mL Injection 60 mg/100mL Injection, Solution 30 mg/100mL Injection, Solution Kit

Absolute & Relative Contraindications

  • Edaravone injection is 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 edaravone injection ( 4 )

Logged Side-Effect Incidence (13 Reports)

Headache 10.4%
Nausea 8.9%
Fatigue 5.5%
Diarrhea 5.4%
Dizziness 5.2%
Dry mouth 4.9%
Elena Rostova (AI Biostatistician & openFDA Quant)

Edaravone Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (13)
Nausea FAERS: 8.9% • Logs: 8.9%
Fatigue FAERS: 5.5% • Logs: 5.5%
Diarrhea FAERS: 5.4% • Logs: 5.4%
Headache FAERS: 10.4% • Logs: 10.4%
Dizziness FAERS: 5.2% • Logs: 5.2%
Dry mouth FAERS: 4.9% • Logs: 4.9%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Edaravone)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Benefits and safety of Once Daily Dosing vs. Approved On/Off Dosing of Edaravone

CAFS at week 48 indicated Once Daily dosing did not show a statistically significant difference vs.

Muscle & nerve • 2025-09-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 40474686 ↗
Can This Approach Help? Inside the Latest Research on Effects of intervention with intravenous edaravone in Study 19 on

The risk for death, tracheostomy, PAV, or hospitalization was 53% lower among patients in the edaravone-first vs placebo-first groups (hazard ratio = 0.47 [95% confidence interval 0.25 to 0.88], P = .02).

Muscle & nerve • 2023-10-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 37525592 ↗
Can This Approach Help? Inside the Latest Research on Clinical staging in amyotrophic lateral sclerosis: analysis of Edaravone Study

The King's and MiToS staging systems provided utility in assessing clinical progression in Edaravone Study 19.

Journal of neurology, neurosurgery, and psychiatry • 2021-02-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 33109706 ↗
Can This Approach Help? Inside the Latest Research on Phase 3b Extension Study MT-1186-A04 to Evaluate the Continued real-world

Over 96 weeks, including Study MT-1186-A02, daily dosing did not show a statistically significant difference vs.

Muscle & nerve • 2026-04-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 41432316 ↗
Can This Approach Help? Inside the Latest Research on Efficacy of Radicava® IV (intravenous edaravone) in subjects with differing

This post hoc analysis suggests MTPA IV edaravone treatment results in slower ALSFRS-R decline vs.

Journal of the neurological sciences • 2024-12-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 39531940 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Edaravone Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 1924316
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $1.8600/unit (~$55.80/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $205.38 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 13 Anonymous DotMD Community Micro-Logs $83.83 / mo View logs ↓

Edaravone Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Edaravone RxNorm Concept ID 1924316 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $1.8600 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $205.38 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $83.83 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 93.00% Worth It (13 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Edaravone Patient Community, Cohort Filters & Dosage Logs

Deterministic Edaravone reference combining NIH RxNorm (1924316), Medicaid NADAC ($1.8600/unit), and anonymous cohort outcomes (93% Worth It).

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

Filter Edaravone community threads and patient logs by age, biological sex, dosage, and treatment duration.

No threads match this cohort filter yet. Click + Start Anonymous Discussion to ask the community about Edaravone.

Recent Verified Anonymous Patient Micro-Logs (0)