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Edaravone

اداراوون

⚠ Unverified

🧠 Nervous SystemFree-radical scavenger

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Safety not established 👴 Older adults:Use with caution 🇮🇷 Registered in Iran ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA209176 ATC N07XX14

Market / country: 🇺🇸 USA

Radicava (US)

🧮 Dose calculator

Disease / regimen

Amyotrophic lateral sclerosis (ALS) · Regimen source: FDA Radicava · 2.1 FDA Radicava · 2.2 FDA Radicava · 2.3

⛔ First cycle: daily for 14 days, then 14 days off. Later cycles: 10 of 14 days, then 14 days off. IV 60 mg (two 30 mg bags) over 60 min; oral 105 mg (5 mL) in the morning fasting, no food for 1 h after. FDA Radicava · 2.1 FDA Radicava · 2.2 FDA Radicava · 2.3

🛡️ Safety & information

Contraindications

⛔ History of hypersensitivity to edaravone or its inactive ingredients. FDA Radicava · 4

Warnings

• Hypersensitivity; contains sodium bisulfite (allergic reactions and asthma in sulfite-sensitive people). FDA Radicava · 5

Formulations

30 mg/100 mL bag (dose = 2 bags) — injection 🇺🇸 USA FDA Radicava · 3
Radicava ORS 105 mg/5 mL oral suspension — suspension 🇺🇸 USA FDA Radicava · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Radicava · 8.1
“Risk Summary There are no adequate data on the developmental risk associated with the use of RADICAVA or RADICAVA ORS in pregnant women.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Radicava · 8.2
“Risk Summary 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 production.”
👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Radicava · 8.4
“Safety and effectiveness of RADICAVA or RADICAVA ORS in pediatric patients have not been established.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Radicava · 8.5
“Of the 184 patients with ALS who received RADICAVA in 3 placebo-controlled clinical trials, a total of 53 patients were 65 years of age and older, including 2 patients 75 years of age and older.”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)NDA209176
DailyMed (FDA label)FDA Radicava
MedlinePlus (NIH)Edaravone Injection Edaravone Oral
WHO ATC/DDDN07XX14
Darooyab (Iran)Edaravone

🇮🇷 Registered in Iran Darooyab · G-1656/Edaravone

Dosage forms with Iranian generic codes, per Darooyab.

52366 · EDARAVONE INJECTION, SOLUTION PARENTERAL 30 mg/20mL · محلول تزریقی اداراوون ۳۰ میلی‌گرم / ۲۰ میلی‌لیتر
52367 · EDARAVONE INJECTION, SOLUTION PARENTERAL 30 mg/100mL · محلول تزریقی اداراوون ۳۰ میلی‌گرم / ۱۰۰ میلی‌لیتر

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Radicava · 3 FDA Radicava · 2.1 FDA Radicava · 2.2 FDA Radicava · 2.3 FDA Radicava · 4 FDA Radicava · 5 FDA Radicava · SPL approval / marketing category FDA Radicava · 8.1 FDA Radicava · 8.2 FDA Radicava · 8.4 FDA Radicava · 8.5
UK SmPC (eMC / MHRA)❌ Not present
Published guideline❌ Not present
Licensed reference (medical school)❌ Not present
Iranian leaflet (IFDA)❌ Not present
Pharmacy website (secondary, unreliable)✅ Present
Darooyab · G-1656/Edaravone
Clinical review⚠ Unverified

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