What the label lists and what reports show
Edaravone side effects
Edaravone's FDA label: “Most common adverse reactions (at least 10% of patients treated with edaravone injection and greater than placebo) are contusion, gait disturbance, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 609-250-7990 or FDA at …” FAERS holds 1,540 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is cerebral infarction (97 reports).
- Generic listed
Check it at the source: the edaravone FDA label on DailyMed (effective May 7, 2024, Gland Pharma Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of RADICAVA and RADICAVA ORS?RADICAVA and RADICAVA ORS may cause serious side effects including: 1. Hypersensitivity (allergic) reactions. Hypersensitivity reactions have happened in people receiving RADICAVA or taking RADICAVA ORS and can happen after your medicine has been given. Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives breathing problems itching swelling of the lips, tongue, face dizziness wheezing fainting 2. Sulfite allergic reactions. RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe allergic reactions, for example, asthma episodes, in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma. […]
Source: FDA drug label (RADICAVA ORS), Shionogi Inc., effective May 5, 2026 (SPL set 0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (at least 10% of patients treated with edaravone injection and greater than placebo) are contusion, gait disturbance, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 609-250-7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reaction | Edaravone Injection (N=184) % | Placebo (N=184) % |
|---|---|---|
| Contusion | 15 | 9 |
| Gait disturbance | 13 | 9 |
| Headache | 10 | 6 |
| Dermatitis | 8 | 5 |
| Eczema | 7 | 4 |
| Respiratory failure, respiratory disorder, hypoxia | 6 | 4 |
| Glycosuria | 4 | 2 |
| Tinea infection | 4 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 edaravone injection and greater than placebo) are contusion, gait disturbance, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 609-250-7990 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 edaravone injection 60 mg in treatment cycles for 6 months. The population consisted of Japanese patients who had a median age of 60 years (range 29 to 75) and were 59% male. Most (93%) of these patients were living independently at the time of screening. …
Source: FDA drug label, Gland Pharma Limited, effective May 7, 2024 (SPL set 46452eb5-db17-400d-b25b-11844a11e711), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,540 reports list edaravone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 438 are coded as a death and 394 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Edaravone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions