OpenClaim

Edaravone Side Effects

The most commonly reported side effects of edaravone include death, disease progression, and fatigue, based on 4,142 FDA adverse event reports from 2004 to 2025. 7.6% of reports found the drug to be ineffective.

Edaravone side effects

Percentages show how often each reaction appears relative to total reports for edaravone.

1
Death17.3%716
2
Disease Progression7.7%320
3
Drug Ineffective7.6%316
4
Fatigue4.9%204
5
Asthenia4.2%175
6
Condition Aggravated3.9%160
7
Muscular Weakness3.7%155
8
Dyspnoea3.7%152
9
Amyotrophic Lateral Sclerosis3.4%139
10
Gait Disturbance3.0%124
11
Diarrhoea2.7%113
12
Fall2.5%102
13
Speech Disorder2.4%98
14
Therapeutic Response Unexpected2.4%98
15
Aphasia2.3%96

These are voluntary reports and do not establish that edaravone caused these reactions.

Report severity

52.8%Serious2,185 reports
15.9%Hospitalizations660 reports
26.7%Fatal1,105 reports

Seriousness is determined by the reporter, not by OpenClaim.

Edaravone drug interactions

Other drugs that appear in adverse event reports alongside edaravone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Riluzole6.6%272
2
Sodium-phenylbutyrate4.4%181
3
Taurursodiol4.4%181
4
Aspirin1.3%52
5
Alteplase1.0%42
6
Argatroban0.8%33
7
Levetiracetam0.8%32
8
Atorvastatin-calcium0.7%31
9
Heparin0.5%21
10
Cilostazol0.5%20
11
Gemfibrozil0.5%19
12
Clopidogrel-bisulfate0.4%18
13
Midazolam0.4%16
14
Methylprednisolone0.3%14
15
Mannitol0.3%14

Taken alongside

1
Riluzole10.7%445
2
Aspirin3.5%146
3
Atorvastatin-calcium2.3%95
4
Ergocalciferol2.2%91
5
Baclofen2.2%90
6
Amlodipine1.9%79
7
Levothyroxine-sodium1.6%65
8
Heparin1.4%59
9
Acetaminophen1.4%59
10
Gabapentin1.4%57
11
Omeprazole1.4%56
12
Cyanocobalamin1.3%55
13
Lisinopril1.3%52
14
Dextromethorphan1.1%47
15
Furosemide1.1%46

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports edaravone side effects

30.2% of edaravone adverse event reports involve female patients and 42.9% involve male patients. The largest age group is adult at 57%. These figures reflect who reports side effects, not underlying risk.

Sex

Female30.2%
Male42.9%
Unknown26.9%

Age group

< 20.5%
2–110.5%
12–170.2%
18–6457.3%
65+41.5%

What is edaravone used for

Conditions and purposes for which patients were taking edaravone when the adverse event was reported.

Acute Encephalitis With Refractory, Repetitive Partial SeizuresAmyotrophic Lateral SclerosisAnterior Spinal Artery SyndromeAntioxidant TherapyArterial Occlusive DiseaseAcute Encephalitis With Refractory, Repetitive Partial SeizuresAir EmbolismAmyotrophic Lateral SclerosisAngiopathyAntacid TherapyAntioxidant TherapyArterial ThrombosisArtery DissectionBehcet^s SyndromeBrain Oedema

Showing 15 of 107 indications

Edaravone brand names and reporting trend

Edaravone is sold under the brand name Edaravone.

Brand names

Edaravone1,340

Quarterly reports (20042025)

20042010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking edaravone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.