Edaravone Adverse Event Reports from FDA FAERS, 2017-2024

U.S. Food and Drug Administration data from the first quarter of 2017 through the fourth quarter of 2024. The dataset contains 3,262 records of adverse reactions associated with the ALS drug edaravone, with 1,534 incidents linked to intravenous and 453 to oral administration. Author Deye Ge published the analysis on figshare in April 2026.

Use Cases

• Compare adverse reaction profiles based on drug administration route (intravenous vs. oral).
• Analyze temporal patterns of adverse events using Weibull distribution and median onset times.
• Identify early failure signals for drug safety based on repeatability and Reporting Odds Ratio (ROR) analysis.
• Investigate system-specific adverse reactions (respiratory, digestive, skin) mentioned in the description.

Strengths

• Contains 3,262 specific adverse event records.
• Covers a defined 8-year time range from Q1 2017 to Q4 2024.
• Includes analysis-derived metrics like median onset times (35 days for intravenous, 27 days for oral).
• Distinguishes between 1,534 intravenous and 453 oral administration incidents.

Limitations

• Row count for the underlying dataset is unknown, which may limit suitability assessment.
• Column-level documentation is absent; field semantics must be inferred after download.
• The 5.5 KB file size suggests a very limited scope, likely containing summary or analysis results rather than raw reports.

Provenance

Source

U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

Collection Method

Analysis employing repeatability analysis, Reporting Odds Ratio (ROR), Weibull distribution, and stratification methods.

Time Range

Q1 2017 through Q4 2024.

Freshness

Last updated 2026-04-13 17:29:11; freshness should be verified.

Geography

United States (inferred from FDA data source).