FAERS Adverse Event Reports for Edaravone, 2017-2024

From Q1 2017 to Q4 2024, this dataset contains 3,262 adverse event reports for the ALS drug edaravone, extracted from the FDA's FAERS database. It distinguishes between 1,534 intravenous and 453 oral administration incidents, analyzing signal intensity and onset timing. The dataset was authored by Deye Ge and published on figshare under a CC-BY-4.0 license.

Use Cases

• Compare adverse event profiles between intravenous and oral drug administration routes based on the reported distinct reaction spectra.
• Analyze temporal patterns of adverse event onset using the reported median times (35 days for IV, 27 days for oral).
• Identify early failure signals for drug safety based on the Weibull distribution analysis described.
• Investigate system-specific adverse reactions (e.g., respiratory, digestive, skin) associated with oral edaravone administration.

Strengths

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

Limitations

• Row count is unknown, which may limit suitability assessment.
• Column-level documentation is absent; field semantics must be inferred after download.
• The dataset is very small at 9.5 KB, indicating limited scope.

Provenance

Source

U.S. FDA Adverse Event Reporting System (FAERS)

Collection Method

Data extraction and analysis using repeatability analysis, Reporting Odds Ratio (ROR), Weibull distribution, and stratification methods.

Time Range

First quarter of 2017 through the fourth quarter of 2024

Freshness

Last updated 2026-04-13 17:29:12; freshness should be verified.

Geography

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