Paroxetine Adverse Event Reports from FDA FAERS, 2004-2025

39,404 adverse event reports for the antidepressant paroxetine were extracted from the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q2 2025. The analysis, authored by Santosh Chokkakula and last updated in April 2026, includes demographic distributions and signal detection using four disproportionality algorithms. The data is presented in a DOCX file of 97.2 KB.

Use Cases

• Signal detection for drug withdrawal syndrome based on reported disproportionality metrics (ROR, PRR, IC, EBGM).
• Demographic analysis of adverse event reporters based on gender distribution percentages.
• Temporal analysis of adverse event onset based on the reported percentage occurring within the first 30 days of therapy.
• Investigating high-signal events within specific System Organ Classes (SOC), such as congenital, familial, and genetic disorders.

Strengths

• Contains 39,404 individual adverse event reports for a specific drug.
• Covers a long time range of over 21 years (Q1 2004 to Q2 2025).
• Analysis includes specific signal strength metrics (e.g., ROR=27.27 for drug withdrawal syndrome).
• Released under a permissive CC-BY-4.0 license.

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 (97.2 KB), suggesting it contains summary analysis rather than the raw report-level data.

Provenance

Source

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

Collection Method

Adverse event reports were extracted and analyzed using disproportionality algorithms (ROR, PRR, BCPNN, MGPS).

Time Range

First quarter of 2004 through the second quarter of 2025.

Freshness

Last updated 2026-04-14 05:28:46; freshness should be verified.

Geography

Likely United States, given the source is the FDA FAERS.