Pralatrexate Adverse Event Reports from FAERS Database

2,241 adverse event reports from 563 patients prescribed the lymphoma drug pralatrexate were analyzed. The study, authored by Wei Yang and published in April 2026, systematically assessed the drug's postmarketing safety profile using FDA Adverse Event Reporting System data from 2004 to 2025.

Use Cases

• Identify positive safety signals like mucositis or hypochloremia using disproportionality analysis algorithms (ROR, PRR, BCPNN, MGPS).
• Analyze time-to-onset patterns for adverse events, where the median was 16 days with an interquartile range of 6-59 days.
• Investigate subgroup differences by comparing signal strength metrics like reporting odds ratios across sex and age categories.
• Examine system organ class distributions, such as the 354 reports for 'General disorders and administration site conditions'.
• Associate specific adverse events like hematologic toxicity with severe outcome categories including death or hospitalization.

Strengths

• Analysis covers 2,241 adverse event reports from a real-world surveillance database.
• Data spans a 21-year period from the first quarter of 2004 through the first quarter of 2025.
• Study detected 84 positive safety signals using four established statistical algorithms.

Limitations

• The dataset is small at 90.0 KB, containing summary analysis results rather than the raw report-level data.
• Findings are based on spontaneous reporting data, which is subject to under-reporting and reporting bias.
• Patient demographics show a bias, with 58.44% male and 45.65% aged 65 years or older.

Provenance

Source

FDA Adverse Event Reporting System (FAERS)

Collection Method

Reports extracted and cleaned following a standardized process for primary suspected drug-related events.

Time Range

First quarter 2004 to first quarter 2025

Freshness

Data current through Q1 2025; metadata last updated April 2026.

Geography

Primarily United States (FDA database)