Pralatrexate Adverse Event Reports from FDA FAERS Database

2,241 adverse event reports from 563 patients treated with the anticancer drug pralatrexate were extracted from the FDA FAERS database. The analysis, authored by Wei Yang and updated in April 2026, identifies 84 safety signals and characterizes the drug's postmarketing safety profile, including median time to onset of adverse events.

Use Cases

• Detect disproportionate reporting signals like mucositis or hypochloremia using algorithms (ROR, PRR, BCPNN, MGPS) on adverse event report data.
• Analyze subgroup differences in adverse event risk, such as toxic epidermal necrolysis by patient sex using reporting odds ratio and confidence intervals.
• Model the time-to-onset distribution of adverse events, characterized by a median of 16 days, using Weibull distribution tests.
• Identify associations between patient age (≥65 vs <65 years) and specific adverse event categories like mucosal injury or malignant neoplasm progression.
• Assess the severity outcomes (death, life-threatening, hospitalization) linked to primary adverse events like mucositis and hematologic toxicity.

Strengths

• Analysis covers 2,241 adverse event reports spanning from Q1 2004 to Q1 2025, providing longitudinal real-world data.
• Employs four established signal detection algorithms (ROR, PRR, BCPNN, MGPS) for robust pharmacovigilance analysis.
• Includes detailed subgroup analyses by sex, age, and report type with statistical metrics like reporting odds ratios and confidence intervals.

Limitations

• The dataset is derived from spontaneous reporting systems, which are subject to under-reporting and reporting biases.
• The 3.1 MB file size suggests the underlying data tables are aggregated results, not the raw, patient-level FAERS data.
• Analysis is specific to a single drug (pralatrexate), limiting generalizability to other therapeutics.

Provenance

Source

FDA Adverse Event Reporting System (FAERS) database.

Collection Method

Standardized data cleaning and signal detection analysis performed on extracted reports where pralatrexate was the primary suspected drug.

Time Range

First quarter of 2004 through first quarter of 2025.

Freshness

Data covers reports up to the first quarter of 2025, with the study last updated in April 2026.

Geography

United States (FDA database).