Infliximab Adverse Event Reports from FAERS, 2014-2025

178,925 adverse reaction reports for the drug infliximab, analyzed by Xiaoke Zheng in 2026. The data compares 5,144 intravenous and 1,084 subcutaneous administration events, including time-to-onset analysis. It was sourced from the U.S. FDA Adverse Event Reporting System (FAERS) from Q1 2014 to Q1 2025.

Use Cases

• Compare adverse event signal strength between intravenous and subcutaneous drug administration based on reporting odds ratio (ROR) analysis.
• Model the time-to-onset of adverse reactions for different administration routes based on Weibull distribution analysis.
• Identify common adverse reaction types, such as infections or infusion-related reactions, associated with a specific biologic therapy.
• Support clinical decision-making for drug administration route selection based on real-world safety evidence.

Strengths

• Contains 178,925 real-world adverse event reports, providing a substantial sample for signal detection.
• Includes specific counts for administration routes: 5,144 intravenous and 1,084 subcutaneous events.
• Reports median onset times: 436.5 days for intravenous and 376 days for subcutaneous administration.
• Covers a long time range from the first quarter of 2014 through the first quarter of 2025.

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.
• Data may reflect reporting bias inherent to spontaneous reporting systems like FAERS.

Provenance

Source

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

Collection Method

Analysis of spontaneous adverse event reports using discriminant, stratified, and reporting odds ratio (ROR) methods.

Time Range

First quarter of 2014 through first quarter of 2025

Freshness

Last updated 2026-06-01 11:51:24; freshness should be verified.

Geography

Reports submitted to the U.S. FDA; global origin of reports is unspecified.