Ophthalmic Atropine Adverse Reaction Signals from the FAERS Database, 425 Reports

425 reports of adverse drug reactions associated with ophthalmic atropine were mined from the FDA Adverse Event Reporting System (FAERS) database. The data, shared by Zihang Xu in March 2026, includes 83 positive safety signals, with endophthalmitis being the most frequent and strongest signal. Statistical measures like the Information Component and Reporting Odds Ratio are provided for each detected signal.

Use Cases

• Prioritizing clinical safety monitoring based on the 83 detected adverse reaction signals.
• Comparing signal strength for specific conditions like endophthalmitis or uveitis using provided IC and ROR metrics.
• Analyzing the distribution of adverse events across body systems such as eye and nervous system disorders.
• Assessing the clinical priority grades assigned to 81.93% of the reported preferred terms.

Strengths

• Includes specific statistical metrics (IC and ROR) for 83 detected safety signals.
• Covers data from the inception of the FAERS database through Q2 2025.
• Provides a concrete count of 425 adverse event reports.

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 reflects reporting bias inherent to spontaneous reporting systems like FAERS.

Provenance

Source

FDA Adverse Event Reporting System (FAERS) database.

Collection Method

Signal detection conducted using Information Component (IC) and Reporting Odds Ratio (ROR) methods.

Time Range

From database inception through the second quarter of 2025.

Freshness

Last updated 2026-03-18 05:21:50