Disproportionality Analysis for Pharmacovigilance Signal Detection in Small Databases or Subsets: Recommendations for Limiting False-Positive Associations

To mitigate the risk of highlighting spurious associations with disproportionality analysis, a minimum size of 500 reports is recommended for national databases. For databases or subsets that are not country-specific, our recommendation is 5000 reports. This study does not consider sensitivity, which is expected to be poor in smaller databases.