FAERS Pharmacovigilance Limitations

FAERS voluntary reporting creates biases from underreporting, inconsistent report quality, and variable reporter awareness. Disproportionality signals indicate statistical associations rather than causal or biological relationships. The small pretomanid report base limits precision for pretomanid-specific signal detection. Further prospective studies are needed to confirm and characterize newly identified signals, especially pretomanid and acute kidney injury. Missing comorbidity information limits the ability to separate drug-induced adverse events from disease progression or coinfections.