FAERS Pharmacovigilance Limitations

Evidence quality

Highlighted claims

• FAERS voluntary reporting creates biases from underreporting, inconsistent report quality, and variable reporter awareness. — Real-world safety profile of novel anti-multidrug-resistant tuberculosis drugs: a disproportionality analysis based on the FAERS database
• Disproportionality signals indicate statistical associations rather than causal or biological relationships. — Real-world safety profile of novel anti-multidrug-resistant tuberculosis drugs: a disproportionality analysis based on the FAERS database
• The small pretomanid report base limits precision for pretomanid-specific signal detection. — Real-world safety profile of novel anti-multidrug-resistant tuberculosis drugs: a disproportionality analysis based on the FAERS database
• Missing comorbidity information limits the ability to separate drug-induced adverse events from disease progression or coinfections. — Real-world safety profile of novel anti-multidrug-resistant tuberculosis drugs: a disproportionality analysis based on the FAERS database
• Further prospective studies are needed to confirm and characterize newly identified signals, especially pretomanid and acute kidney injury. — Real-world safety profile of novel anti-multidrug-resistant tuberculosis drugs: a disproportionality analysis based on the FAERS database