Safety profile and signal detection of tadalafil: a real-world analysis based on the Food and Drug adverse event reporting system - PubMed
6 hours ago
- #Adverse Events
- #Pharmacovigilance
- #Signal Detection
- The study analyzed the safety profile of tadalafil using the FDA Adverse Event Reporting System (FAERS) data from 2004 to 2024.
- Among 85,927 reports, 9,304 identified tadalafil as the primary suspect drug, with adverse events spanning 23 system organ classes.
- Using four disproportionality analysis algorithms, 135 preferred terms showed statistically significant safety signals.
- Several potential safety signals not listed in current labeling were detected, including retinal hemorrhage and elevated intraocular pressure.
- The findings highlight the need for clinical vigilance, especially in patients with vascular or sensory risk factors.
- Limitations include under-reporting, reporting bias, and inability to infer causality, necessitating cautious interpretation.