Safety profile and signal detection of tadalafil: a real-world analysis based on the Food and Drug adverse event reporting system
Abstract
Background: Tadalafil, a phosphodiesterase type 5 inhibitor, is widely used for erectile dysfunction and benign prostatic hyperplasia. Although generally well tolerated, concerns have emerged regarding uncommon but potentially clinically relevant adverse event (AE) reports and safety signals, particularly involving ocular, auditory, and cardiovascular systems.
Aim: To characterize the post-marketing safety profile of tadalafil and identify potential safety signals using a real-world pharmacovigilance database.
Methods: All AE reports with tadalafil as the primary suspected drug were retrieved from the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q1 2024. After data deduplication and Medical Dictionary for Regulatory Activities (MedDRA, version 26.0) recoding, descriptive analyses were conducted to summarize demographic characteristics and AE distributions. Disproportionality analyses-including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and empirical Bayes geometric mean-were applied to detect safety signals at system organ class (SOC) and preferred term (PT) levels.
Outcomes: Primary outcomes included frequencies of reported AEs and identification of statistically significant signals across multiple signal-detection algorithms.
Results: Among 85 927 reports, 9304 identified tadalafil as the primary suspect drug. Reported AEs involving tadalafil spanned 23 SOCs. Using 4 signal detection algorithms, 135 PTs…
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