OBJECTIVE  To mine the adverse drug event(ADE) signals of sildenafil under different indications based on the FDA Adverse Event Reporting System(FAERS) database and to provide references for safe clinical medication use.

METHODS  Data on ADE reports under different indications from the first quarter of 2004 to the third quarter of 2024 were extracted from the FAERS database. ADE signal detection was performed using the reporting odds ratio(ROR) method and the Bayesian Confidence Propagation Neural Network(BCPNN) method.

RESULTS  A total of 16 533 reports were received with sildenafil as the primary suspected drug, among which 6 502 reports were for the indication of erectile dysfunction(ED) and 10 031 reports were for pulmonary arterial hypertension(PAH). Using the ROR and BCPNN, 97 positive signal PTs were identified for ED indication, with the highest number of reports being for malignant melanoma, enhanced erection, and ejaculation disorder, etc. For PAH, 278 positive signal were identified, with the highest number of reports being for death, heart failure, and congestive heart failure, etc. It was found that the number of reports for malignant melanoma in ED patients was high and the signal strength was strong, with a median induction time of 1 783 d, while the number of reports in PAH patients was very low. In both 2 indications, the number and signal strength of ADE in the eye and ear and labyrinth systems were relatively high, such as vision impairment and hearing loss, etc, which require clinical attention.

CONCLUSION  There are differences in ADE among different indications of sildenafil. For ED patients, the report numbers and signal strengths for malignant melanoma were relatively high, whereas those for PAH patients were very low. Further clinical randomized controlled studies are needed to confirm these findings. In both indications, close attention should be paid to adverse events in the eye organs and ear and labyrinth systems, such as visual impairment and hearing loss.