Mining of risk signals for antihypertensive drug-related erectile dysfunction
- VernacularTitle:降压药物相关勃起功能障碍风险信号挖掘
- Author:
Shi LIU
1
;
Peng YANG
2
;
Yue GAO
1
;
Yu WANG
1
;
Shenrong GAO
1
;
Jinsong YAN
3
Author Information
1. Dept. of Pharmacy，Hubei Provincial Hospital of TCM/Affiliated Hospital of Hubei University of Chinese Medicine/Hubei Province Academy of Traditional Chinese Medicine，Wuhan 430061，China;Hubei Key Laboratory of Theory and Application Research of Liver and Kidney in Traditional Chinese Medicine，Wuhan 430061，China;Hubei Shizhen Laboratory，Wuhan 430061，China
2. School of Pharmacy，Hubei University of Chinese Medicine，Wuhan 430065，China
3. Dept. of Pharmacy，Hubei Provincial Hospital of TCM/Affiliated Hospital of Hubei University of Chinese Medicine/Hubei Province Academy of Traditional Chinese Medicine，Wuhan 430061，China;Hubei Key Laboratory of Theory and Application Research of Liver and Kidney in Traditional Chinese Medicine，Wuhan 430061，China
- Publication Type:Journal Article
- Keywords:
antihypertensive drugs;
Erectile dysfunction;
Hypertension;
FAERS database
- From:
China Pharmacy
2026;37(18):2389-2394
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To mine the risk signals associated with erectile dysfunction （ED） related to antihypertensive drugs based on real-world data， and to provide a reference for the safe clinical use and risk monitoring of these drugs.METHODS Reports of ED associated with 15 target antihypertensive drugs were extracted from the US FDA Adverse Event Reporting System （FAERS） database， covering the period from the first quarter of 2004 to the first quarter of 2026. Three proportional disproportionality measures （reporting odds ratio， proportional reporting ratio， and empirical Bayesian geometric mean） were used to mine the risk signals for ED associated with various antihypertensive drugs， and stratified analyses were performed based on patient age and body weight.RESULTS A total of 997 ED reports associated with 15 antihypertensive drugs were included. The majority were male patients （931 reports）， with age concentrated in the 18 to ＜65 years group （511 reports）， body weight in the 50 to ＜100 kg group （366 reports）， and reporters predominantly consumers/patients （497 reports）. The top three drugs by number of reports were amlodipine （413 reports）， metoprolol （133 reports）， and valsartan （82 reports）； the overall demographic distribution characteristics of reports associated with each drug were similar. Positive signals were detected for 8 drugs， including amlodipine and metoprolol. ED associated with atenolol， candesartan， metoprolol， hydrochlorothiazide， and losartan mostly occurred within 30 days after medication； ED associated with valsartan and perindopril mostly occurred over 360 days after medication； and the onset time of amlodipine-associated ED was evenly distributed across all time periods. There were a total of 835 serious reports， with calcium channel blockers （CCBs） accounting for the highest proportion （44.0%） and angiotensin-converting enzyme inhibitors for the lowest （3.7%）. The intensity of risk signals for amlodipine-associated ED increased with advancing age and higher body weight， while the signals for metoprolol were most pronounced in individuals aged 45 to ＜60 years and weighing≥100 kg； positive signals for valsartan were observed only in individuals aged≥60 years and those weighing 50 to ＜75 kg or ≥100 kg.CONCLUSIONS Reports of ED associated with antihypertensive drugs exhibit significant heterogeneity across drug types and differences in the distribution of onset times； CCBs have the highest proportion of serious reports； and the relationship between ED risk signals associated with amlodipine， metoprolol， and valsartan and age and body weight also shows marked heterogeneity.
