Objective  To identify potential adverse drug event (ADE) signals associated with the concomitant use of valsartan and amlodipine in elderly patients with hypertension by mining the U.S. FDA Adverse Event Reporting System (FAERS) database, and provide evidence for pharmacovigilance and rational clinical use.

Methods  ADE reports from the FAERS database between Q1 2004 and Q1 2025 involving patients with hypertension aged ≥60 years who received valsartan, amlodipine, or their combination were retrieved. Signal detection was performed using the reporting odds ratio (ROR) and the proportional reporting ratio (PRR). The Medical Dictionary for Regulatory Activities (MedDRA) version 26.1 was applied for classification by system organ class (SOC) and preferred terms (PT). The time-to-onset (TTO) characteristics of ADE were also analyzed.

Results  A total of 40,276 ADE reports were extracted, including 34,852 reports for valsartan or amlodipine monotherapy and 5,424 for combination therapy. Among the combination therepy reports, females accounted for 58.0%, with the majority in the 65-85 age group (n=3,925, 66.5%). Hospitalization was the most common ADE across all three groups. Signal detection identified 301 adverse signals for valsartan, 312 for amlodipine, and 408 for combination therapy, involving categories such as investigations, vascular and lymphatic disorders, nervous system disorders, cardiac disorders, and metabolic and nutritional disorders.

Conclusion  Compared with valsartan or amlodipine monotherapy, concomitant use of valsartan and amlodipine is associated with more prominent ADE signals. Clinicians should pay close attention to potential ADE during combination therapy and adjust drug regimens in a timely manner.

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