Related Experiment Video
Updated: Jan 16, 2026

Insertion, Maintenance, and Removal of the Percutaneous Dual Lumen Cannula Right Ventricular Assist Device
Published on: July 20, 2022
Auditory system adverse events with sacubitril/valsartan: an active-comparator restricted disproportionality analysis
Atefeh Jafari1,2, Niaz Chalabianloo3, Flory T Muanda1,2,3,4
1Department of Epidemiology & Biostatistics, Western University, London, ON, Canada.
Background:
Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor, is used for heart failure with reduced ejection fraction. Emerging evidence suggests potential ototoxicity, including hearing loss and vestibular disorders, which remain underreported and poorly characterized.
Research Design And Methods:
Our objective was to compare auditory adverse event (AE) reports associated with sacubitril/valsartan versus those associated with lisinopril and losartan. A retrospective active-comparator disproportionality analysis was conducted using individual case safety reports (ICSRs) from the U.S. FDA Adverse Event Reporting System (FAERS) via OpenFDA (2015Q3-2023Q3). The Medical Dictionary for Regulatory Activities (MedDRA) terms identified AEs related to hearing impairment, vestibular disorders, and hypoacusis. Adjusted reporting odds ratios (aRORs) and 95% confidence intervals (CIs) were estimated using logistic regression, adjusting for age, sex, hypertension, and heart failure. Bayesian methods complemented the analysis.
Results:
Among 55,101 ICSRs, 28,091 involved sacubitril/valsartan, with 590 (1.07%) reports of hearing impairment and 4,732 (8.58%) vestibular disorders. Compared to lisinopril, sacubitril/valsartan had higher aRORs for hearing impairment (2.35), vestibular disorders (2.58), and hypoacusis (15.03). Similar elevated risks were found versus losartan. Bayesian analysis confirmed these patterns.
Conclusions:
Sacubitril/valsartan may be associated with a higher risk of auditory AEs than lisinopril and losartan. These findings warrant further confirmation through pharmacoepidemiologic studies.
Related Concept Videos
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Cardiovascular System Abnormal Findings II: Auscultation
Abnormal Heart Sounds
Gallops:
Heart Failure Drugs: Inhibitors of Renin-Angiotensin System
SBAR II: Application of SBAR
SBAR Report from a Nurse to a Health Care Provider
S: "Hello, Dr. Smith. This is Jane, RN, from the Med Surg unit. I am calling to tell you about Ms. White in Room 210, who is experiencing increased pain and redness at her incision site. Her recent...
Local Anesthetics: Adverse Effects
Once absorbed into the systemic circulation, local anesthetics can affect the organs that depend on the functioning of sodium...
Errors occurring during blood pressure monitoring
Several factors...

