Skip to main content
2025 ISPE Annual Meeting Main banner

Pharmacovigilance / Cardiovascular

Poster Session A

(A-231) β-Blockers and Risk of Neuropsychiatric Adverse Events: An Active-Comparator Restricted Disproportionality on the FAERS

Sunday, August 24, 2025
12:00 PM - 1:30 PM ET

    Co-Author(s)

  • LE

    Lujain Ez eddin

    Department of Physiology and Pharmacology, Western University, Ontario, Canada

  • MA

    Mohammad Ali Omrani

    Department of Physiology and Pharmacology, Western University, London, Ontario, Canada, Canada

  • NC

    Niaz Chalabianloo

    Department of Physiology and Pharmacology, Western University, London, Ontario, Canada
    London, Ontario, Canada

    • Presenting Author(s)

  • FT

    Flory T Muanda

    Department of Physiology and Pharmacology, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada, Ontario, Canada

Background: β-blockers, commonly used for cardiovascular conditions, may be linked to neuropsychiatric adverse events. However, many prevalent ones, including delirium and hallucinations, remain insufficiently studied.

Objectives: To compare the neuropsychiatric risks of β-blockers with other antihypertensive drugs using data from the FDA Adverse Event Reporting System (FAERS) and differences between lipophilic and hydrophilic β-blockers.

Methods: An active-comparator restricted disproportionality analysis (ACR-DA) was conducted using data from the FDA Adverse Event Reporting System (FAERS) (2004Q1-2023Q4). Neuropsychiatric adverse events were analyzed using Preferred Terms (PTs) and the System Organ Classes (SOCs) from the Medical Dictionary for Regulatory Activities (MedDRA) for β-blockers compared to lisinopril and losartan. Adjusted RORs were calculated using logistic regression to account for potential confounders.

Results: β-blockers were linked to a significantly higher risk of nervous and psychiatric disorders reports compared to lisinopril and losartan. Among nine types of neuropsychiatric events studied, β-blockers showed higher aRORs for six types, except confusion, delirium, and altered mental status. Propranolol, a lipophilic β-blocker, exhibited the highest aRORs for psychiatric disorders and six types of neuropsychiatric events, including nightmares, delirium, hallucinations, disorientation, altered mental status, and somnolence, compared to lisinopril and losartan. Compared to atenolol, propranolol remained significantly associated with delirium, hallucinations, and disorientation.

Conclusions: : β-blockers, especially propranolol, may be associated with a higher risk of neuropsychiatric adverse events compared to lisinopril and losartan. These findings highlight the importance of considering the specific β-blocker prescribed, particularly in patients at risk for CNS side effects. Further population-based studies are warranted to confirm these results.