Adrian Wong,Angela Li,Kane- Gill,Matthew  P. Gray,Pamela L.  Smithburger,Seohyun  (Claudia) Choi,
Drug-Associated Delirium Identified in The Food and Drug Administration Adverse Events Reporting System
Psychological Disorders and Research
2019
2674-2470
http://dx.doi.org/10.31487/j.PDR.2019.03.01
https://www.sciencerepository.org/drug-associated-delirium-identified-in-the-food-and-drug-administration-adverse-events-reporting-system_PDR-2019-3-101 
Abstract: Introduction: Drug toxicity and polypharmacy are major risk factors for delirium, especially in older adult
patients with underlying comorbidities. However, numerous case reports have described drugs with a lower
suspicion of being deliriogenic. The objective of this study was to identify deliriogenic drugs in the Food
and Drug Administration Adverse Events Reporting System (FAERS) to broaden the public knowledge and
understanding.
Study Design: Retrospective pharmacovigilance evaluation.
Methods: FAERS reports from 2004 through 2015 were reviewed for delirium-associated terms, which
were utilized to identify drugs most frequently reported to cause delirium. Drugs were categorized as: 1)
known to be deliriogenic; 2) potentially deliriogenic; or 3) new potential to be deliriogenic. The 100 most
frequently reported drugs were analyzed in reporting odds ratios (ROR).
Results: Of the known deliriogenic drugs (n=32), paroxetine (ROR 4.1, CI 4.0-4.3), olanzapine (ROR 3.3,
CI 3.2-3.4), and clozapine (ROR 2.9, CI 2.8-3.0) were most reported. Of the potentially deliriogenic drugs
(n=54), duloxetine (ROR 3.2, CI 3.1-3.3), varenicline (ROR 3.1, CI 3.0-3.2), and gabapentin (ROR 2.9, CI
2.7-3.0) were most reported. Three drugs were considered to have new potential to be deliriogenic: heparin
(ROR 1.5, CI 1.4-1.6), metformin (ROR 1.3, CI 1.3-1.4), and dalfampridine (ROR 1.1, CI 1.1-1.2).
Conclusion: The majority of drugs were considered potentially deliriogenic. FAERS can provide postmarketing surveillance data to guide future studies on potentially deliriogenic drugs to guide management
of causal agents.Keywords: FAERS, delirium, drugs, the food and drug administration, adverse events reporting system