Open research questions in Pharmacovigilance and Adverse Drug Reactions
237 unresolved questions extracted from the limitations and future-work sections of 676 Pharmacovigilance and Adverse Drug Reactions papers in our library. Each links back to the study that raised it.
What the literature leaves open
The study remains limited by the modest size of the manually reviewed blind set and one structured-output failure. These results indicate that citation prompting alone is insufficient for reliable regulatory tutoring and that explicit evidence assessment and validation can improve traceability.
A Related Line of Research RegTutor: Self-correcting Agentic Retrieval-Augmented Generation for Medical-Device Compliance Training · 2026 · DOIThe rarity of reported zopiclone-associated hallucinations. The lack of systematic pharmacovigilance evaluation of hypnotic safety in patients with psychiatric comorbidities. The need for population-based quantitative validation of the association between zopiclone and hallucinations.
Zopiclone-associated hallucinations: a case report and database pharmacovigilance study · 2026 · DOIAge data were missing in 15.52% of cases. Body weight data were missing in 79.31% of cases. Only one report documented schizophrenia comorbidity among the hallucination cases. The study lacks population-based quantitative validation. The study is based on spontaneous reports and may not be representative of all cases.
Zopiclone-associated hallucinations: a case report and database pharmacovigilance study · 2026 · DOIUnderreporting, selective reporting, and variable data quality in the FAERS database. Reporting bias and potential overestimation or underestimation of drug-associated risks. Limited understanding of the differential effects of drugs on bone health across sexes.
Sex differences in drug-induced osteoporosis: a pharmacovigilance study based on the FAERS database · 2025 · DOIFurther clinical attention is warranted for the newly identified safety signals, - Future studies should explore the sex-specific differences in the onset and progression of DIOP, - The association between drugs and osteoporosis should be further investigated
Sex differences in drug-induced osteoporosis: a pharmacovigilance study based on the FAERS database · 2025 · DOITrue system-level evaluations were scarce (n=2) and characterized by the adaptation of international macro-indicators.
Pharmacovigilance Practices, Educational Interventions and Barriers to Reporting in University and Teaching Hospitals: a Scoping Review · 2026 · DOIConclusions There is a critical lack of standardized and validated instruments for evaluating PV system in university hospitals.
Pharmacovigilance Practices, Educational Interventions and Barriers to Reporting in University and Teaching Hospitals: a Scoping Review · 2026 · DOITherefore, the clinical impact of DHPCs, their read rates, and their influence on healthcare professionals’ behavioral change could not be assessed within the scope of this study.
Our results support continued monitoring and further investigation into temporal patterns and regional differences in irinotecan-related adverse events to enhance clinical safety.
Safety evaluation of irinotecan: a real-world disproportionality analysis using FAERS and JADER databases during the time period 2004-2024 · 2025 · DOIHowever, a comprehensive understanding of real-world implications remains lacking.
Real-world pharmacovigilance investigation of imipenem/cilastatin: signal detection using the FDA Adverse Event Reporting System (FAERS) database · 2025 · DOIHowever, their safety profiles remain unclear due to limited real-world evidence.
A real-world pharmacovigilance study of adverse drug reactions associated with lecanemab and aducanumab based on WHO-VigiAccess and FAERS databases · 2025 · DOIHowever, there is limited information on adverse drug reactions associated with its use.
Post marketing safety assessment of the novel postpartum depression drug, Zuranolone: evidence from real-world pharmacovigilance analysis based on the FDA adverse event reporting system · 2025 · DOIBackground: Ticagrelor is a commonly used antiplatelet agent, but due to the stringent criteria for trial population inclusion and the limited sample size, its safety profile has not been fully elucidated.
A disproportionality analysis of FDA adverse event reporting system (FAERS) events for ticagrelor · 2024 · DOIHowever, its safety profile has not been systematically evaluated in real-world settings.
Therefore, our findings may provide valuable insights for further studies on the safety of donepezil and memantine combination therapy, which are expected to contribute to the safe use of this therapy in clinical practice.
Adverse event profile of memantine and donepezil combination therapy: a real-world pharmacovigilance analysis based on FDA adverse event reporting system (FAERS) data from 2004 to 2023 · 2024 · DOIAn important discovery was the identification of AEs associated with ear and labyrinth disorders, which had not been documented in the drug's official leaflet before.
Assessing the safety of bedaquiline: insight from adverse event reporting system analysis · 2024 · DOIObjective: Lumateperone, a novel antipsychotic drug that was granted by the Food and Drug Administration (FDA) approval in December 2019, remains insufficiently explored for its adverse event profile.
Post-marketing safety concerns with lumateperone: a pharmacovigilance analysis based on the FDA adverse event reporting system (FAERS) database · 2024 · DOIIntroduction: Drug trials in neonates are scarce, and the neonates may consequently be at risk of adverse drug reactions (ADRs).
Adverse drug reactions in neonates: a brief analysis of the FDA adverse event reporting system · 2024 · DOIHowever, few data on the relationship between antidepressants and delirium are available.
Association between antidepressant use and delirium in older adults: an analysis of the World Health Organization’s global pharmacovigilance database · 2024 · DOIQuarterman, “Lack of Evidence for Polymorphism in Metoprolol Metabolism,” British Journal of Clinicul Phurmucology 16, 188-190 (1983).
Human Variability in Susceptibility to Toxic Chemicals— A Preliminary Analysis of Pharmacokinetic Data from Normal Volunteers · 1987 · DOIIncomplete reporting of time of administration in spontaneous ADR reports. Confounding due to patient behavior, comorbidities, and polypharmacy. Limited awareness among healthcare professionals.
CHRONOPHARMACOVIGILANCE: TIME-DEPENDENT PATTERNS OF ADVERSE DRUG REACTIONS AND THEIR REGULATORY IMPLICATIONS · 2026 · DOIThe conventional pharmacovigilance approach has limitations in incorporating the timing of drug administration. There is a need for a framework to evaluate time-dependent patterns of adverse drug reactions.
CHRONOPHARMACOVIGILANCE: TIME-DEPENDENT PATTERNS OF ADVERSE DRUG REACTIONS AND THEIR REGULATORY IMPLICATIONS · 2026 · DOIHigh implementation costs. Regulatory demands for rigorous validation of AI systems. The need for extensive and diverse datasets.
Future research should focus on developing more advanced AI-powered pharmacovigilance systems. The use of machine learning and natural language processing techniques should be further explored. The implementation of AI-powered pharmacovigilance systems in real-world settings should be studied.
The unique mechanism of action of immune checkpoint inhibitors may trigger immune-related adverse events. The study highlights the need for careful consideration of immune-related adverse events in the middle-aged and older population.
Adverse events associated with the use of nivolumab in the middle-aged and older population (>45 years): A pharmacovigilance analysis based on the FAERS database · 2026 · DOI
Most-cited papers in Pharmacovigilance and Adverse Drug Reactions
- Incidence of Adverse Drug Reactions in Hospitalized Patients · JAMA · 1998 · 3,521 citations
- Incidence of Adverse Drug Events and Potential Adverse Drug Events · JAMA · 1995 · 2,881 citations
- Systems Analysis of Adverse Drug Events · JAMA · 1995 · 1,675 citations
- Under-Reporting of Adverse Drug Reactions · Drug Safety · 2006 · 1,512 citations
- The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada · Canadian Medical Association Journal · 2004 · 1,422 citations
- Bayesian Data Mining in Large Frequency Tables, with an Application to the FDA Spontaneous Reporting System · The American Statistician · 1999 · 919 citations
- Systematic Overview of Warfarin and Its Drug and Food Interactions · Archives of Internal Medicine · 2005 · 893 citations
- Timing of New Black Box Warnings and Withdrawals for Prescription Medications · JAMA · 2002 · 793 citations
- Improving the Human Hazard Characterization of Chemicals: A Tox21 Update · Environmental Health Perspectives · 2013 · 560 citations
- Bleeding Complications With Warfarin Use · Archives of Internal Medicine · 2007 · 456 citations
Most recent work
- VigiBase: Resource Profile Update with a Summary of Global Patterns and Trends in Adverse Event Reports for Medicines and Vaccines · Drug Safety · 2026
- Machine learning models for drug-drug interaction prediction from computational discovery to clinical application · npj Digital Medicine · 2026
- Drug-induced male infertility: a real-world study using FAERS and EudraVigilance databases · Frontiers in Pharmacology · 2026
- Critical Appraisal of Artificial Intelligence for Rare-Event Recognition: Principles and Pharmacovigilance Case Studies · Drug Safety · 2026
- Unveiling the Limits of Anticholinergic Burden Scales: A Study of Adverse Drug Reactions in the French Pharmacovigilance Database · Drug Safety · 2026
- Revisiting ICH S7A after 25 years: Outcomes of a multi-stakeholder workshop and strategic pillars for modernizing safety pharmacology · Regulatory Toxicology and Pharmacology · 2026
- A real-world pharmacovigilance study of Xanomeline-Trospium events in the FDA adverse event reporting system (FAERS) · Psychiatry Research · 2026
- Analytic Misjudgment of Drug Safety Evidence and Causality: From the Prosecutor’s Fallacy and Simpson’s Paradox to Artificial Intelligence · Drug Safety · 2026
- Redefining Diagnostic and Management Approaches to Vancomycin Adverse Drug Reactions · The Journal of Allergy and Clinical Immunology In Practice · 2026
- Safety evaluation of Tofersen in amyotrophic lateral sclerosis based on the FAERS database · Frontiers in Neurology · 2026
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