Psychiatric Adverse Events Associated with Oseltamivir: An In-Depth Review of Evidence

Background:The potential risk of neuropsychiatric adverse events (NPAEs) associated with oseltamivir has been controversial since its market launch, with inconsistent conclusions across different studies, and the product label does not clearly describe the role of oseltamivir in these adverse events.Methods: This article integrates multisource evidence through evidence-based methods, critically evaluates and analyzes key evidence based on the hierarchy of evidence pyramid, and clarifies the specific association between oseltamivir and psychiatric adverse events, the strength of the association, and high-risk factors, providing a scientific basis for clinical decision-making and regulatory measures.Results: Based on current evidence, oseltamivir is unlikely to increase the risk of psychiatric adverse events under the standard dosage and administration guidelines and label instructions, irrespective of its use for the treatment or prevention of influenza.However, prolonged exposure (for 6 weeks, number needed to harm of 94), high-dose regimen (150 mg, twice daily, number needed to harm of 150), and adolescents aged 10-19 years (adjusted HR 2.69, 95% CI 1.05-6.93)may be high-risk factors for psychiatric adverse events. Conclusion:Clinical applications should extensively consider the indications, weigh the benefits and risks, and use the drug rationally; psychiatric-related adverse events should not be solely attributed to oseltamivir.