Signal mining of adverse reactions for neuraminidase inhibitors in pregnant women: a disproportionality analysis based on the FDA adverse event reporting system database - Report - MDSpire

Signal mining of adverse reactions for neuraminidase inhibitors in pregnant women: a disproportionality analysis based on the FDA adverse event reporting system database

  • By

  • Bo Cao

  • Mingfeng Shen

  • Chenchen Du

  • Qiuping Song

  • Zhongjie Ma

  • June 16, 2026

  • 0 min

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Clinical Report: Adverse Effects of Neuraminidase Inhibitors in Pregnant Women

Overview

This study analyzes adverse events associated with neuraminidase inhibitors (NAIs) in pregnant women using the FDA Adverse Event Reporting System database.

Background

Influenza poses increased risks for pregnant women, leading to severe complications and adverse birth outcomes. Neuraminidase inhibitors are recommended for treating influenza in this population.

Data Highlights

DrugAdverse EventsStrongest AE Signals
OseltamivirInjury, poisoning, procedural complicationsProctitis, infantile acne, congenital intestinal obstruction, placental necrosis
ZanamivirInjury, poisoning, procedural complicationsDelivery, bronchospasm, pneumothorax, exposure during pregnancy

Key Findings

  • 3,687 adverse drug event reports were analyzed from Q1 2004 to Q3 2025.
  • Oseltamivir had 3,211 reports, while zanamivir had 471 reports.
  • Significant adverse events for oseltamivir included complications related to pregnancy and general disorders.
  • For zanamivir, significant adverse events included respiratory and procedural complications.
  • The study identified five strongest adverse event signals for both oseltamivir and zanamivir.

Clinical Implications

The findings provide essential data for clinicians regarding the safety of neuraminidase inhibitors in pregnant women. Awareness of potential adverse events can guide treatment decisions and enhance patient safety.

Conclusion

This study contributes valuable insights into the safety profile of neuraminidase inhibitors in pregnant women, supporting their use in clinical practice while highlighting the need for ongoing monitoring of adverse events.

Related Resources & Content

  1. CDC, Recommendations for Obstetric Health Care Providers Related to Use of Antiviral Medications for the Treatment and Prevention of Influenza, 2025
  2. CDC, Influenza Antiviral Medications: Summary for Clinicians, 2025
  3. Drugs - Real World Outcomes — Association Between Prostaglandin Eye Drops and Pregnancy Loss: A Disproportionality Analysis Utilizing Japanese and US Spontaneous Reporting Systems
  4. Drug Safety — Evaluation of Adverse Events in Pregnant Individuals Following COVID-19 and Influenza Vaccination: A Disproportionality Analysis Utilizing Combined US VAERS and EudraVigilance Data
  5. Drug Safety — Assessing the Dependability of Identifying Drug–Drug Interactions Linked to Elevated Gestational Diabetes Risk in Adverse Event Reporting Systems
  6. Drug Safety — Pregnancy Outcomes in Individuals Treated with Upadacitinib: A Review of Clinical Trial and Postmarketing Data
  7. Recommendations for Obstetric Health Care Providers Related to Use of Antiviral Medications for the Treatment and Prevention of Influenza | Influenza (Flu) | CDC
  8. Influenza Antiviral Medications: Summary for Clinicians | Influenza (Flu) | CDC

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