Identification of Top 15 Drugs Associated with Anaphylaxis: A Pharmacovigilance Study

Strategic Insights -

Research at Kyung Hee University Medical Center in Seoul, South Korea, has identified 15 frequently reported drugs associated with anaphylaxis, a severe and potentially life-threatening allergic reaction. The study, supported by the Ministry of Science and ICT, analyzed data from a global pharmacovigilance database to identify reports of drug-associated anaphylaxis and estimated signal detections using two metrics: the information component (IC) and the reporting odds ratio (ROR).

Key Takeaways:

  • The top 15 drugs associated with anaphylaxis were identified through a global pharmacovigilance database analysis.
  • Diclofenac recorded the highest number of reports at 34,413, while cefuroxime indicated the strongest signal detection with anaphylaxis (ROR, 40.89 [95% CI, 40.18-41.61]; IC, 5.14 [IC, 5.11]).
  • Sensitivity analysis revealed a stronger signal detection between the COVID-19 vaccine and anaphylaxis than in the primary analysis (ROR, 2.49 [95% CI, 2.45-2.53]; IC, 1.23 [IC, 1.21]).
  • Time-to-onset analysis showed distinct patterns for certain drugs, suggesting different mechanisms of anaphylaxis.
  • Omalizumab was often associated with reactions occurring after 24 hours, while most drugs reported reactions occurring within 2.5 hours.
  • The study concluded that due to the limitations of spontaneous reporting databases with disproportionality analysis, findings do not permit causal inference.

Statistics:

  • 15 drugs were identified as frequently associated with anaphylaxis.
  • Diclofenac had the highest number of reports at 34,413.
  • Cefuroxime indicated the strongest signal detection with anaphylaxis (ROR, 40.89 [95% CI, 40.18-41.61]; IC, 5.14 [IC, 5.11]).
  • COVID-19 vaccine indicated a stronger signal detection between anaphylaxis in the sensitivity analysis (ROR, 2.49 [95% CI, 2.45-2.53]; IC, 1.23 [IC, 1.21]).
  • 66% of drug-associated anaphylaxis reports occurred within 2.5 hours.
  • 24% of omalizumab-associated anaphylaxis reactions occurred after 24 hours.

Sources:

  • NewsRx. Kyung Hee University Medical Center Reports Findings in COVID-19 (Identification of the Top 15 Drugs Associated With Anaphylaxis: A Pharmacovigilance Study). Chemicals & Chemistry. June 27, 2025; p 7.
  • Identification of the Top 15 Drugs Associated With Anaphylaxis: A Pharmacovigilance Study. Clinical & Experimental Allergy, 2025.