No signal of interactions between influenza vaccines and drugs used for chronic diseases: a case-by-case analysis of the vaccine adverse event reporting system and vigibase

Carla Carnovale, Emanuel Raschi, Luca Leonardi, Ugo Moretti, Fabrizio De Ponti, Marta Gentili, Marco Pozzi, Emilio Clementi, Elisabetta Poluzzi, Sonia Radice

Research output: Contribution to journalArticle


Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and VigiBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from Vigibase were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5–7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful.

Original languageEnglish
Pages (from-to)363-381
Number of pages20
JournalExpert Review of Vaccines
Issue number4
Publication statusPublished - Mar 10 2018



  • Adverse event following immunization
  • antiepileptic toxicity
  • haemorrages
  • influenza vaccination
  • rhabdomyolysis
  • spontaneous reporting system database
  • vaccine-drug interactions

ASJC Scopus subject areas

  • Immunology
  • Molecular Medicine
  • Pharmacology
  • Drug Discovery

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