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Pharmacovigilance analysis of the FGFR inhibitor futibatinib using the FDA adverse event reporting system (FAERS)

Connor Frey1

  • 1Department of Medicine, University of British Columbia, Vancouver, BC, Canada.

Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners
|March 21, 2026
PubMed

Insights

Futibatinib, an FGFR inhibitor for cancer, shows safety signals including hyperphosphatemia and nail toxicities. Further research is needed to understand these adverse events and guide clinical use.

Area of Science:

  • Pharmacology
  • Oncology
  • Drug Safety

Background:

  • Futibatinib is a novel fibroblast growth factor receptor (FGFR) inhibitor.
  • It shows promise for treating cancers with specific FGFR alterations.
  • The safety profile of futibatinib requires further investigation.

Purpose of the Study:

  • To evaluate adverse events associated with futibatinib.
  • To utilize the FDA Adverse Event Reporting System (FAERS) for pharmacovigilance.
  • To identify potential safety signals of futibatinib.

Main Methods:

  • Retrospective pharmacovigilance analysis of FAERS data (January 2013 - March 2025).
  • Disproportionality analysis using OpenVigil 2.1.
  • Safety signals defined by reporting odds ratio (ROR) > 2.00 and 95% CI lower bound > 1.00.

Main Results:

  • Strong safety signals identified for futibatinib.
  • Hyperphosphatemia (ROR 1612.73) and elevated blood phosphorus (ROR 603.85) were highly associated.
  • Dermatologic toxicities, including onycholysis (ROR 520.15) and onychoclasis (ROR 126.20), were also notable.

Conclusions:

  • Futibatinib is associated with a range of adverse events.
  • These events may result from direct drug effects and patient variability.
  • Further studies are necessary to elucidate mechanisms and inform clinical management.
Keywords:
FAERSFGFR inhibitorFutibatinibadverse drug reactionpharmacovigilance

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