Emerging and Established Adverse Events of Pasireotide: A Twelve-Year Pharmacovigilance Study

Endocr PractPublished Pharmacovigilance study

Authors' conclusion

This study underscores the need for ongoing pharmacovigilance to detect both established and emerging AEs associated with pasireotide. Implementing personalized monitoring strategies based on demographic factors such as age and sex can help mitigate risks and optimize treatment outcomes, enhancing patient safety in clinical practice.

Study context

Population
Pasireotide-related AE reports in the FDA Adverse Event Reporting System, Q4 2012 to Q3 20247,892 adverse events (AEs)
Outcome
Pasireotide-related AEs
Methodological detailsretrospective disproportionality analysis of FDA Adverse Event Reporting System (FAERS), disproportionality analysis (ROR, PRR, BCPNN, MGPS), subgroup analyses by demographics
  • Retrospective disproportionality analysis of FAERS
  • Disproportionality analysis (ROR, PRR, BCPNN, MGPS)
  • Subgroup analyses by demographics

Main finding

As reported in the abstract

Pasireotide-related AEs identified

7892

System organ classes involved

27

Observational data: associations, not effects.

Further findings

AEs by demographic subgroup

Metabolic AEs more prevalent in females; males reported higher rates of gastrointestinal symptoms
Older patients more susceptible to cardiovascular AEs

Original publication

Emerging and Established Adverse Events of Pasireotide: A Twelve-Year Pharmacovigilance Study. Endocr Pract. Published 15 April 2025. doi:10.1016/j.eprac.2025.04.005

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