Gastrointestinal toxicity associated with cyclin-dependent kinase 4/6 inhibitors in breast cancer patients: insights from a real-world pharmacovigilance analysis - Takeaways - MDSpire

Gastrointestinal toxicity associated with cyclin-dependent kinase 4/6 inhibitors in breast cancer patients: insights from a real-world pharmacovigilance analysis

  • By

  • Mengjiao Lu

  • Lei Yuan

  • Junjie Liu

  • Yifeng Dou

  • Jinguo Cui

  • July 15, 2026

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  • 1

    The study analyzed 63,722 reports of gastrointestinal adverse events (AEs) linked to CDK4/6 inhibitors in breast cancer patients.

  • 2

    Palbociclib was associated with the highest number of GI AEs, particularly oropharyngeal and upper GI events.

  • 3

    Ribociclib had the highest proportion of serious GI reports, with 82.38% classified as serious and 14.25% resulting in fatal outcomes.

  • 4

    Abemaciclib's most frequently reported GI AE was diarrhea, which was identified as its strongest disproportionate reporting signal.

  • 5

    Over 80% of positive GI pharmacovigilance signals were not included in the current prescribing information for these agents.

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