Cutaneous adverse events with antibody-drug conjugates: a FAERS-based pharmacovigilance study - Takeaways - MDSpire

Cutaneous adverse events with antibody-drug conjugates: a FAERS-based pharmacovigilance study

  • By

  • Huiwen Sun

  • Jinhan Chen

  • Qian Xu

  • Chen Chen

  • Jinsheng Yu

  • Qijin Shu

  • May 25, 2026

  • 0 min

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  • 1

    A total of 3,631 cutaneous adverse events (CAEs) linked to antibody-drug conjugates (ADCs) were identified in the FAERS database.

  • 2

    Thirty-one positive safety signals were detected, including common and severe manifestations like rash and Stevens-Johnson syndrome.

  • 3

    Enfortumab vedotin was associated with the highest number of CAE signals, while belantamab mafodotin showed minimal signals.

  • 4

    The median time-to-onset for CAEs was 15 days, with trastuzumab deruxtecan exhibiting the shortest latency.

  • 5

    Elderly patients and males were found to be more susceptible to ADC-related CAEs, highlighting the need for personalized risk management.

Original Source(s)

Cutaneous adverse events with antibody-drug conjugates: a FAERS-based pharmacovigilance study

  • by Huiwen Sun, Jinhan Chen, Qian Xu, Chen Chen, Jinsheng Yu, Qijin Shu

  • May 25, 2026

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