Chinese Journal of Pharmacovigilance ›› 2026, Vol. 23 ›› Issue (10): 1185-1187.
DOI: 10.19803/j.1672-8629.20260498

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One case of fulminant type 1 diabetes mellitus complicated with diabetic ketoacidosis and hyperosmolar hyperglycemic state caused by nivolumab

Wang Zebin1,2, Jiang Zhiwei2, Gong Guanwen2*   

  1. 1The First School of Clinical Medicine, Nanjing University of Chinese Medicine, Nanjing Jiangsu 210023, China;
    2Department of General Surgery, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing Jiangsu 210029, China
  • Received:2026-06-16 Online:2026-10-15 Published:2026-10-16

Abstract: Objective To explore the clinical characteristics, underlying pathogenesis, and management strategies related to nivolumab-induced fulminant type 1 diabetes mellitus (FT1DM) complicated by diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) in order to provide crucial pharmacovigilance insights for safe medication. Methods The clinical data of a patient with bladder urothelial carcinoma, who developed FT1DM and severe metabolic derangements following nivolumab therapy, was retrospectively analyzed. Causality was assessed and the mechanism was explored based on literature review. Results The patient experienced an abrupt onset of FT1DM concurrent with DKA and HHS following the administration of nivolumab. The causality between this adverse drug reaction and nivolumab was graded as “probable”. Following aggressive fluid resuscitation and intensive insulin therapy, the metabolic crisis was reversed. However, the patient was discharged with lifelong dependence on exogenous insulin replacement. Conclusion Nivolumab can precipitate FT1DM, a life-threatening condition characterized by rapid progression and irreversible destruction of pancreatic islets. Routine glycemic monitoring should be mandated during clinical administration. Notably, high-dose corticosteroids are contraindicated in suspected cases. Early recognition and a multidisciplinary approach are critical to preventing fatal outcomes.

Key words: Nivolumab, Fulminant Type 1 Diabetes Mellitus(FT1DM), Diabetic Ketoacidosis(DKA), Hyperosmolar Hyperglycemic State(HHS), Immune-Related Adverse Events(irAEs)

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