Chinese Journal of Pharmacovigilance ›› 2026, Vol. 23 ›› Issue (4): 456-459.
DOI: 10.19803/j.1672-8629.20250819

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Safety Risks of Diprophylline Injection Preparations

ZHU Huijuan1, WANG Fang2, WANG Dan1, REN Jingtian1   

  1. 1Center for Drug Reevaluation, NMPA/NMPA Center for Innovation and Research in Regulatory Science, Beijing 100163, China;
    2The Pharmacovigilance Center of Hebei, Shijiazhuang Hebei 050000, China
  • Received:2025-11-17 Online:2026-04-15 Published:2026-04-15

Abstract: Objective To analyze reports of adverse reactions of diprophylline injection preparations so as to provide a reference for rational clinical use of the drug. Methods Related reports were retrieved from the National Adverse Drug Reaction Monitoring Database that were collected between January 1, 2004 and September 30, 2023 and from overseas databases that were collected from the inception to January 25, 2026. Related articles were retrieved from literature databases that were published from the inception to October 31, 2025. Risk control measures taken by drug regulatory authorities were summarized. The basic information of cases, organs or systems involved and clinical manifestations of adverse reactions related to diprophylline injection preparations were analyzed. Results Adverse drug reactions of diprophylline injection preparations involved multiple systems or organs. Nausea, vomiting, palpitations, chest discomfort, dyspnoea and pruritus were common manifestations. Diprophylline for injection was involved in a larger proportion of reports about severe adverse reactions than other diprophylline injection preparations. Most of the patients were aged 65 and older. Conclusion Clinicians should be alert to the adverse reactions caused by diprophylline injection preparations, inquire about the allergic history of patients before medication, especially hypersensitivity to dextran-based excipients, monitor the symptoms and signs of severe adverse reactions such as anaphylactic shock so as to offer immediate symptomatic treatment.

Key words: Diprophylline Injection, Dextran 40, Anaphylactic Shock, Dyspnoea, Adverse Drug Reaction

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