Abstract: Objective To analyze the characteristics of adverse drug reactions (ADRs) induced by inosine injection and provide references for safe medications. Methods A total of 214 cases of ADRs induced by inosine injection collected in 2004-2025 were retrieved from the Adverse Drug Reaction Monitoring System of Yunnan Province. Statistical analysis was conducted of the patients’ gender, age, systems-organs involved and clinical manifestations, indications for medication, combined medications, and onset time of ADRs. Results The male-to-female ratio was 0.57:1. Most of the adverse reactions caused by inosine for injection occurred in patients over 65 years old. The primary diseases were indications that were not recorded in package inserts in 57 patients (26.64%). Combined medications included electrolyte/acid-base balance/ nutrition agents, enzymes and other biochemical agents (113 cases, 52.80%). Adverse reactions usually started within 30 minutes of medication. ADRs primarily involved the skin and appendages, the whole body, sites of injection and the gastrointestinal system. The new serious clinical manifestations were rigors, hyperpyrexia, dyspnea, palpitations, anaphylactoid reaction, purpura, anaphylactic shock and hypersensitivity. Conclusion Clinicians should be alert to ADRs caused by inosine for injection in clinical practice, standardize clinical medications, and prevent such serious adverse reactions as anaphylaxis.

Key words: Inosine Injection, Anaphylaxis Shock, Anaphylactoid Reaction, Rational Drug Use, Adverse Drug Reaction