Abstract: Objective To analyze the safety risks of ranitidine hydrochloride injection preparations and provide a reference for safe medication. Methods Related data from the National Adverse Drug Reaction Monitoring Database (collected in 2004-2023), foreign databases (collected from inception to October 2025), domestic and foreign literature (published from inception to October 2025), and from drug inserts was compared while precautions against risks taken by drug regulators were analyzed. Results The number of reports about adverse reactions related to ranitidine hydrochloride injection preparations had trended upward since 2021. Patients ages 45 to 64 were a high-risk group. The dosage had to be adjusted for patients with renal insufficiency and patients with liver dysfunction had to use it with caution. Reports of serious reactions accounted for 12.63% of the total, with systemic diseases and reactions at the site of administration dominating. Reports about anaphylactic shock accounted for 10.86% of the total of reports on serious reactions. Rapid administration could induce serious adverse reactions like arrhythmia. Meanwhile, there were differences in information about safety between domestic and foreign drug inserts. Conclusion Marketing authorization holders of drugs should devote more effort to the monitoring of adverse reactions of the drug while offering guidance. Clinicians ought to take into consideration the patient’s age and liver and kidney function when giving prescriptions. The concentration and speed of administration should be under rigorous control to prevent serious adverse reactions such as anaphylactic shock.

Key words: Ranitidine, Allergic Shock, Adverse Drug Reactions, Risk, Safety