[Analysis of 101 new adverse drug reactions caused by articaine and epinephrine injection].

Objective: To provide guidance for rational clinical medication, reduce the incidence of adverse drug reactions (ADR) to articaine and epinephrine injection, and to investigate the causes and patterns of ADR associated with local anesthetics used in dentistry, thereby offering a reference for clinical practice. Methods: A retrospective analysis was conducted on 101 patients who received treatment with articaine and epinephrine injection (identified by its generic name) at the Department of Pharmacy, Yantai Stomatological Hospital Affiliated to Binzhou Medical College between January 2022 and March 2025. Statistical analysis was performed on the occurrence of new ADR. New ADR were defined as those not listed in the drug's prescribing information, or those where the nature, severity, outcome, or frequency of the reaction differed from or was more severe than described in the information. Data analyzed included patient gender, age (range: 4 to 72 years), body weight (20 to 88 kg), time of ADR onset, and symptoms. Results: Among the 101 reported new ADR, two were serious. One case involved ulceration and necrosis at the injection site, which resolved after 35 days of medical treatment. The other was an allergic reaction manifested as blurred vision and cardiac discomfort, requiring emergency intervention. The remaining 99 cases were new non-serious ADR. Among these, ulceration at the injection site was the most common, accounting for 81.82% (81/99). Local skin reactions at the injection site, such as discoloration, swelling, and pain, comprised approximately 13.13% (13/99). Cardiovascular and central nervous system reactions, including chest tightness, vomiting, palpitations, limb weakness, and dizziness, accounted for 4.04% (4/99). Single cases of skin blistering, pain with cold clammy skin at the injection site, and lip swelling were also reported. Conclusions: The spectrum of new ADR associated with articaine and epinephrine injection is primarily characterized by ulceration at the injection site. Other commonly observed reactions include pain, rash, and pruritus at the injection site, as well as palpitations, cold sweats, dizziness, nausea, and hypotension.