Abstract: Objective To analyze 97 cases of adverse drug reactions (ADRs) and related factors in thioctic acid injection, prevent or reduce the incidence of ADRs and promote the safety of clinical medication. Methods 97 cases of ADRs induced by thioctic acid injection from May 2014 to April 2017 in our hospital were retrospectively investigated and analyzed. Results ADR mainly affected the skin and its appendages (45.57%), followed by local injection damage (17.09%), digestive system (17.09%) and central and peripheral nervous system (9.49%). The ADRs mainly occurred on the first day of medication and most improved after 60 minutes with discontinuation or symptomatic treatment. ADRs were related to the patient's food and drug allergy history, off-label uses (including indications, usage, dosage, speed of infusion), the impurities and excipients of thioctic acid injection. Conclusion It is recommended that clinicians should strictly follow the instructions of thioctic acid injection in terms of indications, daily dose, solvent, concentration, drip rate and light avoidance, and the manufacturers should purify thioctic acid injection further so as to reduce the occurrence of ADRs.

Key words: thioctic acid injection, adverse drug reaction, related factors