Analysis of adverse drug reactions of azathioprine in the treatment of patients with inflammatory bowel disease

Abstract

Objective To summarize the current situation, management and prognosis of adverse drug reactions (ADRs) of azathioprine (AZA) in treating patients suffered from inflammatory bowel disease (IBD). Methods A retrospective analysis was conducted based on the data of 364 IBD patients, including 292 cases of Crohn′s disease and 72 cases of ulcerative colitis, who were treated with AZA from December 1994 to September 2015 at Sir Run Run Shaw Hospital. Results Among the 364 patients with inflammatory bowel disease, a total of 178 adverse events were observed in 147 patients (40.4% of all the patients), including myelotoxicity in 74 cases, hepatic dysfunction in 31 cases, gastrointestinal reaction in 18 cases, infection in 14 cases, arthralgia in 11 cases, besides, other 30 adverse events included pancreatitis, dizziness, headache, tetter, alopecia, fever and so on. 42.1% (75/178) of adverse events occurred within the first month of therapy. 20.1% of patients (73/364) stopped the administration because of the side effects, and among them, 52.1% (38/73) of patients stopped in the first month of therapy. All the adverse reactions could be self-recovered or recovered under proper treatment. There were no irreversible and fatal cases in this study. Conclusions Rates of adverse reactions and drug-withdraw in IBD patients treated by AZA are quite high. The clinical manifestations of ADRs are varied, usually in myelotoxicity and abnormal liver function. Close attention should be paid to the ADRs caused by AZA, especially at the beginning of therapy. ADRs about special infections, pancreatitis and agranulocytosis are rare. AZA is relatively safe. Key words: Ulcerative colitis; Crohn′s disease; Azathioprine; Adverse reaction