In a trial using thalidomide 200 to 300 mg/day, sedation was reported to some extent by all patients, often requiring a reduction in the dose. Overall, three of the 22 patients (14%) discontinued the drug because of adverse events. The safety profile improved in a trial using a lower dose (50 to 100 mg/day); the most common side effects were sedation (58%), peripheral neuropathy (42%), edema (17%) and dermatitis (8%), and were reported to be mild and mostly transient.
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For patients with inflammatory bowel disease (IBD), the overall rate of side effects with long term 6-MP treatment was 15%, including infections (7%), pancreatitis (3%), bone marrow depression (2%), allergic reactions (2%) and hepatitis (0.3%). In a meta-analysis, withdrawal of therapy because of adverse events was reported in 27 of 302 (8.9%) patients treated with AZA or 6-MP, and in six of 353 (1.7%) patients given placebo. The frequency of malignancy in patients treated over the long term with AZA or 6-MP for IBD has been reported to be 3% to 4% (31,32). Although this rate may represent an increased risk compared with that of control populations, it is suggested that the risk is due to an increased incidence of malignancy, mostly lymphoma, in patients with IBD.