The most frequent adverse reactions seen in clinical trials are diarrhoea, nausea, abdominal pain, headache, vomiting, and rash.
Hypersensitivity reactions and drug fever may occasionally occur.
Following rectal administration local reactions such as pruritus, rectal discomfort and urge may occur (for Enema and Suppository only).
Frequency of adverse effects, based on clinical trials and reports from post-marketing surveillance. (See Table 2.)
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It is important to note that several of these disorders can also be attributed to the inflammatory bowel disease itself.