Pentasa Adverse Reactions

Tablet/Suppository: The most frequent adverse reactions seen in clinical trials are diarrhea (3%), nausea (3%), abdominal pain (3%), headache (3%), vomiting (1%), and rash (1%). Hypersensitivity reactions and drug fever may occasionally occur.
Frequency of adverse effects, based on clinical trials and reports from post-marketing surveillance: Common (≥1% and <10%): Headache, diarrhea, abdominal pain, nausea, vomiting, rash.
Rare (≥0.01% and <0.1%): Myo- and pericarditis, increased amylase, pancreatitis.
Very Rare (<0.01%): Reversible alopecia, isolated reports of lupus erythematosus-like reactions, increased liver enzymes and bilirubin, hepatotoxicity, abnormal renal function, allergic lung reactions, myalgia, arthralgia, eosinophilia, anemia, aplastic anemia, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.
Following rectal administration, local reactions eg, pruritus, rectal discomfort and urge may occur.
Several of these adverse reactions can also be attributed to the inflammatory bowel disease itself.
Granules: 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, and severe cutaneous adverse reactions, including SJS and TEN, have been reported in association with mesalazine treatment (see Precautions). (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.