Mezavant XL Adverse Reactions

The most frequently reported adverse drug reactions (ADRs) within the pooled safety analysis of clinical studies with Mezavant XL, including 3,611 patients, were colitis (including ulcerative colitis) 5.8%, abdominal pain 4.9%, headache 4.5%, liver function test abnormal, 2.1%, diarrhoea 2.0%, and nausea 1.9%.
Adverse reactions are listed by System Organ Class (see table as follows). Within each system organ class, adverse reactions are listed under headings of frequency using the categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from the available data). (See Table 2.)

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Description of selected adverse reactions: Increased intracranial pressure: Cases of increased intracranial pressure with papilledema (pseudotumor cerebri or benign intracranial hypertension) have been reported with the use of mesalamines. If undetected, this condition may result in restriction of the visual field and may progress to permanent loss of vision. Mesalamine should be discontinued, if this syndrome occurs.
Photosensitivity: More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN): Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment (see Precautions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.