The most frequent adverse effects were gastrointestinal symptoms (2.64%), mainly nausea, vomiting, epigastric discomfort, abdominal pain, diarrhoea and anorexia. These were followed by CNS effects (0.89%: Headache, dizziness and sleep disturbances) and dermatological or hypersensitivity reactions (0.53%: Skin eruption, pruritus, rash, eczema and itching). The incidence or severity of these various adverse effects did not appear to be dose-related and serious reactions were rare.
Minor changes in mean laboratory values were not considered clinically significant and were usually attributable to the disease process, but some cases of eosinophilia were considered possibly drug-related. Shock and shock-like symptoms (discomfort, perspiration, dyspnoea and hypotension) may occasionally occur.
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