Cortiment Adverse Reactions

Adverse drug reactions reported in clinical trials with Budesonide (CORTIMENT) are presented in Table 2. Adverse drug reactions reported for the therapeutic class are presented in Table 3. In Phase II and III clinical trials, the incidence of adverse events for Budesonide (CORTIMENT) tablets, at the recommended dose of 9 mg/day, was comparable to placebo. Most adverse events were of mild to moderate intensity and of a non-serious nature.
Adverse reactions reported are listed according to the following frequency: 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); very rare (< 1/10,000). (See Tables 2 and 3.)

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Most of the adverse events mentioned in this package insert can also be expected for other treatments with glucocorticoids.
Side effects typical of systemic glucocorticosteroids (e.g. cushingoid features and growth retardation) may occur. These side effects are dependent on dose, treatment time, concomitant and previous corticosteroid intake and individual sensitivity.
Paediatric population: No data available.
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.