Nefecon Adverse Reactions

Summary of the safety profile: In the Nefecon phase 3 clinical study the most commonly reported adverse drug reactions were acne reported in approximately 10% of patients, hypertension, peripheral oedema, face oedema, and dyspepsia, each occurring in approximately 5% of patients; these were mainly of mild or moderate severity and reversible, reflecting the low systemic exposure to budesonide after oral administration.
Tabulated list of adverse reactions: Adverse drug reactions reported in the pivotal phase 3 clinical study with Nefecon are presented in the table. (See table.)
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).

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Description of selected adverse reactions: Potential class effects: Adverse drug reactions typical of systemic glucocorticosteroids may occur (e.g., cushingoid features, increased blood pressure, increased risk of infection, delayed wound healing, reduced glucose tolerance, sodium retention with oedema formation, muscle weakness, osteoporosis, glaucoma, mental disorders, peptic ulcer, increased risk of thrombosis). These adverse drug reactions are dependent on dose, treatment time, concomitant and previous glucocorticosteroid intake, and individual sensitivity. Not all of these adverse reactions were observed in the clinical study program of Nefecon.
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.