Budenofalk Adverse Reactions

The following frequency conventions are used in the evaluation of undesirable effects: 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), not known (cannot be estimated from the available data). (See Table 2.)

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Most of the adverse events mentioned in this monograph can also be expected for treatments with other glucocorticosteroids.
Occasionally, adverse events may occur which are typical for systemic glucocorticosteroids. These adverse events depend on the dosage, the period of treatment, concomitant or previous treatment with other glucocorticosteroids and the individual sensitivity.
Clinical studies showed that the frequency of glucocorticosteroid-associated adverse events is lower with oral Budenofalk than with oral treatment of equivalent dosages of prednisolone.
An exacerbation or the reappearance of extra-intestinal manifestations (especially affecting skin and joints) can occur on switching a patient from systemically acting glucocorticosteroids to the locally acting budesonide.
Undesirable effects in clinical studies in patients with autoimmune hepatitis: In a clinical study involving patients with autoimmune hepatitis, undesirable effects were reported in 57% of the 102 patients treated with budesonide (by comparison: in 79% of the 105 patients on prednisone). The most common undesirable effects reported in those patients on budesonide were skin changes (particularly acne) [23% of those treated], endocrine disorders, such as Cushing's symptoms [16% of those treated], gastrointestinal disorders [14% of those treated], psychiatric disorders (mainly mood swings) [14% of those treated] and headache [12% of those treated]. With the exception of headache, these undesirable effects were observed more rarely with budesonide than with prednisone.