Budenofalk Rectal Foam 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.)

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The following adverse reactions were additionally reported in clinical studies with Budenofalk 2mg rectal foam (frequency: uncommon): increased appetite, increase in erythrocyte sedimentation rate, leucocytosis, nausea, abdominal pain, flatulence, paraesthesias in the abdominal region, anal fissure, aphthous stomatitis, frequent urge to defecate, rectal bleeding, increase in transaminases (GOT, GPT), increase in parameters of cholestasis (GGT,AP), increase in amylase, change in cortisol, urinary tract infection, dizziness, disturbances of smell, insomnia, increased sweating, asthenia, increase in body weight.
Most of the adverse events mentioned in this SmPC 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.
Some of these undesired effects were reported after long-term use of orally administered budesonide.
Due to its local action, the risk of undesired effects of Budenofalk rectal foam is generally lower than with systemically acting glucocorticoids.
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.