Budenofalk Adverse Reactions



Dr Falk


Agencia Lei Va Hong


A. Menarini
Full Prescribing Info
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.)

Click on icon to see table/diagram/image

The following adverse reactions were additionally reported in clinical studies with Budenofalk 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 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.
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 according to the guidelines issued by the local health authority.
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