The frequencies of ADRs reported with Glucobay based on placebo-controlled studies sorted by CIOMS III categories of frequency (placebo-controlled studies in clinical trial database: Glucobay N=8595; placebo N=7278; status: 10 Feb 2006) are summarized in the table as follows:
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000).
The ADRs identified only during post-marketing surveillance (status: 31 Dec 2005), and for which a frequency could not be estimated are listed under "not known".
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In addition events reported as liver disorder, abnormal hepatic function and liver injury have been received especially from Japan.
Individual cases of fulminant hepatitis with fatal outcome have been reported in Japan. The relationship to Glucobay is unclear.
If the prescribed diabetic diet is not observed, the intestinal side effects may be intensified.
If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced.
In patients receiving the recommended daily dose of Glucobay 150-300 mg/day, rarely clinically relevant abnormal liver function tests (3 times above upper limit of normal range) were observed. Abnormal values may be transient under ongoing Glucobay therapy.