The undesirable effects of acarbose found in the placebo controlled clinical trials and classified according to CIOMS III frequency categories (placebo controlled studies in the clinical trial database: acarbose N = 8595; placebo N = 7278; status: 10 February 2006) are described below.
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 postmarketing surveillance (status: 31 Dec 2005), and for which a frequency could not be estimated, are listed under “not known”.
System Organ Class (MedDRA) | Very Common | Common | Uncommon | Rare | Not known |
Blood and the lymphatic system disorders | | | | | Thrombocytopenia |
Immune system disorders | | | | | Drug hypersensivity and hypersensivity (rash, erythema, exanthema, urticaria) |
Vascular disorders | | | | Oedema | |
Gastrointestinal disorders | Flatulence | Diarrhoea Gastrointestinal and abdominal pains | Nausea Vomiting Dyspepsia | | Subileus/Ileus Pneumatosis cystoidis intestinalis i |
Hepatobiliary disorders | | | Increase in transaminases. | Jaundice | Hepatitis |
Skin and subcutaneous tissue disorders | | | | | acute generalised exanthematous pustulosis |
“The MedDRA preferred term is used to describe a certain reaction and its synonyms and related conditions. ADR term representation is based on MedDRA version 11.1”.
In postmarketing, cases of liver disorder, hepatic function abnormal, and liver injury have been reported. Individual cases of fulminant hepatitis with fatal outcome have also been reported, particularly from Japan.
The lack of compliance with the prescribed diet may give rise to intensification of intestinal side effects. In the event that they should appear in spite of complying with the prescribed diabetic diet, the doctor should be consulted and the dose reduced either temporarily or permanently.
In patients treated with the recommended daily dose of 150 mg to 300 mg acarbose a day, clinically relevant abnormal liver function tests (3 times above normal limits) were rarely observed. Abnormal values may be transient during treatment with acarbose (see section 4.4).
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.