Amaryl Adverse Reactions

The following adverse reactions from clinical investigations are based on experience with Amaryl and other sulfonylureas and are listed as follows by system organ class and in order of decreasing incidence (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).
Metabolism and nutrition disorders: Rare: hypoglycaemia.
These hypoglycaemic reactions mostly occur immediately, may be severe and are not always easy to correct. The occurrence of such reactions depends, as with other hypoglycaemic therapies, on individual factors such as dietary habits and dose.
Eye disorders: Not known: visual disturbances, transient, may occur especially on initiation of treatment, due to changes in blood glucose levels.
Gastrointestinal disorders: Very rare: nausea, vomiting, diarrhoea, abdominal distension, abdominal discomfort and abdominal pain, which seldom lead to discontinuation of therapy.
Rare: dysgeusia.
Blood and lymphatic system disorders: Rare: thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, erythropenia, haemolytic anaemia and pancytopenia, which are in general reversible upon discontinuation of medication.
Not known: severe thrombocytopenia with platelet count less than 10,000/μl and thrombocytopenic purpura.
Immune system disorders: Very rare: leukocytoclastic vasculitis, mild hypersensitivity reactions that may develop into serious reactions with dyspnoea, fall in blood pressure and sometimes shock.
Not known: cross-allergenicity with sulfonylureas, sulfonamides or related substances is possible.
Hepato-biliary disorders: Not known: hepatic enzymes increased.
Very rare: hepatic function abnormal (e.g. with cholestasis and jaundice), hepatitis and hepatic failure.
Skin and subcutaneous tissue disorders: Not known: hypersensitivity reactions of the skin may occur as pruritus, rash, urticaria and photosensitivity.
Rare: alopecia.
Investigations: Very rare: blood sodium decrease.
Rare: weight gain.
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 national reporting system.