Tablet: Side effects, as with amoxicillin, are uncommon and mainly of mild and transitory nature. Gastrointestinal reactions, effects include diarrhea, indigestion, nausea and vomiting. Candidiasis, antibiotic associated colitis (including pseudomembranous colitis and haemorrhagic colitis) have been reported rarely. Nausea, although uncommon, is more often associated with higher oral dosages. If gastrointestinal side effects occur with oral therapy, they may be reduced by taking INDCLAV* at the start of meal. As with other antibiotics, gastrointestinal side effects may be raised in children under 2 years. In clinical trials, however, only 4% of children under 2 years were withdrawn from treatment.
Hepatic effects: A moderate rise in AST and/or ALT has been noted in patients with semi-synthetic penicillins, but the significance of these findings is unknown.
Hepatitis and cholestatic jaundice have been reported rarely with INDCLAV*. They may be severe and continue for several months. They are reported as occurring predominantly in adult or elderly patients and slightly more frequently in males. Signs and symptoms may occur during treatment but are more frequently reported after cessation of therapy with a delay of up to six weeks. The hepatic events are usually reversible. However, in extremely rare circumstances, deaths have been reported. Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment.
Hypersensitivity reactions: Urticarial and erythematous rashes sometimes occur. Rarely, erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis and exfoliative dermatitis have been reported. Treatment should be discontinued if one of these types of rash appears.
In common with other beta-lactam antibiotics, angioedema, anaphylaxis, serum sickness-like syndrome and hypersensitivity vasculitis have been reported.
Interstitial nephritis can occur rarely.
Haematological effects: As with other beta-lactams, reversible leucopenia (including neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia have been reported rarely. CNS effects have been seen very rarely. These include reversible hyperactivity, dizziness, headache and convulsions. Convulsions may occur with impaired renal function or in those receiving high doses.
Syrup: Gastrointestinal side-effects, such as nausea, vomiting and diarrhoea, seem to be more common with amoxicillin/Clavulanic acid than with amoxicillin alone.