No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines.
The ADRs derived from clinical studies and post-marketing surveillance with Augmentin, sorted by MedDRA System Organ Class are listed below.
The following terminologies have been used in order to classify the occurrence 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)
|Infections and infestations|
|Overgrowth of non-susceptible organisms||Not known|
|Blood and lymphatic system disorders|
|Reversible leucopenia (including neutropenia)||Rare|
|Reversible agranulocytosis||Not known|
|Haemolytic anaemia||Not known|
|Prolongation of bleeding time and prothrombin time1||Not known|
|Immune system disorders10|
|Angioneurotic oedema||Not known|
|Serum sickness-like syndrome||Not known|
|Hypersensitivity vasculitis||Not known|
|Nervous system disorders|
|Reversible hyperactivity||Not known|
|Aeseptic meningitis||Not known|
|Antibiotic-associated colitis4||Not known|
|Black hairy tongue||Not known|
|Rises in AST and/or ALT5||Uncommon|
|Cholestatic jaundice6||Not known|
|Skin and subcutaneous tissue disorders7|
|Stevens-Johnson syndrome||Not known|
|Toxic epidermal necrolysis||Not known|
|Bullous exfoliative-dermatitis||Not known|
|Acute generalised exanthemous pustulosis (AGEP)9||Not known|
|Renal and urinary disorders|
|Interstitial nephritis||Not known|
3 Nausea is more often associated with higher oral doses. If gastrointestinal reactions are evident, they may be reduced by taking amoxicillin/clavulanic acid with a meal.
4 Including pseudomembranous colitis and haemorrhagic colitis (see section 4.4)
5 A moderate rise in AST and/or ALT has been noted in patients treated with beta-lactam class antibiotics, but the significance of these findings is unknown.
6 These events have been noted with other penicillins and cephalosporins (see section 4.4).
7 If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued (see section 4.4).