Amoksiklav Adverse Reactions

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting.
The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin/clavulanic acid, sorted by MedDRA System Organ Class are listed as follows.
The following terminologies have been used in order to classify the occurence 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: Common: Mucocutaneous candidosis.
Not known; Overgrowth of non-susceptible organisms.
Blood and lymphatic system disorders: Rare: Reversible leucopenia (including neutropenia), thrombocytopenia.
Not known: Reversible agranulocytosis, haemolytic anaemia, prolongation of bleeding time and prothrombin time¹.
Immune system disorders¹⁰: Not known: Angioneurotic oedema, anaphylaxis, serum sickness-like syndrome, hypersensitivity vasculitis.
Nervous system disorders: Uncommon: Dizziness, headache.
Not known: Reversible hyperactivity, convulsions², aseptic meningitis.
Gastrointestinal disorders: Very common: Diarrhoea.
Common: Nausea³, vomiting.
Uncommon: Ingestion.
Not known: Antibiotic-associated colitis⁴, back hairy tongue, tooth discolouration¹¹.
Hepatobiliary disorders: Uncommon: Rises in AST and/or ALT⁵.
Not known: Hepatitis⁶, cholestatic jaundice⁶.
Skin and subcutaneous tissue disorders⁷: Uncommon: Skin rash, pruritus, urticaria.
Rare: Erythema multiforme.
Not known: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative-dermatitis, acute generalized exanthemous pustulosis (AGEP)⁹ and drug reaction with eosinophilia and systemic symptoms (DRESS).
Renal and urinary disorders: Not known: Interstitial nephritis, crystalluria⁸.
¹See Precautions.
²See Precautions.
³Nausea is more often associated with higher oral doses. If gastrointestinal reactions are evident, they may be reduced by taking amoxicillin/clavulanic acid at the start of a meal.
⁴Including pseudomembranous colitis and haemorrhagic colitis (see Precautions).
⁵A 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.
⁶These events have been noted with other penicillins and cephalosporins (see Precautions)
⁷If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued (see Precautions).
⁸See Overdosage.
⁹See Precautions.
¹⁰See Contraindications and Precautions.
¹¹Superficial tooth discolouration has been reported very rarely in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.