Orapen-S Adverse Reactions

Amoxicillin with Clavulanic acid is generally well tolerated. The majority of side effects observed in clinical trials were of a mild and transient nature. The most frequently reported adverse effects were diarrhoea/loose stools, nausea, skin rashes, urticaria, vomiting and vaginitis (1%). The overall incidence of side effects and in particular diarrhoea, increased with the higher recommended dose. Other less frequently reported reactions include abdominal discomfort, flatulence and headache.
Infections and infestations: Mucocutaneous candidosis: Common.
Overgrowth of non-susceptible organisms: Not known.
Blood and lymphatic system disorders: Reversible leucopenia (including neutropenia): Rare.
Thrombocytopenia: Rare.
Reversible agranulocytosis: Not known.
Haemolytic anaemia: Not known.
Prolongation of bleeding time and prothrombin time: Not known.
Immune system disorders: Angioneurotic oedema: Not known.
Anaphylaxis: Not known.
Serum sickness-like syndrome: Not known.
Hypersensitivity vasculitis: Not known.
Nervous system disorders: Dizziness: Uncommon.
Headache: Uncommon.
Reversible hyperactivity: Not known.
Convulsions: Not known.
Aeseptic meningitis: Not known.
Gastrointestinal disorders: Diarrhoea: Common.
Nausea: Common.
Vomiting: Common.
Indigestion: Uncommon.
Antibiotic-associated colitis: Not known.
Black hairy tongue: Not known.
Tooth discolouration: Not known.
Hepatobiliary disorders: Rises in AST and/or ALT: Uncommon.
Hepatitis: Not known.
Cholestatic jaundice: Not known.
Skin and subcutaneous tissue disorders: Skin rash: Uncommon.
Pruritus: Uncommon.
Urticaria: Uncommon.
Erythema multiforme: Rare.
Stevens-Johnson syndrome: Not known.
Toxic epidermal necrolysis: Not known.
Bullous exfoliative-dermatitis: Not known.
Acute generalised exanthemous pustulosis (AGEP): Not known.
Drug reaction with eosinophilia and systemic symptoms (DRESS): Not known.
Renal and urinary disorders: Interstitial nephritis: Not known.
Crystalluria: Not known.