Moxilen Adverse Reactions

The following convention has been utilised for the classification of undesirable effects: Very common ≥1/10, common ≥1/100, <1/10, uncommon ≥1/1000, <1/100, rare ≥1/10,000, <1/1000, very rare <1/10,000.
The majority of side effects listed as follows are not unique to amoxicillin and may occur when using other penicillins.
Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years of post-marketing reports.
Infections and infestations: Very rare: Mucocutaneous candidiasis.
Blood and lymphatic system disorders: Very rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia.
Prolongation of bleeding time and prothrombin (see Interactions).
Immune system disorders: Very rare: As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Precautions), serum sickness and hypersensitivity vasculitis.
If a hypersensitivity reaction is reported, the treatment must be discontinued. (See Skin and Subcutaneous Tissue Disorders as follows.)
Nervous system disorders: Very rare: Aseptic meningitis, hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Gastrointestinal disorders: Clinical Trial Data: *Common: Diarrhoea and nausea.
*Uncommon: Vomiting.
Post-marketing data: Very rare: Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis); black hairy tongue.
Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.
Hepatobiliary disorders: Very rare: Hepatitis and cholestatic jaundice. A moderate rise in aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT).
The significance of a rise in AST and/or ALT is unclear.
Skin and subcutaneous tissue disorders: Clinical trial data: *Common: Skin rash. *Uncommon: Urticaria and pruritus.
Post-marketing data: Very rare: Skin reactions eg, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliating dermatitis and acute generalized exanthematous pustulosis (AGEP). (See Immune System Disorders as mentioned previously.)
Renal and urinary tract disorders: Very rare: Interstitial nephritis, crystalluria (see Overdosage).
*The incidence of these adverse effects was derived from clinical studies involving a total of approximately 6000 adults and paediatric patients taking amoxicillin.