|Frequency, type and severity of adverse reactions in children are the same as in adults.|
Gastrointestinal disorders- epigastric pain, nausea, vomiting, malaise, diarrhoea.- oral mucositis, taste disorders, dry mouth, anorexia.- reversible cases of pancreatitis.- tongue discolouration/furry tongue.
Immune system disorders- angioedema anaphylactic shock.
Nervous system disorders- peripheral sensory neuropathy, paraesthesia- headache, convulsions, dizziness.- reports of encephalopathy (e.g. confusion) and subacute cerebellar syndrome (e.g. ataxia, dysathria, gait impairment, nystagmus and tremor) which may resolve with discontinuation of the drug.- aseptic meningitis
Psychiatric disorders- psychotic disorders including confusion, hallucinations- depressed mood
Eye disorders- transient vision disorders such as diplopia, myopia, blurred vision, decreased visual acuity, changes in color vision.- Optic neuropathy/neuritis.
Blood and lymphatic system disorders- cases of agranulocytosis, neutropenia and thrombocytopenia have been reported.Hepatobiliary disorders- increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver injury, sometimes with jaundice, have been reported.- cases of liver failure requiring liver transplant have been reported in patients treated with metronidazole mostly when used in combination with other antibiotic drugs.
Skin and subcutaneous tissue disorders- rash, pruritus, flushing, urticaria- pustular eruptions- Stevens-Johnson syndrome, toxic epidermal necrolysis.
General disorders and administration site conditions- fever
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: email@example.com