Frequency, type and severity of adverse reactions in children are the same as in adults.
- 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
- psychotic disorders including confusion, hallucinations- depressed mood
- transient vision disorders such as diplopia, myopia, blurred vision, decreased visual acuity, changes in color vision.- Optic neuropathy/neuritis.
Ear and labyrinth disorders
- hearing impaired/hearing loss (including sensorineural)
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- fixed drug eruption- Stevens-Johnson syndrome, toxic epidermal necrolysis.
General disorders and administration site conditions
Reporting of suspected adverse reactions
Reporting 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: email@example.com