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.

Ear and labyrinth disorders

-          hearing impaired/hearing loss (including sensorineural)

-          tinnitus

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

-      pustalar eruptions

-      fixed drug eruption

-      Stevens-Johnson syndrome, toxic epidermal necrolysis.

General disorders and administration site conditions

-  fever

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 HPRAPharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie