Ornidazole

There is no clinical data available for ornidazole exposure in pregnancy. Studies conducted on animals do not demonstrate direct or indirect harmful effects on pregnancy/embryonic/foetal development/birth or post-natal development. The effect of ornidazole on women of childbearing potential or birth control methods is unknown.

Extensive studies in various species have revealed no sign of any teratogenic or foetotoxic action of ornidazole. However, no controlled studies have been carried out in pregnant women. As a matter of principle, ornidazole should not be prescribed in early pregnancy or to nursing mothers except when absolutely necessary.

It is not known whether ornidazole is excreted in human milk. The excretion of ornidazole via milk in animals has not been researched. In making the decision whether or not to discontinue breastfeeding or whether or not ornidazole treatment should be discontinued/avoided, the benefit of breastfeeding to the infant and the benefit of ornidazole treatment for the nursing mother must be considered.

Fertility

When ornidazole is administered at a high dosage of 400mg/kg/day, it produces infertility in male rats by inhibiting epididymal sperm motility in terms of decreased sperm velocity.

No data has been obtained from research involving humans.

Somnolence, dizziness, tremor, rigidity, poor coordination, seizures, vertigo or temporary loss of consciousness may occur in patients receiving ornidazole. If they occur, such effects may affect tasks requiring alertness including the patient’s ability to drive and operate machinery.

Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)

Diseases of the vascular and lymph system

Rare: Leukopenia

Nervous system disorders

Very rare: Somnolence, headache, dizziness, tremor, rigidity, coordination impairments, seizures, fatigue, vertigo, temporary loss of consciousness and sensory or mixed peripheral neuropathy.

Gastrointestinal disorders

Uncommon: Nausea, vomiting, diarrhoea, epigastric discomfort, dry mouth, loss of appetite.

Rare: Impairment of the sense of taste

Hepatobiliary diseases

Unknown: Jaundice, abnormal liver function tests

Skin and subcutaneous tissue diseases

Rare: Pruritus and skin reactions