Animal studies have revealed evidence of embryofetal lethality and increased number of abortions, pre- and post-implantation losses, early embryofetal deaths, premature deliveries, prolonged parturition, decreased number of live fetuses, increased number of minor skeletal abnormalities and variants, reversible infertility in males, and decreased fertility in females. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

AU, US: Use of this drug during pregnancy is contraindicated.
UK: There is no relevant use of this drug in women; use during pregnancy is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: X

See references

There is no relevant use of this drug in women; use during breastfeeding is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available.

Comments: The effects in the nursing infant are unknown.

See references