Animal studies have revealed no evidence of teratogenicity. There are no controlled data in human pregnancy. Use of drugs that act on the renin-angiotensin system (RAS) during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.

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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended during the first trimester of pregnancy. Use is contraindicated during the second and third trimesters of pregnancy.

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

Comments: Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.

See references

Use is not recommended.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references