Ramipril Pregnancy and Breastfeeding Warnings

Brand names: Altace, Vostally

Ramipril Pregnancy Warnings

This drug should not be used during pregnancy unless there are no alternatives, and the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated.
-According to some authorities: Use is not recommended during the first trimester and is contraindicated during the second and third trimesters.

AU TGA pregnancy category: D
US FDA pregnancy category:
-Capsules: D
-Oral solution: Not assigned

Risk summary: This drug can cause fetal harm when administered to a pregnant woman. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments: Adequate methods of contraception should be encouraged.

Animal studies have failed to reveal evidence of teratogenicity. In humans, use of drugs that act on the renin angiotensin system during the second and third trimesters increases fetal and neonatal morbidity and death. 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 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.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Ramipril Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: Angiotensin converting enzyme inhibitors have the potential to adversely affect a nursing infant.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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