Skip to Content
Is it time for a new insulin treatment? Learn more >>

Fosinopril Pregnancy and Breastfeeding Warnings

Fosinopril is also known as: Monopril

Fosinopril Pregnancy Warnings

AU: Use is contraindicated. UK: Use is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters. US: Use is not recommended. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: Adequate methods of contraception should be encouraged.

Limited data have shown an association between major congenital malformations and the use of angiotensin-converting enzyme (ACE) inhibitors during the first trimester. The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased renal function and is associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. There are no controlled data in human pregnancy. Infants with in utero exposure to this drug should be closely monitored for hypotension, oliguria, and hyperkalemia. When pregnancy is detected or expected, this drug should be discontinued as soon as possible. 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.

See references

Fosinopril Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Monopril (fosinopril)." Bristol-Myers Squibb, Princeton, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Monopril (fosinopril)." Bristol-Myers Squibb, Princeton, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide