Skip to Content
Get expert answers to vaginal health questions. Go >

Mirabegron Pregnancy and Breastfeeding Warnings

Mirabegron is also known as: Myrbetriq

Mirabegron Pregnancy Warnings

Use is not recommended in women of childbearing potential not using contraception unless the potential benefit to the patient outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: -Women who become pregnant during treatment with this drug are encouraged to contact their physician.

In animals, embryofetal toxicities, including heart malformations (dilated aorta cardiomegaly), pulmonary malformations, postimplantation loss, wavy ribs, delayed ossification, and decreased number of ossified sternebrae, metacarpi or metatarsi, have been reported at doses associated with maternal toxicity and significantly higher than would be expected in humans. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Mirabegron Breastfeeding Warnings

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

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  3. "Product Information. Myrbetriq (mirabegron)." Astellas Pharma US, Inc, Deerfield, IL.

References for breastfeeding information

  1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  2. "Product Information. Myrbetriq (mirabegron)." Astellas Pharma US, Inc, Deerfield, IL.
  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