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Fesoterodine Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Sep 24, 2021.

Fesoterodine is also known as: Toviaz

Fesoterodine Pregnancy Warnings

Animal studies have revealed evidence of fetotoxicity at doses exceeding the maximum recommended human dose (MRHD). There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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.

Use is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on animal data, this drug may cause fetal harm; animal studies have revealed evidence of fetotoxicity.

See references

Fesoterodine Breastfeeding Warnings

Benefit should outweigh risk.
According to some authorities use is not recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-No information is available on the use of this drug during breastfeeding. Long-term use might reduce milk production or milk letdown. During long-term use, observe for signs of decreased lactation (e.g., insatiety, poor weight gain).

See references

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Product Information. Fesoterodine (fesoterodine). Aspire Pharma Ltd. 2023.

References for breastfeeding information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
  3. Product Information. Fesoterodine (fesoterodine). Aspire Pharma Ltd. 2023.

Further information

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