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Oxybutynin Pregnancy and Breastfeeding Warnings

Oxybutynin is also known as: Anturol, Ditropan, Ditropan XL, Gelnique, Oxytrol, Oxytrol for Women, Urotrol

Medically reviewed on Apr 2, 2018

Oxybutynin Pregnancy Warnings

(AU, US): Benefit should outweigh risk.
(UK): Not recommended.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

-(AU, US): No embryo/fetal toxicity was observed in animal studies at doses 50 times that of the maximum recommended human dose (MRHD).
-(UK): Studies in animals have shown minor reproductive toxicity, but it is observed only in the presence of maternal toxicity. In the absence of understanding the association between maternal toxicity and developmental effect, the relevance to human safety cannot be addressed.
-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.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Oxybutynin Breastfeeding Warnings

-Anticholinergics can inhibit lactation in animals apparently by inhibiting growth hormone and oxytocin secretion.
-Long-term use of this drug during lactation might reduce milk production or milk letdown, but a single dose is not likely to interfere with breastfeeding.
-During long-term use, observe for signs of decreased lactation (e.g., insatiety, poor weight gain).
-Anticholinergic drugs can reduce serum prolactin in nonnursing women. Cases of lactation suppression have been reported with this drug postmarketing. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

(AU, US): Caution is recommended.
(UK): Not recommended.

Excreted into human milk: Probably, in small amounts
Excreted into animal milk: Yes

Comment: Effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Ditropan (oxybutynin)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Ditropan (oxybutynin)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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