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Cyclizine Pregnancy and Breastfeeding Warnings

Cyclizine is also known as: Bonine for Kids, Cyclivert, Marezine

Medically reviewed by Drugs.com. Last updated on Aug 7, 2018.

Cyclizine Pregnancy Warnings

Animal studies have revealed evidence of malformations (e.g., cleft palate, cephalic abnormalities) at doses above 25 to 50 mg/kg/day. 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 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.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not formally assigned to a pregnancy category.

Comment: Some experts recommend avoiding use during pregnancy.

See references

Cyclizine Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Yes

Comments:
-The amount of excreted drug expressed in breastmilk is unknown.
-Some breastfed infants exposed to other antihistamines developed irritability, colicky symptoms, and/or drowsiness.
-Some experts state that occasional use of this drug may be acceptable during breastfeeding.

Higher doses or prolonged use, especially with sympathomimetic agents, may affect prolactin secretion.

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. Bonine For Kids (cyclizine)." Heritage/Insight Consumer Products, Plymouth, PA.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. 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 -]):
  4. "Product Information. Bonine For Kids (cyclizine)." Heritage/Insight Consumer Products, Plymouth, PA.

Further information

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

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