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Ciclesonide nasal Pregnancy and Breastfeeding Warnings

Brand names: Omnaris, Zetonna

Medically reviewed by Drugs.com. Last updated on Mar 22, 2023.

Ciclesonide nasal Pregnancy Warnings

Animal studies have shown that subcutaneous administration produced fetal toxicity. There are no adequate and well-controlled studies in pregnant women on the teratogenic effects from this drug.

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.

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments:
-Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy.
-These infants should be carefully monitored.

See references

Ciclesonide nasal Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Product Information. Omnaris (ciclesonide nasal). Sepracor Inc. 2008.
  2. Product Information. Zetonna (ciclesonide nasal). Sunovion Pharmaceuticals Inc. 2020.

References for breastfeeding information

  1. Product Information. Omnaris (ciclesonide nasal). Sepracor Inc. 2008.
  2. Product Information. Zetonna (ciclesonide nasal). Sunovion Pharmaceuticals Inc. 2020.

Further information

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