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Cromolyn nasal Pregnancy and Breastfeeding Warnings

Cromolyn nasal is also known as: Nasal Allergy Control, NasalCrom, Nasalcrom Child

Medically reviewed on Aug 23, 2018

Cromolyn nasal Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

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

Animal studies have revealed no evidence of teratogenicity with doses 205 times the maximum human dose. Increased fetal resorption and decreased fetal weight were observed at high parenteral doses that resulted in maternal toxicity. There are no controlled data in human pregnancy.

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

Cromolyn nasal Breastfeeding Warnings

Maternal systemic absorption of this drug is expected to be very low. While it is unknown if this drug is excreted into milk, if excreted it would be poorly absorbed from the infant's gastrointestinal tract.

Use is considered acceptable; caution is recommended.

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

See references

References for pregnancy information

  1. "Product Information. Cromolyn Sodium Nasal (cromolyn nasal (sodium cromoglycate nasal))." Bausch and Lomb, Rochester, NY.
  2. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."

References for breastfeeding information

  1. "Product Information. Cromolyn Sodium Nasal (cromolyn nasal (sodium cromoglycate nasal))." Bausch and Lomb, Rochester, NY.
  2. 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 -]):
  3. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."

Further information

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

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