Cromolyn nasal Pregnancy and Breastfeeding Warnings
Brand names: Nasal Allergy Control, NasalCrom, Nasalcrom Child
Medically reviewed by Drugs.com. Last updated on Aug 13, 2024.
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.
Cromolyn nasal Breastfeeding Warnings
Use is considered acceptable; caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
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.
See also
References for pregnancy information
- MHRA. Medicines and Health Regulatory Agency (2013) MHRA Drug Safety Update. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate
- (2022) "Product Information. Cromolyn Sodium Nasal (cromolyn nasal)." Bausch and Lomb Americas, Inc.
References for breastfeeding information
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
- MHRA. Medicines and Health Regulatory Agency (2013) MHRA Drug Safety Update. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate
- (2022) "Product Information. Cromolyn Sodium Nasal (cromolyn nasal)." Bausch and Lomb Americas, Inc.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.