Dimenhydrinate Pregnancy and Breastfeeding Warnings
Brand names: Calm-X, DMH, Dimetabs, Dinate, Dramamine, Dramamine Chewable, Dramamine Original Formula, Dramamine for Kids, Dramanate, Dramoject, Driminate, Dymenate, Hydrate, Travel-Eze, Triptone
Medically reviewed by Drugs.com. Last updated on Jan 30, 2024.
Dimenhydrinate Pregnancy Warnings
Use during pregnancy is recommended only if clearly needed.
AU TGA pregnancy category: A
US FDA pregnancy category: B
Comments:
-Although data suggest fetal harm is remote when this drug is used during pregnancy, the possibility of harm cannot be ruled out.
-This drug crosses the placenta and may have an oxytocic effect; the safety of this drug given during labor and delivery has not been established.
Animal studies at doses up to 25 times the human dose have revealed no evidence of fetal harm or impaired fertility. Clinical studies in pregnant women have not indicated an increased risk of abnormalities when this drug is administered in any trimester of pregnancy.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
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.
Dimenhydrinate Breastfeeding Warnings
A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Yes
Comments:
-Small, occasional doses are not expected to cause any adverse effects in breastfed infants.
-Larger doses or more prolonged use may cause side effects in the breastfed infant or decrease the milk supply, particularly before lactation is well established and when used in combination with a sympathomimetic.
-Single bedtime doses after the last feeding of the day should minimize drug effects.
See also
References for pregnancy information
- (2001) "Product Information. Dramamine (dimenhydrinate)." Pharmacia and Upjohn
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee (2007) Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. http://www.tga.gov.au/docs/pdf/medpreg.pdf
- Cerner Multum, Inc. (2015) "Canadian Product Information."
- (2017) "Product Information. Driminate (dimenhydrinate)." Major Pharmaceuticals Inc
- (2017) "Product Information. DimenhyDRINATE (dimenhydrinate)." APP (Abraxis Pharmaceutical Products)
References for breastfeeding information
- (2001) "Product Information. Dramamine (dimenhydrinate)." Pharmacia and Upjohn
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
- Cerner Multum, Inc. (2015) "Canadian Product Information."
- (2017) "Product Information. Driminate (dimenhydrinate)." Major Pharmaceuticals Inc
- (2017) "Product Information. DimenhyDRINATE (dimenhydrinate)." APP (Abraxis Pharmaceutical Products)
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.