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Dimenhydrinate Pregnancy and Breastfeeding Warnings

Dimenhydrinate is also known as: Calm-X, DMH, Dimetabs, Dinate, Dramamine, Dramamine Chewable, Dramamine Original Formula, Dramamine for Kids, Dramanate, Dramoject, Driminate, Dymenate, Hydrate, Travel-Eze, Triptone

Medically reviewed on March 7, 2018

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.

See references

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 references

References for pregnancy information

  1. "Product Information. Driminate (dimenhyDRINATE)." Major Pharmaceuticals Inc, Livonia, MI.
  2. "Product Information. Dramamine (dimenhydrinate)" Pharmacia and Upjohn, Kalamazoo, MI.
  3. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):
  4. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL: http://www.tga.gov.au/docs/pdf/medpreg.pdf." ([1999]):
  5. "Product Information. DimenhyDRINATE (dimenhyDRINATE)." APP (Abraxis Pharmaceutical Products), Schaumberg, IL.

References for breastfeeding information

  1. 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 -]):
  2. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):
  3. "Product Information. DimenhyDRINATE (dimenhyDRINATE)." APP (Abraxis Pharmaceutical Products), Schaumberg, IL.
  4. "Product Information. Dramamine (dimenhydrinate)" Pharmacia and Upjohn, Kalamazoo, MI.
  5. "Product Information. Driminate (dimenhyDRINATE)." Major Pharmaceuticals Inc, Livonia, MI.

Further information

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

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