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Diphenhydramine Pregnancy and Breastfeeding Warnings

Diphenhydramine is also known as: 40 Winks, Banophen, Beldin, Benadryl, Benadryl Allergy, Benadryl Children's Allergy, Buckley's Bedtime, DPH, Dicopanol, Diphedryl, Diphen, Diphen Cough, Diphenadryl, Diphenhist, Diphenydramine Quick Melt, Diphenyl, Hydramine, Nytol, Q-Dryl, Sleep, Sleep-Eze-3, Sominex, Unisom SleepGels, Valu-Dryl, ZzzQuil

Medically reviewed on Apr 17, 2017

Diphenhydramine Pregnancy Warnings

Animal models have failed to reveal evidence of impaired fertility or fetal harm at doses up to 5 times the human dose. There are no controlled data in human 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.

Use is recommended only if clearly needed and the benefit outweighs the risk.

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

Comment:
-Exposure during the third trimester may result in adverse reactions in premature infants and neonates.

See references

Diphenhydramine Breastfeeding Warnings

Use is not recommended.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-This drug may affect milk production, especially at high doses given early in the postpartum period and/or when used concomitantly with a sympathomimetic drug.

See references

References for pregnancy information

  1. "Product Information. Benadryl Childrens Allergy Fastmelt (diphenhydrAMINE)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Benadryl (diphenhydramine)." Parke-Davis, Morris Plains, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Benadryl (diphenhydramine)." Parke-Davis, Morris Plains, NJ.
  4. 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 -]):
  5. "Product Information. Benadryl Childrens Allergy Fastmelt (diphenhydrAMINE)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

Further information

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

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