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Diphenhydramine Pregnancy and Breastfeeding Warnings

Brand names: Aler-Dryl, Banophen, Benadryl, Benadryl Allergy, Benadryl Children's Allergy, Buckley's Bedtime, Bydramine, Calm-Aid, Complete Allergy Relief, DPH, Dicopanol, Diphen, Diphenhist, Diphenydramine Quick Melt, Hydramine, Nervine, Nytol, Simply Sleep, Sleep, Sleep Tabs, Sleepwell 2-nite, Sominex, Unisom SleepGels, Valu-Dryl, ZzzQuil

Medically reviewed by Drugs.com. Last updated on Aug 1, 2023.

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 (diphenhydramine). Parke-Davis. 2002;PROD.
  2. Product Information. Benadryl Children's Allergy Fastmelt (diphenhydrAMINE). Pfizer U.S. Pharmaceuticals Group. 2022.
  3. Cerner Multum, Inc. UK Summary of Product Characteristics.
  4. Cerner Multum, Inc. Australian Product Information.
  5. Product Information. DiphenhydrAMINE Hydrochloride (diphenhydramine). West-Ward Pharmaceuticals Corporation (previously Roxane Laboratories Inc). 2019.

References for breastfeeding information

  1. Product Information. Benadryl (diphenhydramine). Parke-Davis. 2002;PROD.
  2. Product Information. Benadryl Children's Allergy Fastmelt (diphenhydrAMINE). Pfizer U.S. Pharmaceuticals Group. 2022.
  3. Cerner Multum, Inc. UK Summary of Product Characteristics.
  4. Cerner Multum, Inc. Australian Product Information.
  5. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.

Further information

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