Is Benadryl (diphenhydramine) safe to use at 9 weeks gestation?

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Last updated: June 8, 2025View editorial policy

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From the Guidelines

Benadryl (diphenhydramine) can be used at 9 weeks gestation, but with caution, due to some concerns over a potential association with cleft palate, although recent studies have not detected any increased risk for congenital malformations 1. When considering the use of Benadryl during pregnancy, it's essential to weigh the benefits against the potential risks. The first trimester is a critical period for organogenesis, and medication use during this time should be approached with caution 1. Some key points to consider when using Benadryl during pregnancy include:

  • The typical recommended dose is 25-50 mg every 4-6 hours as needed, not exceeding 300 mg in 24 hours.
  • Benadryl is classified as FDA Pregnancy Category B, meaning animal studies have not shown risk to the fetus, and there are no adequate studies in pregnant women showing adverse effects.
  • While no significant birth defects or problems have been consistently linked to Benadryl use during pregnancy, it's always best to use the lowest effective dose for the shortest time necessary to manage your symptoms.
  • Some women may experience increased drowsiness or dry mouth when taking Benadryl during pregnancy. It's crucial to consult with your healthcare provider before taking Benadryl, especially during early pregnancy, as they may recommend alternative treatments that are better studied or more appropriate for your specific situation 1.

From the FDA Drug Label

If pregnant or breast-feeding, ask a healthcare professional before use The FDA drug label does not answer the question.

From the Research

Safety of Benadryl at 9 Weeks Gestation

  • The safety of Benadryl (diphenhydramine) at 9 weeks gestation is a concern due to the potential risks associated with medication use during pregnancy 2, 3.
  • Studies have shown that women are often unaware of the specific risks associated with medication use during pregnancy and may be unable to articulate negative outcomes 2.
  • Healthcare providers face challenges in advising pregnant women about medication safety due to a lack of data and incomplete information on package inserts 3.
  • The use of medication during pregnancy requires careful consideration of the risks and benefits, and healthcare providers should communicate effectively with patients to inform their decisions 4, 5.
  • Diphenhydramine, the active ingredient in Benadryl, has been studied for its antihistaminic effects, but its safety during pregnancy is not well-established 6.
  • There is no direct evidence to confirm the safety of Benadryl at 9 weeks gestation, and healthcare providers should exercise caution when recommending its use during pregnancy 2, 3, 4, 5.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Medication Safety During Pregnancy: Improving Evidence-Based Practice.

Journal of midwifery & women's health, 2016

Research

The Use of Medication in Pregnancy.

Deutsches Arzteblatt international, 2019

Research

Suppression of histamine-induced pruritus by three antihistaminic drugs.

The Journal of allergy and clinical immunology, 1975

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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