Diphenhydramine (Benadryl) Safety During Pregnancy
Diphenhydramine (Benadryl) should be used with caution during pregnancy due to potential risks including association with cleft palate, and alternative second-generation antihistamines should be considered first if antihistamine treatment is necessary. 1
Safety Classification and Concerns
- Diphenhydramine carries an FDA warning requiring pregnant women to "ask a healthcare professional before use," indicating safety concerns 2
- The American Academy of Allergy, Asthma, and Immunology recommends using diphenhydramine with caution during pregnancy due to its association with potential risks, including cleft palate 1
- Most antihistamines, including diphenhydramine, are classified as FDA Category B or C, indicating limited evidence of harm but incomplete safety data 1
Specific Risks and Considerations
- First-generation antihistamines like diphenhydramine should generally be avoided during pregnancy when possible 3
- Administration of diphenhydramine during pregnancy has been associated with the development of cleft palate, which is a significant concern 1
- The National Institute of Child Health and Human Development recommends avoiding all antihistamines if possible during pregnancy, especially in the first trimester 1
Alternative Options
- Second-generation antihistamines are preferable to first-generation antihistamines like diphenhydramine due to their better safety profile 1
- Cetirizine and loratadine are the second-generation antihistamines of choice during pregnancy 3
- Chlorpheniramine is often chosen by clinicians when antihistamine therapy is necessary during pregnancy because of its long safety record 1
Clinical Decision-Making Framework
- Consider if antihistamine treatment is absolutely necessary, as avoiding medication during pregnancy is preferable when possible 1, 4
- If treatment is necessary, use the lowest effective dose for the shortest duration possible 1
- Always weigh the risk of untreated maternal conditions against the potential risks of medication 1
- Great caution should be taken when prescribing any medication during pregnancy as no drug is entirely without side effects 5
Common Pitfalls and Caveats
- Many pregnant women use over-the-counter medications including antihistamines without medical supervision, which can pose risks 6
- There is limited research on the safety of over-the-counter medications during pregnancy despite their widespread use 6
- Drug development specifically for pregnant women lags behind other population groups, leading to limited safety data 7
- No antihistamine has been proven completely safe during pregnancy, and all should be used with caution 1