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Diphenhydramine / naproxen Pregnancy and Breastfeeding Warnings

Diphenhydramine / naproxen is also known as: Aleve PM

Medically reviewed by Drugs.com. Last updated on Nov 17, 2020.

Diphenhydramine / naproxen Pregnancy Warnings

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

Comments:
-Naproxen should not be used during the last 3 months of pregnancy unless clearly directed by a doctor. It may cause problems in the unborn child or delivery complications.

-Animal studies are not available for this combination product.
-There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Diphenhydramine / naproxen Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

Comments:
-Small doses of diphenhydramine may not cause any adverse effects in breastfed infants. Larger doses or prolonged use may cause effects and decrease milk supply. A non-sedating antihistamine may be a preferred alternative.
-Limited data shows that levels of naproxen in breastmilk are low. However, due to its long half-life and reported adverse reactions in the breastfed neonates, other agents may be preferred while nursing.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

References for pregnancy information

  1. "Product Information. Diphenhydramine Hydrochloride-Naproxen Sodium (diphenhydramine-naproxen)." Amneal Pharmaceuticals LLC, Bridgewater, NJ.
  2. "Product Information. Benadryl (diphenhydramine)." Parke-Davis, Morris Plains, NJ.
  3. "Product Information. Naprosyn (naproxen)." Syntex Laboratories Inc, Palo Alto, CA.

References for breastfeeding information

  1. "Product Information. Naprosyn (naproxen)." Syntex Laboratories Inc, Palo Alto, CA.
  2. "Product Information. Benadryl (diphenhydramine)." Parke-Davis, Morris Plains, NJ.
  3. National Library of Medicine (US) "Drugs and Lactation Database (LactMed) Available from: URL: https://www.ncbi.nlm.nih.gov/books/NBK501922/" (2006):

Further information

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