Naproxen/diphenhydramine
Combination of
NaproxenNSAID
DiphenhydramineAntihistamine
Clinical data
Trade namesAleve PM
AHFS/Drugs.comaleve-pm
Routes of
administration
By mouth
ATC code
Legal status
Legal status

Naproxen/diphenhydramine (trade name Aleve PM) is a formulation of naproxen with diphenhydramine marketed by Bayer Healthcare.[1] It is made as an over-the-counter drug. The intended use of the drug is relieve pain specifically when going to sleep.[2]

Adverse effects

See also: Naproxen § Adverse effects, and Diphenhydramine § Adverse effects

Women in the third trimester of pregnancy should avoid this drug because there is a risk that naproxen, like other NSAIDs, may cause premature closure of the ductus arteriosus.[2]

In October 2020, the U.S. Food and Drug Administration (FDA) required the drug label to be updated for all nonsteroidal anti-inflammatory medications to describe the risk of kidney problems in unborn babies that result in low amniotic fluid.[3][4] They recommend avoiding NSAIDs in pregnant women at 20 weeks or later in pregnancy.[3][4]

References

  1. ^ "Aleve PM (Naproxen Sodium and Diphenhydramine Hydrochloride) Tablets". U.S. Food and Drug Administration. 13 May 2015. Retrieved 19 July 2015.
  2. ^ a b Michele, T. M. (2014, January 16). Center for Drug Evaluation and Research: Summary Review. Retrieved April 21, 2016, from http://www.accessdata.fda.gov
  3. ^ a b "FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications". U.S. Food and Drug Administration (FDA) (Press release). 15 October 2020. Retrieved 15 October 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ a b "NSAIDs may cause rare kidney problems in unborn babies". U.S. Food and Drug Administration. 21 July 2017. Retrieved 15 October 2020. Public Domain This article incorporates text from this source, which is in the public domain.