Skip to Content

Naproxen / pseudoephedrine Pregnancy and Breastfeeding Warnings

Naproxen / pseudoephedrine is also known as: Aleve-D Sinus & Cold, Aleve-D Sinus & Headache, Sinus & Cold D, Sudafed 12 Hour Pressure+Pain

Medically reviewed on Nov 6, 2017

Naproxen / pseudoephedrine Pregnancy Warnings

Naproxen has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Use late in pregnancy may cause premature closure of the ductus arteriosus and prolong labor and delivery. Naproxen should be avoided in the third trimester. Naproxen is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Pseudoephedrine has not been formally assigned to a pregnancy category by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Based on available data, pseudoephedrine is not thought to be teratogenic. Pseudoephedrine is only recommended for use during pregnancy when benefit outweighs risk.

See references

Naproxen / pseudoephedrine Breastfeeding Warnings

Naproxen is excreted into human milk in very small amounts. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants (prostaglandin-inhibiting effect on neonates), the use in nursing women should be avoided.

Pseudoephedrine is excreted into human milk. The effects in the nursing infant are unknown. The American Academy of Pediatrics considers pseudoephedrine to be compatible with breast-feeding.

See references

References for pregnancy information

  1. "Product Information. Anaprox (naproxen)." Roche Laboratories, Nutley, NJ.
  2. "Product Information. Aleve Cold and Sinus (naproxen-pseudoephedrine)." Bayer Pharmaceutical Inc, West Haven, CT.

References for breastfeeding information

  1. "Product Information. Aleve Cold and Sinus (naproxen-pseudoephedrine)." Bayer Pharmaceutical Inc, West Haven, CT.
  2. "Product Information. Anaprox (naproxen)." Roche Laboratories, Nutley, NJ.

Further information

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

Hide