Skip to Content
Be ready for a severe allergy emergency. Read more >>

Pseudoephedrine Pregnancy and Breastfeeding Warnings

Pseudoephedrine is also known as: Allermed, Cenafed, Children's Dimetapp Decongestant Infant, Contac Cold, Drixoral Decongestant Non-Drowsy, Drixoral Non-Drowsy, Efidac, ElixSure Congestion, Elixsure Decongestant, Entex, Genaphed, Nexafed, Novafed, Ridafed, Seudotabs, Silfedrine, Sudafed 12-Hour, Sudafed 24-Hour, Sudafed Children's Nasal Decongestant, Sudafed Congestion, SudoGest, Suphedrin, Suphedrine, Unifed, nasofed

Pseudoephedrine Pregnancy Warnings

Doses of 35 to 50 times the human daily dose to rabbits and rats, respectively, have not produced teratogenic effects. A case-controlled surveillance study reported an elevated relative risk (3.2) of gastroschisis with first-trimester use in 76 cases. The authors hypothesized vascular disruption as the etiology of gastroschisis. In a review of 229,101 deliveries to Michigan Medicaid patients, 940 first-trimester exposures to this drug were recorded and 1919 exposures anytime during pregnancy. A total of 37 birth defects were reported with first trimester exposure (40 expected) and included (observed/expected) 3/9 cardiovascular defects, 2 oral clefts, and 3/2 polydactyly. These researchers reviewed nine cases of abdominal wall defects in the 1980 through 1983 Medicaid data. Seven of the nine cases occurred in 3752 woman who had taken pseudoephedrine for a relative risk of 1.8. There are no adequate and well controlled studies in pregnant women. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B2 US FDA pregnancy category: Not formally assigned

See references

Pseudoephedrine Breastfeeding Warnings

Based on limited data, it has been estimated that 0.5% to 0.7% of the mother's dose is excreted into breast milk over 24 hours. In 1 study, irritability was reported in up to 20% of infants. A 24% mean decrease in milk production was observed after a single 60 mg dose in 8 nursing mothers.

Caution is recommended Excreted into human milk: Yes Comments: -Single doses are unlikely to harm a nursing infant, but may cause irritability or disturbed sleep. -Repeated doses may interfere with lactation in mothers who are having difficulties producing sufficient milk or in those whose lactation is not well established.

See references

References for pregnancy information

  1. Werler MM, Mitchell AA, Shapiro S "First trimester maternal medication use in relation to gastroschisis." Teratology 45 (1992): 361-7
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Smith CV, Rayburn WF, Anderson JC, Duckworth AF, Appel LL "Effect of a single dose of oral pseudoephedrine on uterine and fetal Doppler blood flow." Obstet Gynecol 76 (1990): 803-6

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide