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Acetylcysteine Pregnancy and Breastfeeding Warnings

Acetylcysteine is also known as: Acetadote, Acys-5, Cetylev, Mucomyst, Mucomyst-10, Mucomyst-20, NAC, Parvolex, Solgar NAC

Medically reviewed on February 27, 2018

Acetylcysteine Pregnancy Warnings

Animal studies did not show teratogenicity; slightly decreased fertility was seen at doses above the maximum human dose. Limited case reports did not report any adverse fetal or neonatal outcomes. This drug crosses the placenta and was measurable in the serum of the infant. A 1999 report concluded that pregnant women should be managed the same way as nonpregnant patients for acetaminophen overdose, and that acetylcysteine therapy was protective to both mother and fetus. There are no controlled data in human pregnancy

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B2
US FDA pregnancy category: B

See references

Acetylcysteine Breastfeeding Warnings

Animal studies did not show adverse effects during lactation. It is unknown in this drug or its metabolites are excreted in milk. Based on the pharmacokinetics, it should be nearly cleared 30 hours after administration.

Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: May consider resuming nursing 30 hours after the last administration.

See references

References for pregnancy information

  1. "Product Information. Acetylcysteine (acetylcysteine)." American Regent Laboratories Inc, Shirley, NY.
  2. Briggs GG, Freeman RK, Yaffe SJ. "Drugs in Pregnancy and Lactation. 9th ed." Philadelphia, PA: Llippincott Williams & Wilkins (2011):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Acetadote (acetylcysteine)." Cumberland-Swan Inc, Smyrna, TN.
  5. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Acetylcysteine (acetylcysteine)." American Regent Laboratories Inc, Shirley, NY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Acetadote (acetylcysteine)." Cumberland-Swan Inc, Smyrna, TN.

Further information

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

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