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Acetylcysteine Pregnancy and Breastfeeding Warnings

Brand names: Acetadote, Acys-5, Cetylev, Legubeti, Mucomyst, Mucomyst-10, Mucomyst-20, N-A-C Sustain, NAC, Parvolex, Solgar NAC

Medically reviewed by Drugs.com. Last updated on Nov 29, 2023.

Acetylcysteine Pregnancy Warnings

Use is not recommended unless clearly needed.

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

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

See references

Acetylcysteine Breastfeeding Warnings

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.

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.

See references

References for pregnancy information

  1. (2004) "Product Information. Acetadote (acetylcysteine)." Cumberland-Swan Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. Briggs GG, Yaffe SJ., Freeman RK (2011) "Drugs in Pregnancy and Lactation." Philadelphia, PA: Llippincott Williams & Wilkins
  5. (2015) "Product Information. Acetylcysteine (acetylcysteine)." American Regent Laboratories Inc

References for breastfeeding information

  1. (2004) "Product Information. Acetadote (acetylcysteine)." Cumberland-Swan Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2015) "Product Information. Acetylcysteine (acetylcysteine)." American Regent Laboratories Inc

Further information

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