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Nortriptyline Pregnancy and Breastfeeding Warnings

Nortriptyline is also known as: Aventyl Hydrochloride, Pamelor

Medically reviewed on July 20, 2018

Nortriptyline Pregnancy Warnings

Animal studies have revealed inconclusive fetal harm results. There are no controlled data in human pregnancy.

To monitor maternal-fetal outcomes of pregnant women exposed to antidepressant therapy, a National Pregnancy Registry for Antidepressants has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned

Risk summary: There are inconclusive data available on use of this drug in pregnant women to inform a drug-related risk.

Comment: A pregnancy exposure registry is available.

See references

Nortriptyline Breastfeeding Warnings

Benefit should outweigh risk.
-Some experts recommend: Use is contraindicated.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics classifies this drug as an agent whose effects on the nursing infant are unknown but may be of concern.
-Some authorities consider this drug a preferred antidepressant for use during breastfeeding.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Pamelor (nortriptyline)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Pamelor (nortriptyline)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.
  4. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  5. 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 -]):

Further information

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

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