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Phenelzine Pregnancy and Breastfeeding Warnings

Phenelzine is also known as: Nardil

Medically reviewed on December 15, 2017

Phenelzine Pregnancy Warnings

Animal studies at doses exceeding the recommended human dose showed a significant decrease in the number of viable offspring, and growth retardation. There are no controlled data in human pregnancy. Epidemiological studies suggest an increased risk of congenital abnormalities with antidepressant use during pregnancy as well as an increase in pre-term delivery. Neonates exposed to antidepressants late in the third trimester have shown drug withdrawal symptoms such as dyspnea, lethargy, colic irritability, hypotension or hypertension, and tremor or spasms.

AU TGA pregnancy category B3: 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 have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

Safety has not been established during pregnancy; do not use during pregnancy, especially during the first and last trimesters, unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

See references

Phenelzine Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-Based on the molecular weight and moderately long elimination half-life, this drug is probably excreted in breast milk.

See references

References for pregnancy information

  1. "Product Information. Nardil (phenelzine)." Parke-Dvis, Morris Plains, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  4. "Product Information. Nardil (phenelzine)." Parke-Dvis, Morris Plains, NJ.

Further information

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

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