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Macimorelin Pregnancy and Breastfeeding Warnings

Brand names: Macrilen

Medically reviewed by Last updated on Sep 7, 2023.

Macimorelin Pregnancy Warnings

Animal studies have not been conducted. There are no controlled data in human pregnancy. This drug is administered as a single dose, which limits the risk of adverse developmental outcomes from exposure.

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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

See references

Macimorelin Breastfeeding Warnings

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

-Weigh the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication against any potential adverse effects on the infant from this drug or the mother's underlying condition.

See references

References for pregnancy information

  1. Product Information. Macrilen (macimorelin). Aeterna Zentaris. 2018.

References for breastfeeding information

  1. Product Information. Macrilen (macimorelin). Aeterna Zentaris. 2018.

Further information

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