Nabilone Pregnancy and Breastfeeding Warnings

Brand names: Cesamet

Nabilone Pregnancy Warnings

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

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Teratogenicity has not been demonstrated in animals given doses up to 150 times the human dose. However, dose-related developmental toxicity occurred in animals as evidenced by increased embryo lethality, fetal resorptions, decreased fetal weights, and pregnancy disruptions. Postnatal toxicity and hypothermia in offspring also were observed in some animals. Animal studies have not shown any effect on fertility and reproductive performance with doses up to 150 times the human dose. There are no controlled data in human pregnancy.

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.

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Nabilone Breastfeeding Warnings

Use of this drug by breastfeeding mothers is not recommended.

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

Comments: Some cannabinoids are excreted in breast milk.

This drug is known to have an inhibitory effect on prolactin release, which may have contributed to reduced milk production observed in rats given doses 150 times the maximum recommended human dose.

See references

Further information

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

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