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Pimavanserin Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Jan 2, 2023.

Pimavanserin is also known as: Nuplazid

Pimavanserin Pregnancy Warnings

Animal studies have failed to reveal evidence of adverse developmental effects and teratogenicity. Maternal toxicity occurred at levels associated with decreased pup survival, litter size, pup weight, and maternal food consumption. 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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: There are no data available on use of this drug in pregnant women to inform of a drug-related risk.

See references

Pimavanserin Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comment: The effects in the nursing infant are unknown.

There are no data regarding the presence of this drug in human milk or its effect on milk production.

See references

References for pregnancy information

  1. "Product Information. Nuplazid (pimavanserin)." Accelis Pharma (2016):

References for breastfeeding information

  1. "Product Information. Nuplazid (pimavanserin)." Accelis Pharma (2016):

Further information

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