Droperidol Pregnancy and Breastfeeding Warnings

Brand names: Inapsine

Medically reviewed by Drugs.com. Last updated on Jun 18, 2025.

Droperidol Pregnancy Warnings

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

Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy; however, neonates exposed to this drug during the third trimester are at risk of extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. During postmarketing surveillance, agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorders have been reported in these neonates. The severity of these reactions varied from self-limited to those requiring treatment or monitoring.

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.

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Droperidol Breastfeeding Warnings

AU: Use of droperidol is contraindicated.
UK: Treatment with droperidol should be limited to a single administration.
US: Caution is recommended.

Excreted into human milk: Unknown (droperidol); Yes (butyrophenones)

Comments: The effects in the nursing infant are unknown.

Single-dose or short-term use during breastfeeding (such as during surgery), is not likely to adversely affect the breastfed infant, especially if the infant is older than 2 months. If multiple doses are given to the mother, the infant should be monitored for drowsiness, especially in younger, exclusively breastfed infants and when using combinations of psychotropic drugs.

UK manufacturer information states that administration of droperidol during lactation should be limited to a single administration and repeat use is not recommended.

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Further information

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

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