Droperidol Pregnancy and Breastfeeding Warnings

Brand names: Inapsine

Medically reviewed by Drugs.com. Last updated on Jun 19, 2023.

Droperidol Pregnancy Warnings

Droperidol should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy; however, neonates exposed to droperidol 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.

FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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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.

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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