Prochlorperazine Pregnancy and Breastfeeding Warnings

Brand names: Compazine, Compazine Spansule, Compro, Procot

Medically reviewed by Drugs.com. Last updated on Apr 14, 2025.

Prochlorperazine Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated (buccal tablets)

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk summary: The malformative risk with use of this drug in pregnant women is unknown. Based on data in animals and reports in neonates, this drug may cause adverse effects at high doses in late pregnancy.

Comments:
-The dose and duration of treatment in pregnant patients should be as low and short as possible.
-Neonates exposed to this drug during the third trimester are at risk of developing severe and/or prolonged side effects (e.g., agitation, hyper/hypotonia, tremor, somnolence, respiratory distress, feeding disorder, gastrointestinal reactions). Severity and duration of effects in neonates are varied; some have required intensive care support and prolonged hospitalization.
-Monitor neonates for the signs/symptoms of extrapyramidal syndrome and/or withdrawal if exposed to this drug.
-Use during labor: This drug should be withheld until the cervix is dilated to 3 to 4 cm.

Animal studies have revealed evidence of harmful effects, with the potential for teratogenic effects in humans. There are no controlled data in human pregnancy.

Male animal models have revealed evidence of spermatocyte and sperm aberrations with neuroleptic use. There are no controlled data in human males.

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.

See references

Prochlorperazine Breastfeeding Warnings

Use is not recommended unless clearly needed and the benefit outweighs the risk.

Excreted into human milk: Unknown; however, other phenothiazines (e.g., chlorpromazine) have been detected in breast milk in trace amounts.
Excreted into animal milk: Yes

Comments:
-According to some experts: Occasional short-term use of this drug for the treatment of nausea and vomiting poses little risk to the infant.
-The effects in the nursing infant are unknown.
-Galactorrhea has been reported; the dopamine-blocking action of this drug may cause hyperprolactinemia.

See references

Further information

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