Trifluoperazine Pregnancy and Breastfeeding Warnings

Brand names: Stelazine

Medically reviewed by Drugs.com. Last updated on Apr 15, 2024.

Trifluoperazine Pregnancy Warnings

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

AU TGA pregnancy category: C
US FDA pregnancy category: Not formally assigned to a pregnancy category.

Risk Summary: Neonates exposed 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). The side effects have varied in severity and duration, with some neonates requiring intensive care support and prolonged hospitalization.

Comments:
-Some experts recommend avoiding use during the first trimester; local protocol and/or manufacturer product information should be consulted regarding use during pregnancy.
-Exposed neonates should be monitored for the signs/symptoms of extrapyramidal syndrome and/or withdrawal.

Animal studies have revealed evidence of fetal malformations and reduced litter size/weight at maternally toxic doses. There are no controlled data in human pregnancy. Based on observed outcomes in more than 800 patients given the low dose regimen, placental transfer was observed in humans.

In male animal models, evidence of chromosomal aberrations in spermatocytes and abnormal sperm were revealed. There are no data regarding changes

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

Trifluoperazine Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments: The effects in the nursing infant are unknown.

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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