Loxapine Pregnancy and Breastfeeding Warnings

Brand names: Adasuve, Loxitane, Loxitane C, Loxitane IM

Medically reviewed by Drugs.com. Last updated on Jul 25, 2025.

Loxapine Pregnancy Warnings

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

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.

Comment: Exposed neonates should be monitored for the signs/symptoms of extrapyramidal syndrome and/or withdrawal.

Animal studies have revealed evidence of embryotoxicity and teratogenicity. There are no controlled data in human pregnancy.

Agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in exposed neonates have been reported. These complications have varied in severity up to the requirement of intensive care unit support and prolonged hospitalization.

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

Loxapine Breastfeeding Warnings

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:
-Some experts recommend that patients avoid breastfeeding for 48 hours and discard any milk produced during this interval.
-An alternate drug may be preferred, especially when breastfeeding a newborn or premature infant.

This drug is present in the milk of lactating dogs. There is no information available on the use of this drug during breastfeeding.

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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