Animal studies have revealed evidence of developmental toxicity, including possible teratogenic effects at doses similar to therapeutic doses in humans. There are no controlled data in human pregnancy.

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 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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

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

Comments: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and /or withdrawal symptoms following delivery.

See references

Breastfeeding is not recommended during use of this drug.

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

The effects in the nursing infant are unknown.

See references