Eperon Use In Pregnancy & Lactation

Pregnancy: There are no adequate data from the use of risperidone in pregnant women. Neonates exposed to antipsychotics (including risperidone) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Consequently, newborns should be monitored carefully. Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see Pharmacology: Toxicology: Preclinical safety data under Actions).
The potential risk for humans is unknown.
Therefore, Eperon should not be used during pregnancy unless clearly necessary. If discontinuation during pregnancy is necessary, it should not be done abruptly.
Lactation: In animal studies, risperidone and 9-hydroxyrisperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxyrisperidone are also excreted in human breast milk in small quantities. Therefore, women receiving Eperon should not breast-feed.