Risperidone Pregnancy and Breastfeeding Warnings

Risperidone is also known as: Risperdal, Risperdal Consta, Risperdal M-Tab

Risperidone Pregnancy Warnings

Hyperprolactinemia caused by risperidone may impair reproductive function in both male and female patients. Hyperprolactinemia causes a reduction in the pituitary secretion of gonadotropin which, in turn, impairs gonadal steroidogenesis.

Risperidone has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryolethality (possibly due to maternal toxicity) but have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in human neonates following in utero exposure to antipsychotics in the third trimester. Risperidone is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Risperidone Breastfeeding Warnings

Risperidone and its active 9-hydroxymetabolite are excreted into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Additionally, women should not breast-feed during treatment with risperidone long-acting injection and for at least 12 weeks after the last injection.

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