It is not known if Aripiprazole Orally Disintegrating Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aripiprazole Orally Disintegrating Tablets while you are pregnant. Using Aripiprazole Orally Disintegrating Tablets during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if Aripiprazole Orally Disintegrating Tablets are found in breast milk. Do not breast-feed while taking Aripiprazole Orally Disintegrating Tablets.
Aripiprazole Pregnancy Warnings
According to 1 case report, exposure to aripiprazole (10 mg/day initially then increased to 15 mg/day over 2 weeks) at week 29 of gestation until 6 days prior to delivery did not result in adverse peri- or post- natal effects.
Aripiprazole has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of developmental toxicity, including possible teratogenic effects. There are no controlled data in human pregnancy. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Aripiprazole should only be given during pregnancy if the potential benefits outweigh the potential risks.
Aripiprazole Breastfeeding Warnings
There are no data on the excretion of aripiprazole into human milk. The manufacturer recommends that women receiving aripiprazole should not breast-feed.