Category C—No reports describing the use of paliperidone in human pregnancy have been located. Developmental toxicity, in the absence of maternal toxicity, was not observed in two animal species. Risperidone was carcinogenic in rodents, but the relationship of this effect to humans has not been studied. Although there are no human pregnancy data with paliperidone, there are limited data for risperidone. However, the absence of specific information for paliperidone prevents a better assessment of the embryo-fetal risk. Nevertheless, if the mother's disease requires the use of paliperidone, the benefits to her probably outweigh any fetal risk.
No reports describing the use of paliperidone during breastfeeding have been located.
All atypicals may increase mortality in elderly patients by 1.7 times greater than placebo.
Max recommended dose 3 mg/day in moderate or severe renal impairment (CrCl < 50 mL/ min). Dose reduction (max 6 mg/day) is recommended with mild renal impairment (CrCl ≥50 mL/ min to <80 mL/ min)
No dose adjustment is required in patients with mild or moderate hepatic impairment.