Risperidone

DRUG INFORMATION

  ADULT
    - May increase to dosages above 1.5 mg twice daily at intervals of at least one
      week.
      Source: US FDA label for risperidone (RISPERIDONE), section 'dosage and
      administration', retrieved 2026-08-29
    - May increase the dose at intervals of 24 hours or greater, in increments of 1 to 2
      mg per day, as tolerated, to a recommended dose of 4 to 8 mg per day.
      Source: US FDA label for risperidone (RISPERIDONE), section 'dosage and
      administration', retrieved 2026-08-29
    - Efficacy has been demonstrated in a range of 4 mg to 16 mg per day .
      Source: US FDA label for risperidone (RISPERIDONE), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Approved Pediatric Indications Schizophrenia The efficacy and safety of
      risperidone tablets in the treatment of schizophrenia were demonstrated in 417
      adolescents, aged 13 – 17 years, in two short-term (6 and 8 weeks, respectively)
      double-blind controlled trials [see Indications and Usage (1.1) , Adverse
      Reactions (6.1) , and Clinical Studies (14.1) ] .
      Source: US FDA label for risperidone (RISPERIDONE), section 'pediatric use',
      retrieved 2026-08-29
    - Juvenile Animal Studies Juvenile dogs were treated with oral risperidone from
      weeks 10 to 50 of age (equivalent to the period of childhood through adolescence
      in humans), at doses of 0.31, 1.25, or 5 mg/kg/day, which are 1.2, 3.4, and 13.5
      times the MRHD of 6 mg/day for children, based on mg/m 2 body surface area.
      Source: US FDA label for risperidone (RISPERIDONE), section 'pediatric use',
      retrieved 2026-08-29
    - Bone length and density were decreased with a no-effect dose of 0.31 mg/kg/day;
      this dose produced plasma AUC of risperidone plus its active metabolite
      paliperidone (9-hydroxy-risperidone) that were similar to those in children and
      adolescents receiving the MRHD of 6 mg/day.
      Source: US FDA label for risperidone (RISPERIDONE), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Patients experiencing persistent somnolence may benefit from a once-daily dose
      administered at bedtime or administering half the daily dose twice daily, or a
      reduction of the dose. 2.4 Dosing in Patients with Severe Renal or Hepatic
      Impairment For patients with severe renal impairment (CLcr < 30 mL/min) or hepatic
      impairment (10-15 points on Child Pugh System), the initial starting dose is 0.5
      mg twice daily.
      Source: US FDA label for risperidone (RISPERIDONE), section 'dosage and
      administration', retrieved 2026-08-29
    - Because elderly patients are more likely to have decreased renal function, care
      should be taken in dose selection, and it may be useful to monitor renal function
      [see Dosage & Administration (2.4) ] . 8.6 Renal Impairment In patients with
      moderate to severe (Clcr 59 to 15 mL/min) renal disease, clearance of the sum of
      risperidone and its active metabolite decreased by 60%, compared to young healthy
      subjects.
      Source: US FDA label for risperidone (RISPERIDONE), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Patients experiencing persistent somnolence may benefit from a once-daily dose
      administered at bedtime or administering half the daily dose twice daily, or a
      reduction of the dose. 2.4 Dosing in Patients with Severe Renal or Hepatic
      Impairment For patients with severe renal impairment (CLcr < 30 mL/min) or hepatic
      impairment (10-15 points on Child Pugh System), the initial starting dose is 0.5
      mg twice daily.
      Source: US FDA label for risperidone (RISPERIDONE), section 'dosage and
      administration', retrieved 2026-08-29
    - Risperidone tablets doses should be reduced in patients with renal disease [see
      Dosage and Administration (2.4) ] . 8.7 Hepatic Impairment While the
      pharmacokinetics of risperidone in subjects with liver disease were comparable to
      those in young healthy subjects, the mean free fraction of risperidone in plasma
      was increased by about 35% because of the diminished concentration of both albumin
      and α 1 -acid glycoprotein.
      Source: US FDA label for risperidone (RISPERIDONE), section 'use in specific
      populations', retrieved 2026-08-29
    - Risperidone tablets doses should be reduced in patients with liver disease [see
      Dosage and Administration (2.4) ] . 8.8 Patients with Parkinsons Disease or Lewy
      Body Dementia Patients with Parkinsons Disease or Dementia with Lewy Bodies can
      experience increased sensitivity to risperidone tablets.
      Source: US FDA label for risperidone (RISPERIDONE), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors
      pregnancy outcomes in women exposed to atypical antipsychotics, including
      risperidone, during pregnancy.
      Source: US FDA label for risperidone (RISPERIDONE), section 'pregnancy', retrieved
      2026-08-29
    - Healthcare providers are encouraged to register patients by contacting the
      National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or
      online at http://womensmentalhealth.org/clinical-and-research-
      programs/pregnancyregistry/ .
      Source: US FDA label for risperidone (RISPERIDONE), section 'pregnancy', retrieved
      2026-08-29
    - Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of
      pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following
      delivery (see Clinical Considerations) .
      Source: US FDA label for risperidone (RISPERIDONE), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Infertility Females Based on the pharmacologic action of risperidone (D2 receptor
      antagonism), treatment with risperidone may result in an increase in serum
      prolactin levels , which may lead to a reversible reduction in fertility in
      females of reproductive potential [see Warnings and Precautions ( 5.6 )].
      Source: US FDA label for risperidone (RISPERIDONE), section 'nursing mothers',
      retrieved 2026-08-29
    - Rat offspring mortality increased during the first 4 days of lactation when
      pregnant rats were dosed throughout gestation at 0.16 to 5 mg/kg/day which are 0.1
      to 3 times the MRHD of 16 mg/day based on mg/m 2 body surface area.
      Source: US FDA label for risperidone (RISPERIDONE), section 'use in specific
      populations', retrieved 2026-08-29
    - Risperidone also appeared to impair maternal behavior in that offspring body
      weight gain and survival (from Day 1 to 4 of lactation) were reduced in offspring
      born to control but reared by drug-treated dams.
      Source: US FDA label for risperidone (RISPERIDONE), section 'use in specific
      populations', retrieved 2026-08-29