{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "lurasidone",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Recommended starting dose is 20 mg per day.",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      },
      {
        "text": "Maximum recommended dose is 80 mg per day ( 2.6 , 7.1 ) Concomitant Use of a Moderate CYP3A4 Inducer: It may be necessary to increase the dose of lurasidone hydrochloride ( 2.6 , 7.1 ) 2.1 Schizophrenia Adults The recommended starting dose of lurasidone hydrochloride is 40 mg once daily.",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      },
      {
        "text": "Lurasidone hydrochloride has been shown to be effective in a dose range of 40 mg per day to 160 mg per day [see Clinical Studies ( 14.1 )] .",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Schizophrenia The safety and effectiveness of lurasidone hydrochloride 40-mg/day and 80-mg/day for the treatment of schizophrenia in adolescents (13 to 17 years) was established in a 6-week, placebo-controlled clinical study in 326 adolescent patients [see Dosage and Administration ( 2.1 ), Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.1 )].",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      },
      {
        "text": "Bipolar Depression The safety and effectiveness of lurasidone hydrochloride 20 to 80 mg/day for the treatment of bipolar depression in pediatric patients (10 to 17 years) was established in a 6-week, placebo-controlled clinical study in 347 pediatric patients [see Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1 ), and Clinical Studies ( 14.2 )].",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      },
      {
        "text": "Efficacy was not demonstrated in a 6-week study evaluating lurasidone hydrochloride 20 mg/day and 60 mg/day for the treatment of pediatric patients 6 to 17 years of age with irritability associated with autistic disorder diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria.",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Therefore, the physician who elects to use lurasidone hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.1 and 2.2) ] . 2.4 Dose Modifications for Renal Impairment Dose adjustment is recommended in moderate (creatinine clearance: 30 to <50 mL/min) and severe renal impairment (creatinine clearance <30 mL/min) patients.",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      },
      {
        "text": "Lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning , Warnings and Precautions ( 5.1 , 5.3 )] . 8.6 Renal Impairment Reduce the maximum recommended dosage in patients with moderate or severe renal impairment (CLcr <50 mL/minute).",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Moderate and Severe Hepatic Impairment: Recommended starting dose is 20 mg per day.",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      },
      {
        "text": "The maximum recommended dose is 80 mg per day in moderate hepatic impairment and 40 mg per day in severe hepatic impairment ( 2.5 , 8.6 ).",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      },
      {
        "text": "The dose in these patients should not exceed 80 mg per day [see Use in Specific Populations ( 8.6 )] . 2.5 Dose Modifications for Hepatic Impairment Dose adjustment is recommended in moderate (Child-Pugh Score = 7 to 9) and severe hepatic impairment (Child-Pugh Score = 10 to 15) patients.",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride during pregnancy.",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      },
      {
        "text": "For more information, contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ .",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      },
      {
        "text": "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 lurasidone (lurasidone hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary Lactation studies have not been conducted to assess the presence of lurasidone in human milk, the effects on the breastfed infant, or the effects on milk production.",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      },
      {
        "text": "The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for lurasidone hydrochloride and any potential adverse effects on the breastfed infant from lurasidone hydrochloride or from the underlying maternal condition.",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      },
      {
        "text": "Pregnant rats were treated with oral lurasidone at doses of 0.4, 2, and 10 mg/kg/day during the periods of organogenesis and lactation.",
        "source": "US FDA label for lurasidone (lurasidone hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/lurasidone.json",
        "verbatim": true
      }
    ]
  }
}