{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "olanzapine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 2.5 , 2.6 ) Safety of co-administration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in adults.",
        "source": "US FDA label for olanzapine (Olanzapine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": true
      },
      {
        "text": "( 2.5 ) 2.1 Schizophrenia Adults Dose Selection — Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 mg to 10 mg initially, with a target dose of 10 mg/day within several days.",
        "source": "US FDA label for olanzapine (Olanzapine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": true
      },
      {
        "text": "When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.",
        "source": "US FDA label for olanzapine (Olanzapine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of oral olanzapine in the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder were established in short-term studies in adolescents (ages 13 to 17 years). Use of olanzapine in adolescents is supported by evidence from adequate and well-controlled studies of olanzapine in which 268 adolescents received olanzapine in a range of 2.5 mg/day to 20 mg/day [see Clinical Studies ( 14.1 , 14.2 )] .",
        "source": "US FDA label for olanzapine (Olanzapine), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": true
      },
      {
        "text": "Use of olanzapine in adolescents is supported by evidence from adequate and well-controlled studies of olanzapine in which 268 adolescents received olanzapine in a range of 2.5 mg/day to 20 mg/day [see Clinical Studies ( 14.1 , 14.2 )] .",
        "source": "US FDA label for olanzapine (Olanzapine), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": true
      },
      {
        "text": "( 2.5 , 2.6 ) Safety of co-administration of doses above 12 mg olanzapine with 50 mg fluoxetine has not been evaluated in children and adolescents ages 10 to 17.",
        "source": "US FDA label for olanzapine (Olanzapine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for olanzapine (Olanzapine), retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "Olanzapine monotherapy is not indicated for treatment of treatment resistant depression (major depressive disorder in patients who do not respond to 2 antidepressants of adequate dose and duration in the current episode).",
        "source": "US FDA label for olanzapine (Olanzapine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including Olanzapine Tablets, during pregnancy.",
        "source": "US FDA label for olanzapine (Olanzapine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": true
      },
      {
        "text": "Healthcare providers are encouraged to register patients by contacting 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 olanzapine (Olanzapine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": true
      },
      {
        "text": "Risk Summary Neonates exposed to antipsychotic drugs, including olanzapine, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations) .",
        "source": "US FDA label for olanzapine (Olanzapine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Infertility Females Based on the pharmacologic action of olanzapine (D 2 receptor antagonism), treatment with olanzapine 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 ( 5.15 )] .",
        "source": "US FDA label for olanzapine (Olanzapine), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": true
      },
      {
        "text": "In an oral rabbit teratology study, fetal toxicity manifested as increased resorptions and decreased fetal weight, occurred at a maternally toxic dose of 30 mg/kg/day (30 times the daily oral MRHD based on mg/m 2 body surface area). 8.2 Lactation Risk Summary Olanzapine is present in human milk.",
        "source": "US FDA label for olanzapine (Olanzapine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": true
      },
      {
        "text": "There are reports of excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed to olanzapine through breast milk (see Clinical Considerations) .",
        "source": "US FDA label for olanzapine (Olanzapine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/olanzapine.json",
        "verbatim": true
      }
    ]
  }
}